[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29886-29906]
[FR Doc No: 2017-13720]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1486]

Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) for in vitro diagnostic devices for detection of the
Zika virus in response to the Zika virus outbreak in the Americas. FDA
issued these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Nanobiosym Diagnostics, Inc. and
DiaSorin Inc. The Authorizations contain, among other things,
conditions on the emergency use of the authorized in vitro diagnostic
devices. The Authorizations follow the February 26, 2016, determination
by the Secretary of Health and Human Services (HHS) that there is a
significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On the basis of such determination, the Secretary of HHS declared on
February 26, 2016, that circumstances exist justifying the
authorization of emergency use of in vitro diagnostic tests for
detection of Zika virus and/or diagnosis of Zika virus infection,
subject to the terms of any authorization issued under the FD&C Act.
The Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.

DATES: The Authorization for Nanobiosym Diagnostics, Inc. is effective
as of March 20, 2017; the Authorization for DiaSorin Inc. is effective
as of April 5, 2017.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product

intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351
of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after
consultation with the HHS Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances),
FDA\1\ concludes: (1) That an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
The product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564,
approved or cleared under the FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and (B) the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product, taking into consideration the material threat posed by the
agent or agents identified in a declaration under section 564(b)(1)(D)
of the FD&C Act, if applicable; (3) that there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition; and (4) that such
other criteria as may be prescribed by regulation are satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Requests for In Vitro Diagnostic Devices for Detection of the
Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is
a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On February 24, 2017, Nanobiosym
Diagnostics, Inc. requested, and on March 20, 2017, FDA issued, an EUA
for the Gene-RADAR[supreg] Zika Virus Test, subject to the terms of the
Authorization. On March 30, 2017, DiaSorin Inc. requested, and on April
5, 2017, FDA issued an EUA for the LIAISON[supreg] XL Zika Capture IgM
Assay, subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the Internet at https://www.regulations. gov/.

IV. The Authorizations

    Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of two in vitro diagnostic devices for
detection of Zika virus subject to the terms of the Authorizations. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follow and provide an
explanation of the reasons for issuance, as required by section
564(h)(1) of the FD&C Act:

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    Dated: June 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13720 Filed 6-29-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Page 89688]
[FR Doc No: 2023-28640]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2040-0299; FRL-11641-01-OMS]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux
for Drinking Water (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), Use of Lead Free Pipes,
Fittings, Fixtures, Solder and Flux for Drinking Water (EPA ICR Number
2563.02, OMB Control Number 2040-0299) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through December 31, 2023. Public comments were
previously requested via the Federal Register on July 11, 2023 during a
60-day comment period. This notice allows for an additional 30 days for
public comments.

