[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21242-21244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the information collection associated with 
establishing and maintaining a list of U.S. manufacturers and 
processors interested in exporting to the People's Republic of China.

DATES: Submit either electronic or written comments on the collection 
of information by June 15, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 15, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted,

[[Page 21243]]

such as medical information, your or anyone else's Social Security 
number, or confidential business information, such as a manufacturing 
process. Please note that if you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-1207 for ``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.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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--Extension

    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 the Office of 
Management and Budget (OMB) granted emergency review under 5 CFR 
1320.13 of a new information collection request. Accordingly, we are 
now inviting comment on the estimated burden we associate with the 
proposed information collection.
    We estimate the burden of this collection of information as 
follows:

[[Page 21244]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
       Type of respondent            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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U.S. manufacturers/processors of             450               1             450           0.083              38
 covered products...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This information collection gathers 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. 
Because similar information is currently maintained by respondents in 
conjunction with registration, we believe burden associated with this 
collection to be minimal. However, as a new information collection, we 
invite comment specifically in this regard. This is a new information 
collection. Our estimate is based on our experience with similar 
information collection.

    Dated: April 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08007 Filed 4-15-20; 8:45 am]
BILLING CODE 4164-01-P


