[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Rules and Regulations]
[Pages 54259-54263]
[FR Doc No: 2020-19351]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0182; FRL-10011-47]

Citrus Tristeza Virus Expressing Spinach Defensin Proteins 2, 7,
and 8; Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends and extends a temporary exemption from
the requirement of a tolerance for residues of the Citrus tristeza
virus expressing spinach defensin proteins 2, 7, and 8 alone or in
various combinations on citrus fruit (Citrus spp., Fortunella spp.,
Crop Group 10-10) when applied/used as a microbial pesticide in
accordance with the terms of Experimental Use Permit (EUP) No. 88232-
EUP-2. Southern Gardens Citrus submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting extension of
the temporary tolerance exemption. This regulation eliminates the need
to establish a maximum permissible level for residues of Citrus
tristeza virus expressing spinach defensin proteins 2, 7, and 8 alone
or in various combinations. The temporary tolerance exemption expires
on August 31, 2023.

DATES: This regulation is effective August 31, 2020. Objections and
requests for hearings must be received on or before November 2, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0182, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jean Overstreet, Acting Director,
Biopesticides and Pollution Prevention Division (7511P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-
7090; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0182 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 2, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0182, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of June 28, 2019 (84 FR 30976) (FRL-9995-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9G8741) by Southern Gardens Citrus, 1820 County Road 833,
Clewiston, FL 33440. The petition requested that 40 CFR 180.1337 be
amended to extend a temporary exemption from the requirement of a
tolerance for residues of Citrus tristeza virus expressing spinach
defensin proteins 2, 7, and 8 in or on the commodities in fruit, citrus
group 10-10 from August 31, 2020, to August 31, 2023. That document
contains a summary of the petition prepared by the petitioner Southern
Gardens Citrus, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit VII.C.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe '' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .'' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    The pesticide chemical is a genetically altered Citrus tristeza
virus that expresses spinach defensin proteins 2 (SoD2), 7 (SoD7), and
8 (SoD8) to combat citrus greening disease. Although EPA did not
receive data on the altered virus itself, EPA has sufficient data to
evaluate each component of the pesticide individually--i.e., the Citrus
tristeza virus and the spinach defensin proteins 2, 7, and 8. Assessing
overall risk based on the virus and spinach defensin proteins'
individual risks is reasonable because the antimicrobial spinach
defensin proteins are unlikely to change the host range of the plant
virus and the plant virus is unlikely to affect the toxicity or
allergenicity profile of the antimicrobial spinach defensin proteins.
    Citrus whole fruits and juices have been an important part of the
American and international diets for centuries. ``History of Citrus,''
All Foods Natural (2013) (available online at: http://www.allfoodnatural.com/article/history-of-citrus.html). The U.S. human
population has been exposed to the Citrus tristeza (C. tristeza) virus
in citrus products for at least two decades since its discovery as
being widespread in the Florida citrus industry in the mid-1990s. No
adverse effects from this exposure in people have been reported. This
lack of adverse effects is consistent with the fact that C. tristeza is
a plant virus, and plant viruses do not cause disease in humans; human
intestines commonly harbor plant viruses without any adverse effect.
(Ref. 1.)
    Spinach defensin proteins are naturally found in every spinach
plant, and oral exposure to the spinach plant provides exposure to
these proteins. There is a long history of mammalian consumption of the
entire spinach plant (both raw and cooked) as food, without causing any
known deleterious human health effects or any evidence of toxicity.
Spinach plant leaves have long been part of the human diet, and there
have been no findings that indicate toxicity or allergenicity of
spinach proteins.
    Diverse defensin proteins are expressed by most eukaryotic species
to combat various bacterial and fungal organisms. Bioinformatic
sequence comparisons to assess the toxicity potential of spinach
defensin 2 (SoD2), spinach defensin 7 (SoD7), and spinach defensin 8
(SoD8) were conducted for this tolerance exemption extension and
yielded no potential significant toxicity matches. Furthermore,
literature searches did not produce any papers that showed any
mammalian toxicity associated with spinach or spinach defensins. In
addition, available data demonstrate that SoD2, SoD7, and SoD8 proteins
have very low oral toxicity. In an acute oral toxicity study conducted
with a single dose of 5,000 milligram/kilogram (mg/kg) of microbial-
produced SoD2 protein, no evidence of toxic or adverse effects was
observed. Due to the high similarity between SoD2, SoD7, and SoD8, the
toxicity assessment is applicable to all three proteins.
    Because SoD2, SoD7, and SoD8 are proteins, EPA also evaluated their
potential for allergenicity. An updated bioinformatics analysis was
conducted for this EUP extension in which sequence comparisons were
made between the novel proteins from spinach against those of known and
putative allergens in a search of the AllergenOnline.org database based
on the 35% amino acid identity criterion established by Codex (Ref. 2).
The analysis (Ref. 3) indicated that there are no sequence homology
matches that are of concern with known allergens based on the Codex
criterion.
    In an in vitro study, microbial produced SoD2 and SoD7 proteins
were rapidly and extensively hydrolyzed in stimulated gastric and
intestinal conditions in the presence of pepsin (at pH 1.2) and
pancreatin, respectively. Both microbial-produced SoD2 and SoD7
proteins demonstrated half-lives of approximately five minutes when
subjected to pepsin digest, and both proteins were completely
proteolyzed to amino acids and small peptide fragments in less than one
minute in the presence of 0.15 milligram/liter (mg/ml) pancreatin.
These results indicate that both the SoD2 and SoD7 proteins are highly
susceptible to degradation in conditions similar to the human digestive
tract.
    An evaluation of the similarities of SoD8 compared to SoD2 and SoD7
proteins to estimate SoD8 protein digestibility was conducted. The
sequences are homologous, but SoD8 is longer on both N and C terminal
ends. The proteins were found to be nearly

