Project Information

Bid Title

NIAID CLINICAL PRODUCTS CENTER (CPC)

Issuing Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Location

N/A

Published Date

Oct 18, 2024

Closing Date

Jan 17, 2025

Government Level

Federal

Status

Closed

Ref. #

RFP-NIAID-75N93024R00018

Original Source

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Bid Inquiries

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Bid Documents

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Set Aside

Total Small Business Set-Aside (FAR 19.5)

Project Description

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NIAID CLINICAL PRODUCTS CENTER (CPC)

Active

Contract Opportunity

Notice ID

RFP-NIAID-75N93024R00018

Related Notice

NIAID-75N93024R00018

Department/Ind. Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier

NATIONAL INSTITUTES OF HEALTH

Office

NATIONAL INSTITUTES OF HEALTH NIAID

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General Information

• Contract Opportunity Type: Solicitation (Original)
• Original Published Date: Oct 18, 2024 11:07 am EDT
• Original Date Offers Due: Jan 17, 2025 03:00 pm EST
• Inactive Policy: 15 days after date offers due
• Original Inactive Date: Feb 01, 2025
• Initiative:
  • None

Classification

• Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
• Product Service Code: AN12 - HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH
• NAICS Code:
  • 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
• Place of Performance:
  N/A
  AX1

Description

The purpose of this contract is to provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis, to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., IP management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation); placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring); 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocols and testing, and labeling and packaging; 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies; and 4) Clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc.

Attachments/Links

Contact Information

Contracting Office Address

• 5601 FISHERS LANE, SUITE 3D11
• BETHESDA , MD 20892
• USA

Primary Point of Contact

• Deborah Blyveis
• blyveisd@niaid.nih.gov
• Phone Number 2406695143

Secondary Point of Contact

• Emily Bannister
• emily.bannister@nih.gov

History

• Oct 18, 2024 11:07 am EDTSolicitation (Original)
• Oct 02, 2024 03:55 pm EDT Presolicitation (Original)

Commodity Codes

• FSC AResearch and development

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

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