# NIAID CLINICAL PRODUCTS CENTER (CPC)

Canonical: https://abierto.us/opportunities/rfpniaid75n93024r00018

- Solicitation number: RFP-NIAID-75N93024R00018
- Notice type: Solicitation
- Status: Closed. Deadline was January 17, 2025 at 3:00 PM EST
- Department: Department of Health and Human Services
- Agency: National Institutes of Health
- Contracting office: National Institutes of Health Niaid (75N930)
- NAICS: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Product or service code: AN12 Health R&D Services; Health Care Services; Applied Research
- Set-aside: Total small business set-aside
- Place of performance: N/A, AX1
- First posted: October 18, 2024
- Last posted: October 18, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/c418c9f44b534339939d87e2d6098a32/view

## 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.

## Publications

- October 18, 2024: Solicitation, due January 17, 2025 at 3:00 PM EST. Notice c418c9f44b534339939d87e2d6098a32. https://sam.gov/workspace/contract/opp/c418c9f44b534339939d87e2d6098a32/view

## Points of contact

- Deborah Blyveis, blyveisd@niaid.nih.gov, 2406695143
- Emily Bannister, emily.bannister@nih.gov

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/rfpniaid75n93024r00018.