0645 Change Request Memo

UNITED STATES FOOD & DRUG ADMINISTRATION
FDA Adverse Event and Products Experience Reporting Program (MedWatch);
Electronic Submissions
OMB Control No. 0910-0645
JUSTIFICATION MEMORANDUM FOR 83-C NON-SUBSTANTIVE CHANGE
REQUEST; CFSAN SAFETY REPORTING PORTAL QUESTIONNAIRES
This information collection supports Food and Drug Administration (FDA, us or we) laws and
regulations governing adverse event reports and product experience reports for FDAregulated products; electronic submissions. The FDA Safety Reporting Portal (SRP) is one of
the IT systems we employ to collect data electronically. The SRP enables industry, health
professionals, consumers, and others to report adverse events or problems associated with
regulated products by completing web-based rational questionnaires tailored to product
categories. The information submitted through the SRP is routed to appropriate FDA
components so that we have real time access to reports and are able to more rapidly analyze
safety problems.
This non-substantive change request relates to rational questionnaires (RQ) used for
submitting adverse event reports for the following CFSAN-regulated products: dietary
supplements, food, infant formula, and cosmetics. Previously, we solicited public comment
on two revised dietary supplement rational questionnaires (one mandatory and one voluntary),
and three new voluntary rational questionnaires for food, infant formula, and cosmetics. We
included a discussion of these changes in our ICR submission on February 29, 2016 (see pp.
5-6 of our Supporting Statement) and the ICR was approved by OMB. As we then discussed,
however, the RQs were in the planning and development stage. Currently we are prepared to
deploy the RQs and are including the screenshots for approval prior to implementation.
Although we are simultaneously preparing a submission to renew all other elements of the
ICR as well, in accordance with applicable regulations, we want to begin collection of the
specific elements discussed here as anticipated in our previous submission. For ease of
review, we have consolidated the screen shots into one PDF document.
Submitted: April 2019