Requirements Document FDA-CDER-25-130459.pdf
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- Solicitation number
- FDA-CDER-25-130459
About this file
This Statement of Work (SOW) is for the purchase of liquid nitrogen and carbon dioxide for research laboratories at the Division of Applied Regulatory Science (DARS) within the FDA's Center for Drug Evaluation and Research (CDER). The contract (CDER-OTS-25-C-1766) requires delivery of 3 liquid nitrogen vessels (160L and 240L) with digital gauges every 2 weeks, 5 carbon dioxide cylinders every 3 months, and includes a guaranteed 1-hour delivery window. The performance period is 12 months from the award date, with deliveries to the FDA facility at 10903 New Hampshire Ave. The gases are critical for supporting scientific research across disciplines including immunology, bioanalytics, proteomics, pharmacokinetics, and other areas essential to drug application reviews and emerging public health issues.
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| File | Type | Posted |
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| Solicitation NOI- SS FDA-CDER-25-130459.pdf |
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Statement of Work (SOW)
CDER-OTS-25-C-1766: Purchase of liquid nitrogen and carbon dioxide for use in research laboratories
Background:
The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER operates 6 total labs that provides mission-critical research supporting review questions, translational science, and emerging public health issues for CDER and FDA. We develop and evaluate novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products. These operational supplies are essential for the continuance of projects supporting BsUFA, GDUFA, PDUFA and Opioid research, and for continued preparedness to be able to respond to emergent public health issues when called upon.
DARS is completing a wide range of projects to answer scientific questions associated with the review of drug applications. Projects are from disciplines including immunology/toxicology, bioanalytics, proteomics/genomics, microphysiological systems, pharmacokinetics/pharmacodynamics, and electrophysiology. The liquid nitrogen supply is needed for the operation of liquid nitrogen dewars storing valuable biological samples.
Carbon dioxide is needed to maintain critical equipment operation, i.e., cell culture incubators.
Requirements:
Liquid nitrogen and carbon dioxide should be delivered at the quantities and schedules outlined in the table below:
Item # Description Unit Quantity Item Price
Total Price Deliveries/ Usage
Yearly cost
RLN160DG
LIQUID NITROGEN VL 160
LITERS, 22 PSIG, W/
DIGITAL GAUGE
Each 3 every 2 weeks
RLN240DG
LIQUID NITROGEN 240
LITERS RB 22 PSIG, W/
DIGITAL GAUGE
Each 1 every 2 weeks
GD01
GUARANTEED DELIVERY
TIME (1HOUR WINDOW)
Each 1 every 2 weeks
Shipping Shipping Each 1 every 2 weeks
Rental Fee Estimated Monthly Rental Charges
Each 1 monthly
R23
CARBON DIOXIDE, EXTRA
DRY 50LB
Each 5 every 3 months
Total
Period of Performance: 12 months from the date of award
Deliverables:
Gases must be delivered according to the established schedule and within the agreed-upon delivery window (within one hour of the scheduled time). The contractor shall also retrieve empty cylinders promptly during each delivery to minimize rental fees and ensure efficient inventory turnover.
CDER/OTS/OCP/DARS
US. Food and Drug Administration 10903 New Hampshire Ave, WO64 Rm 2068
Attn: Ksenia Blinova Ksenia.Blinova@fda.hhs.gov
Freight should be delivered to WO Bldg 62 Loading Dock, and then to WO64-2014
Points of Contact:
Project Officer
Ksenia Blinova
CDER/OTS/OCP/DARS
US. Food and Drug Administration 10903 New Hampshire Ave, WO64 Rm 2010 Email: Ksenia.Blinova@fda.hhs.gov
Deliveries contact:
Sharron Stewart
CDER/OTS/OCP/DARS
US. Food and Drug Administration 10903 New Hampshire Ave, WO64 Rm 2030 Email: Sharron.Stewart@fda.hhs.gov
COR
Robert J. Parker (Lead Pharmacologist)
CDER/OTS/OCP/DARS
US. Food and Drug Administration 10903 New Hampshire Ave, WO64 Rm 2018 Email: robertj.parker@fda.hhs.gov mailto:Ksenia.Blinova@fda.hhs.gov mailto:Ksenia.Blinova@fda.hhs.gov mailto:Sharron.Stewart@fda.hhs.gov
INSPECTION AND ACCEPTANCE CRITERIA
The Government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. The contractor shall submit the reporting Requirements/Deliverables to the COR in accordance with the delivery schedule.
The COR will perform inspection and acceptance of materials.
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