0331 Non Sub Change FARM System

UNITED STATES FOOD AND DRUG ADMINISTRATION
Notification Procedures for Statements on Dietary Supplements
OMB Control Number 0910-0331

JUSTIFICATION MEMORANDUM FOR NON-SUBSTANTIVE CHANGE
REQUEST
The Food and Drug Administration (FDA, us or we) is requesting a non-substantive change
request (83-C) for the information collection under OMB control no. 0910-0331,
“Notification Procedures for Statements on Dietary Supplements.” The information
collection supports food labeling provisions of the Federal Food, Drug, and Cosmetic Act (21
CFR 101.93). We are requesting approval to upgrade the current electronic system, the FDA
Unified Registration Listing System (FURLS) (Form FDA 3880), to the Food Applications
Regulatory Management (FARM) system. This results in certain formatting changes for our
respondents, but it results in an operational efficiency for us. Because the same information
will be collected, we expect no change in burden. The FARM system intends to minimize
changes for consumers while maximizing operational efficiency for FDA. The FARM
system was developed to closely follow FURLS in appearance and should require no
additional burden on the consumer. However, FURLS does not interface with other systems
we utilize that house relevant data and information. Here, the benefit to FDA is that the
FARM system provides a single resource that allows access to data from multiple modules,
improving our efficiency with items such as correspondence tracking.
Currently, we are underway in our renewal of the information collection, having published a
60 day notice soliciting public comment on February 7, 2019 (84 FR 2528), however, we are
ready to deploy the FARM system and wish to begin the transition immediately. To that end,
we have provided screen shots for review and approval, and have also invited public
comment in our 30 day notice, which is currently pending publication.
Submitted: May 2019