Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption From the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry; Availability, 34508-34510 [2020-12109]
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34508
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Rules and Regulations
Entity
License
requirement
Nanjing FiberHome Starrysky Communication Development Co., a.k.a., the
following two aliases:
—Nanjing Fenghuo Xingkong Communication Development Co.; and
—Fiberhome StarrySky Co., Ltd.
88 Yunlongshan Road, Jianye District,
Nanjing China.
For all items subject to
the EAR. (See § 744.11
of the EAR).
*
*
NetPosa, a.k.a., the following three
aliases:
—Dongfang Netpower Technology Co.;
—Dongfang Wangli Technology; and
—NetPosa Technologies Ltd.
Room 408, 4th Floor, Shining Xueyuan
Road, Haidian District, Beijing,
China; and Room 3603, Wanda
Plaza, No. 555 Xuanwuhu Road,
Economic and Technological Development Zone, Urumqi, China; and
26F, BLK C, Wangjing SOHO Tower
2, #1 Futong Ave, Chaoyang District,
Beijing, China.
*
*
SenseNets, a.k.a., the following six
aliases:
—Deep Net Vision;
—Deep Network Vision;
—Sensenets Corporation;
—Shenzhen Net Vision;
—Shenzhen Shenwang Vision Technology Co., Ltd.; and
—Shenzhen Vision.
8th Floor, East Tower, Skyworth Semiconductor Design Building, No. 18
Gaoxin South 4th Road, Yuehai
Street, Nanshan District, Shenzhen,
China; and 16F, China Merchants
Development Center, No. 1063,
Nanhai Avenue, Nanshan District,
Shenzhen, China.
*
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR).
Country
*
*
*
For all items subject to
the EAR. (See § 744.11
of the EAR).
*
Dated: May 15, 2020.
Wilbur Ross,
Secretary, U.S. Department of Commerce.
[FR Doc. 2020–10868 Filed 6–3–20; 11:15 am]
BILLING CODE 3510–33–P
License
review policy
Case-by-case review for
ECCNs 1A004.c,
1A004.d, 1A995,
1A999.a, 1D003,
2A983, 2D983, and
2E983, and for EAR99
items described in the
Note to ECCN 1A995;
presumption of denial
for all other items subject to the EAR.
*
*
Case-by-case review for
ECCNs 1A004.c,
1A004.d, 1A995,
1A999.a, 1D003,
2A983, 2D983, and
2E983, and for EAR99
items described in the
Note to ECCN 1A995;
presumption of denial
for all other items subject to the EAR.
85 FR [INSERT FR PAGE
NUMBER] 6/5/20.
*
*
Case-by-case review for
ECCNs 1A004.c,
1A004.d, 1A995,
1A999.a, 1D003,
2A983, 2D983, and
2E983, and for EAR99
items described in the
Note to ECCN 1A995;
presumption of denial
for all other items subject to the EAR.
*
85 FR [INSERT FR PAGE
NUMBER] 6/5/20.
*
*
*
*
*
*
*
Food and Drug Administration
21 CFR Part 112
lotter on DSK9F5VC42PROD with RULES
[Docket No. FDA–2020–D–1386]
Temporary Policy During the COVID–
19 Public Health Emergency Regarding
the Qualified Exemption From the
Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption: Guidance for
Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
16:46 Jun 04, 2020
Jkt 250001
PO 00000
Notification of availability.
Frm 00016
Fmt 4700
*
85 FR [INSERT FR PAGE
NUMBER] 6/5/20.
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Federal Register
citation
Sfmt 4700
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Temporary Policy During the COVID–
19 Public Health Emergency Regarding
the Qualified Exemption from the
Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption.’’ Given the public
health emergency presented by COVID–
19, this guidance document is being
implemented without prior public
comment because FDA has determined
that prior public participation is not
feasible or appropriate, but it remains
subject to comment in accordance with
the Agency’s good guidance practices.
The guidance communicates the
Agency’s intention to exercise
SUMMARY:
E:\FR\FM\05JNR1.SGM
05JNR1
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Rules and Regulations
enforcement discretion, in the manner
described in the guidance, regarding
sales to qualified end-users when
determining eligibility for the qualified
exemption from the Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption, due to disruptions to
supply chains, for the duration of the
COVID–19 public health emergency.
DATES: The announcement of the
guidance is published in the Federal
Register on June 5, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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,
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’’).
lotter on DSK9F5VC42PROD with RULES
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–D–1386 for ‘‘Temporary Policy
VerDate Sep<11>2014
16:46 Jun 04, 2020
Jkt 250001
During the COVID–19 Public Health
Emergency Regarding the Qualified
Exemption from the Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption.’’ Received comments 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-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, 240–402–7500.
