[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Rules and Regulations]
[Pages 56173-56176]
[FR Doc No: 2017-25715]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0616; FRL-9970-06]

Polyethyleneimine; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of polyethyleneimine when used as an inert
ingredient in a pesticide chemical formulation on growing crops and raw
agricultural commodities after harvest. BASF Corporation submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of polyethyleneimine when used as an
inert in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest.

DATES: This regulation is effective November 28, 2017. Objections and
requests for hearings must be received on or before January 29, 2018,
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-2016-0616, 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 review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Director, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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 Printing 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-2016-0616 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
January 29, 2018. 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-2016-0616, 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. Petition for Exemption

    In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-
86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10981) by
Spring Trading Company, LLC, on behalf of BASF Corporation, 100 Campus
Drive, Florham, NJ 07932. The petition requested that 40 CFR 180.910 be
amended by establishing an exemption from the requirement of a
tolerance for residues of polyethyleneimine (CAS Reg. No. 9002-98-6)
when used as an inert ingredient emulsifier, surfactant, adjuvant,
dispersant, and/or coating in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest. That document
referenced a summary of the petition prepared by BASF Corporation, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient through food, drinking water, and through other

exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for polyethyleneimine including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with polyethyleneimine
follows.
    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.
    In the case of certain chemical substances that are defined as
polymers, the Agency has established a set of criteria to identify
categories of polymers expected to present minimal or no risk. The
definition of a polymer is given in 40 CFR 723.250(b) and the exclusion
criteria for identifying these low-risk polymers are described in 40
CFR 723.250(d). Polyethyleneimine conforms to the definition of a
polymer given in 40 CFR 723.250(b) and meets the following criteria
that are used to identify low-risk polymers.
    1. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    2. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    3. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    4. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the Toxic Substances Control Act
(TSCA) Chemical Substance Inventory or manufactured under an applicable
TSCA section 5 exemption.
    5. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    6. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria: Specified in 40 CFR 723.250(e):
    7. The polymer's number average MW of 1,300 is greater than 1,000
and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Polyethyleneimine conforms to the definition of polymer and meets
all of the exclusion criteria in 40 CFR Sec.  723.250, as listed in
this section, except that it is cationic. Cationic polymers are
excluded from the polymer exemption from tolerance under 40 CFR Sec.
723.250 (in which manufacture and distribution of polymers meeting the
exemption criteria can take place without submission of a
Premanufacture Notice (PMN) or an exemption notice prior to
commencement of manufacture for a commercial purpose) because of their
potential to cause aquatic toxicity. The petitioner has submitted
aquatic toxicity studies and based on these studies, the Agency does
not expect toxicity to nontarget aquatic organisms. Because of its
conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to
polyethyleneimine.

V. Aggregate Exposure

    For the purposes of assessing potential exposure under this
exemption, EPA considered that polyethyleneimine could be present in
all raw and processed agricultural commodities and drinking water, and
that non-occupational non-dietary exposure was possible. The number
average MW of polyethyleneimine is 1,300 daltons. Generally, a polymer
of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since
polyethyleneimine conforms to the human health criteria that identify a
low-risk polymer, there are no concerns for risks associated with any
potential exposure scenarios that are reasonably foreseeable. The
Agency has determined that a tolerance is not necessary to protect the
public health.

VI. 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.''
    EPA has not found polyethyleneimine to share a common mechanism of
toxicity with any other substances, and polyethyleneimine does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
polyethyleneimine does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VII. Additional Safety Factor for the Protection of Infants and
Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of polyethyleneimine, based
on its conformance to the human health criteria under 40 CFR 723.250,
EPA has not used a safety factor analysis to assess the risk. For the
same reasons the additional tenfold safety factor is unnecessary.

VIII. Determination of Safety

    Taking into consideration all available information on
polyethyleneimine with a minimum number average molecular weight of
1,300 amu, EPA has determined that there is a reasonable certainty that
no harm to any population subgroup will result from aggregate exposure
to polyethyleneimine under reasonable foreseeable circumstances.
Therefore, the establishment of an exemption from tolerance under 40
CFR 180.910 for residues of polyethyleneimine when used as an inert
ingredient in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest, is safe under FFDCA section
408.

