Document ID: FDA-2020-N-1207-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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
Posted Date: 2020-08-06T04:00Z

[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47796-47797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17161]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1207]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 8, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0884. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
Number 0910-0884

    This information collection request allows FDA to include 
respondents who are U.S. manufacturers/processors of feed additives, 
premixes, compound feed, distillers' dried grains, and distillers' 
dried grains with solubles (hereinafter, ``manufacturers/processors'' 
of ``covered products'') on a list of those who 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. Since the timing of the 
Agreement did not allow for publication of a 60-day notice under the 
PRA in advance of its implementation, FDA requested and OMB granted 
emergency review under 5 CFR 1320.13 of a new information collection 
request.
    In the Federal Register of April 16, 2020 (85 FR 21242), subsequent 
to implementation under the emergency clearance, we published a 60-day 
notice requesting public comment on the proposed collection of 
information. No comments were received.
    Respondents: Manufacturing/processing facilities of covered 
products interested in exporting animal feed to China.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
    21 CFR Section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Sec.   1.101(b)(1); Request for              450               1             450           0.083              38
 list placement to export to
 China--data elements
 demonstrating that product
 meets the foreign purchaser's
 specifications.................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have revised our burden table. In the 60-day notice published on 
April 16, 2020, the burden table identified types of respondents. Here 
we are clarifying that the information being collected is a request 
from those respondents to be placed on a list. By requesting to be 
placed on the list, respondents agree to disclose data elements, as 
agreed upon by the U.S. government and China, that demonstrate the 
product meets acceptable entry criteria. Since establishing the 
collection, we have 197 facilities on the list to date. There were 
fewer emails received, as some of the

[[Page 47797]]

companies registered multiple facilities in a single email.
    Based on our experience with a similar information collection, upon 
requesting to be placed on the list, data elements that may be provided 
to China include the facility name, street address, city, State, and 
ZIP code of U.S. manufacturers and processors of covered products, who 
want to be included on the list sent to China.
    Manufacturers of these products must currently register with FDA 
consistent with 21 CFR part 1, subpart H. Therefore, we believe burden 
associated with this collection should be minimal, but we welcome 
specific feedback in this regard.

    Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17161 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P