You may submit comments on any
guidance at any time (21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Compliance, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr. (HFS–
607), College Park, MD 20740. Send two
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
34509
self-addressed adhesive labels to assist
that office in processing your request.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT:
Samir Assar, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr. (HFS–
607), College Park, MD 20740, 240–402–
1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Temporary Policy During the COVID–
19 Public Health Emergency Regarding
the Qualified Exemption from the
Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption.’’ This policy
relates to the supply chain disruptions
caused by the public health emergency
related to COVID–19, as declared by the
Department of Health and Human
Services.
Given this public health emergency,
this guidance is being implemented
without prior public comment because
FDA has determined that prior public
participation for this guidance is not
feasible or appropriate. This guidance
document is being implemented
immediately, but it remains subject to
comment in accordance with the
Agency’s good guidance practices.
This guidance document concerns
flexibility for the eligibility criteria for
the qualified exemption from the
Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption (part 112 (21 CFR
part 112)) due to disruptions to supply
chains due to COVID–19. A farm is
eligible for a qualified exemption and
associated modified requirements in a
calendar year if during the previous 3year period preceding the applicable
calendar year, the average annual
monetary value of food the farm sold
directly to qualified end-users exceeded
the average annual monetary value of
the food the farm sold to all other
buyers during that period, and the
average annual monetary value of all
food the farm sold during the 3-year
period was less than $500,000, adjusted
for inflation. In order to provide
flexibility to affected farms during the
COVID–19 public health emergency,
under the circumstances described in
the guidance FDA does not intend to
enforce the criteria regarding the portion
of sales that are made to qualified endusers in 2020 (and any subsequent years
that are affected by the COVID–19
public health emergency). Specifically,
E:\FR\FM\05JNR1.SGM
05JNR1
34510
Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Rules and Regulations
for farms that either met the criteria for
the qualified exemption in 2020 based
on sales that were made in 2017 to 2019,
or that did not have 3 years of sales
prior to 2020, but that met the relevant
requirements during the years they were
in operation prior to 2020, FDA does not
intend to enforce the criteria regarding
the portion of sales that are made to
qualified end-users in years that are
affected by the COVID–19 public health
emergency. This guidance does not
affect the status of farms who continue
to sell a majority of their food to
qualified end-users despite COVID–19
supply chain disruptions.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation § 10.115(g)(2). The
guidance represents the current thinking
of FDA on ‘‘Temporary Policy During
the COVID–19 Public Health Emergency
Regarding the Qualified Exemption from
the Standards for the Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in part 112
have been approved under OMB control
number 0910–0816.
III. Electronic Access
lotter on DSK9F5VC42PROD with RULES
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances, https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/coronavirusdisease-2019-covid-19, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: May 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12109 Filed 6–4–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:46 Jun 04, 2020
Jkt 250001
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 569
Syria-Related Sanctions Regulations
Office of Foreign Assets
Control, Treasury.
ACTION: Final rule.
AGENCY:
The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is adding regulations to
implement Executive Order 13894 of
October 14, 2019 (‘‘Blocking Property
and Suspending Entry of Certain
Persons Contributing to the Situation in
Syria’’). OFAC intends to supplement
these regulations with a more
comprehensive set of regulations, which
may include additional interpretive and
definitional guidance, general licenses,
and statements of licensing policy.
DATES: This rule is effective June 5,
2020.
FOR FURTHER INFORMATION CONTACT:
OFAC: Assistant Director for Licensing,
202–622–2480; Assistant Director for
Regulatory Affairs, 202–622–4855; or
Assistant Director for Sanctions
Compliance & Evaluation, 202–622–
2490.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Electronic Availability
This document and additional
information concerning OFAC are
available on OFAC’s website
(www.treasury.gov/ofac).
Background
On October 14, 2019, the President,
invoking the authority of, inter alia, the
International Emergency Economic
Powers Act (50 U.S.C. 1701–1706)
(IEEPA), issued Executive Order 13894
(84 FR 55851, October 17, 2019) (E.O.
13894).
In E.O. 13894, the President
determined that the situation in and in
relation to Syria, and in particular the
recent actions by the Government of
Turkey to conduct a military offensive
into northeast Syria, undermines the
campaign to defeat the Islamic State of
Iraq and Syria, or ISIS, endangers
civilians, and further threatens to
undermine the peace, security, and
stability in the region, and thereby
constitutes an unusual and
extraordinary threat to the national
security and foreign policy of the United
States, and declared a national
emergency to deal with that threat.
OFAC is issuing the Syria-related
Sanctions Regulations, 31 CFR part 569
(the ‘‘Regulations’’), to implement E.O.
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
13894, pursuant to authorities delegated
to the Secretary of the Treasury in E.O.
13894. A copy of E.O. 13894 appears in
appendix A to this part.
The Regulations are being published
in abbreviated form at this time for the
purpose of providing immediate
guidance to the public. OFAC intends to
supplement this part 569 with a more
comprehensive set of regulations, which
may include additional interpretive and
definitional guidance, general licenses,
and statements of licensing policy. The
appendix to the Regulations will be
removed when OFAC supplements this
part with a more comprehensive set of
regulations.