IX. 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.

X. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for polyethyleneimine with a number
average molecular weight of 1,300 amu (CAS Reg. No. 9002-98-6) when
used as an inert ingredient (emulsifier, surfactant, adjuvant,
dispersant, and/or coating) in pesticide formulations applied to
growing crops and raw agricultural commodities after harvest.

XI. Statutory and Executive Order Reviews

    This action establishes 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); Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); or 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).

XII. 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: November 14, 2017.
Michael Goodis,
Director, Registration Division.
    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. In Sec.  180.910, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.910   Inert ingredients used pre- and post-harvest;
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------

                              * * * * * * *
Polyethyleneimine (CAS Reg.   Minimum number        Emulsifier,
 No. 9002-98-6).               average molecular     surfactant,
                               weight 1,300 amu.     adjuvant,
                                                     dispersant and/or
                                                     coating.

                              * * * * * * *
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[FR Doc. 2017-25715 Filed 11-27-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50943-50945]
[FR Doc No: 2018-21957]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by December 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidances to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on September 14, 2018.
    This notice announces new or revised draft product-specific
guidances that are being posted on FDA's website concurrently with
FDA's new draft guidance for industry entitled ``Assessing the
Irritation and Sensitization Potential of Transdermal and Topical
Delivery Systems for ANDAs'' and FDA's revised draft guidance for
industry entitled ``Assessing Adhesion With Transdermal and Topical
Delivery Systems for ANDAs.'' FDA recommends that applicants consult
the relevant product-specific guidance, in conjunction with the
guidances referenced above, when considering the design and conduct of
studies that may be appropriate to support a topical delivery system
product intended for submission in an ANDA.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Capsaicin
Estradiol; Norethindrone acetate
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Buprenorphine
Clonidine
Diclofenac epolamine
Estradiol (multiple Reference Listed Drugs)
Ethinyl estradiol; Norelgestromin
Fentanyl
Granisetron
Lidocaine
Menthol; Methyl salicylate
Methylphenidate
Nicotine

Nitroglycerin (multiple Reference Listed Drugs)
Oxybutynin (multiple Reference Listed Drugs)
Rivastigmine
Rotigotine
Scopolamine
Selegiline
Testosterone
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21957 Filed 10-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 34785-34788]
[FR Doc No: 2020-12276]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88993; File No. SR-EMERALD-2020-05]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Exchange Rule 510, Minimum Price Variations and Minimum Trading
Increments, To Conform the Rule to Section 3.1 of the Plan for the
Purpose of Developing and Implementing Procedures Designed To
Facilitate the Listing and Trading of Standardized Options

June 2, 2020.
    Pursuant to the provisions of 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 May 29, 2020, MIAX Emerald, LLC (``MIAX
Emerald'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend certain of the Exchange's rules to
conform to Section 3.1 of the Plan for the Purpose of Developing and
Implementing Procedures Designed to Facilitate the Listing and Trading
of Standardized Options (the ``OLPP'') and add new subparagraphs
(a)(3)(i)-(iii) and (b) to Exchange Rule 510.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald at MIAX
Emerald's principal office, 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
    The purpose of this rule change is to amend Exchange Rule 510,
Minimum Price Variations and Minimum Trading Increments, to align the
Exchange's rules with the recently approved amendment to the OLPP.
Background
    On January 23, 2007, the Commission approved on a limited basis a
Penny Pilot in option classes in certain issues (``Penny Pilot''). The
Penny Pilot was designed to determine whether