identical in major overlapping sequences, while SoD8 has one more
pepsin cleavage site compared to SoD2 and SoD7. This analysis indicates
that SoD8 should be digested very similarly to SoD2 and SoD7.
    Based on the source, bioinformatics, and digestibility of these
proteins, EPA concludes that these spinach defensin proteins will not
pose any allergenicity concerns. In sum, EPA concludes that due to the
lack of toxicity and pathogenicity concerns for C. tristeza and any
toxicity or allergenicity concerns for the spinach defensin proteins 2,
7, and 8, the altered C. tristeza virus expressing these spinach
defensin proteins does not pose any toxicity, pathogenicity, or
allergenicity concerns. Therefore, EPA did not identify any points of
departure for regulating exposure, and a qualitative assessment was
conducted. For further information about EPA's assessment of the Citrus
tristeza virus that has been genetically altered to express spinach
defensin proteins 2 (SoD2), 7 (SoD7), and 8 (SoD8), see the C. tristeza
SoD2, SoD7, and SoD8 March 2016 Human Health Review found in Docket ID
EPA-HQ-OPP-2016-0034 and the August 2020 review found in Docket ID No.
EPA-HQ-OPP-2019-0182.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for residue from genetically engineered C. tristeza expressing spinach
defensins SoD2, SoD7, and SoD8 (i.e., including 88232-EUP-1), and
exposure from non-occupational sources.
    The Agency anticipates that there may be dietary exposure to Citrus
tristeza virus expressing spinach defensin proteins 2, 7, and 8 (either
alone or in combinations with each other) from the consumption of
citrus products treated with this pesticide. Significant dietary
exposure to spinach defensin proteins 2, 7, and 8 (either alone or in
combinations with each other) from use of this pesticide is not
expected due to the very low expression of the defensin proteins from
the C. tristeza vector. Dietary exposure to spinach defensins from
consumption of treated citrus products containing them will be far
below the amount consumed from raw and cooked spinach. Recent U.S.
consumption statistics indicate that, on average, 2 lbs. of spinach are
consumed per person per year in the United States. ``Spinach Profile,''
Agricultural Marketing Resource Center (June 2013). (http://www.agmrc.org/commodities_products/vegetables/spinach-profile/). EPA
has also approved another experimental use permit (88232-EUP-1)
involving use of defensin proteins SoD2 and SoD7, to which people may
be exposed. A total of 75 kg of SoD proteins was authorized for
treatment of 720 acres in Florida and Texas. May 6, 2015 (80 FR 25943)
(FRL-9926-99) and August 28, 2015 (80 FR52270) (FRL-9931-26). In terms
of nonpesticidal dietary exposure, the U.S. population will continue to
be exposed to C. tristeza virus through infected citrus plants and will
continue to be exposed to these spinach defensin proteins through
consumption of spinach plants. Exposure to the C. tristeza vector and
spinach defensin proteins is likely; however, risk via consumption is
unlikely due to the low toxicity and high digestibility of the active
ingredients.
    Residues in drinking water from use of this pesticide will be
extremely low or non-existent since the pesticide will be present only
in the vascular tissue of citrus trees and is applied under the bark;
therefore, it is highly unlikely that any environmental exposure will
occur.
    The Agency does not expect there to be any non-occupational
exposure to this pesticide chemical residue. Exposure via the skin or
inhalation is not likely since the viral vector will be phloem limited
in citrus trees, and very little phloem is present in citrus fruit,
which essentially eliminates these exposure routes or reduces these
exposure routes to negligible.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    Citrus tristeza virus expressing spinach defensin proteins 2, 7,
and 8 (either alone or in combinations with each other) is not toxic
and does not have a common mechanism of toxicity with any other
substances. Consequently, section 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility
of infants and children to pesticide chemical residues, and the
cumulative effects on infants and children of the residues and other
substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional
tenfold (10X) margin of exposure (safety) for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of exposure (safety) will
be safe for infants and children. This additional margin of exposure
(safety) is commonly referred to as the Food Quality Protection Act
Safety Factor (FQPA SF).
    In applying this provision, EPA either retains the default value of
10X or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. Based on the
information discussed in Unit III, EPA concludes that there are no
threshold effects of concern to infants, children, or adults from
exposure to the spinach defensing proteins SoD2, SoD7, and SoD8. As a
result, EPA concludes that no additional margin of exposure (safety) is
necessary to protect infants and children and that not adding any
additional margin of exposure (safety) will be safe for infants and
children.
    Based on the discussion in this document and supporting documents,
EPA concludes that there is a reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to the residues of C. tristeza expressing spinach
defensin proteins SoD2, SoD7, and SoD8. Such exposure includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
based on a lack of toxicity and anticipated low likelihood of
allergenicity of the C. tristeza expressing spinach defensin proteins
SoD2, SoD7, and SoD8.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation based on the lack of any
toxicity or allergenicity of the C. tristeza virus expressing spinach
defensin proteins 2, 7, and 8.

