2 SBIR CARE application

OMB No.: 0925-0766
Expiration Date: 04/30/2023
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NCI SBIR Development Center Program with FDA
CARE – Connecting Awardees with Regulatory Experts
Application Form for NCI Small Businesses
Thank you for your interest in the CARE Program. Please complete one application form per applicable project. To be eligible to
participate, your small business:
Received a Phase I or II SBIR/STTR award from the National Cancer Institute (NCI) in fiscal year 2020 or later
Has a technology that falls under the regulatory authority of the U.S. Food and Drug Administration (FDA)
Has not met/discussed this product with FDA or participated in the CARE Program previously for this product
Has visited this website to answer basic regulatory questions https://sbir.cancer.gov/resources/fdaresources
Agrees to provide feedback in a brief survey at the end of the program
Acknowledges this application will be shared with NCI and FDA

I have reviewed the eligibility requirements listed above and meet all the criteria.
Please note the text space limits within the application fields. All forms must be submitted by
March 11, 2023. Email completed application form to [email protected].

Award Information
NCI SBIR Award Number for this product/technology:
NCI SBIR Program Director:
Company Information
Company name:
Contact person for this application:
Title/Role:
Email:
Phone:
Indicate the technology area(s) that describe the SBIR/STTR-funded technology (select all that apply):
Surgical or ablative device
Imaging agent
Small molecule
Hospital
device
Imaging device
Biologics/vaccine
Drug delivery device
Bioinformatics/health IT/digital health
Cell/gene therapy
In vitro diagnostic
Indicate the development stage of the SBIR/STTR-funded technology:
Early stage (in vitro or untested prototype)
Ready to commercialize
Ongoing (in vivo testing or refining an early design)
Commercial product
Testing in a clinical setting
Technology name (please provide a short, ten words or fewer, description of your technology):

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What is the unmet medical need that your technology addresses? How does your technology solve the
problem? Limit your response to 500 characters maximum, including spaces.

Does your potential technology fall under FDA’s regulatory authority?
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Unsure
Has your company met with FDA previously to discuss the regulatory strategy for this technology?
Yes
No
Unsure
If yes, please provide approximate date and type of meeting.

Has your company attended any educational workshops, webinars, or other events hosted by FDA in
the past 2 years?
Yes
No
Unsure
If yes, please list the name(s) and approximate date(s).

Does your company currently have access to a regulatory consultant?
Yes
No
Unsure
If yes, have you discussed your questions on page 4 with the consultant?

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Are you familiar with any of FDA’s industry education websites (i.e., CBER/CDER/CDRH Learn)?
Yes
No
Unsure
Are you familiar with CBER’s Manufacturers Assistance and Technical Training Branch
(Manufacturers Assistance and Technical Training Branch (MATTB) | FDA)?
Yes
No
Unsure
Not applicable to my technology
Are you familiar with CDER’s Oncology Regulatory Expertise and Early Guidance Initiative
(https://www.fda.gov/about-fda/oncology-center-excellence/oncology-regulatory-expertise-and-earlyguidance-oreeg)?
Yes
No
Unsure
Not applicable to my technology
Are you familiar with CDRH’s Early Payor Feedback Program (https://www.fda.gov/about-fda/cdrhinnovation/payor-communication-task-force/#2)?
Yes
No
Unsure
Not applicable to my technology
Are you familiar with CDRH’s Regulatory Science Tools Catalog to help assess new medical devices
(https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatoryscience-tools-help-assess-new-medical-devices)?
Yes
No
Unsure
Not applicable to my technology

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PLEASE USE THIS WEBSITE TO FIND BASIC INFORMATION BEFORE YOU SUBMIT
YOUR QUESTIONS TO THE FDA: https://sbir.cancer.gov/resources/fdaresources
Please state up to five regulatory questions you have for FDA. Please number each
question separately (i.e., do not include multi-part questions).

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4.

5.

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Please include relevant background information for each question on the previous page.
This will allow FDA to provide a more informed response to your questions.
The CARE Program is intended to provide small businesses with product type information
from FDA. This program does not replace any formal or informal meetings encouraged or
required by FDA. Information provided as part of this program will not be used by FDA
for any preliminary or future decision-making regarding the technology.

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2.

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5.

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