investors would benefit from options being quoted in penny increments,
and in which classes the benefits were most significant. The Penny
Pilot was initiated at the then existing option exchanges in January
2007 \3\ and expanded and extended numerous times over the last 13
years.\4\ In each instance, these approvals relied upon the
consideration of data periodically provided by the Exchanges that
analyzed how quoting options in penny increments affects spreads,
liquidity, quote traffic, and volume. Today, the Penny Pilot includes
363 option classes, which are among the most actively traded, multiply
listed option classes. The Penny Pilot is scheduled to expire by its
own terms on June 30, 2020.\5\
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    \3\ See Securities Exchange Act Release Nos. 55154 (January 23,
2007), 72 FR 4743 (February 1, 2007) (SR-CBOE-2006-92); 55161
(January 24, 2007), 72 FR 4754 (February 1, 2007) (SR-ISE-2006-62);
54886 (December 6, 2006), 71 FR 74979 (December 13, 2006) (SR-Phlx-
2006-74); 54590 (October 12, 2006), 71 FR 61525 (October 18, 2006)
(SR-NYSEArca-2006-73); and 54741 (November 9, 2006), 71 FR 67176
(November 20, 2006) (SR-Amex-2006-106).
    \4\ See Securities Exchange Act Release Nos. 85225 (March 1,
2019), 84 FR 8353 (March 7, 2019) (SR-EMERALD-2019-06); 86048 (June
6, 2019), 84 FR 27382 (June 12, 2019) (SR-EMERALD-2019-23); 87608
(November 25, 2019), 84 FR 66046 (December 2, 2019) (SR-EMERALD-
2019-36).
    \5\ See Securities Exchange Act Release No. 87608 (November 25,
2019), 84 FR 66046 (December 2, 2019) (SR-EMERALD-2019-36).
---------------------------------------------------------------------------

    In light of the imminent expiration of the Penny Pilot, on June 30,
2020, the Exchange, together with other participating exchanges, filed
on July 18, 2019, a proposal to amend the OLPP.\6\ On April 1, 2020,
the U.S. Securities and Exchange Commission (``Commission'') approved
the amendment to the OLPP to make permanent the Pilot Program (the
``OLPP Program'').\7\
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    \6\ See Securities Exchange Act Release No. 87681 (December 9,
2019), 84 FR 68960 (December 17, 2019) (``Notice'').
    \7\ See Securities Exchange Act Release No. 88532 (April 1,
2020), 85 FR 19545 (April 7, 2020) (File No. 4-443) (``Approval
Order'').
---------------------------------------------------------------------------

    The OLPP Program replaces the Penny Pilot by instituting a
permanent program that would permit quoting in penny increments for
certain option classes. Under the terms of the OLPP Program, designated
option classes would continue to be quoted in $0.01 and $0.05
increments according to the same parameters for the Penny Pilot. In
addition, the OLPP Program would: (i) Establish an annual review
process to add option classes to, or to remove option classes from, the
OLPP Program; (ii) allow an option class to be added to the OLPP
Program if it is a newly listed option class and it meets certain
criteria; (iii) allow an option class to be added to the OLPP Program
if it is an option class that has seen significant growth in activity;
(iv) provide that if a corporate action involves one or more option
classes in the OLPP Program, all adjusted and unadjusted series and
classes emerging as a result of the corporate action will be included
in the OLPP Program; and (v) provide that any series in an option class
participating in the OLPP Program that have been delisted, or are
identified by OCC as ineligible for opening Customer transactions, will
continue to trade pursuant to the OLPP Program until they expire.
    To conform its rules with the OLPP Program, the Exchange proposes
to delete Interpretation and Policy .01 to Exchange Rule 510 (the
``Penny Pilot Rule''), which will be ``Reserved,'' and replace it with
new Exchange Rule 510(b) (Requirements for Penny Interval Program),
which is described below.
    The Exchange also proposes to amend Exchange Rule 510, Minimum
Price Variations and Minimum Trading Increments, to amend the
hierarchical heading scheme. Currently, Exchange Rule 510 only has
subparagraphs (1) and (2). The Exchange now proposes that the first
unnumbered paragraph of Exchange Rule 510 will be renumbered
subparagraph (a), and subparagraphs (1) and (2) will be renumbered as
subparagraphs (a)(1) and (a)(2). The purpose of this change is for
uniformity and clarity throughout the Exchange's rulebook.
    The Exchange also proposes to adopt subparagraphs (a)(3)(i)-(iii)
to conform the Exchange's rules regarding minimum price variations for
options in the proposed Penny Interval Program with similar rules of
other option exchanges.\8\ In particular, the Exchange proposes to
adopt subparagraphs (a)(3)(i)-(iii), which will describe that for
options contracts traded pursuant to the proposed Penny Interval
Program (which the Exchange has proposed as new Exchange Rule 510(b)):
(i) All option contracts in QQQ, SPY and IWM will quote in a minimum of
one cent ($0.01) price variations; (ii) for all other option contracts
included in the Penny Interval Program that are trading at less than
$3, those option contracts will quote in a minimum of one cent ($0.01)
price variations; and (iii) for all other option contracts included in
the Penny Interval Program that are trading at or above $3, those
option contracts will quote in a minimum of five cents ($0.05) price
variations. The Exchange notes that the Commission previously approved
minimum quoting increments of one cent ($0.01) for all option contracts
in QQQ, IWM and SPY, regardless of price, over the course of the
expansion of the Penny Pilot rules.\9\ Accordingly, the Exchange
proposes to align its rules regarding minimum price variations for
option contracts in the Penny Interval Program with other option
exchanges.
---------------------------------------------------------------------------