B. Response to Comments

    One comment was received in response to the Notice of Filing. The
submitted comment suggested that Citrus tristeza virus expressing
spinach defensin proteins 2, 7, and 8 could be correlated with
Creutzfeldt-Jakob disease and dementia.
    Creutzfeldt-Jakob disease (CJD) is caused by misfolding of human
protein PrP, which can occur genetically, sporadically, or through
infection, not from exposure to Citrus tristeza or SoD nucleic acids or
proteins. Inherited form is not caused by any external infectious agent
but by mutation in the gene. The epidemiological evidence strongly
suggests that sporadic form of CJD is also not acquired from an
external infectious source. Infectious CJD is associated with exposure
to the tissues of an affected person via surgical procedures or medical
treatments, or dietary exposure to bovine spongiform encephalopathy via
consumption of contaminated beef meat or other products. Presently,
there is no concern about any association between CJD and Citrus
tristeza or SoD nucleic acids or proteins.
    Dementia is a symptom rather than a disease and can occur as a
result of multiple diseases and disorders, in particular, as a result
of CJD. There is no evidence at all that any form of dementia can be
associated with CTV or SoD nucleic acids or protein consumption or
exposure by other routes.
    EPA has no evidence of the consumption Citrus tristeza virus or
spinach has led to adverse outcomes. The U.S. human population has been
exposed to the Citrus tristeza virus in citrus products for at least
two decades since its discovery as being widespread in the Florida
citrus industry in the mid-1990s. Also, there is a long history of
mammalian consumption of the entire spinach plant (both raw and cooked)
as food, without causing any known deleterious human health effects or
any evidence of toxicity. Furthermore, diverse defensin proteins are
expressed by most eukaryotic species to combat various bacterial and
fungal organisms.

VIII. Conclusion

    Therefore, the expiration date for the current temporary exemption
for residues of Citrus tristeza virus expressing spinach defensin
proteins 2, 7, and 8 associated with Experimental Use Permit No. 88232-
EUP-2 is extended from August 31, 2020, to August 31, 2023.

IX. References

1. U.S. Environmental Protection Agency. Meeting Minutes of the
FIFRA Scientific Advisory Panel Meeting Held December 6-8, 2005 on
Plant-Incorporated Protectants Based on Virus Coat Protein Genes:
Science Issues Associated with the Proposed Rule, http://www.regulations.gov. Docket No. EPA-HQ-OPP-2005-0249-12.
2. Codex Alimentarius Commission. 2003. Alinorm 03/34: Appendix III.
Guideline for the conduct of food safety assessment of foods derived
from recombinant DNA plants. Annex IV. Annex on the assessment of
possible allergenicity, Rome, Italy.
3. Updated bioinformatics analysis for extension of experimental use
permit 88232-EUP-2 and extension of the associated temporary
tolerance exemption for Citrus tristeza virus expressing spinach
defensin proteins 2, 7 and 8 at 40 CFR part 180.1337 for additional
3 years. Memorandum from N. Baranova through J. Kough to K. Welch,
dated June 23, 2020. http://www.regulations.gov. Docket No. EPA-HQ-
OPP-2019-0182.

X. Statutory and Executive Order Reviews

    This action modifies an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 26, 2020.
Jean Overstreet,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  180.1337 to read as follows:

Sec.  180.1337  Citrus tristeza virus expressing spinach defensin
proteins 2, 7, and 8; exemption from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is
established for residues of the microbial pesticide Citrus tristeza
virus expressing spinach defensin proteins 2, 7, and 8 (either alone or
in combinations with each other) in or on the commodities listed in
fruit, citrus group 10-10, when used in accordance with the terms of
Experimental Use Permit No. 88232-EUP-2. This temporary exemption from
the requirement of a tolerance expires on August 31, 2023.

[FR Doc. 2020-19351 Filed 8-28-20; 4:15 pm]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Page 46664]
[FR Doc No: 2016-16895]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-96-000]

PJM Interconnection, L.L.C.; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On July 11, 2016, the Commission issued an order in Docket No.
EL16-96-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of certain aspects of PJM Interconnection, L.L.C.'s
Amended and Restated Operating Agreement. PJM Interconnection, L.L.C.,
156 FERC ] 61,030 (2016).
    The refund effective date in Docket No. EL16-96-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: July 12, 2016.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-16895 Filed 7-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67018-67020]
[FR Doc No: 2013-26474]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0936; Directorate Identifier 2013-CE-033-AD;
Amendment 39-17652; AD 2013-22-20]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Embraer
S.A. Model EMB-505 airplanes. This AD results from mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as cracking
in the stator pressure plate of the brake assembly, which may lead to
loss of brake parts on the runway and reduced brake capability with
possible runway excursion. We are issuing this AD to require actions to
address the unsafe condition on these products.

DATES: This AD is effective November 8, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of November 8,
2013.
    We must receive comments on this AD by December 23, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact EMBRAER
S.A., Phenom Maintenance Support, Avenida Brigadeiro Faria Lima, 2170,
Putim, CEP: 12227-901, Sao Jose dos Campos, Sao Paulo, Brasil; phone:
(+55 12) 3927-1000; Fax: (+55 12) 3927-6600, Ext. 1448; email:
<EMAIL_ADDRESS>Internet: http://www.embraerexecutivejets.com/en-US/customer-support/Pages/Service-Center-Network.aspx. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The Agencia Nacional De Aviacoa Civil (ANAC), which is the aviation
authority for Brazil, has issued emergency AD No.: 2013-09-01, dated
September 26, 2013 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    It has been found the occurrence of cracks in the stator
pressure plate of the brake assembly of the airplane, which may lead
to loss of brake parts in the runway, and to a reduced airplane
brake capability with possible runway excursion event. Since this
condition may occur in other airplanes of the same type and affects
flight safety, an immediate corrective action is required. Thus,
sufficient reason exists to request compliance with this EAD in the
indicated time limit without prior notice.

The MCAI requires an inspection to determine if the airplane has the
affected part number (P/N) brake assembly installed and inspection for
cracks of the affected brake assembly with repair or replacement as
necessary. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2013-0936.

