Professional, Scientific, and Non-Scientific Support and Pandemic Readiness Services for FDA/CDRH
ID: 75F40125Q00003Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Administrative Management and General Management Consulting Services (541611)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Original Source

https://sam.gov/opp/a291e430bac34ca2b8692528023c823c/view
Timeline
    Description

    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking qualified vendors to provide professional, scientific, and non-scientific support services for pandemic readiness and other critical functions within the Center for Devices and Radiological Health (CDRH). The procurement aims to secure consultants with expertise in various scientific disciplines, including microbiology, toxicology, and diagnostics testing, to assist in evaluating medical devices and ensuring public health safety during emergencies. This initiative is vital for maintaining operational efficiency and regulatory compliance, particularly in response to public health crises like the COVID-19 pandemic. Interested vendors must submit their responses, including a completed Vendor Feedback Form, by October 16, 2024, at 2:00 PM EST, to the designated contacts, Melinda Kim and Nicholas Bisher, as no formal solicitation is currently available.

    Point(s) of Contact
    Melinda Kim
    Melinda.Kim@fda.hhs.gov
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    Attachment A - Draft Statement of Work (SOW) 75F40125Q00003.docx
    The Center for Devices and Radiological Health (CDRH) seeks professional, scientific, and non-scientific support to enhance its pandemic readiness and assist during public health emergencies. This Statement of Work outlines the need for consultants with expertise in various scientific disciplines, such as microbiology, toxicology, epidemiology, and diagnostics testing, to aid in the evaluation of medical devices and products within the FDA's jurisdiction. The primary objective is to ensure safe and effective health innovations while maintaining consumer confidence. Key responsibilities include project management, ad-hoc expert consultations on device submissions, and surge support during crises like the COVID-19 pandemic. Deliverables will be monitored through regular meetings and detailed reporting. The contract, likely structured as a Blanket Purchase Agreement, covers essential activities ranging from research and data analysis to developing and evaluating medical devices. The performance period spans five years, including one base year and four optional extensions. This initiative emphasizes the CDRH's commitment to public health, regulatory compliance, and operational efficiency, ensuring readiness to respond swiftly to unforeseen health-related demands.
    Attachment B - Vendor Feedback Form 75F40125Q00003.docx
    The Vendor Feedback Form is part of a Request for Proposals (RFP) issued by the FDA to assess prospective vendors' capabilities in providing various professional, scientific, and non-scientific services outlined in the Draft Statement of Work (SOW). The form requires vendors to confirm if they can deliver all requested services and whether they operate under an existing contract vehicle with the FDA. It seeks detailed responses regarding each vendor's relevant experiences, including contract specifics, performance periods, and whether they acted as a prime or sub contractor in past engagements. Key areas of service include pandemic readiness, ad-hoc expert consultations, and support roles. Vendors are also encouraged to provide feedback on the SOW and suggest applicable NAICS codes. Additional queries relate to the vendors' GSA Schedule contracts and their coverage for the anticipated performance period of five years. Overall, the document aims to streamline the evaluation of potential contractors for critical services within a government context, emphasizing compliance and relevant experience.
    Similar Opportunities
    Preventive Maintenance Agreement for a NanoSight NS300
    Active
    Health And Human Services, Department Of
    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified vendors for a Preventive Maintenance Agreement for a NanoSight NS300 and Hydro EV Accessory. The procurement aims to establish a contract that includes on-site preventive maintenance, unlimited corrective repairs, and services performed by OEM-certified engineers, adhering to Original Equipment Manufacturer specifications. This maintenance is crucial for ensuring the reliability and performance of the FDA's laboratory equipment, which plays a vital role in regulatory and research activities. Interested vendors must submit their qualifications, including business information and past performance, by October 18, 2024, to Yolanda Rankin at yolanda.rankin@fda.hhs.gov or by phone at 214-253-4954. The contract will have a base period plus three one-year option periods, starting from November 8, 2024.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is soliciting proposals for the FY25 Broad Agency Announcement (BAA) aimed at advancing research and development in regulatory science. This initiative seeks to acquire innovative research proposals that enhance the FDA's mission to protect public health by modernizing the evaluation of FDA-regulated products and improving post-market surveillance. Eligible applicants, including private organizations and academic institutions, are encouraged to submit proposals that address critical knowledge gaps and align with FDA priorities, with a submission deadline for full proposals set for February 24, 2025. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    RRPV Solicitation Summary: NextGen Oral Formulation Vaccines for COVID-19
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Office of Assistant Secretary for Preparedness and Response, is seeking proposals for the "NextGen Oral Formulation Vaccines for COVID-19" initiative under the Rapid Response Partnership Vehicle (RRPV) Consortium. The objective of this solicitation is to advance oral vaccine platforms and technologies into a proof-of-concept Phase 1 clinical trial, enhancing the understanding of their potential to provide improved solutions for COVID-19 and bolster preparedness against future health security threats. This effort is critical in the ongoing response to public health challenges, particularly in developing effective vaccination strategies. Interested parties should note that the due date for project proposals has been extended to November 1, 2024, and can contact Rebecca Harmon at rebecca.harmon@ati.org for further information.