    \8\ See NYSE Arca Rule 6.72-O (Trading Differentials); see also
Nasdaq Stock Market, Options 3, Section 3, Supplementary Material
.01.
    \9\ See Securities Exchange Act Release Nos. 55156 (January 23,
2007), 72 FR 4759 (February 1, 2007) (SR-NYSEArca-2006-73) (Order
Granting Approval to Proposed rule Change as Modified by Amendment
No. 1 Thereto, To Create an Options Penny Pilot Program); 61061
(November 24, 2009), 74 FR 62857 (December 1, 2009) (SR-NYSEArca-
2009-44) (Order Granting Partial Approval of a Proposed Rule Change,
as Modified by Amendment No. 4 Thereto, Expanding the Penny Pilot
Program).
---------------------------------------------------------------------------

Penny Interval Program
    The Exchange proposes to codify the OLPP Program in new Exchange
Rule 510(b) (Requirements for Penny Interval Program) (the ``Penny
Program''), which will replace the Penny Pilot Rule and permanently
permit the Exchange to quote certain option classes in minimum
increments of one cent ($0.01) and five cents ($0.05) (``penny
increments''). The penny increments that currently apply under the
Penny Pilot will continue to apply for option classes included in the
Penny Program. Specifically, (i) the minimum quoting increment for all
series in the QQQ, SPY, and IWM would continue to be $0.01, regardless
of price (which the Exchange proposes to codify in proposed Exchange
Rule 510(a)(3)(i)-(iii)); (ii) all series of an option class included
in the Penny Program with a price of less than $3.00 would be quoted in
$0.01 increments; and (iii) all series of an option class included in
the Penny Program with a price of $3.00 or higher would be quoted in
$0.05 increments.\10\
---------------------------------------------------------------------------

    \10\ See proposed Exchange Rule 510(a)(3)(i)-(iii).
---------------------------------------------------------------------------

    The Penny Program would initially apply to the 363 most actively
traded multiply listed option classes, based on National Cleared Volume
at The Options Clearing Corporation (``OCC'') in the six full calendar
months ending in the month of approval (i.e., November 2019-April 2020)
that currently quote in penny increments, or overlie securities priced
below $200, or any index at an index level below $200. Eligibility for
inclusion in the Penny Program will be determined at the close of
trading on the monthly Expiration Friday of the second full month
following April 1, 2020 (i.e., June 19, 2020).
    Once in the Penny Program, an option class will remain included
until it is no longer among the 425 most actively

