Form 1 2023 CARE Feedback survey

OMB No.: 0925-0648
Expiration Date: 06/30/2024
The Public Health Service Act, Section 411 (42 USC 285a) allows the collection this information. The rights of participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing at any time. Refusal to participate will not affect
your benefits in any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report. Information provided will be combined for all participants and reported as summaries. You are being contacted by email to complete this
form so that NCI can improve the progam.
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2023 NIH Small Business Program with FDA
CARE – Connecting Awardees with Regulatory Experts
* 1. Company Information
Company Name
Contact Person
Title/Role
Email

* 2. Please indicate the extent to which you agree with the following. Participation in the
CARE Program helped our team…
Strongly Agree
Learn and/or confirm the FDA Center
(CBER, CDER, CDRH) or Office that will
regulate our technology
Begin developing the regulatory strategy
for our technology
Plan the next regulatory step(s) for our
technology
Clarify and/or confirm the appropriate
regulatory path for our technology
Gain a better understanding of the process
to contact FDA for a meeting request
Find information on FDA’s website related
to a particular regulatory topic
Understand how to contact an FDA office
that provides free resource assistance to
industry (i.e., MATTB, SBIA, or DICE)

Agree

Disagree

Strongly
Disagree

* 3. Please indicate the extent to which you agree with the following. Following the CARE
Program, our team plans to…

Strongly Agree

Agree

Disagree

Strongly
Disagree

Contact an FDA office via phone or email that
provides free resource assistance to industry (i.e.,
MATTB, SBIA, or DICE)
Watch an FDA webinar(s) on a particular
regulatory topic
Read an FDA guidance(s) on a particular
regulatory topic
Access an FDA website to learn more on a
particular regulatory topic
Submit a meeting request to FDA to discuss
regulatory strategy (e.g., INTERACT meeting,
pre-IND meeting, pre-submission meeting, etc.)
Hire a regulatory consultant or other personnel to
help with the team's regulatory strategy
Schedule a free regulatory consultation with an
NIH Regulatory Specialist
https://seed.nih.gov/support-for-smallbusinesses/commercialization-enhancementprograms/entrepreneurialdevelopment#innovator-consultations
or
https://www.nhlbi.nih.gov/about/divisions/divisionextramural-research-activities/office-translationalalliances-and-coordination

* 4. Please indicate the extent to which you agree with the following. Our team…

Strongly Agree

Agree

Disagree

Found the CARE Program useful
Found the NCI SBIR FDA resources website
useful https://sbir.cancer.gov/resources/fdaresources
Received information from the CARE
Program that will affect our future
SBIR/STTR specific aims
Would recommend the CARE Program to
other companies

5. We welcome any additional feedback or comments you wish to provide.

Strongly
Disagree