DATES: Comments may be submitted on or before January 29, 2024.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2040-0299, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460. EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Kevin Roland, Drinking Water
Infrastructure Development Division, Office of Ground Water and
Drinking Water, (4606M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-
4588: fax number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through December 31, 2023. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays currently valid OMB
control number.
    Public comments were previously requested via the Federal Register
on July 11, 2023 during a 60-day comment period (88 FR 44129). This
notice allows for an additional 30 days of public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: The Reduction of Lead in Drinking Water Act of 2011
(RLDWA, the Act) modified the technical definition of ``lead free'' by
lowering the maximum lead content of pipes, fittings, and fixtures from
8% to 0.25% and introduced greater complexity to calculating lead free
by requiring that level be met based on a weighted average of wetted
surfaces. The Act also created exemptions for certain plumbing products
from pre-existing lead free requirements. The final rule establishes
product certification requirements for products intended for potable
use applications in public water systems and residential or non-
residential facilities to demonstrate compliance with the lead free
requirements. EPA expects that these requirements for lead content in
plumbing materials used in new installations and repairs will result in
fewer sources of lead in drinking water and, consequently, will reduce
adverse health effects associated with exposure to lead in drinking
water. Manufacturers with 10 or more employees or importers entering
products purchased from or manufactured by manufacturers with 10 or
more employees must demonstrate compliance with the lead free
definition by obtaining third party certification by an American
National Standards Institute (ANSI) accredited, third party
certification body. Firms with fewer than 10 employees can use a third
party certification body or self-certify that their products conform to
the Safe Drinking Water Act's (SDWA) lead free requirements. This self-
certification option also extends to custom fabricated products
regardless of a manufacturer's number of employees. This rule imposes a
burden on states to enforce the statutory provisions in SDWA Section
1417(a)(1), which cross references updated statutory definition of lead
free within the meaning of SDWA Section 1417(d) according to the 2011
Reduction of Lead in Drinking Water Act and the 2013 Community Fire
Safety Act.
    Form Numbers: None.
    Respondents/affected entities: Primacy Agencies, Manufacturers of
lead-free pipes, fixtures and fittings.
    Respondent's obligation to respond: Mandatory for compliance with
Reduction of Lead in Drinking Water Act of 2011.
    Estimated number of respondents: 2,250 (total).
    Frequency of response: Annual.
    Total estimated burden: 97,186 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $12.2 million (per year), including $7.5
million annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase of 19,349 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is a result of shifts in respondent
activities required as the rule comes into full effect. Manufacturers
have complied with initial requirements to conduct rule familiarization
and initial product certifications and are now responsible for
recertifications and recordkeeping. In the three-year period covered by
this ICR, primacy agencies are responsible for developing and
implementing oversight plans. These changes are considered adjustments
because the parameters of this overall collection as defined by the
September 2020 rule (85 FR 54235) have not been modified.

Courtney Kerwin,
Director, Information Engagement Division.
[FR Doc. 2023-28640 Filed 12-27-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Proposed Rules]
[Pages 34379-34380]
[FR Doc No: 2020-11620]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2019-0681; FRL-10006-86-Region 2]

Approval and Promulgation of Implementation Plans; New Jersey;
Revisions to Emissions Reporting Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of New Jersey. This proposed revision requests to remove from the
SIP the recordkeeping, emission reporting, photochemical dispersion
modeling, and inventory requirements for t-butyl acetate (TBAC) as a
volatile organic compound (VOC). The proposed revision is consistent
with the Clean Air Act (CAA).

DATES: Written comments must be received on or before July 6, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R02-
OAR-2019-0681, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information or
other information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Ysabel Banon, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 29, 2017, the State of New
Jersey through the Department of Environmental Protection (NJDEP),
formally submitted a proposed revision to the New Jersey SIP which
repeals New Jersey Administrative Code (NJAC) 7:27-34, ``TBAC Emission
Reporting.''

I. Background

    TBAC is a VOC that is used as a solvent in coating operations, and
may be found in products, such as paints, inks, and adhesives. VOCs are
organic compounds of carbon that, in the presence of sunlight, react
with sources of oxygen molecules, such as nitrogen oxides
(NOX), in the atmosphere to produce tropospheric ozone,
commonly known as smog. Common sources that may emit VOCs include
paints, coatings, housekeeping and maintenance products, and building
and furnishing materials.
    VOCs have different levels of volatility, depending on the
compound, and react at different rates to produce varying amounts of
ozone. VOCs that are non-reactive or of negligible reactivity to form
ozone react slowly and/or form less ozone; therefore, reducing their
emissions has limited effects on local or regional ozone pollution.
Section 302(s) of the CAA specifies that the EPA has the authority to
define the meaning of VOC and thus what compounds shall be treated as
VOCs for regulatory purposes.
    It is the EPA's policy that organic compounds with a negligible
level of reactivity should be excluded from the regulatory definition
of VOC in order to focus control efforts on compounds that
significantly affect ozone concentrations. The EPA uses the reactivity
of ethane as the threshold for determining whether a compound has
negligible reactivity. Compounds that are less reactive than, or
equally reactive to, ethane under certain assumed conditions may be
deemed negligibly reactive and, therefore, suitable for exemption by
the EPA from the regulatory definition of VOC. The policy of excluding
negligibly reactive compounds from the regulatory definition of VOC was
first laid out in