traded option classes at the time the annual review is conducted
(described below), at which point it will be removed from the Penny
Program. As described in more detail below, the removed class will be
replaced by the next most actively traded multiply listed option class
overlying securities priced below $200 per share, or any index at an
index level below $200, and not yet in the Penny Program. Advanced
notice regarding the option classes included, added, or removed from
the Penny Program will be provided to the Exchange's Members via
Regulatory Circular and published by the Exchange on its website.
Annual Review
    The Penny Program would include an annual review process that
applies objective criteria to determine option classes to be added to,
or removed from, the Penny Program. Specifically, on an annual basis
beginning in December 2020 and occurring every December thereafter, the
Exchange will review and rank all multiply listed option classes based
on National Cleared Volume at OCC for the six full calendar months from
June 1st through November 30th for determination of the most actively
traded option classes. Any option classes not yet in the Penny Program
may be added to the Penny Program if the class is among the 300 most
actively traded multiply listed option classes and priced below $200
per share, or any index at an index level below $200.
    Following the annual review, option classes to be added to the
Penny Program would begin quoting in penny increments (i.e., $0.01 if
trading at less than $3.00; and $0.05 if trading at $3.00 and above) on
the first trading day of January. In addition, following the annual
review, any option class in the Penny Program that falls outside of the
425 most actively traded option classes would be removed from the Penny
Program. After the annual review, option classes that are removed from
the Penny Program will be subject to the minimum trading increments set
forth in Exchange Rule 510, effective on the first trading day of
April.
Changes to the Composition of the Penny Program Outside of the Annual
Review Newly Listed Option Classes and Option Classes With Significant
Growth in Activity
    The Penny Program would specify a process and parameters for
including option classes in the Penny Program outside the annual review
process in two circumstances. These provisions are designed to provide
objective criteria to add to the Penny Program new option classes in
issues with the most demonstrated trading interest from market
participants and investors on an expedited basis prior to the annual
review, with the benefit that market participants and investors will
then be able to trade these new option classes based upon quotes
expressed in finer trading increments.
    First, the Penny Program provides for certain newly listed option
classes to be added to the Penny Program outside of the annual review
process, provided that (i) the class is among the 300 most actively
traded, multiply listed option classes, as ranked by National Cleared
Volume at OCC, in its first full calendar month of trading and (ii) the
underlying security is priced below $200 or the underlying index is at
an index level below $200. Such newly listed option classes added to
the Penny Program pursuant to this process would remain in the Penny
Program for one full calendar year and then would be subject to the
annual review process.
    Second, the Penny Program would allow an option class to be added
to the Penny Program outside of the annual review process if it is an
option class that meets certain specific criteria. Specifically, new
option classes may be added to the Penny Program if: (i) The option
class is among the 75 most actively traded multiply listed option
classes, as ranked by National Cleared Volume at OCC, in the prior six
full calendar months of trading and (ii) the underlying security is
priced below $200 or the underlying index is at an index level below
$200. Any option class added under this provision will be added on the
first trading day of the second full month after it qualifies and will
remain in the Penny Program for the rest of the calendar year, after
which it will be subject to the annual review process.
Corporate Actions
    The Penny Program would also specify a process to address option
classes in the Penny Program that undergo a corporate action and is
designed to ensure continuous liquidity in the affected option classes.
Specifically, if a corporate action involves one or more option classes
in the Penny Program, all adjusted and unadjusted series of an option
class would continue to be included in the Penny Program.\11\
Furthermore, neither the trading volume threshold, nor the initial
price test would apply to option classes added to the Penny Program as
a result of the corporate action. Finally, the newly added adjusted and
unadjusted series of the option class would remain in the Penny Program
for one full calendar year and then would become subject to the annual
review process.
---------------------------------------------------------------------------

    \11\ For example, if Company A acquires Company B and Company A
is not in the Penny Program but Company B is in the Penny Program,
once the merger is consummated and an options contract adjustment is
effective, then Company A would be added to the Penny Program and
remain in the Penny Program for one calendar year.
---------------------------------------------------------------------------

Delisted or Ineligible Option Classes
    Finally, the Penny Program would provide a mechanism to address
option classes that have been delisted or those that are no longer
eligible for listing. Specifically, any series in an option class
participating in the Penny Program in which the underlying has been
delisted, or is identified by OCC as ineligible for opening customer
transactions, would continue to quote pursuant to the terms of the
Penny Program until all options series have expired.
Implementation
    This proposed rule change will become operative on July 1, 2020,
upon expiration of the current Penny Pilot on June 30, 2020. The
Exchange proposes to implement the Penny Program on July 1, 2020, which
is the first trading day of the third month following the Approval
Order issued on April 1, 2020--i.e., July 1, 2020.
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \12\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \13\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the proposed rule change, which conforms the
Exchange rules to the recently adopted OLPP Program, allows the
Exchange to provide market participants with a permanent Penny Program
for quoting options in penny increments, which maximizes the benefit of
quoting in a finer quoting increment to investors while minimizing the
burden that a finer quoting increment places on quote traffic.

