[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22279-22280]
[FR Doc No: 2016-08681]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1114]

Pharmaceutical Distribution Supply Chain Pilot Projects; Request
for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting
information regarding issues related to utilizing the product
identifier for product tracing, improving the technical capabilities of
the supply chain, and identifying system attributes that are necessary
to implement the requirements established under the Drug Supply Chain
Security Act (DSCSA). The information gathered from public comments
will assist with the design and development of the pilot project(s)
that FDA establishes under the DSCSA.

DATES: Submit written or electronic comments and information by May 16,
2016.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1114 for ``Pharmaceutical Distribution Supply Chain Pilot
Projects; Request for Information.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was
signed into law. The DSCSA outlines critical steps to build an
electronic, interoperable system by November 27, 2023, which will
identify and trace certain prescription drugs as they are distributed
within the United States. Section 202 of the DSCSA added new sections
581 and 582 to the Food Drug

and Cosmetic Act (21 U.S.C. 360eee and 360eee-1). Under section 582(j),
FDA is required to establish one or more pilot projects, in
coordination with authorized manufacturers, repackagers, wholesale
distributors, and dispensers, to explore and evaluate methods to
enhance the safety and security of the pharmaceutical distribution
supply chain. The projects established by FDA will take into
consideration any pilot projects that were conducted prior to enactment
of the DSCSA.

II. Purpose of the Request for Information

    The request for information is intended to provide interested
persons an opportunity to submit comments relating to FDA's
implementation of the DSCSA. We are particularly interested in comments
regarding past or present pilot projects related to enhancing the
safety and security of the pharmaceutical distribution supply chain.
Stakeholders that may be interested in responding to this request for
information include: Manufacturers, repackagers, wholesale
distributors, dispensers, State and Federal authorities, solution
providers, standards organizations, and other interested persons. FDA
is particularly interested in learning about the practices, processes,
and systems that supply chain stakeholders have used or considered
using in such pilot projects. This includes, but is not limited to,
information about the following:
     Utilizing the product identifier for tracing of a product,
which may include verification of the product identifier of a product,
including the use of aggregation and inference;
     Technical capabilities each sector of the supply chain to
comply with systems and processes needed to utilize the product
identifier to enhance the tracing of a product; or
     System attributes that are necessary to implement the
requirements established under the DSCSA.
    Interested persons are requested to provide any other relevant
information that may assist with FDA's development of a pilot project
under the DSCSA.

    Dated: April 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08681 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Rules and Regulations]
[Pages 13972-13975]
[FR Doc No: 2021-05142]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1123; Project Identifier MCAI-2020-01294-R;
Amendment 39-21448; AD 2021-05-05]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2016-23-
05, which applied to certain Airbus Helicopters Model SA-365N1, AS-
365N2, AS 365 N3, SA-366G1, EC 155B, and EC155B1 helicopters. AD 2016-
23-05 required repetitive checks of the oil level of the tail rotor
gearbox and, if necessary, filling the oil to the maximum level; and
replacement of a certain control rod double bearing (bearing) with a
new bearing. This AD retains the requirements of AD 2016-23-05 and also
requires modifying the helicopter by replacing the tail gearbox (TGB)
control shaft guide bushes; repetitive inspections of the TGB magnetic
plug and corrective actions if necessary; repetitive replacements of
the bearing; and modifying the helicopter by replacing the TGB; as
specified in a European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD, which is incorporated by reference.
This AD also adds helicopters to the applicability. This AD was
prompted by reports of occurrences of loss of yaw control due to
failure of the TGB bearing. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective April 16, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 16,
2021.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1123.

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-
1123; 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 final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

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

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2017-0125, dated July 21, 2017 (EASA
AD 2017-0125) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Model SA 365 N1, AS 365 N2, AS 365 N3, SA
366 G1, EC 155 B, and EC 155 B1 helicopters. EASA AD 2017-0125
supersedes EASA AD 2017-0007, dated January 13, 2017, which superseded
EASA AD 2016-0097R1, dated May 25, 2016 (which corresponds to FAA AD
2016-23-05). EASA AD 2017-0125 adds helicopters to the applicability,
adds repetitive inspections of the magnetic plug after bearing
replacement, requires the use of the revised Airbus Helicopters Alert
Service Bulletin (ASB) instructions, and requires replacement of the
TGB with a modified unit, which terminates the repetitive inspections.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2016-23-05, Amendment 39-18712 (81 FR
85126, November 25, 2016) (AD 2016-23-05). AD 2016-23-05 applied to
certain Airbus Helicopters Model SA-365N1, AS-365N2, AS 365 N3, SA-
366G1, EC 155B, and EC155B1 helicopters. The NPRM published in the
Federal Register on December 14, 2020 (85 FR 80689). The NPRM was
prompted by a determination that additional inspections, replacements,
and modifications are necessary to address the unsafe condition. The
NPRM proposed to retain the requirements of AD 2016-23-05 and also
require modifying the helicopter by replacing the TGB control shaft
guide bushes; repetitive inspections of the TGB magnetic plug and
corrective actions if necessary; repetitive replacements of the
bearing; and modifying the helicopter by replacing the TGB; as
specified in an EASA AD. The NPRM also proposed to add helicopters to
the applicability.