Relevant Service Information

    Embraer S.A. has issued Phenom Alert Service Bulletin No. 505-32-
A011, dated September 13, 2013. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
cracking of the stator pressure plate of the brake assembly could lead
to loss of brake parts on the runway, which could result in reduced
brake capability with a possible runway excursion. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2013-0936; Directorate
Identifier 2013-CE-033-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD will affect 88 products of U.S. registry.
We also estimate that it would take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $14,960, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour and require parts costing $2,324, for a cost of
$2,409 per product for repair; or 3 work-hours and require parts
costing $25,187, for a cost of $25,442 per product for brake assembly
replacement. We have no way of determining the number of products that
may need these actions.
    According to the manufacturer, all of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-22-20 Embraer--Empresa Brasileira de Aeronautica S.A.:
Amendment 39-17652; Docket No. FAA-2013-0936; Directorate Identifier
2013-CE-033-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective November 8,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Embraer S.A. Models EMB-505 airplanes, all
serial numbers, that are:
    (1) Equipped with a part number (P/N) DAP00097-01 or P/N
DAP00097-02 brake assembly; and
    (2) certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 32: Landing
Gear.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as cracking in the
stator pressure plate of the brake assembly, which may lead to loss
of brake parts on the runway. We are issuing this AD to detect and
correct cracking of the stator pressure plate and possible loss of
brake parts on the runway, which could result in reduced brake
capability and a possible runway excursion.

 (f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (f)(9) of this AD, including all subparagraphs.
    (1) If the number of cycles is unknown, calculate the compliance
times of cycles in this AD by using hours time-in-service (TIS).
Multiply the number of hours TIS on the brake assembly by .71 to
come up with the number of cycles. For the purposes of this AD some
examples are below:
    (i) 500 hours TIS equates to 355 cycles; and
    (ii) 12 hours equates to 9 cycles.
    (2) Do a general visual inspection (GVI) for cracks in the
stator pressure plate on both the left hand (LH) and right hand (RH)
brake assemblies following the Accomplishment Instructions in
Embraer Phenom Alert Service Bulletin No. 505-32-A011, dated
September 13, 2013. Use the compliance times in paragraphs (f)(2)(i)
and (f)(2)(ii):
    (i) For brake assemblies with 300 flight cycles or less since
new or since the last overhaul: Before or upon accumulating 150
flight cycles or within the next 30 flight cycles, whichever occurs
later, and repetitively thereafter at intervals not to exceed 60
flight cycles or the next tire change, whichever occurs first.
    (ii) For brake assemblies with more than 300 flight cycles since
new or since the last overhaul: Within the next 10 flight cycles and
repetitively thereafter at intervals not to exceed 60 flight cycles
or the next tire change, whichever occurs first.
    (3) If no cracks are found during any of the inspections
required in paragraph (f)(2) of this AD, continue the repetitive
inspection intervals required in paragraph (f)(2) of this AD,
including all subparagraphs.
    (4) If during any of the inspections required in paragraph
(f)(2) of this AD, including all subparagraphs, any crack is found
in the stator pressure plate, before further flight, do a detailed
inspection (DET) following the Accomplishment Instructions in
Embraer Phenom Alert Service Bulletin No. 505-32-A011, dated
September 13, 2013.
    (5) If no cracks beyond the acceptable limits are found during
the DET required in paragraph (f)(4) of this AD, continue the
repetitive inspection intervals required in paragraph (f)(2) in this
AD, including all subparagraphs.
    (6) If cracks that exceed the acceptable limits are found during
the DET required in paragraph (f)(4) of this AD, before further
flight, repair the brake assembly following Appendix 2 of Embraer
Phenom Alert Service Bulletin No. 505-32-A011, dated September 13,
2013; or replace the brake assembly with a brake assembly that has
been inspected and found free of cracks that exceed the acceptable
limits following the Accomplish Instructions of Embraer Phenom Alert
Service Bulletin No. 505-32-A011, dated September 13, 2013. After
repair or replacement of the brake assembly, the brake assembly is
subject to the inspections required in paragraphs (f)(2), including
all subparagraphs, of this AD.

    Note 1 to paragraph (f)(6) of this AD: Appendix 2 of Embraer
Phenom Alert Service Bulletin No. 505-32-A011, dated September 13,
2013, includes Meggitt Aircraft Braking System Service Bulletin No.
SB-32-1625, dated September 13, 2013.

    (7) For the purposes of this AD, a GVI is a visual examination
of an interior or exterior area, installation or assembly, to detect
obvious damage, failure, or irregularity. This level of inspection
is made from within touching distance, unless otherwise specified. A
mirror may be necessary to enhance visual access to all exposed
surfaces in the inspection area. This level of inspection is made
under normally available lighting conditions such as daylight,
hangar lighting, flashlight, or drop-light. It may require removal
or opening of access panels or doors. Stands, ladders, or platforms
may be required to gain proximity to the area being checked.
    (8) For the purposes of this AD, a DET is an intensive
examination of a specific item, installation or assembly, to detect
damage, failure, or irregularity. Available lighting is normally
supplemented with a direct source of good lighting at an intensity
deemed appropriate. Inspection aids such as mirrors, magnifying
lenses, etc., may be necessary. Surface cleaning and elaborate
access procedures may be required.
    (9) After the effective the date of this AD, do not install on
any airplane a brake assembly P/N DAP00097-01 or P/N DAP00097-02
unless it is inspected per the requirements of this AD and continues
to be crack free or the cracks do not exceed the allowable limits.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI Agencia Nacional De Aviacoa Civil (ANAC) AD No.:
2013-09-01, dated September 26, 2013, for related information. You
may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2013-0936.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Embraer Phenom Alert Service Bulletin No. 505-32-A011, dated
September 13, 2013.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
EMBRAER S.A., Phenom Maintenance Support, Avenida Brigadeiro Faria
Lima, 2170, Putim, CEP: 12227-901, Sao Jose dos Campos, Sao Paulo,
Brasil; phone: (+55 12) 3927-1000; Fax: (+55 12) 3927-6600, Ext.
1448; email<EMAIL_ADDRESS>Internet: http://www.embraerexecutivejets.com/en-US/customer-support/Pages/Service-Center-Network.aspx.
    (4) You may review copies of the referenced service information
at the FAA, Small Airplane Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on October 30, 2013.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013-26474 Filed 11-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 17, 2006 (Volume 71, Number 95)]
[Notices]
[Page 28730-28732]
[DOCID:fr17my06-96]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53787; File No. SR-NASD-2006-053]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change and Amendment No. 1 Thereto To Establish
Additional Routing Options in the INET System for Securities Listed on
the New York Stock Exchange or the American Stock Exchange

