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, 21242-21244 [2020-08007]
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<![CDATA[
21242
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
compile and submit the readily
available pediatric use information
required under section 515A(a) of the
FD&C Act. Respondents are permitted to
submit information relating to uses of
the device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A(a)
of the FD&C Act will choose to submit
this information and that it will take 30
minutes for them to do so.
In the Federal Register of December 2,
2019 (84 FR 65986), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Pediatric information in an original PMA or PDP—
814.20(b)(13).
Pediatric information in a PMA amendment—
814.37(b)(2).
Pediatric information in a PMA supplement—
814.39(c)(2)(i).
Pediatric information in an HDE—814.104(b)(6) .......
Pediatric information for uses outside approved indication.
Total ....................................................................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR part
Average
burden per
response
Total annual
responses
Total hours
11
1
11
8 ..............................
88
5
1
5
8 ..............................
40
928
1
928
2 ..............................
1,856
1
800
1
1
1
800
8 ..............................
.5 (30 minutes) ........
8
400
........................
........................
........................
.................................
2,392
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden and
corresponding responses reflect the
requirements under section 515A(a) of
the FD&C Act, in addition to the
submission of data related to pediatric
uses outside an approved indication, as
described in the document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff.’’ OMB previously
approved the information collection
related to uses outside an approved
indication under OMB control number
0910–0762. As the information
collection uses the same data and relies
upon the same legal authority as OMB
control number 0910–0748, we intend
to discontinue OMB control number
0910–0762 and consolidate the
information collection accordingly. Our
estimated burden for the information
collection reflects an overall increase of
632 hours. Additionally, we have
altered the title of the collection to
reflect all collections of pediatric uses.
Our estimated burden for the
information collection reflects an
overall increase of 632 hours and a
corresponding increase of supplements
and of uses outside of approved
indications. We attribute this
adjustment to an increase in the number
of supplements we received over the
last 5 years and merging data from
discontinued OMB control number
0910–0762.
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
Dated: April 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08010 Filed 4–15–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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,
E:\FR\FM\16APN1.SGM
16APN1
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
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-201509-18/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
PO 00000
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Fmt 4703
Sfmt 4703
21243
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:
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21244
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent
U.S. manufacturers/processors of covered products ..........
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification Procedures
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 May 18,
2020.
SUMMARY:
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
ADDRESSES:
jbell on DSKJLSW7X2PROD with NOTICES
450
Total annual
responses
1
450
Average
burden per
response
0.083
Total hours
38
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.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
by using the search function. The OMB
control number for this information
collection is 0910–0120. Also include
the FDA docket number found in
brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Premarket Notification Procedures—21
CFR Part 807, Subpart E
OMB Control Number 0910–0120—
Revision
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360(k)) and implementing
regulations in part 807 (21 CFR part 807,
subpart E) require a premarket
notification submission (‘‘510(k)’’) at
least 90 days before the introduction, or
delivery for introduction into interstate
commerce, for commercial distribution
of a device intended for human use.
Based on the information provided in
the notification, FDA determines
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3). If the device
is determined to be not substantially
equivalent to a legally marketed device,
it must have an approved premarket
approval application (PMA), product
development protocol, humanitarian
device exemption (HDE), request for an
evaluation of automatic class III
designation (De Novo request), or be
reclassified into class I or class II before
being marketed (see OMB control
numbers 0910–0231, 0910–0332, 0910–
0844, and 0910–0138). FDA makes the
final decision of whether a device is
substantially equivalent or not
substantially equivalent.
Section 807.81 governs when a 510(k)
is required. A 510(k) is required to be
submitted by a person who is: (1)
Introducing a device to the market for
the first time; (2) introducing a device
PO 00000
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Fmt 4703
Sfmt 4703
into commercial distribution for the first
time by a person who is required to
register; or (3) introducing or
reintroducing a device that is
significantly changed or modified in
design, components, method of
manufacturer, or the intended use that
could affect the safety and effectiveness
of the device. Section 807.87 lists the
information required in each 510(k).
Form FDA 3514, a summary cover
sheet form, assists respondents in
categorizing administrative 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, De
Novo requests, HDEs, etc.
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the FD&C Act
(21 U.S.C. 360d). Amended section 514
of the FD&C Act allows FDA to
recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions including 510(k) or other
requirements. FDA has published and
updated regularly the list of recognized
standards since enactment of FDAMA
and has allowed 510(k) submitters to
certify conformance to recognized
standards to meet the requirements of
§ 807.87.
Under § 807.90(a)(3), inquiries
regarding a 510(k) submission should be
in writing and sent to one of the
addresses in § 807.90(a).
Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) as required by § 807.92
(510(k) summary) or a statement
certifying that the submitter will make
available upon request the information
in the 510(k) with certain exceptions as
per § 807.93 (510(k) statement).
Section 745A(b) of the FD&C Act (21
U.S.C. 379k–1(b), amended by section
207 of the FDA Reauthorization Act of
2017 (FDARA) (Pub. L. 115–52),
requires that submissions for devices
under section 510(k), among other
submission types, be submitted in
electronic format specified by FDA. In
addition, in the Medical Device User
E:\FR\FM\16APN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Type of respondent Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
U.S. manufacturers/processors of 450 1 450 0.083 38
covered products...............
----------------------------------------------------------------------------------------------------------------
\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