    The FAA is issuing this AD to address damage to the bearing, which
could result in end play, loss of tail rotor pitch control, and
subsequent loss of control of the helicopter. See the MCAI for
additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Update to the Costs of Compliance

    The FAA has updated the costs for the new required actions and on-
condition actions based on data received since the NPRM was issued.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2017-0125 describes procedures for modifying the helicopter
by replacing TGB control shaft guide bushes, repetitive inspections
(checks) of the oil level of the tail rotor gearbox and, if necessary,
filling the oil to the maximum level, repetitive inspections of the TGB
magnetic plug for the presence of particles and corrective actions if
necessary (corrective actions include removing the TGB, complying with
certain work cards to address particles and other conditions such as
abrasions, scales, flakes, and splinters, and replacing the bearing),
repetitive replacements of the bearing; and modifying the helicopter by
replacing the TGB.
    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.

Explanation of Retained Requirements

    Although this AD does not explicitly restate the requirements of AD
2016-23-05, this AD retains certain requirements of AD 2016-23-05.
Those requirements are referenced in paragraphs (2) and (5) of EASA AD
2017-0125, which, in turn, is referenced in paragraph (g) of this AD.

Costs of Compliance

    The FAA estimates that this AD affects 52 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost            Parts cost      Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2016-   17 work-hours x $85     $1,125...........  $2,570...........  $133,640.
 23-05.                           per hour = $1,445.
New actions....................  71 work-hours x $85     Up to $155,300...  Up to $161,335...  Up to $8,389,420.
                                  per hour = $6,035.
----------------------------------------------------------------------------------------------------------------

                  Estimated Costs for Optional Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
Up to 8 work-hours x $85 per hour =                 $0             $680
 $680.................................
------------------------------------------------------------------------

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
Up to 4 work-hours x $85 per hour =       Up to $1,395     Up to $1,735
 $340.................................
------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 removing Airworthiness Directive (AD)
2016-23-05, Amendment 39-18712 (81 FR 85126, November 25, 2016), and
adding the following new AD:

2021-05-05 Airbus Helicopters: Amendment 39-21448 Docket No. FAA-
2020-1123; Project Identifier MCAI-2020-01294-R.

(a) Effective Date

    This airworthiness directive (AD) is effective April 16, 2021.

(b) Affected ADs

    This AD replaces AD 2016-23-05, Amendment 39-18712 (81 FR 85126,
November 25, 2016) (AD 2016-23-05).

(c) Applicability

    This AD applies to Airbus Helicopters Model SA-365N1, AS-365N2,
AS 365 N3, SA-366G1, EC 155B, and EC155B1 helicopters, certificated
in any category, all serial numbers.

(d) Subject

    Joint Aircraft System Component (JASC) Code 65, Tail Rotor.

(e) Reason

    This AD was prompted by reports of occurrences of loss of yaw
control due to failure of the tail gearbox (TGB) control rod double
bearing (bearing). This AD was also prompted by the determination
that additional inspections, replacements, and modifications are
necessary to address the unsafe condition. The FAA is issuing this
AD to address damage to the bearing, which could result in end play,
loss of tail rotor pitch control, and subsequent loss of control of
the helicopter.

(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 Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2017-0125, dated July 21, 2017
(EASA AD 2017-0125).