Public Participation
Because the Regulations involve a
foreign affairs function, the provisions
of Executive Order 12866 and the
Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed
rulemaking, opportunity for public
participation, and delay in effective
date, as well as the provisions of
Executive Order 13771, are
inapplicable. Because no notice of
proposed rulemaking is required for this
rule, the Regulatory Flexibility Act (5
U.S.C. 601–612) does not apply.
Paperwork Reduction Act
The collections of information related
to the Regulations are contained in 31
CFR part 501 (the ‘‘Reporting,
Procedures and Penalties Regulations’’).
Pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3507), those
collections of information have been
approved by the Office of Management
and Budget under control number 1505–
0164. An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless the collection of information
displays a valid control number.
List of Subjects in 31 CFR Part 569
Administrative practice and
procedure, Banks, Banking, Blocking of
assets, Penalties, Reporting and
recordkeeping requirements, Sanctions,
Syria, Turkey.
For the reasons set forth in the
preamble, the Department of the
Treasury’s Office of Foreign Assets
Control adds part 569 to 31 CFR chapter
V to read as follows:
PART 569—SYRIA-RELATED
SANCTIONS REGULATIONS
Subpart A—Relation of This Part to Other
Laws and Regulations
Sec.
569.101 Relation of this part to other laws
and regulations.
E:\FR\FM\05JNR1.SGM
05JNR1
]]>Agencies
[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Rules and Regulations]
[Pages 34508-34510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12109]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2020-D-1386]
Temporary Policy During the COVID-19 Public Health Emergency
Regarding the Qualified Exemption From the Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption:
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Temporary Policy During the COVID-19 Public Health Emergency
Regarding the Qualified Exemption from the Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption.''
Given the public health emergency presented by COVID-19, this guidance
document is being implemented without prior public comment because FDA
has determined that prior public participation is not feasible or
appropriate, but it remains subject to comment in accordance with the
Agency's good guidance practices. The guidance communicates the
Agency's intention to exercise
[[Page 34509]]
enforcement discretion, in the manner described in the guidance,
regarding sales to qualified end-users when determining eligibility for
the qualified exemption from the Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption, due to
disruptions to supply chains, for the duration of the COVID-19 public
health emergency.
DATES: The announcement of the guidance is published in the Federal
Register on June 5, 2020.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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, 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-D-1386 for ``Temporary Policy During the COVID-19 Public
Health Emergency Regarding the Qualified Exemption from the Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption.'' Received comments 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, 240-402-7500.
You may submit comments on any guidance at any time (21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Office of Compliance, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr. (HFS-607), College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.
(HFS-607), College Park, MD 20740, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Temporary Policy During the COVID-19 Public Health Emergency
Regarding the Qualified Exemption from the Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption.''
This policy relates to the supply chain disruptions caused by the
public health emergency related to COVID-19, as declared by the
Department of Health and Human Services.
Given this public health emergency, this guidance is being
implemented without prior public comment because FDA has determined
that prior public participation for this guidance is not feasible or
appropriate. This guidance document is being implemented immediately,
but it remains subject to comment in accordance with the Agency's good
guidance practices.
This guidance document concerns flexibility for the eligibility
criteria for the qualified exemption from the Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption (part 112 (21 CFR part 112)) due to disruptions to supply
chains due to COVID-19. A farm is eligible for a qualified exemption
and associated modified requirements in a calendar year if during the
previous 3-year period preceding the applicable calendar year, the
average annual monetary value of food the farm sold directly to
qualified end-users exceeded the average annual monetary value of the
food the farm sold to all other buyers during that period, and the
average annual monetary value of all food the farm sold during the 3-
year period was less than $500,000, adjusted for inflation. In order to
provide flexibility to affected farms during the COVID-19 public health
emergency, under the circumstances described in the guidance FDA does
not intend to enforce the criteria regarding the portion of sales that
are made to qualified end-users in 2020 (and any subsequent years that
are affected by the COVID-19 public health emergency). Specifically,
[[Page 34510]]
for farms that either met the criteria for the qualified exemption in
2020 based on sales that were made in 2017 to 2019, or that did not
have 3 years of sales prior to 2020, but that met the relevant
requirements during the years they were in operation prior to 2020, FDA
does not intend to enforce the criteria regarding the portion of sales
that are made to qualified end-users in years that are affected by the
COVID-19 public health emergency. This guidance does not affect the
status of farms who continue to sell a majority of their food to
qualified end-users despite COVID-19 supply chain disruptions.
This guidance is being issued consistent with FDA's good guidance
practices regulation Sec. 10.115(g)(2). The guidance represents the
current thinking of FDA on ``Temporary Policy During the COVID-19
Public Health Emergency Regarding the Qualified Exemption from the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
part 112 have been approved under OMB control number 0910-0816.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/FoodGuidances, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19,
or https://www.regulations.gov. Use the FDA website listed in the
previous sentence to find the most current version of the guidance.
Dated: May 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12109 Filed 6-4-20; 8:45 am]
BILLING CODE 4164-01-P