May 11, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 21, 2006, the National Association of Securities Dealers,
Inc., through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``SEC'' or the ``Commission'') the proposed rule change as described
in Items I and II below, which items have been prepared by Nasdaq. On
May 5, 2006, Nasdaq submitted Amendment No. 1 to the proposed rule
change.\3\ Nasdaq has designated the proposed rule change as a ``non-
controversial'' rule change pursuant to Section 19(b)(3)(A) of the Act
\4\ thereunder,\5\ which renders the proposal effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, Nasdaq revised the proposed rule text to
specify that the Nasdaq-specified time period under the proposed DOT
Alternative 2 routing option would not exceed 30 seconds and added a
representation to the purpose section regarding communicating
changes to the Nasdaq-specified time period to INET users promptly.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to establish two additional routing options in its
INET System for orders in securities listed on the New York Stock
Exchange LLC (``NYSE'') or the American Stock Exchange LLC (``AMEX'').
    The text of the proposed rule change is below. Proposed new
language is underlined; proposed deletions are in [brackets].\6\
---------------------------------------------------------------------------

    \6\ Changes are marked to the rule text that appears in the
electronic NASD Manual that can be found at http://www.nasd.com.

---------------------------------------------------------------------------

    4956. Routing
    (a) INET Order Routing Process.
    (1) The INET Order Routing Process shall be available to
Participants from 7 a.m. to 8 p.m. Eastern Time, and shall route orders
as described below:
    (A) Exchange-Listed Routing Options.
    The System provides [six] eight routing options for orders in
exchange-listed securities. Of these [six] eight, [only three] five--
DOT Immediate, DOT Alternative, DOT Alternative 2, Reactive Only DOT
and DOT Nasdaq--are available for orders ultimately sought to be
directed to either the New York Stock Exchange (``NYSE'') or the
American Stock Exchange (``AMEX''). The System also allows firms to
send individual orders to the NYSE Direct + System, and to elect to
have orders not be sent to the AMEX. The [six] eight System routing
options for NYSE and/or Amex listed orders are:
    (i) DOT Immediate (``DOTI'')--under this option, after checking the
INET System for available shares, orders are sent directly to the NYSE
or the AMEX as appropriate. When checking the INET book, the System
will seek to execute at the better price of either the limit price
specified in the order, or the best price displayed at that time at the
NYSE. If no liquidity is available in the INET System, the order will
be routed directly to the NYSE or AMEX at the limit order price. This
option may only be used for orders with time-in-force parameters of
either DAY, IOC, or market-on-open/close. Only limit orders may be used
with this option.
    (ii) DOT Alternative (``DOTA'')--under this option, after checking
the INET System for available shares, orders are sent to other
available market centers for potential execution before the destination
exchange. Any un-executed portion will thereafter be sent to the NYSE
or AMEX, as appropriate, at the order's original limit order price.
This option may only be used for orders with time-in-force parameters
of either DAY, IOC, or market-on-open/close. Only limit orders may be
used with this strategy.
    (iii) DOT Alternative 2 (``DOTA2'')--under this option, orders
first check the INET book and then other market centers for potential
execution. Any portion of the order that remains unexecuted is posted
on the INET book until the expiration of the Nasdaq-specified time
period at either the order's limit price or, if the limit price would
lock or cross the market, at the highest bid or lowest offer that would
not lock the market. At the expiration of the period specified by
Nasdaq (which will not exceed 30 seconds), any remaining unexecuted
portion of the order is sent to the NYSE or AMEX, as appropriate (the
destination exchange). DOTA2 orders entered prior to the destination
exchange's opening time will be displayed on the INET book until
immediately prior to the opening time and then sent to the destination
exchange. This option may only be used for orders with a time-in-force
parameter of DAY. Only limit orders may be used with this strategy.
    (iv) Reactive Only DOT (``DOTR'')--under this option, orders first
check the INET book and then other market centers and the destination
exchanges (the NYSE or the AMEX, as appropriate) for potential
execution. Any portion of the order that remains unexecuted is posted
on the INET book (unless they were sent to the destination exchange).
Subsequently, if an order that was posted on the INET book became
locked or crossed by another accessible market center or destination
exchange, the System will route the order to the locking or crossing
market center or destination exchange. Whenever an order is sent to the
destination exchange, it is sent at its original price for potential
display and/or execution. This option may only be used for orders with
a time-in-force parameter of DAY. Only limit orders may be used with
this strategy.
    [(iii)] (v) Reactive Electronic Only (``STGY'')--under this option,
after checking the INET System for available shares, orders are sent to
other available market centers for potential execution. When checking
the INET book, the System will seek to execute at the price it would
send the order to a non-INET destination market center. If shares
remain un-executed after routing, they are posted on the INET book and
are not sent to the NYSE or AMEX. Once on the INET book, should the
order subsequently be locked or crossed by another accessible market
center, the System shall route the order to the locking or crossing
market center for potential execution. With the exception

