0509 June 2018 Nonsub Change

United States Food and Drug Administration
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors
with Interest in Exporting
OMB Control Number 0910-0509
Expiration Date: November 30, 2020
JUSTIFICATION MEMORANDUM FOR NON-SUBSTANTIVE CHANGE REQUEST

The Food and Drug Administration (FDA) is requesting a change to the information collection OMB
control no. 0910-0509, “Establishing and Maintaining Lists of U.S. Milk Product
Manufacturers/processors with Interest in Exporting.” We are revising the Dairy Listing Module of our
electronic reporting system (Form FDA 3972), to include data elements from other approved information
collections: OMB control nos. 0910-0320 and 0910-0839 (“Request for Information from U.S.
Processors that Export to the European Community” and “Establishing and Maintaining Lists of U.S.
Manufacturers/Processors with Interest in Exporting CFSAN-Regulated Products to China,”
respectively). There are no changes to the information being collected, however, the latter collections
utilize paper-based submissions where this change allows for electronic submission. Upon
implementation of the electronic data elements, we intend to discontinue or otherwise modify the latter
collections accordingly.
Background
The United States exports a large volume and variety of foods in international trade. For certain food
products, foreign governments may require assurances from the responsible authority of the country of
origin of an imported food that the producer of the food is in compliance with applicable country of origin
regulatory requirements. The electronic system approved under 0910-0509, entitled “the Dairy Listing
Module” or DLM, collects only submissions for milk product firm lists. Allowing the system to collect
submissions for firms covered under 0910-0320 and 0910-0839 will afford these firms the efficiencies of
submitting information electronically. As currently approved, these collections accept the submission of
paper-based documentation to FDA from U.S. firms wishing to be added to the respective export list.
Processing of paper-based information is time-consuming due to its volume and non-standardized format.
The use of an electronic system to receive information will standardize information, eventually leading to
reduced burden for respondents and faster processing and response times for FDA. As users become
more comfortable with the electronic system, FDA expects that the overall burden will decrease because
of increased efficiency and ease of use.