Pre-Clinical Consulting Services
ID: 75N95025Q00127_SBType: 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)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/e9a3901b0f5246868df00f8cdc5bfa5a/view
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 small businesses to provide Pre-Clinical Consulting Services. The objective of this procurement is to gather information on the capabilities of potential contractors to support the Clinical Trials Unit (CTU) at the National Institute of Neurological Disorders and Stroke (NINDS), which oversees numerous clinical research programs and requires expertise in IND and IDE preparations. This initiative is crucial for enhancing clinical trial methodologies and improving research outcomes through strategic partnerships and expert guidance. Interested vendors must submit their capability statements electronically by January 17, 2025, to Frederick Weddington at frederick.weddington@nih.gov, ensuring compliance with specified formatting guidelines and confidentiality requirements.

Point(s) of Contact
Frederick Weddington
(301) 594-6835
frederick.weddington@nih.gov
Files
Title
Posted
B. Sources Sought Notice - (SB).pdf
Jan 15, 2025, 4:05 PM UTC
The file is a Sources Sought Notice (Solicitation Number: 75N95025Q00127_SB) issued by the federal government for Pre-Clinical Consulting Services. The notice seeks information on the availability and capabilities of small business sources, including those that are HUBZone, service-disabled, veteran-owned, woman-owned, and small disadvantaged businesses. The primary goal is to assess potential contractors' qualifications and domestic sourcing capabilities related to clinical research and gene therapy. Interested companies are required to submit detailed capability statements addressing each project requirement, including employee count and qualifications, along with their business type and NAICS code compliance. Responses can help determine acquisition methods, including possible set-asides for small businesses. The notice explicitly states it is for information gathering only and does not commit the government to any contract or payment, nor will responses be regarded as proposals. Responses must be submitted electronically by January 17, 2025, and must adhere to specified formatting guidelines. The notice also emphasizes the need for confidentiality regarding proprietary information. This Sources Sought Notice underscores the government's intention to identify qualified vendors for pre-clinical consulting services, promoting opportunities for small businesses in relevant sectors.
Statement of Work.pdf
Jan 15, 2025, 4:05 PM UTC
The National Institutes of Health (NIH), through its National Institute of Neurological Disorders and Stroke (NINDS), is seeking consultancy services to support its Clinical Trials Unit (CTU). The CTU plays a pivotal role in overseeing over 120 clinical research programs, ensuring adherence to quality practices from protocol development through to data analysis. The need for external expertise arises due to the complexities involved in IND (Investigational New Drug) and IDE (Investigational Device Exemption) preparations, necessitating input from multiple stakeholders including the pharmaceutical industry, academia, and patient advocacy groups. Services will be provided virtually from the NINDS campus in Bethesda, MD, facilitating seamless collaboration using NINDS IT resources. The designated points of contact for this service order are Dr. Lauren Reoma and Mr. Bradley Alvarez. This initiative illustrates NINDS's commitment to enhancing clinical trial methodologies and improving research outcomes through strategic partnerships and expert guidance.
Lifecycle
Title
Type
Pre-Clinical Consulting Services
Currently viewing
Sources Sought
Similar Opportunities
NULISAseq CNS Disease Panel 120 Kit or Equivalent
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information from qualified sources regarding the availability of the Alamar NULISAseq CNS Disease Panel 120 Kit or equivalent products. The objective is to procure three kits to aid in the investigation of biomarkers for neurodegenerative diseases, which are critical for early diagnosis and potential preventive measures. This procurement is essential for the NIH's Laboratory of Clinical Investigation, which focuses on isolating and measuring biomarkers from patient plasma to improve disease detection and management. Interested companies must submit their capability statements by April 11, 2025, to Eric McKay at eric.mckay@nih.gov, ensuring they include relevant details such as their business type and manufacturing information.
Return to Office Design Services
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals from qualified small businesses for Return to Office Design Services. The primary objective of this procurement is to assist the NIH's Office of Research Services in optimizing workspace efficiency, managing facilities, and implementing cost-saving measures through the repurposing of underutilized areas, while providing strategic recommendations for long-term space utilization. This contract, which is set aside for small businesses under NAICS code 561499, will cover a base year from July 1, 2025, to June 30, 2026, with options for two additional years, and emphasizes compliance with federal guidelines and sustainability goals. Interested parties should contact Isaac J. Bellamy at isaac.bellamy@nih.gov for further details and to ensure their proposals meet the necessary requirements by the submission deadline.