(h) Exceptions to EASA AD 2017-0125

    (1) Where EASA AD 2017-0125 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2017-0125 refers to June 4, 2011 (the
effective date of EASA AD 2011-0105), this AD requires using the
effective date of this AD.
    (3) Where EASA AD 2017-0125 refers to May 25, 2016 (the
effective date of EASA AD 2016-0197R1), this AD requires using the
effective date of this AD.
    (4) The ``Remarks'' section of EASA AD 2017-0125 does not apply
to this AD.
    (5) Where paragraph (2) of EASA AD 2017-0125 requires
inspections (checks) to be done ``in accordance with the
instructions of Paragraph 3.B.1 of the applicable inspection ASB,''
for this AD, those instructions are for reference only and are not
required for the actions in paragraph (2) of EASA AD 2017-0125. The
inspections (checks) required by paragraph (2) of EASA AD 2017-0125
may be performed by the owner/operator (pilot) holding at least a
private pilot certificate and must be entered into the aircraft
records showing compliance with this AD in accordance with 14 CFR
43.9 (a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record must
be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
    (6) Where paragraph (5) of EASA AD 2017-0125 specifies to
``accomplish the applicable corrective action(s) in accordance with
the instructions of Paragraph 3.B.1 of the applicable inspection
ASB,'' for this AD, a qualified mechanic must add oil to the TGB to
the ``max'' level if the oil level is not at maximum. The
instructions are for reference only and are not required for the
actions in paragraph (5) of EASA AD 2017-0125.
    (7) Where EASA AD 2017-0125 refers to flight hours (FH), this AD
requires using hours time-in-service.
    (8) Where EASA AD 2017-0125 requires action after the last
flight of the day or ``ALF,'' this AD requires those actions before
the first flight of the day.
    (9) Where the service information referred to in EASA AD 2017-
0125 specifies to perform a metallurgical analysis and contact the
manufacturer if collected particles are not clearly characterized,
this AD does not require contacting the manufacturer to determine
the characterization of the particles collected.
    (10) Although service information referenced in EASA AD 2017-
0125 specifies to scrap parts, this AD does not include that
requirement.
    (11) Although service information referenced in EASA AD 2017-
0125 specifies reporting information to Airbus Helicopters and
filling in a ``particle detection'' follow-up sheet, this AD does
not include those requirements.
    (12) Although service information referenced in EASA AD 2017-
0125 specifies returning certain parts to an approved workshop, this
AD does not include that requirement.
    (13) Where paragraph (6) of EASA AD 2017-0125 refers to ``any
discrepancy,'' for this AD, discrepancies include the presence of
particles and other conditions such as abrasions, scales, flakes,
and splinters.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, 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 manager of the Strategic Policy Rotorcraft Section,
send it to: Manager, Strategic Policy Rotorcraft Section, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.

(j) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Aviation Safety Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2017-0125, dated
July 21, 2017.
    (ii) [Reserved].
    (3) For EASA AD 2017-0125, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. 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-
2020-1123.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 17, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-05142 Filed 3-11-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Proposed Rules]
[Pages 43231-43233]
[FR Doc No: 2022-15518]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2022-0161; FRL-9410-03-OCSPP]

Receipt of Pesticide Petitions Filed for Residues of Pesticide
Chemicals in or on Various June 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notices of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of initial
filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before August 19, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0161, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (RD) (7505P), main telephone number:<PHONE_NUMBER>, email
address: [email protected]. The mailing address for each contact
person is Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. As part
of the mailing address, include the contact person's name, division,
and mail code. The division to contact is listed at the end of each
application summary.

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. What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing receipt of pesticide petitions filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain data or information prescribed in FFDCA section 408(d)(2), 21
U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data supports
granting of the pesticide petitions. After considering the public
comments, EPA intends to evaluate whether and what action may be
warranted. Additional data may be needed before EPA can make a final
determination on these pesticide petitions.
    Pursuant to 40 CFR 180.7(f), summaries of the petitions that are
the subject of this document, prepared by the petitioners, are included
in dockets EPA has created for these rulemakings. The dockets for these
petitions are available at https://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.

A. Amended Tolerance Exemptions for Inerts (Except PIPS)

    IN-11470. (EPA-HQ-OPP-2021-0183). Croda, Inc., 300-A Columbus
Circle, Edison, NJ 08837 requests to amend an exemption from the
requirement of a tolerance for residues of styrene, copolymers with
acrylic acid and/or methacrylic acid, with none and/or one or more of
the following monomers: Acrylamidopropyl methyl sulfonic acid,
methallyl sulfonic acid, 3-sulfopropyl acrylate, 3-sulfopropyl
methacrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate,
hydroxyethyl methacrylate, hydroxyethyl acrylate, and/or lauryl
methacrylate; and its sodium, potassium, ammonium, monoethanolamine,
and triethanolamine salts; the resulting polymer having a minimum
number average molecular weight (in amu), 1200 by adding poly (oxy-1,2-
ethanediyl),[alpha]-(2-methyl-1-oxo-2-propenyl)- [omega]-

methoxy- (CAS Reg. No. 26915-72-0) to the descriptor when used as a
pesticide inert ingredient in pesticide formulations under 40 CFR
180.960. The petitioner believes no analytical method is needed because
it is not required for an exemption from the requirement of a
tolerance. Contact: RD.

B. Amended Tolerances for Non-Inerts

    1. PP 2F8992. (EPA-HQ-OPP-2022-0488). BASF Corporation, 26 Davis
Dr., P.O. Box 13528, Research Triangle Park, N.C. 27709, requests to
amend the tolerance(s) in 40 CFR 180.714 for residues of the
insecticide, broflanilide, including its metabolites and degradates, in
or on poultry, fat by increasing the tolerance from 0.02 ppm to 0.3
parts per million (ppm) and by increasing the tolerance in or on
poultry, meat byproducts from 0.02 ppm to 0.04 ppm. The BASF Analytical
Method Number D1604/01 and high-pressure liquid chromatography/triple
stage quadrupole mass spectrometry (LC/MS/MS) is used to measure and
evaluate the chemical broflanilide residues. Contact: RD.
    2. PP 2F9002. (EPA-HQ-OPP-2022-0479). Bayer CropScience, 800 N.
Lindbergh Blvd., St. Louis, MO, 63141, requests to amend the tolerance
in 40 CFR 180.653 for residues of the herbicide indaziflam including
its metabolites and degradates in or on the raw agricultural
commodities: Grass forage, fodder, and hay group 17, forage at 50 ppm
and hay at 80 ppm and for livestock fat, meat, meat byproducts, milk
and milk fat at 0.1, 0.01, 0.30, 0.015, and 0.04 ppm respectively. The
LC/MS/MS method is used to measure and evaluate the chemical
indaziflam. Contact: RD.

