0502 Change Request for Food Reg Module Update

UNITED STATES FOOD AND DRUG ADMINISTRATION
Registration of Food Facilities
OMB Control Number 0910-0502
Expiration Date: August 31, 2022
JUSTIFICATION MEMORANDUM FOR NON-SUBSTANTIVE CHANGE REQUEST”
The Food and Drug Administration (FDA) is requesting a nonmaterial/non-substantive change
request (83-C) to OMB control no. 0910-0502, “Registration of Food Facilities.” We are
requesting to make two updates to Form FDA 3537, “DHHS/FDA Food Facility Registration”
with the electronic version called the Food Facility Registration Module. The first update
involves adding a data field for a United States Agent identification number. This field has been
considered and approved by OMB in its last extension of the approval. The second update
involves adding a data field for a Unique Facility Identifier (UFI), which FDA recognizes the
DUNS number as acceptable. Most respondents already have this information readily available
as part of its reporting activities required under 21 CFR 1.232(a)(2) considered in this collection
and OMB control no. 0910-0752, “Foreign Supplier Verification Programs for Importers of
Food for Humans and Animals.” FDA will use the DUNS number to verify that a facility’s
specific address associated with the DUNS number is the same address associated with the
facility’s registration. Accordingly, we are providing screenshots of the system interface for
OMB approval.
Dated: August 2020