    PRIMO Software Licensing
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide PRIMO Software Licensing and Maintenance Support Services. The procurement involves supplying 21 PRIMO software licenses for a base year, with two additional option years, to ensure the continuous operation of the FDA's CFSAN CAEMS system. This software is crucial for pharmacovigilance and regulatory compliance, enhancing the FDA's capabilities in monitoring food safety. Interested parties must submit their quotes by August 26, 2024, and are encouraged to contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov for further details. The contract will be awarded as a firm-fixed-price purchase order, emphasizing compliance with federal acquisition regulations and accessibility standards.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Center for Advancing Translational Sciences (NCATS), is seeking qualified small businesses to provide Chemistry, Manufacturing, and Controls (CMC) and related services for the development of drug products. The objective of this procurement is to support the Therapeutic Development Branch in ensuring the delivery of drug products of sufficient quality and quantity for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic candidates through the drug development pipeline. This opportunity is part of a Small Business Sources Sought notice, aimed at gathering information on the capabilities of small businesses to fulfill these requirements, with a focus on compliance with applicable regulations and the potential for a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Interested vendors must submit their capability statements by 10:00 AM Eastern Time on July 21, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov.
    NIAID PROFESSIONAL, SCIENTIFIC AND TECHNICAL SUPPORT SERVICES (PSTSS)
    Active
    Health And Human Services, Department Of
    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 issuing a presolicitation notice for professional, scientific, and technical support services under RFP number 75N93023R00010. This procurement aims to secure a re-competition of existing contracts to support NIAID's mission in research, vaccine development, and management of infectious diseases, with key tasks including laboratory support, clinical trials, and consultancy in various scientific specialties. The anticipated contract duration is five years, commencing on June 1, 2025, with proposals expected to be submitted electronically after the RFP release around October 24, 2024. Interested vendors should contact Rosemary Gomes at Rosemary.Gomes@nih.gov or Kristel Turansky at Kristel.Turansky@nih.gov for further information.
    Pegfilgrastim with VMI
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS) is seeking proposals for the procurement of Pegfilgrastim 6MG/.06ML injection solutions and Vendor Managed Inventory (VMI) services under Solicitation No. 75A50324R00004. The primary objective is to ensure the availability of this critical medication, which is essential for treating acute radiation syndrome and supporting public health emergencies, through a five-year contract that includes a base year and four optional ordering periods. Interested contractors must adhere to strict compliance with FDA regulations, manage inventory effectively, and ensure rapid deployment capabilities during emergencies. Proposals are due by October 2, 2024, and inquiries can be directed to LaMonica Norwood at OSContracting@hhs.gov.
    Q301--Base Yr. Plus 4 Option Yrs. HPV Testing RFI
    Active
    Veterans Affairs, Department Of
    The Department of Veterans Affairs (VA) is seeking qualified vendors to provide HPV testing supplies and services for the Washington DC VA Medical Center through a Request for Information (RFI). The procurement aims to gather information on potential sources capable of supplying Aptima HPV test kits and associated services, including training, preventive maintenance, and equipment repair, over a base period of one year starting December 1, 2024, with four optional one-year extensions. This initiative is critical for enhancing the laboratory's capabilities in HPV holistic testing, which plays a vital role in patient care and disease prevention. Interested vendors must submit their responses, including pricing and capabilities, by October 14, 2024, to Contract Specialist Michael Jones at michael.jones16@va.gov.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    Active
    Health And Human Services, Department Of
    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 proposals for the NIAID Clinical Products Center (CPC) contract, aimed at supporting clinical trials focused on immunologic, infectious, and allergic diseases. The contract will provide essential pharmacy and pharmaceutical oversight for national and international clinical trials, ensuring product integrity, participant safety, and compliance with regulatory standards, while also expanding support for additional NIH-funded trials and emergency public health programs as needed. This initiative is critical for advancing research in various immune-mediated diseases, including asthma, autoimmune disorders, and organ transplant rejection. Interested parties should prepare to submit proposals electronically via the NIAID electronic Contract Proposal Submission (eCPS) website, with the presolicitation notice expected to be published on or around October 18, 2024. For further inquiries, contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov.
    NIOSH IT Services
    Active
    Health And Human Services, Department Of
    The Centers for Disease Control and Prevention (CDC) is seeking qualified vendors to provide Information Technology (IT) support services for the National Institute for Occupational Safety and Health (NIOSH) Office of the Director for Information Technology (ODIT). The contract will focus on enhancing IT infrastructure, supporting scientific applications, and facilitating data sharing among interdisciplinary teams, with a contract period from August 1, 2025, to July 31, 2030. This initiative is vital for advancing NIOSH’s mission and operational needs, including system maintenance, cloud infrastructure management, data security, and agile project management. Interested parties must submit their capability statements by October 9, 2024, to Joseph Butkus at jbutkus@cdc.gov, as the government plans to issue a Request for Proposal (RFP) in early January 2025.