C. New Tolerance Exemptions for Inerts (Except PIPS)

    1. PP IN-11559. (EPA-HQ-OPP-2021-0305). Valent BioSciences LLC,
1910 Innovation Way, Suite 100, Libertyville, Il, 60048, requests to
establish an exemption from the requirement of a tolerance for residues
of malic acid (CAS Reg. No. 6915-15-7) when used as a pesticide inert
ingredient (buffering, stabilizing agent) in pesticide formulations
under 40 CFR 180.920. The petitioner believes no analytical method is
needed because it is not required for an exemption from the requirement
of a tolerance. Contact: RD.
    2. PP IN-11645. (EPA-HQ-OPP-2022-0390). Spring Regulatory Sciences,
6620 Cypresswood Dr., Suite 250, Spring, TX 77379 on behalf of Stepan
Company, 22 W. Frontage Rd., Northfield, IL 60093, requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180.960 for residues of oxirane, 2-(phenoxymethyl)-, polymer with
oxirane, monobutyl ether, block (A CI) (CAS Reg. No. 1010819-15-4),
when used as a pesticide inert ingredient (surfactant and/or adjuvant
of surfactants) in pesticide formulations. The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. Contact: RD.
    3. PP IN-11697. (EPA-HQ-OPP-2022-0507). The Dow Chemical Company,
715 E Main Street, Midland MI, requests to establish an exemption from
the requirement of a tolerance in 40 CFR part 180.960 for residues of
siloxanes and silicones, di-me, me hydrogen, reaction products with
vinyl group-terminated di-me siloxanes (CAS Reg. No. 156065-02-0) when
used as a pesticide inert ingredient (foam control additive) in
pesticide formulations. The petitioner believes no analytical method is
needed because it is not required for an exemption from the requirement
of a tolerance. Contact: RD.

D. New Tolerances for Non-Inerts

    1. PP 1E8939. (EPA-HQ-OPP-2021-0789). BASF Corporation, 26 Davis
Dr., Research Triangle Park, NC 27709 requests to establish a tolerance
in 40 CFR part 180.589 for residues of the herbicide glufosinate-
ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-
monoammonium salt) and its metabolites, 2-acetamido-4-
methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid,
expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid
equivalents in or on fresh tea leaves at 0.05 ppm and dried tea leaves
at 0.50 ppm. Analytical methods include water extraction, filtration,
addition of an isotopically labeled internal standard followed by solid
phase extraction and high-performance LC/MS/MS and are used to measure
and evaluate the chemical glufosinate-ammonium (butanoic acid, 2-amino-
4-(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents. Contact: RD.
    2. PP 1E8952. (EPA-HQ-OPP-2021-0789). BASF Corporation, 26 Davis
Drive, Research Triangle Park, NC 27709 requests to establish a
tolerance in 40 CFR part 180.589 for residues of the herbicide
glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)
butanoic acid equivalents in or on rice, grain at 0.9 ppm. Analytical
methods include water extraction, filtration, addition of an
isotopically labeled internal standard followed by solid phase
extraction and LC/MS/MS and are used to measure and evaluate the
chemical glufosinate-ammonium(butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents. Contact: RD.
    3. PP 2E8990. (EPA-HQ-OPP-2022-0508). Tea Association of the U.S.A.
Inc., 362 5th Avenue, Suite 1002, New York, NY 10001, requests to
establish a tolerance in 40 CFR part 180 for residues of the
insecticide cypermethrin ([cyano-(3-phenoxyphenyl)methyl]-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate), in or on tea,
dried at 15 parts ppm. The GC-ECD method C is used to measure and
evaluate the chemical cypermethrin. Contact: RD.
    4. PP 2E8999. (EPA-HQ-OPP-2022-0502). Gowan Company P.O. Box 5569,
Yuma, AZ 85366, requests to establish a tolerance in 40 CFR part 180
for residues of the herbicide trifluralin in or on tea at 0.05 ppm. The
analytical method used is acetone water extraction with QuEChERS clean
up. Quantitation was performed by gas chromatography with tandem mass
spectrometric detection. This method is used to measure and evaluate
the chemical residues of trifluralin. Contact: RD.
    5. PP 1F8974. (EPA-HQ-OPP-2022-0258). BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528 requests
to establish a tolerance in 40 CFR part 180.666 for residues of the
fungicide fluxapyroxad (3-(difluoromethyl)-1-methyl-N-(3',4',5'-
trifluoro[1,1'-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide) in or on
avocado at 0.6 ppm. Independently validated analytical methods that
have been submitted are used to measure and evaluate the chemical
fluxapyroxad and its metabolites, M700F008, M700F048, and M700F002.
Contact: RD.
    6. PP 2F8986. (EPA-HQ-OPP-2022-0314). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419,