    Accordingly, the Exchange believes that the proposal is consistent
with the Act because, in conforming the Exchange rules to the OLPP
Program, the Penny Program would employ processes, based upon objective
criteria, that would rebalance the composition of the Penny Program,
thereby helping to ensure that the most actively traded option classes
are included in the Penny Program, which helps facilitate the
maintenance of a fair and orderly market.
    The Exchange believes the proposed changes to the hierarchical
heading scheme in Exchange Rule 510 promote just and equitable
principles of trade and remove impediments to and perfect the mechanism
of a free and open market and a national market system because the
proposed rule changes provide uniformity in the Exchange's rulebook and
do not alter the application of the rule. As such, the proposed changes
would foster cooperation and coordination with persons engaged in
facilitating transactions in securities and would remove impediments to
and perfect the mechanism of a free and open market and a national
exchange system by providing greater clarity to Members and the public
regarding the Exchange's Rules. It is in the public interest for rules
to be accurate and concise so as to eliminate the potential for
confusion.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed Penny Program,
which modifies the Exchange's rules to align them with the Commission
approved OLPP Program, is not designed to be a competitive filing nor
does it impose an undue burden on intermarket competition as the
Exchange anticipates that the options exchanges will adopt
substantially identical rules. Moreover, the Exchange believes that by
conforming Exchange rules to the OLPP Program, the Exchange would
promote regulatory clarity and consistency, thereby reducing burdens on
the marketplace and facilitating investor protection. To the extent
that there is a competitive burden on those option classes that do not
qualify for the Penny Program, the Exchange believes that it is
appropriate because the proposal should benefit all market participants
and investors by maximizing the benefit of a finer quoting increment in
those option classes with the most trading interest while minimizing
the burden of greater quote traffic in option classes with less trading
interest. The Exchange believes that adopting rules, which it
anticipates will likewise be adopted by all option exchanges that are
participants in the OLPP, would allow for continued competition between
Exchange market participants trading similar products as their
counterparts on other exchanges, while at the same time allowing the
Exchange to continue to compete for order flow with other exchanges.

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

    Because the foregoing 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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(6) \15\
thereunder.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
---------------------------------------------------------------------------

    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 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_ADDRESS>Please include
File Number SR-EMERALD-2020-05 on the subject line.

Paper Comments

     Send paper comments in triplicate to Vanessa Countryman,
Secretary, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-EMERALD-2020-05.
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-EMERALD-2020-05 and should be submitted
on or before June 29, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-12276 Filed 6-5-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Proposed Rules]
[Pages 23257-23259]
[FR Doc No: 2020-08750]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0336; Product Identifier 2020-NM-032-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD
was prompted by a report that sticking effects have been observed
affecting the breathing bag on certain passenger oxygen masks. This
proposed AD would require replacement of affected passenger oxygen
masks, as specified in a European Union Aviation Safety Agency (EASA)
AD, which will be incorporated by reference. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by June 11,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the material identified in this proposed AD that will be
incorporated by reference (IBR), contact the EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; phone: +49 221 89990 1000; email:
<EMAIL_ADDRESS>internet: www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu. You may view
this IBR material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0336.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0336; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or

arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0336;
Product Identifier 2020-NM-032-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM based on those comments.
    The FAA will post all comments, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0031, dated February 18, 2020
(``EASA AD 2020-0031'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A350-941 and -1041 airplanes.
    This proposed AD was prompted by a report that sticking effects
have been observed affecting the breathing bag on certain passenger
oxygen masks. The FAA is proposing this AD to address sticking of the
breathing bag on certain passenger oxygen masks, which could prevent
the breathing bag from fully inflating, and possibly injure cabin
occupants following a depressurization event. See the MCAI for
additional background information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0031 describes procedures for replacement of affected
passenger oxygen masks. This material is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0031 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0031
will be incorporated by reference in the FAA final rule. This proposed
AD would therefore require compliance with EASA AD 2020-0031 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0031 that is required for compliance with EASA AD 2020-
0031 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0336 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 13 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
6 work-hours x $85 per hour = $510...........................            $0 *             $510           $6,630
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the FAA to provide cost estimates of the parts cost
  for the replacement specified in this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known 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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
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 airworthiness
directive (AD):

Airbus SAS: Docket No. FAA-2020-0336; Product Identifier 2020-NM-
032-AD.