National Institute on Aging Animal Care Support Services
Buyer not available
The National Institute on Aging (NIA), part of the Department of Health and Human Services, is seeking qualified small businesses to provide comprehensive animal care support services for its Intramural Research Program (IRP) focused on aging and related diseases. The contractor will be responsible for a range of services including animal husbandry, veterinary support, technical research assistance, and ensuring compliance with strict animal welfare standards at the Biomedical Research Center (BRC) in Baltimore, Maryland. This opportunity is critical for maintaining the integrity of research data and the humane treatment of laboratory animals, reflecting the NIA's commitment to rigorous scientific standards. Interested parties must submit their capability statements by April 17, 2025, to Emily Palombo at emily.palombo@nih.gov and Karen Mahon at karen.mahon@nih.gov, with a focus on demonstrating their qualifications and compliance with the specified requirements.
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. The contract, identified as RFP No. 75N93025R00013, aims to enhance clinical care for adult and pediatric inpatients involved in research, requiring contractors to supply up to four postgraduate medical residents who will deliver essential medical services. Proposals must be submitted by April 14, 2025, with a total contract value ranging from $2,000 to $7,500,000 over a performance period from May 31, 2025, to May 30, 2030. Interested parties can direct inquiries to Sevag Kasparian or Maya Joseph via their respective emails for further clarification on the proposal requirements.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Partners for Clinical Research Collaborations on Therapeutics, Diagnostics or Devices for the Liver Cirrhosis Network
Buyer not available
Special Notice HEALTH AND HUMAN SERVICES, DEPARTMENT OF seeks industry partners for clinical research collaborations on therapeutics, diagnostics or devices for the Liver Cirrhosis Network. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is looking for industry collaborators to provide novel or repurposed therapeutic agents, diagnostic markers, biomarkers, devices, or services for use in NIH-sponsored multi-center clinical trials and ancillary studies in adult patients with advanced liver disease and cirrhosis. The Liver Cirrhosis Network aims to promote clinical and translational research on cirrhosis of the liver and related complications in adults. The network is interested in conducting research that will lead to improved clinical outcomes in adults with cirrhosis and advanced liver disease. Commercial organizations interested in pursuing clinical collaborations with NIDDK for cirrhosis liver disease are required to submit a Capability Statement to the NIDDK.
NOTICE OF INTENT FOR LABORATORY EQUIPMENT AND SUPPLIES
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a sole source contract to Plexon, Inc. for the procurement of laboratory equipment and supplies essential for research purposes. The contract will cover various items including headstages and cables, multi-electrode arrays, acquisition and analysis software, an overhead camera system, and optogenetics systems, all of which are critical for data acquisition and analysis in laboratory settings. Interested vendors who believe they can provide equivalent products are invited to submit a capability package to the Contract Specialist, Ms. Van Holley, by 9:00 AM ET on April 18, 2025. Responses must include company details and product specifications, and all contractors must be registered with the System for Award Management (SAM).
National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program - Fiscal Year 2026
Buyer not available
The National Cancer Institute (NCI), part of the Department of Health and Human Services, is seeking proposals from small businesses for the SBIR Innovative Concept Award Program for Fiscal Year 2026. This program aims to support the development of innovative technologies for the treatment and prevention of pediatric and rare cancers, specifically targeting therapeutic technologies and diagnostic tools. The initiative is crucial for addressing cancers with low survival rates and encourages proposals that demonstrate technical feasibility and a clear development path, including initial proof-of-concept experiments. Interested small businesses must submit their proposals by September 26, 2025, with an interim white paper submission deadline in June 2025 for feedback. For further inquiries, contact Tanya Renwick at ncioasbir@mail.nih.gov.
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.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Partners for Clinical Research Collaborations on Therapeutics, Diagnostics or Devices for Childhood Cholestatic Liver Diseases
Buyer not available
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking industry partners for clinical research collaborations focused on therapeutics, diagnostics, or devices for childhood cholestatic liver diseases. The initiative aims to engage collaborators in providing novel therapeutic agents and diagnostic tools for use in NIH-sponsored multi-center clinical trials targeting conditions such as biliary atresia and alpha-one antitrypsin deficiency, among others. This collaboration is critical for advancing research and improving clinical outcomes for children suffering from these rare liver diseases. Interested organizations must submit a Capability Statement detailing their proposed solutions and capabilities, with no funding provided by NIDDK for this opportunity. For inquiries, contact Edward Doo at dooe@niddk.nih.gov or Katrina Loh at katrina.loh@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.