OMB Memo: Post-Event Survey for a Continuing Education (CE) Webinar on Pregnancy and Lactation Medication Information for the He

United States Food and Drug Administration
Generic Clearance: Customer Satisfaction Surveys
OMB Control Number 0910-0360
Gen IC Request for Approval
The generic clearance will only be used for customer satisfaction and website usability surveys where FDA seeks to
gather information that is planned for internal use only and can provide a justification for qualitative or anecdotal
collections that may nonetheless produce useful information for program and service improvement.

Title of Gen IC: Post-Event Survey for a Continuing Education (CE) Webinar on Pregnancy and
Lactation Medication Information for the Healthcare Provider
Statement of Need: This is a post-event survey that will be administered to healthcare providers and
certain other individuals who attended a continuing education (CE) webinar relating to Pregnancy
and Lactation medication information. The purpose of the survey is to evaluate the quality of the
course content, speakers’ effectiveness, and educational impact. This survey is a required component
for CE accreditation, and it will serve to improve future educational offerings. This survey is required
only for those attendees who wish to seek continuing education (CME, CNE, CPE) credit, which is
required to maintain their professional licensure. For webinar attendees not seeking CE credit, this
survey will be optional.
1. Intended Use of the Information:
This information will be collected and reviewed by the FDA Continuing Education Consultation
and Accreditation Team (CECAT) to evaluate the quality of the course content, effectiveness of
the speakers (faculty), and educational impact. The survey responses will be anonymous.
CECAT supports the FDA Center for Drug Evaluation and Research, which is jointly accredited
by the Accreditation Council for Continuing Medical Education (ACCME), Accreditation
Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center
(ANCC) to provide continuing education that is recognized by state professional licensing boards.
2. Description of Respondents:
The respondents will include physicians, physician assistants, pharmacists, nurses, and other
members of the scientific or clinical care community who are interested in drug labeling to inform
prescribing in pregnant and lactating individuals and who are seeking CE credit which is required
to maintain their professional licensure.
The information will be collected via a web-based system. Following the webinar, all registrants
will be sent an email that includes a link to the FDA CE Portal with instructions for only those
registrants who wish to receive continuing education (CE) credit on how to access the FDA CE
Portal and complete the post-event evaluation. Learners who are new to using the FDA CE Portal
will need to create an account. The following information is needed to create an account:
-

First and last name
FDA email address
Username
Credentials
Job title
Profession
Birthday (MM/YY) [for pharmacists seeking CE]
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National Association of Boards of Pharmacy (NABP) CE identifier [for pharmacists seeking
CE]

After successful completion of the post-event evaluation, learners seeking CE credit will be
instructed on how to view and print their statement of credit and/or certificate of completion.
3. How the Information is Collected:
The information will be collected via FDA’s web-based continuing education portal (CE Portal).
Following the webinar, all registrants will be sent an email that includes a link to the FDA CE
Portal with instructions. Only those registrants who wish to receive CE credit will be required to
access and complete the post-event evaluation. After successful completion of the post-event
evaluation, learners seeking CE credit will be instructed on how to view and print their statement
of credit and/or certificate of completion.
4. Confidentiality of Respondents:
Respondents will login to the CE Portal using their email address and password, where they can
be identified by their email address and name. Pharmacists seeking CE are also required to enter
their birthday in MM/DD format and e-Profile ID# which was assigned to them by the National
Association of Boards of Pharmacy (NABP), and which NABP uses for tracking Continuing
Pharmacy Education (CPE) credit for pharmacist licensure renewal.
The following statement will be highlighted to survey participants in the email to participants:
“Your participation / nonparticipation is completely voluntary, and your responses will not have
an effect on your eligibility for receipt of any FDA services. In instances where respondent
identity is needed (e.g., for follow-up of non-respondents), this information collection fully
complies with all aspects of the Privacy Act and data will be kept private to the fullest extent
allowed by law.”
5. Amount and Justification for Proposed Incentive:
Is an incentive (e.g., stipend, reimbursement of expenses, token of appreciation) provided to
participants [ ] Yes [ x ] No
6. Questions of a Sensitive Nature:
The survey does not include any questions of a sensitive nature.
7. Description of Statistical Methods:
No statistical tabulations will be performed other than looking at the number of respondents.

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8.

Burden:
Type of information collection/
Category of Respondent

No. of Respondents

Webform Satisfaction Survey

500 (expected based on
historical context)

Participation
Time
(minutes)
7

Burden
(hours)
58

9. Date(s) to be Conducted: May 11, 2022
10. Requested Approval Date: April 22, 2022
11. FDA Contacts:
Program Office Contact
Erin South, 240-506-9182
[email protected]
Office of the Commissioner, Office of
Women’s Health

FDA PRA Contact
Jonna Capezzuto. 301-796-3794
[email protected]
Paperwork Reduction Act Staff, Division of
Information Governance, Office of
Enterprise Management Services

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