(a) Comments Due Date

    The FAA must receive comments by June 11, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by a report that sticking effects have been
observed affecting the breathing bag on certain passenger oxygen
masks. The FAA is issuing this AD to address sticking of the
breathing bag on certain passenger oxygen masks, which could prevent
the breathing bag from fully inflating, and possibly injure cabin
occupants following a depressurization event.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0031, dated February 18, 2020 (``EASA AD 2020-0031'').

(h) Exceptions to EASA AD 2020-0031

    (1) Where EASA AD 2020-0031 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0031 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0031 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2020-0031, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 89990
6017; email<EMAIL_ADDRESS>internet: www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0336.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on April 17, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-08750 Filed 4-24-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]
[Page 58639]
[DOCID:fr13no09-66]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0292]

Michelle Lynn Torgerson; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the agency) is issuing
an order under the Federal Food, Drug, and Cosmetic Act (the act)
permanently debarring Michelle Lynn Torgerson, from providing services
in any capacity to a person that has an approved or pending drug
product application. We base this order on a finding that Ms. Torgerson
was convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the act. Ms. Torgerson was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. As of
October 26, 2009, Ms. Torgerson has failed to respond. Ms. Torgerson's
failure to respond constitutes a waiver of her right to a hearing
concerning this action.

DATES: This order is effective November 13, 2009.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kenny Shade, Office of Regulatory
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual
if FDA finds that the individual has been convicted of a felony under
Federal law for conduct otherwise relating to the regulation of any
drug product under the act.
    On January 4, 2006, the U.S. District Court for the District of
Minnesota entered judgment against Michelle L. Torgerson for one count
of misbranding a drug, a federal felony offense under sections 301(k),
303(a)(2), and 352(b)(1) (21 U.S.C. 331(k), 333(a)(2), and 353(b)(1)),
after accepting her guilty plea on May 19, 2005. This offense was
committed when Michelle L. Torgerson was employed as a nurse by Maxim
Health Systems in the State of Minnesota. During that time, Ms.
Torgerson conducted unauthorized flu vaccination clinics on the campus
of Augsburg College, without the approval of her employer, Maxim Health
Systems. Ms. Torgerson also falsely represented that the American Heart
Association was sponsoring or otherwise authorizing the clinics.
Michelle L. Torgerson acknowledged that, in conducting the unauthorized
clinics, she acted with the intent to defraud and mislead the public
and that she caused a quantity of a prescription drug, namely, the flu
virus vaccine Fluzone[reg], to be misbranded within the meaning of 21
U.S.C. 353(b)(1), while the flu virus vaccine was being held for sale
after being shipped in interstate commerce. Specifically, Ms. Torgerson
acknowledged that she dispensed the flu virus vaccine without a written
prescription of a practitioner licensed by law to administer the flu
virus vaccine. Ms. Torgerson knew that, as a Licensed Practical Nurse,
she was not authorized to dispense the flu virus vaccine without a
physician's orders. She also acknowledged that she diluted some of the
vaccine with saline knowing that this would reduce the flu vaccine's
quality and strength.
    As a result of this conviction, FDA sent Ms. Torgerson by certified
mail on August 7, 2009, a notice proposing to permanently debar her
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(B) of the act that Michelle L.
Torgerson was convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the act. The
proposal also offered Ms. Torgerson an opportunity to request a
hearing, providing her 30 days from the date of receipt of the letter
in which to file the request, and advised her that failure to request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Ms. Torgerson failed to respond
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and any contentions concerning her
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the act, and under
authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Michelle L. Torgerson has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the act.
    As a result of the foregoing finding, Ms. Torgerson is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B), 306(c)(2)(A)(ii), and 201(dd) of the act
(21 U.S.C.321(dd)). Any person with an approved or pending drug product
application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Michelle L. Torgerson, in
any capacity, during Ms. Torgerson's permanent debarment, will be
subject to civil money penalties (section 307(a)(6) of the act (21
U.S.C. 335b(a)(6)). If Ms. Torgerson, during her period of debarment,
provides services in any capacity to a person with an approved or
pending drug product application, she will be subject to civil money
penalties (section 307(a)(7) of the act). In addition, FDA will not
accept or review any abbreviated new drug applications submitted by or
with the assistance of Ms. Torgerson during her period of debarment
(section 306(c)(1)(B) of the act).
    Any application by Ms. Torgerson for special termination of
debarment under section 306(d)(4) of the act should be identified with
Docket No. FDA-2009-N-0292 and sent to the Division of Dockets
Management (see ADDRESSES). All such submissions are to be filed in
four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 28, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-27223 Filed 11-12-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Rules and Regulations]
[Pages 22033-22035]
[FR Doc No: 2011-9582]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0263]
RIN 1625-AAOO