of the Minimum Quantity order type, all time-in-force parameters and
order types may be used in conjunction with this routing option. This
process is one of the routing strategies allowed by the System for all
securities.
    [(iv)] (vi) Electronic Only Scan (``SCAN'')--under this option,
after checking the INET System for available shares, orders are sent to
other available market centers for potential execution. When checking
the INET book, the System will seek to execute at the price it would
send the order to a non-INET destination market center. If shares
remain un-executed after routing, they are posted on the INET book and
are not sent to the NYSE or AMEX. Once on the INET book, should the
order subsequently be locked or crossed by another accessible market
center, the System will not route the order to the locking or crossing
market center. With the exception of the Minimum Quantity order type,
all time-in-force parameters and order types may be used in conjunction
with this routing option. This process is one of the routing strategies
allowed by the System for all securities.
    [(v)] (vii) Aggressive Electronic Only (``SPDY'')--under this
option, after checking the INET System for available shares, orders are
sent to other available market centers for potential execution. When
checking the INET book, the System will seek to execute at the price it
would send the order to a non-INET destination market center. If shares
remain un-executed after routing, they are posted on the INET book and
are not sent to the NYSE or AMEX. Once on the INET book, should the
order subsequently be locked or crossed by another accessible market
center, the System shall route the order to the locking or crossing
market center for potential execution. Market orders with the SPDY
designation will, during a locked or crossed market, have their price
adjusted by the System to match the best price displayed on the same
side of the market as the market order (i.e., a buy order to the bid, a
sell to the offer). If the order is for a security eligible for a de
minimis exception to the trade-through rule set forth in Section 8
(d)(i) of the ITS Plan, the System will ignore AMEX prices when
adjusting the SPDY order. With the exception of the Minimum Quantity
order type, all time-in-force parameters and order types may be used in
conjunction with this routing option. This process is one of the
routing strategies allowed by the System for all securities.
    [(vi)] (viii) DOT Nasdaq (``DOTN'')--under this option, after
checking the INET System for available shares, orders are sent to other
available market centers that are owned by Nasdaq, including the Nasdaq
Market Center and/or Nasdaq's Brut Facility for potential execution
before the destination exchange. When checking the INET book, the
System will seek to execute at the price it would send the order to a
non-INET destination market center as designated by the entering party.
Any un-executed portion will thereafter be sent to the NYSE or AMEX, as
appropriate, at the order's original limit order price. This option may
only be used for orders with time-in-force parameters of either DAY,
IOC, or market-on-open/close.
    (B) and (C) No change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change, as
amended, and discussed any comments it received on the proposal. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Users of Nasdaq's INET System are currently able to select (subject
to their best execution obligations to their own customers, if
applicable) from among six different routing options for orders in
securities listed on the NYSE or the AMEX. Some of the existing user
choices instruct INET to route such orders to the NYSE or the AMEX,
while others instruct INET to route to a subset of market centers.
    Nasdaq is proposing to give INET System users two additional
options for how and when INET should route their orders to the NYSE or
the AMEX (the ``destination exchanges''). Under the proposed DOT
Alternative 2 option, the INET System first checks the INET book and
then other market centers (but not the destination exchanges) for
potential executions. Any portion of the order that remains unexecuted
is then posted on the INET book at the order's limit price. (If the
limit price would lock or cross the market, the order is posted at the
highest price for buy orders or lowest price for sell orders that would
not lock or cross the market.) At the posted order's expiration time,
any portion that still remains unexecuted is sent to the NYSE or the
AMEX for display or execution at the original limit price. The length
of time from the posting of an order to its expiration will be set by
Nasdaq for all orders that select the DOT Alternative 2 option. The
expiration time is currently set at three seconds from the time of
order posting, but in response to INET System users' preferences,
Nasdaq may adjust it from time to time in the future. Nasdaq represents
that it will promptly communicate to INET System users any adjustments
it makes to the length of this time period.
    The proposed Reactive Only DOT order is similar to the Reactive
Electronic Only order, but it also includes the manual NYSE and AMEX
markets in its initial routing. Under the Reactive Only DOT option, the
INET System first checks the INET book and then other market centers
and the destination exchanges (the NYSE and the AMEX) for potential
executions. Any portion of the order that remains unexecuted is posted
on the INET book. (Of course, any portion of the order that during the
checking process had appeared marketable at the destination exchange
and was sent there, but then failed to execute, would be displayed at
that exchange and not in the INET book.) If any accessible market
center or destination exchange subsequently locks or crosses the order,
INET will route it to the locking/crossing market center or exchange.
If an order is sent to the destination exchange but fails to execute
completely, the unexecuted portion will be displayed by that exchange
and will not return to INET for display purposes. Nasdaq notes that the
new choices will give users of the INET System added flexibility when
handling orders for NYSE- and AMEX-listed securities. Nasdaq believes
that such flexibility will undoubtedly help users as they seek to
achieve best execution of orders. The proposal does not remove or
change any of the INET System's existing functions, and its users will
remain free not to take advantage of the new choices that are being
made available to them.
2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of Section 15A of the Act,\7\ in
general, and with Section