the ``Recommended Policy on Control of Volatile Organic Compounds'' (42
FR 35314, July 8, 1977) and was supplemented subsequently with the
``Interim Guidance on Control of Volatile Organic Compounds in Ozone
State Implementation Plans'' (70 FR 54046, September 13, 2005). The
regulatory definition of VOC as well as a list of compounds that are
designated by the EPA as negligibly reactive can be found at 40 CFR
51.100(s)(1).
    On September 30, 1999, EPA proposed to revise the regulatory
definition of VOC in 40 CFR 51.100(s)(1) to exclude TBAC as a VOC. 64
FR 52731. In most cases, when a negligibly reactive VOC is exempted
from the definition of VOC, emissions of that compound are no longer
recorded, collected, or reported to states or the EPA as part of VOC
emissions. However, the EPA's November 29, 2004 final rule excluded
TBAC from the definition of VOC for purposes of VOC emissions
limitations or VOC content requirements but continued to define TBAC as
a VOC for purposes of all recordkeeping, emissions reporting,
photochemical dispersion modeling, and inventory requirements that
apply to VOCs. 69 FR 69298 (November 29, 2004).
    On February 25, 2016, the EPA revised the regulatory definition of
VOC under 40 CFR 51.100(s)(1) to remove TBAC's recordkeeping, emissions
reporting, photochemical dispersion modeling, and inventory
requirements. 81 FR 9339. Accordingly, on October 24, 2017, the NJDEP
repealed N.J.A.C. 7:27-34 which includes TBAC emissions reporting
requirements within the State of New Jersey.

II. Summary of the SIP Revision and the EPA's Analysis

    In order to conform with the EPA's current regulatory requirements
for TBAC in the February 25, 2016 final rule, New Jersey is now
requesting that NJAC 7:27-34, ``TBAC Emissions Reporting,'' consisting
of TBAC's recordkeeping, emissions reporting, photochemical dispersion
modeling, and inventory requirements, be removed from the SIP.
    The EPA has already made the determination that TBAC is
``negligible reactive'' and therefore has low contribution to ozone as
well as a low likelihood of risk to human health or the environment,
and removed the recordkeeping, emission reporting, photochemical
dispersion modeling, and inventory requirements for TBAC. 69 FR 69298
(November 29, 2004), 81 FR 9339 (February 25, 2016).
    The EPA is proposing to approve the removal of the recordkeeping,
emission reporting, photochemical dispersion modeling, and inventory
requirements for TBAC from the New Jersey SIP. This proposed SIP
revision will not interfere with attainment of any national ambient air
quality standard (NAAQS), reasonable further progress, or any other
requirement of the CAA, including section 110(l), and is consistent
with the EPA's February 25, 2016 final rule. 81 FR 9339.

III. Proposed Action

    Based on a review of the submitted material, the EPA is proposing
to approve the removal from New Jersey SIP of NJAC 7:27-34, ``TBAC
Emissions Reporting,'' which includes recordkeeping, emissions
reporting, photochemical dispersion modeling, and inventory
requirements for TBAC. Therefore, the EPA is proposing to approve New
Jersey's SIP revision, which was submitted on November 29, 2017. The
EPA is soliciting public comments on the issues discussed in this
rulemaking action. These comments will be considered before taking
final action.

IV. Incorporation by Reference

    In this document, the EPA is proposing to amend regulatory text
that includes incorporation by reference. As described above in section
III, the EPA is proposing to remove NJAC 7:27-34, ``TBAC Emissions
Reporting,'' from the New Jersey State Implementation Plan, which is
incorporated by reference in accordance with the requirements of 1 CFR
part 51.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking action, pertaining to TBAC,
is not approved to apply on any Indian reservation land or in any other
area where EPA or an Indian tribe has demonstrated that a tribe has
jurisdiction. In those areas of Indian country, the rule does not have
tribal implications and will not impose substantial direct costs on
tribal governments or preempt tribal law as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, and Volatile organic
compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 22, 2020.
Peter Lopez,
Regional Administrator, Region 2.
[FR Doc. 2020-11620 Filed 6-3-20; 8:45 am]
 BILLING CODE 6560-50-P