requests to establish a tolerance in 40 CFR part 180 for residues of
the fungicide, sedaxane (N-[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide), in or on
vegetable, cucurbit, group 9 at 0.01 ppm and vegetable, dry bulb, crop
subgroup 3-07A at 0.01 ppm. Methods GRM023.01A and modified method
GRM023.01B, taken through an extraction procedure with final
determination by high-performance LC/MS/MS are used to measure and
evaluate the chemical Sedaxane in its cis and trans isomer forms.
Contact: RD.

    Authority: 21 U.S.C. 346a.

    Dated: July 13, 2022.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2022-15518 Filed 7-19-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Notices]
[Pages 6169-6170]
[FR Doc No: 2015-02161]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0003]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated January 6, 2015, Union Pacific Railroad (UP) has petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 213, Track Safety Standards. FRA assigned the petition
Docket Number FRA-2015-0003.
    Pursuant to 49 CFR 213.113(a), UP requests a waiver from the
accepted practice of stop/start rail testing to start a pilot test
process for nonstop continuous testing. The projected starting date for
implementing the test process would be June 1, 2015, and the test
process would continue for a period of 2 years. The test process would
occur on two separate locations within the UP system: the Marysville
Subdivision main tracks between Gibbon Junction, NE., and Marysville,
KS, and the Baird Subdivision main tracks between Fort Worth and
Sweetwater, TX.
    For this pilot test, the process would be similar to the waivers
granted to CSX Transportation in Docket Number FRA-2011-0107 and the
Illinois Central Railroad as prescribed in Docket Number FRA-2014-0029.
UP would not have parallel or redundant stop/start testing on the
segments being tested in a nonstop process. UP would produce a progress
report on a bimonthly basis for review by FRA's Rail Integrity Office.
This report would include the in-service rail failure ratios per 49 CFR
part 213, a report on the miles tested, and the frequency of testing.
    UP currently tests the Marysville Subdivision every 30 days and the
Baird Subdivision approximately every 90-120 days. UP plans to increase
the frequency on the Marysville Subdivision to every 15-20 days and the
frequency on the Baird Subdivision to approximately every 60 days with
this process. The nonstop continuous high-speed rail test vehicle will
be a self-propelled ultrasonic/induction rail flaw detection vehicle
operating at test speeds of up to 25 mph. Upon completion of each daily
run, data will be analyzed offline, at a remote location, by technical
experts with experience on another Class I railroad with this process.
The offline analysts will categorize and prioritize suspect locations
for posttest field verifications and hand tests. Field verification
will be conducted within an FRA-prescribed timeframe by UP qualified/
certified rail test professionals with recordable field validation
equipment based on Global Positioning System locations. All suspect
locations will be validated for 30 feet on either side of the suspect
GPS locations. Remedial actions will be applied based on the
verification results per 49 CFR 213.113, Defective Rails for confirmed
rail defect locations.
    UP believes nonstop continuous rail testing will provide the
capability to test track more quickly and frequently, and minimize the
risk of rail service failures.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue, SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 23, 2015 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if

submitted on behalf of an association, business, labor union, etc.). In
accordance with 5 U.S.C. 553(c), DOT solicits comments from the public
to better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy. See also
http://www.regulations.gov/#!privacyNotice for the privacy notice of
regulations.gov.

    Issued in Washington, DC, on January 28, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-02161 Filed 2-3-15; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Rules and Regulations]
[Pages 53214-53217]
[FR Doc No: 2021-20841]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2019-0824]
RIN 1625-AA09

Drawbridge Operation Regulation; Milwaukee, Menomonee, and
Kinnickinnic Rivers and Burnham Canals, Milwaukee, WI

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Final rule.

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SUMMARY: The Coast Guard is altering the operating schedules of the
bridges over the Milwaukee, Menomonee, and Kinnickinnic Rivers and
Burnham Canals. The City of Milwaukee requested the regulations to be
reviewed and updated to allow for a more balanced flow of maritime and
land based transportation.