15A(b)(6) of the Act,\8\ in particular, in that it is designed to
promote just and equitable principles of trade and to remove
impediments to and perfect the mechanism of a free and open market and
a national market system. Specifically, Nasdaq notes that the proposal
offers users of the INET System additional flexibility in selecting the
most appropriate routing strategy for their orders.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3.
    \8\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Nasdaq has designated the foregoing rule change, as amended, as a
``non-controversial'' rule change pursuant to Section 19(b)(3)(A) of
the Act \9\ and Rule 19b-4(f)(6) thereunder \10\ because the rule
change does not: (i) Significantly affect the protection of investors
or the public interest; (ii) impose any significant burden on
competition; or (iii) become operative for 30 days from the day on
which it was filed, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest. Nasdaq has requested that the Commission waive the
requirement that the rule change not become operative for 30 days after
the date of the filing. The Commission hereby grants the request. The
Commission believes that waiving the 30-day operative delay for the
proposed rule change, as amended, is consistent with the protection of
investors and the public interest because the proposal would give INET
System users two, additional options for routing their orders and,
therefore, should be implemented without delay. For this reason, the
Commission designates the proposal to be effective and operative upon
filing with the Commission.\11\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\12\
---------------------------------------------------------------------------

    \12\ The effective date of the original proposed rule change is
April 21, 2006 and the effective date of Amendment No. 1 is May 5,
2006. For purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposed rule change, as
amended, under Section 19(b)(3)(C) of the Act, the Commission
considers the period to commence on May 5, 2006, the date on which
the Exchange submitted Amendment No. 1. See 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-053 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASD-2006-053. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASD-2006-053 and should be submitted on or before June
7, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E6-7462 Filed 5-16-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16913-16915]
[FR Doc No: 2019-08100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85669; File No. SR-Phlx-2019-13]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Extend the
Pilot Period for the Exchange's Nonstandard Expirations Pilot Program

April 17, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 10, 2019, Nasdaq PHLX LLC (``Phlx'' or the ``Exchange'')
filed with the Securities and Exchange Commission (the ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been prepared by the Exchange. The Exchange filed the
proposal as a ``non-controversial'' proposed rule change pursuant to
Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6)
thereunder.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot period for the Exchange's
nonstandard expirations pilot program, currently set to expire on May
6, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On December 15, 2017, the Commission approved a proposed rule
change for the listing and trading on the Exchange, on a twelve month
pilot basis, of p.m.-settled options on broad-based indexes with
nonstandard expirations dates.\5\ The pilot program permits both Weekly
Expirations and End of Month (``EOM'') expirations similar to those of
the a.m.-settled broad-based index options, except that the exercise
settlement value of the options subject to the pilot are based on

the index value derived from the closing prices of component stocks.
The Exchange previously filed to extend the pilot through May 6,
2019.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 82341 (December 15,
2017), 82 FR 60651 (December 21, 2017) (approving SR-Phlx-2017-79)
(Order Approving a Proposed Rule Change, as Modified by Amendment
No. 1 and Granting Accelerated Approval of Amendment No. 2, of a
Proposed Rule Change To Establish a Nonstandard Expirations Pilot
Program).
    \6\ See Securities Exchange Act Release No. 84835 (December 17,
2018), 83 FR 65773 (December 21, 2018) (approving SR-Phlx-2018-80)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Pilot Period for the Exchange's Nonstandard
Expirations Pilot Program).
---------------------------------------------------------------------------

    Pursuant to Phlx Rule 1101A(b)(5)(A) the Exchange may open for
trading Weekly Expirations on any broad-based index eligible for
standard options trading to expire on any Monday, Wednesday, or Friday
(other than the third Friday-of- the- month or days that coincide with
an EOM expiration). Weekly Expirations are be subject to all provisions
of Exchange Rule 1101A and are treated the same as options on the same
underlying index that expire on the third Friday of the expiration
month. Unlike the standard monthly options, however, Weekly Expirations
are p.m.-settled.
    Similarly, pursuant Rule 1101A(b)(5)(B) the Exchange may open for
trading End of Month (``EOM'') on any broad-based index eligible for
standard options trading to expire on the last trading day of the
month. EOMs are subject to all provisions of Rule 1101A and treated the
same as options on the same underlying index that expire on the third
Friday of the expiration month. However, the EOMs are p.m.-settled.
    The Exchange now proposes to amend Exchange Rule 1101A(b)(5)(C) so
that the duration of the pilot program for these nonstandard
expirations will be through November 4, 2019. The Exchange continues to
have sufficient systems capacity to handle p.m.-settled options on
broad-based indexes with nonstandard expirations dates and has not
encountered any issues or adverse market effects as a result of listing
them. Additionally, there is continued investor interest in these
products. The Exchange will make public on its website any data and
analysis it submits to the Commission under the pilot program.
    Finally, the Exchange proposes to amend Phlx Rule 1101A(b)(3)(d).
The Exchange proposes to capitalize the ``d'' so the cite becomes Phlx
Rule 1101A(b)(3)(D).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
The Exchange believes the proposed rule change will protect investors
and the public interest by providing the Exchange, the Commission and
investors the benefit of additional time to analyze nonstandard
expiration options. By extending the pilot program, investors may
continue to benefit from a wider array of investment opportunities.
Additionally, both the Exchange and the Commission may continue to
monitor the potential for adverse market effects of p.m.-settlement on
the market, including the underlying cash equities market, at the
expiration of these options.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Options with nonstandard
expirations would be available for trading to all market participants.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
investors may continue to trade nonstandard expiration options listed
by the Exchange as part of the pilot program on an uninterrupted basis.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest as
it will allow the pilot program to continue uninterrupted, thereby
avoiding investor confusion that could result from a temporary
interruption in the pilot program. Accordingly, the Commission hereby
waives the operative delay and designates the proposed rule change
operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2019-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2019-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2019-13 and should be submitted on
or before May 14, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-08100 Filed 4-22-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68503-68504]
[FR Doc No: 2022-24805]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0526]

David Elias Mendoza: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
David Elias Mendoza for a period of 5 years from importing or offering
for import any drug into the United States. FDA bases this order on a
finding that Mr. Mendoza engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Mr. Mendoza was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of March 28, 2022 (30 days after receipt
of the notice), Mr. Mendoza had not responded. Mr. Mendoza's failure to
respond and request a hearing within the timeframe prescribed by
regulation constitutes a waiver of his right to a hearing and any
contentions concerning this matter.

