Timothy Stenzel, MD, PhD and Toby Lowe 

Center for Devices and Radiological Health

February 10, 2021
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Federal funding opportunity: Solicitation for Area of Interest (AoI)

AoI-0003 FA811921SC001: 

SUPPLY CHAIN COVID-19 DIAGNOSTIC TESTING

Funding: Coordinated between HHS/OASH and 

DoD to meet HHS COVID-19 response priorities

AoI Open Period: Closes 4:00PM CST March 7, 

2021

AoI Link: 

https://beta.sam.gov/opp/477a27c88b634668bee5a

a33532bee62/view

Click blue “View Changes” button, scroll to 

Attachments/Links for document dated Feb 05, 2021

Any questions: 

supplychain.cso.dafact@afwerx.af.mil

Capacity expansion investment funding for vendors that have 

developed or are developing products relevant to COVID-19 

diagnostic tests 

Supply chain materials and equipment in scope (see AoI for all)

– Sample collection and testing consumables

– Raw materials, components, processes supporting diagnostics 

tests, kits/cartridges and related instruments

– Equipment to expand manufacturing capacity and/or increase test 

throughput

– Manufacturing and equipment related to temperature sensitive 

diagnostic testing, including their distribution and storage

Some Limitations

– Does not include distributors

– Manufacturing expansion limited to domestic or within US 

territories, although manufacturers may be foreign-owned

See AoI for solution brief contents

– Product description, diagnostic activity supported, technology 

– Ability to ramp up production, other operational and commercial 

considerations

– Total proposal cost/price (requested investment, per item price 

quotes)
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Resources for COVID-19 Test Development and Validation

• To sign up to receive emails on this CDRH topic, please subscribe to the In Vitro Diagnostics Mailing List: https://www.fda.gov/about-fda/centerdevices-and-radiological-health/subscribe-cdrh-mailing-lists

• Questions about COVID-19 IVD EUAs: CDRH-EUA-Templates@fda.hhs.gov

• Questions about laboratory data harmonization for COVID-19 testing: SHIELD-LabCodes@fda.hhs.gov

• In Vitro Diagnostics EUAs webpage: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizationsmedical-devices/vitro-diagnostics-euas

• FAQs on COVID-19 Testing: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

• Serology Testing Performance: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-testperformance

• Independent Evaluations of COVID-19 Serological Tests https://open.fda.gov/apis/device/covid19serology/

• January 2021 HHS FAQ: COVID-19 Diagnostic Data Standards & Core Data Elements for Test Reporting:

• https://www.hhs.gov/sites/default/files/hhs-diagnostic-data-faqs.pdf

• HHS COVID-19 Testing and Diagnostics Working Group (TDWG): Additional Testing Information:

• https://www.hhs.gov/coronavirus/testing/testing-diagnostics-working-group/index.html

Publications:

• https://www.nejm.org/doi/full/10.1056/NEJMp2023830?query=featured_home

• https://thehill.com/opinion/healthcare/515628-fda-were-constantly-working-on-covid-testing-options

Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Subheading: In Vitro Diagnostics

Please complete a short survey about your FDA CDRH webinar experience. The survey can be found at: 

www.fda.gov/cdrhwebinar

immediately following the conclusion of the live webinar