DATES: This rule is effective October 27, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov. Type USCG-
2019-0824 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Lee D. Soule, Bridge Management Specialist, Ninth
Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IGLD85 International Great Lakes Datum of 1985
LWD Low Water Datum based on IGLD85
NPRM Notice of proposed rulemaking (Advance, Supplemental)
OMB Office of Management and Budget
PVA Passenger Vessel Association
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On November 26, 2019, we published in the Federal Register (84 FR
65045) an advanced notice of proposed rulemaking request for comments
and on March 9, 2020, we published in the Federal Register (85 FR
13517) notice of temporary deviation from regulations; request for
comments that allowed the city to test the new schedule and allow
residents to comment all summer. The comments we received from these
document led us to publish in the Federal Register (86 FR 20344, April
19, 2021) a notice of proposed rulemaking. Several comments were
directed at the operation of the Canadian Pacific Railroad Bridge, mile
1.05, over the Menomonee River. Most of the comments were complaints
filed on Coast Guard Delay reports that claims the Canadian Pacific
Railroad Bridge, mile 1.05, over the Menomonee River, did, on August 6,
2020, on or about noon that day fail to respond to signals for opening
and fail to open the bridge within the 2-hour requirement. The tender
stated the request for advance notice for bridge opening was not passed
on by the previous drawtender and that priority was given to working on
a train and not tending to the bridge. This resulted in three large
vessels stuck between bridges waiting for the railroad bridge to open
for two hours and forty-five minutes past the arrival time provided by
the vessels. We received a separate report that the bridge was out of
service for four days, no report was given to the U.S. Coast Guard
Command Center and at least one vessel was delayed for four days. We
received another report that the bridge was unable to open on October
6, 2020, because the bridge supervisor directed the drawtender to a
different location for the day and no other operators were available
until the following day. We received a separate report on the same day
of October 6, 2020, from a second vessel that was told railroad had
been attempting to call in another drawtender from 4:30 a.m. to 8:19
a.m. without success and the bridge would not open for maritime
traffic. On or about June 13, 2020, three sailing vessels were observed
waiting at the Canadian Pacific Railroad Bridge at 3:23 p.m. and were
not provided an opening until after 5:30 p.m.
    The second report was a comment submitted to the regulations.gov
portal that requested the schedules to return to the original schedules
citing vessels were using excessive speed to go through the river to
make the new schedule. The speed limits in the harbor needs to be
addressed by the agency responsible for posting the speed limits in the
harbor and the author did not consider the needs of all modes of
transportation involved with the decision.
    On March 30, 2021, we received a report from a public vessel that
the drawtender did inform the vessel that requested an opening that a
new law required the bridge to remain closed if ice was present.
    Separately we discussed with residents who comments on the two hour
advance notice required by some bridges, a carryover of the original
1984 regulation that mariners didn't notice before or that was not
enforced locally.
    Milwaukee Harbor is host to several different vessels and having a
large recreational or commercial vessel station keeping between two
bridges could be a danger to other vessels traveling between the
bridges. The exemption prevents vessels from using excessive speed to
clear the bridges before the special bridge hours go into effect and
prevents vessels from endangering others waiting for the bridges to
open.
    After careful review of the comments received against the 50 ton
proposed rule we decided that vessels with a documented capacity of 12
tons or greater could cause significant danger to life and property if
trapped between two bridges and caused to station keep, especially with
other vessels nearby.
    We explained this is not an exclusion for documented vessels 12
tons and larger. This provision is allowing vessels of this size to
complete their passage in or out of the Milwaukee Harbor. A vessel at
dock or not yet in the river, would be required to wait.
    Our office did engage with residents verbally over the phone on
several occasions to answer questions and encouraged them to leave
comments on the regulations.gov website. Most of these engagements were
with citizens that did not fully read the previous documents concerning
the regulation change.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
    The Milwaukee River is approximately 104 miles long. Beginning in
Fond du Lac County the river flows easterly to a low head dam just
above the Humboldt Avenue Bridge at mile 3.22 in downtown Milwaukee,
WI. From here the river flows south to Lake Michigan. This southerly
course of the Milwaukee River divides the lakefront area from the rest
of the city. The Menomonee River joins the Milwaukee River at Mile 1.01
with the Kinnickinnic River joining the Milwaukee River at Mile 0.39.
21 bridges cross the Milwaukee River from mile 0.19 to mile 3.22. In
the early 20th Century, the Milwaukee River was heavily used to support
the industries in and around the Great Lakes. Today, the river has been
redeveloped as a tourist and recreational destination. From its

