Establish & Maintain List of US Mfr/Processors of Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains and Dried Grains w/Solubles for Use w/Animals; Interest in Exporting to China

Establishing and Maintaining a List of U.S. Manufacturers/Processors of Feed Additives,
Premixes, Compound Feed, Distillers’ Dried Grains, and Distillers’ Dried Grains with
Solubles for Use with Animals with Interest in Exporting to The People’s Republic of
China
OMB Control No. 0910-NEW
Request for Emergency Processing to Approve the Collection of Information from U.S.
Manufacturers/Processors of Feed Additives, Premixes, Compound Feed, Distillers’ Dried
Grains, and Distillers’ Dried Grains with Solubles with Interest in Exporting to The
People’s Republic of China
The Food and Drug Administration (FDA or we) is requesting emergency processing under 5
CFR § 1320.13 of a new information collection request (ICR). This ICR supports an agency
program by which respondents may be included on a list of U.S. manufacturers and processors of
feed additives, premixes, compound feed, distillers’ dried grains, and distillers dried grains with
solubles for use with animals (hereinafter, “manufacturers/processors” of “covered products”)
that wish to export their products to the People’s Republic of China (China). On January 15,
2020, the United States and China entered into an Economic and Trade Agreement (the
Agreement) which, among other things, will streamline the procedures for, and improve the
efficiencies of, the exportation of U.S. covered products to China. These provisions of the
Agreement are intended to facilitate trade between the two countries to better meet the demand
for U.S. animal feed products in China and to promote the development of animal husbandry in
China.
If certain conditions are met, an agency head or designee may request expedited OMB review of
an ICR, also known as an "emergency" review. OMB may grant expedited review if the
collection is essential to the mission of the agency, clearance is needed sooner than the normal
timeframe, and the agency cannot reasonably comply with the normal clearance procedures of
the Paperwork Reduction Act of 1995 (the PRA) because: "(i) public harm is reasonably likely to
result if normal clearance procedures are followed; (ii) an unanticipated event has occurred; or
(iii) the use of normal clearance procedures is reasonably likely to prevent or disrupt the
collection of information or is reasonably likely to cause a statutory or court ordered deadline to
be missed" (5 CFR § 1320.13(a)(2)). When OMB expedites review, OMB acts promptly to
review the ICR through a suitably streamlined process, consistent with the purposes of the PRA.
For example, OMB may modify—or, if necessary, waive—the public comment requirements.
Emergency clearance may be granted for a maximum of six months.
We are seeking emergency processing for the following reasons:
1. The collection of information is essential to FDA’s mission. As the competent authority
recognized by China with respect to FDA-regulated foods, including animal feeds, FDA
helps facilitate international trade of such products. With respect to the collection of
information at issue, we intend to facilitate trade by establishing and maintaining a list of
U.S. manufacturers/processors that are interested in exporting the covered products to
China and that meet the requirements of the Agreement. Specifically, under the

Agreement, FDA intends to include on the export list those manufacturers/processors
over which FDA has regulatory oversight and can verify that these facilities are
registered with FDA per section 415 of the Federal Food, Drug, and Cosmetic Act. The
information collection is critical for FDA to meet the U.S. government’s obligation under
this agreement and to facilitate trade of these covered products to China. The collection
of information is thus essential to the mission of the agency under § 1320.13(a)(1)(ii).
2. FDA cannot reasonably comply with the normal clearance procedures. On January 15,
2020, the United States and the People’s Republic of China entered into an Economic and
Trade Agreement. This Agreement goes into effect on Friday, February 14, 2020.
Pursuant to the agreement, we have to provide a list. In order to compile the list,
manufacturers need to send us a request and authorization to include a facility on the list.
FDA currently does not have approval under the PRA to collect this information. The
collection of information is needed in a shorter time than standard processing time would
allow for. Following normal clearance procedures will result in a prolonged delay in
FDA’s ability to receive the information from U.S. exporters necessary for the agency to
prepare the list of the covered products pursuant to the Agreement. Thus, under
§ 1320.13(a)(2)(ii) an unanticipated event has occurred, and, under § 1320.13(a)(2)(iii),
the use of normal clearance procedures is reasonably likely to prevent the collection of
information for an indeterminate length of time.
Accordingly, FDA requests that OMB authorize emergency processing of FDA’s new ICR,
entitled “Establishing and Maintaining a List of U.S. Manufacturers/Processors of Feed
Additives, Premixes, Compound Feed, Distillers’ Dried Grains, and Distillers’ Dried Grains with
Solubles for Use with Animals with Interest in Exporting to China.” FDA is submitting with this
request a copy of the Agreement that was signed on January 15, 2020. We are requesting
OMB approval or disapproval as soon as OMB deems practicable.

Steven Solomon -S

Digitally signed by Steven Solomon -S

Date: 2020.02.10 11:22:45 -05'00'
______________________________________
Steven M. Solomon, DVM, MPH

Center Director, Center for Veterinary Medicine