DATES: This order is applicable November 15, 2022.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4144), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged
in a pattern of importing or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer) that are not designated in
an authorized electronic data interchange system as products regulated
by FDA.
    After an investigation, FDA discovered that Mr. Mendoza has engaged
in numerous instances of importing or offering for import misbranded
drugs (i.e., in an amount, frequency, or dosage that is inconsistent
with his personal or household use) that were not designated in an
authorized electronic data interchange system as products that are
regulated by FDA; all the parcels containing the misbranded drugs
serving as the basis for this action, described in further detail
below, were intercepted by FDA at the John F. Kennedy (JFK)
International Mail Facility (IMF) and were addressed to Mr. Mendoza at
one of two addresses connected to him.
    On or about June 4, 2019, Mr. Mendoza offered for import a parcel
that contained 250 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label and lacked
adequate directions for use in its labeling. The product was refused
entry on July 9, 2019.
    On or about January 24, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 20, 2020.
    On or about January 29, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 25, 2020.
    On or about January 30, 2020, Mr. Mendoza offered for import a
parcel that contained 270 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on February 25, 2020.
    On or about February 14, 2020, Mr. Mendoza offered for import a
parcel that contained 330 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 17, 2020.
    On or about February 14, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 17, 2020.
    On or about February 24, 2020, Mr. Mendoza offered for import a
parcel that contained 250 tablets of CENFORCE-100, which was a
misbranded drug because the product was determined to be a prescription
drug product that failed to contain the ``Rx-only'' symbol on its label
and lacked adequate directions for use in its labeling. The product was
refused entry on March 19, 2020.
    On or about June 10, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 10, 2020.
    On or about June 10, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 7, 2020.
    On or about June 16, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product failed to contain adequate directions for use in
its labeling. The product was refused entry on July 14, 2020.
    On or about June 16, 2020, Mr. Mendoza offered for import a parcel
that contained 320 tablets of CENFORCE-100, which was a misbranded drug

because the product failed to contain adequate directions for use in
its labeling. The product was refused entry on July 14, 2020.
    On or about June 18, 2020, Mr. Mendoza offered for import a parcel
that contained 300 tablets of CENFORCE-100, which was a misbranded drug
because the product was determined to be a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on July 15, 2020.
    As a result of Mr. Mendoza's pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA, in accordance with section 306(b)(3)(D) of
the FD&C Act, FDA sent Mr. Mendoza, by certified mail on February 17,
2022, a notice proposing to debar him for a 5-year period from
importing or offering for import any drug into the United States.
    In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Mr. Mendoza's pattern of conduct and concluded that his
conduct warranted the imposition of a 5-year period of debarment.
    The proposal informed Mr. Mendoza of the proposed debarment and
offered him an opportunity to request a hearing, providing 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. Mr. Mendoza received the proposal and notice of opportunity for
a hearing on February 26, 2022. Mr. Mendoza failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a hearing and waived any contentions
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. David
Elias Mendoza has engaged in a pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. FDA finds that this pattern of conduct
should be accorded a debarment period of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
    As a result of the foregoing finding, Mr. Mendoza is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Mr. Mendoza is a
prohibited act.
    Any application by Mr. Mendoza for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0526 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24805 Filed 11-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Page 63711]
[FR Doc No: 2019-24920]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. 2120-0559]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: SF-272,
Federal Cash Transaction Report; 9550-5, Final Project Report; SF-424
Application for Federal Assistance; SF-3881, ACH Vendor/Miscellaneous
Payment Enrollment Form; SF-269, Financial Status Report; SF-270,
Request for Advance or Reimbursement

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
Federal Aviation Administration (FAA) invites public comments about its
intention to request the Office of Management and Budget (OMB) approval
to renew an information collection. The information to be collected
will be used to and/or is necessary for the purpose of grant
administration and review in accordance with applicable OMB circulars
A-110, and A-21.

DATES: Written comments should be submitted by January 12, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number
2120-0559 into search field).
    By mail: Trina M. Bellamy, Grants Officer, William J. Hughes
Technical Center, Building 300, Acquisition & Grants Division, Atlantic
City International Airport, Atlantic City, NJ 08405.

FOR FURTHER INFORMATION CONTACT: Subject Matter Expert (SME) Trina M.
Bellamy by email at<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0559.
    Title: Same title as above.
    Form Numbers: SF-272, 9550-5, SF-424, SF-3881, SF-269, SF-270.
    Type of Review: Renewal.
    Background: The FAA Aviation Research Grant Program establishes
uniform policies and procedures for the award and administration of
research grants and cooperative agreements to colleges, universities,
not for profit research institutions for research that is of potential
benefit to the long-term growth of civil aviation and Commercial Space
Transportation. This program implements OMB Circular A-110, Public Law
101-508, Section 9205 and 9208 and Public Law 101-604, Section 107(d).
The information is collected through a solicitation that has been
published by the FAA. Prospective grantees respond to the solicitation
using a proposal format outlined in the solicitation in adherence to
applicable FAA directives, statutes, and OMB circulars.
    Respondents: Colleges, Universities, Non-profit research
institutions.
    Frequency:
    Estimated Average Burden per Response: 90 Minutes.
    Estimated Total Annual Burden: 90 Minutes per respondent.

    Issued in Atlantic City, NJ, on November 13, 2019.
Trina M. Bellamy,
Grants Officer, Acquisition & Grants Division/AAQ-600.
[FR Doc. 2019-24920 Filed 11-15-19; 8:45 am]
 BILLING CODE 4910-13-P