confluence with the Milwaukee River the Menomonee River flows west for
33 miles. The lower three miles of the Menomonee River is passable by
vessels over 600 feet in length. Seven bridges cross the navigable
portion of the Menomonee River.
    The South Menomonee Canal and the Burnham Canal were both excavated
during a waterways improvement project in 1864. Both man-made canals
are tributaries of the Menomonee River branching just above its mouth.
The South Menomonee Canal is crossed by two bridges and the Burnham
Canal is crossed by three bridges.
    The Kinnickinnic River flows north through the southern portion of
the City of Milwaukee connecting with the Milwaukee River near Lake
Michigan. Only the lower 2.30 miles of the river have been improved for
vessel use. Five bridges cross the river with the Lincoln Avenue Bridge
at the head of navigation. Freighters up to 1,000 feet in length
transfer cargoes at the confluence of the Kinnickinnic and Milwaukee
Rivers. Most of the recreational vessels in Milwaukee moor in the lake
front marinas and only transit the rivers. Boat yards on the Menomonee
and Kinnickinnic rivers haul out and store most of the recreational
vessels in the fall and winter months and launch the vessels in the
spring. This action contributes to a considerable surge in drawbridge
openings in the fall and spring.
    The following bridges will be included in the rule: The Union
Pacific Railroad Bridge, mile 0.59, over the Milwaukee River with a
vertical clearance in the closed position of 7 feet above internet
Great Lakes Datum of 1985 (IGLD85). The Broadway Street Bridge, mile
0.79, over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. The Water Street Bridge, mile 0.94,
over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. The St. Paul Avenue Bridge, mile
1.21, over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. The Clybourn Street Bridge, mile
1.28, over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. Michigan Street Bridge, mile 1.37,
over the Milwaukee River with a vertical clearance in the closed
position of 12 feet above IGLD85. The Wisconsin Avenue Bridge, mile
1.46, over the Milwaukee River with a vertical clearance in the closed
position of 12 feet above IGLD85. The Wells Street Bridge, mile 1.61,
over the Milwaukee River with a vertical clearance in the closed
position of 12 feet above IGLD85. The Kilbourn Avenue Bridge, mile
1.70, over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. The State Street Bridge, mile 1.79,
over the Milwaukee River with a vertical clearance in the closed
position of 14 feet above IGLD85. The Highland Avenue Pedestrian
Bridge, mile 1.97, over the Milwaukee River with a vertical clearance
in the closed position of 12 feet above IGLD85. The Juneau Avenue
Bridge, mile 2.06, over the Milwaukee River with a vertical clearance
in the closed position of 14 feet above IGLD85. The Knapp Street/Park
Freeway Bridge, mile 2.14, over the Milwaukee River with a vertical
clearance in the closed position of 16 feet above IGLD85. The Cherry
Street Bridge, mile 2.29, over the Milwaukee River with a vertical
clearance in the closed position of 14 feet above IGLD85. The Pleasant
Street Bridge, mile 2.58, over the Milwaukee River with a vertical
clearance in the closed position of 14 feet above IGLD85. The Canadian
Pacific Railroad Bridge, mile 1.05, over the Menomonee River with a
vertical clearance in the closed position of 8 feet above IGLD85. The
North Plankinton Avenue Bridge, mile 1.08, over the Menomonee River
with a vertical clearance in the closed position of 14 feet above
IGLD85. The North Sixth Street Bridge, mile 1.37, over the Menomonee
River with a vertical clearance in the closed position of 23 feet above
IGLD85. The Ember Lane Bridge, mile 1.95, over the Menomonee River with
a vertical clearance in the closed position of 12 feet above IGLD85.
The Sixteenth Street Bridge, mile 2.14, over the Menomonee River with a
vertical clearance in the closed position of 35 feet above IGLD85. The
South Sixth Street Bridge, mile 1.51, over the South Menomonee Canal
with a vertical clearance in the closed position of 8 feet above
IGLD85. The Union Pacific Railroad Bridge, mile 1.19, over the
Kinnickinnic River with a vertical clearance in the closed position of
8 feet above IGLD85. The Kinnickinnic Avenue Bridge, mile 1.67, over
the Kinnickinnic River with a vertical clearance in the closed position
of 8 feet above IGLD85. The Canadian Pacific Railroad Bridge, mile
1.67, over the Kinnickinnic River with a vertical clearance in the
closed position of 15 feet above IGLD85. Finally, the South First
Street Bridge, mile 1.78, over the Kinnickinnic River with a vertical
clearance in the closed position of 14 feet above IGLD85. These bridges
currently operate under title 33 of the Code of Federal Regulations (33
CFR), Sec.  117.1093.

IV. Discussion of Comments, Changes and the Final Rule

    There is a typographical error in the NPRM describing the operation
of the Sixth Street Bridge as remaining closed by regulation and that
should have read as the Sixteenth Street Bridge. A typographical error
referring to the Canadian Pacific Railroad Bridge as the Canadian
National Railroad Bridge have been corrected in this copy. All other
comments have been addressed previously.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protesters.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, it has
not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the ability that
vessels can still transit the bridge given advanced notice.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 did not receive any comments from the Small
Business Administration on this rule. The PVA claimed that this rule
would have a significant impact on one or more of its members. We
assisted the PVA and its members to submit documentation to the Local
Milwaukee office of the Small Business Administration and made
ourselves available for any questions they may have. They did not have
any concerns and they did not have any questions for us. 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.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section V.A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. 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).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.
    We did not receive any comments from local Indian tribes during any
comment periods for this rule.