Safety Zone; Red River Safety Zone, Red River, MN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard Captain of the Port, Marine Safety Unit
Duluth, MN is establishing a temporary safety zone on the Red River,
MN. This safety zone is being established to ensure the safety of the
public. The safety zone will prevent individuals from entering all
navigable waters of the Red River in the State of Minnesota north of a
line drawn across latitude 46[deg]20'00'' N, including those portions
of the river in Wilkin, Clay, Norman, Polk, Marshall and Kittson
counties, to the United States-Canada international border.

DATES: This rule is effective in the CFR from April 20, 2011 until July
15, 2011. This rule is effective with actual notice for purposes of
enforcement from April 7, 2011 until 5 p.m. on July 15, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0263 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0263 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Aaron L. Gross, Chief

of Port Operations, Marine Safety Unit Duluth, Coast Guard; telephone
218-720-5286 ext 111, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be contrary to the
public interest due to the emergency nature under which this safety
zone is being established and would hinder the protection of the
public.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Good cause for making this rule
effective less than 30 days after publication exists because delaying
the execution of the rule would be contrary to the public interest due
to the emergency nature under which this safety zone is being
established and would hinder the protection of the public.

Background and Purpose

    This temporary safety zone is necessary to ensure the safety of the
public from hazards involved with the flooding of the Red River.
Restricted access to the Red River by the public will help ensure the
safety of persons and property along the Red River.

Discussion of Rule

    Flooding conditions along the Red River have created serious
dangers to the boating public. The strong currents and floating debris
associated with the flooding of the Red River necessitate the Coast
Guard limiting access to the portions of the river affected by this
rule in order to protect the public. This rule is effective from 5 p.m.
on April 7, 2011 until 5 p.m. on July 15, 2011. The Captain of the Port
Duluth may stop enforcement of this safety zone before 5 p.m. on July
15, 2011 if river conditions change such that enforcement of the safety
zone is no longer necessary for the public's safety. The Captain of the
Port Duluth will notify the public via a Broadcast Notice to Mariners.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit or anchor in the portions of the Red River affected by this
safety zone. This safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons because few small business entities operate on the affected
portion of the river and because this rule will be in effect only until
the Red River is deemed safe to transit.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to

health or risk to safety that may disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a safety zone.
An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0263 to read as follows:

Sec.  165.T09-0263  Safety zone; Red River Safety Zone, Red River, MN.

    (a) Location. The following area is a temporary safety zone: all
navigable waters of the Red River in the State of Minnesota north of a
line drawn across latitude 46[deg]20'00'' N, including those portions
of the river in Wilkin, Clay, Norman, Polk, Marshall and Kittson
counties, to the United States--Canada international border.
    (b) Effective period. This rule is effective from 5 p.m. on April
7, 2011 until 5 p.m. on July 15, 2011. If the river conditions change
such that enforcement of the Safety Zone is unnecessary prior to 5 p.m.
on July 15, 2011, the Captain of the Port Duluth will notify the public
via a Broadcast Notice to Mariners.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Duluth, or
his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Duluth or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Duluth is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Duluth to act on his
behalf. The on-scene representative of the Captain of the Port Duluth
will be aboard either a Coast Guard or Coast Guard Auxiliary vessel.
The Captain of the Port Duluth or his designated on-scene
representative may be contacted via VHF Channel 16.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Duluth or his on-scene
representative to obtain permission to do so. Vessel operators given
permission to enter or operate in the safety zone must comply with all
directions given to them by the Captain of the Port Duluth or his on-
scene representative.

    Dated: April 7, 2011.
K.R. Bryan,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2011-9582 Filed 4-19-11; 8:45 am]
BILLING CODE 9110-04-P