E. 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. We did not receive any comments.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series) which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that 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 promulgates the operating
regulations or procedures for drawbridges and is categorically excluded
from further review, under paragraph L49, of Chapter 3, Table 3-1 of
the U.S. Coast Guard Environmental Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. Revise Sec.  117.1093 to read as follows:

Sec.  117.1093   Milwaukee, Menomonee, and Kinnickinnic Rivers and
South Menomonee and Burnham Canals.

    (a) The draws of the bridges over the Milwaukee River shall operate
as follows:
    (1) The draws of the North Broadway Street bridge, mile 0.5, and
North Water Street bridge, mile 0.6, and Michigan Street bridge, mile
1.1, shall open on signal; except that, from April 16th through
November 1st, from 7:30 a.m. to 8:30 a.m. and from 4 p.m. to 5:30 p.m.
Monday through Friday, except Federal holidays, the draws need not be
opened, and from midnight to 7 a.m. Monday through Saturday except
Federal holidays the bridges will open on signal if a 2-hour advance
notice is provided.
    (2) The draws of all other bridges across the Milwaukee River shall
open on signal if at least 2-hours' notice is given except that, from
April 16th through November 1st, from 7:30 a.m. to 8:30 a.m. and from 4
p.m. to 5:30 p.m. Monday through Friday, except Federal holidays, the
draws need not be opened.
    (3) The following bridges are remotely operated, are required to
operate a radiotelephone, and shall open as noted in this section: St.
Paul Avenue, mile 1.21, Clybourn Street, mile 1.28, Wells Street, mile
1.61, Kilbourn Street, mile 1.70, State Street, mile 1.79, Highland
Avenue, mile 1.97, and Knapp Street, mile 2.14.
    (4) No vessel documented 12 tons or greater shall be held between
any bridge at any time and must be passed as soon as possible.
    (5) From November 2nd through April 15th, all drawbridges over the
Milwaukee River will open on signal if a 12-hour advance notice is
provided.
    (b) The draws of bridges across the Menomonee River and South
Menomonee Canal operate as follows:
    (1) The draw of the North Plankinton Avenue bridge across the
Menomonee River, mile 1.08, and the Canadian Pacific Railroad bridge,
mile 1.05, shall open on signal; except that, from April 16th through
November 1st, from 7:30 a.m. to 8:30 a.m. and from 4 p.m. to 5:30 p.m.
Monday through Friday, except Federal holidays, the draws need not be
opened, and from midnight to 7 a.m. Monday through Friday except
Federal

holidays the bridges will open on signal if a 2-hour advance notice is
provided.
    (2) The draws of all other bridges across the Menomonee River and
South Menomonee Canal shall open on signal if at least 2-hours' notice
is given except that, from April 16th through November 1st, from 7:30
a.m. to 8:30 a.m. and from 4 p.m. to 5:30 p.m. Monday through Friday,
except Federal holidays, the draws need not be opened.
    (3) The following bridges are remotely operated, are required to
operate a radiotelephone, and shall open as noted in this section:
North Plankinton Avenue, mile 1.08, North Sixth Street, mile 1.37, and
North Ember Lane, mile 1.95, all over the Menomonee River and South
Sixth Street, mile 1.51, over the South Menomonee Canal.
    (4) No vessel documented over 12 tons shall be held between any
bridge at any time and must be passed as soon as possible.
    (5) From November 2nd through April 15th, all drawbridges over the
Menomonee River and South Menomonee Canal will open on signal if a 12-
hour advance notice is provided.
    (c) The draws of bridges across the Kinnickinnic River operate as
follows:
    (1) The draw of the Kinnickinnic Avenue bridge, mile 1.5, shall
open on signal; except that, from April 16th through November 1st, from
7:30 a.m. to 8:30 a.m. and from 4 p.m. to 5:30 p.m. Monday through
Friday, except Federal holidays, the draws need not be opened, and from
midnight to 7 a.m. Monday through Friday, except Federal holidays, the
bridges will open on signal if a 2-hour advance notice is provided.
    (2) The draws of all other bridges across the Kinnickinnic River
shall open on signal if at least 2-hours' notice is given except that,
from April 16th through November 1st, from 7:30 a.m. to 8:30 a.m. and
from 4 p.m. to 5:30 p.m. Monday through Friday, except Federal
holidays, the draws need not be opened.
    (3) The following bridges are remotely operated, are required to
operate a radiotelephone, and shall open as noted in this section: The
South First Street Bridge, mile 1.78.
    (4) No vessel documented over 12 tons shall be held between any
bridge at any time and must be passed as soon as possible.
    (5) From November 2nd through April 15th, all drawbridges over the
Kinnickinnic River will open on signal if a 12-hour advance notice is
provided.
    (d) The Canadian Pacific Railroad Bridge at Mile 1.74 over the
Burnham Canal, and the Sixteenth Street Bridge, mile 2.14, over the
Menomonee River are closed by regulation and do not need to open for
the passage of vessels.

M.J. Johnston,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2021-20841 Filed 9-24-21; 8:45 am]
BILLING CODE 9110-04-P