[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Rules and Regulations]
[Pages 18865-18869]
[FR Doc No: 2011-8133]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0323; Directorate Identifier 2011-SW-005-AD;
Amendment 39-16651; AD 2011-08-01]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron, Inc. Model 212
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are superseding an existing emergency airworthiness
directive (EAD) for the Bell Helicopter Textron, Inc. (Bell) Model 212
helicopters with a certain main rotor hub inboard strap fitting
(fitting) installed. That EAD requires, before further flight, removing
certain serial-numbered fittings and replacing them with airworthy
fittings. It also requires performing a magnetic particle inspection
(MPI) on fittings with certain serial numbers (S/Ns) to inspect for a
crack. If a crack is found, the cracked fitting must be replaced with
an airworthy fitting, and certain data must be reported to the FAA.
This airworthiness directive (AD) retains the requirements of that EAD
and expands the applicability to require performing an MPI for a crack
on additional serial-numbered fittings. This AD is prompted by the
determination that certain fittings were not manufactured in accordance
with the approved manufacturing processes and controls. In total, eight
fittings have been found that have cracks. We are issuing this AD to
prevent failure of a fitting, loss of a main rotor blade, and
subsequent loss of control of the helicopter.

DATES: This AD is effective April 21, 2011.
    We must receive any comments on this AD by June 6, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Bell
Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX 76101, telephone
(817) 280-3391, fax<PHONE_NUMBER>, or at http://www.bellcustomer.com/files/.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Michael Kohner, Aerospace Engineer,
Rotorcraft Directorate, Rotorcraft Certification Office, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137, phone:<PHONE_NUMBER>; fax:
(817) 222-5783; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    This AD supersedes EAD 2010-25-51, issued November 24, 2010 (EAD
2010-25-51), which superseded EAD 2010-24-52, issued November 19, 2010
(EAD 2010-24-52). EAD 2010-24-52 superseded EAD 2010-24-51, issued
November 12, 2010 (EAD 2010-24-51). EAD 2010-24-51, EAD 2010-24-52, and
EAD 2010-25-51 were all issued for the Bell Model 212 helicopters with
a certain fitting installed.
    EAD 2010-24-51, the initial EAD, was issued for all Bell Model 212
helicopters with a fitting, part number (P/N) 212-010-103-007, S/Ns
9956 through 10005 with a prefix of ``A''. That EAD required, before
further flight, removing any affected fitting and replacing it with an
airworthy fitting. That EAD also prohibited installing any affected
fitting on any helicopter. That EAD was prompted by an accident that
resulted in several fatalities. During the investigation of the
accident, a crack was found on a fitting. Subsequently, four additional
fittings from the same manufacturing lot were inspected, and two were
found to exhibit the same type of cracking. We issued EAD 2010-24-51 to
remove this lot from service to prevent failure of a fitting, loss of a
main rotor blade, and subsequent loss of control of the helicopter.
    After we issued EAD 2010-24-51, additional fittings from a
different manufacturing lot were found to have the same type of crack
as that found on the fitting involved in the accident. Therefore, we
issued superseding EAD 2010-24-52 to require the same actions as EAD
2010-24-51, and to expand the applicability to include additional
fittings. In addition to S/Ns 9956 through 10005 with a prefix of
``A'', EAD 2010-24-52 added S/Ns 52, 54, 55, 57 through 65, 67, 69, 70,
71, 73, 103, 112, 113, 137, and 139 with a prefix of ``SH'' to the
applicability. EADs 2010-24-51 and 2010-24-52 were issued as interim
actions to address a known unsafe condition, and Bell continued to
investigate the cause of the cracking.
    Because the root cause of the cracking had not been determined, and
due to the severity of a fitting failure, we issued superseding EAD
2010-25-51 to require the same action as EAD 2010-24-52 and to also
require performing an MPI on fittings with S/Ns 9911 through 9955,
10006 through 10049, 10075 through 10174, 10455 through 10460, 10581
through 10655, 10742 through 10791, and 10862 through 10946 with a
prefix of ``A'' to detect a crack on those fittings. If you find a
crack, you are required to replace the cracked fitting with an
airworthy fitting, and within 24 hours, report the information
specified in Appendix 1 of the EAD to the Manager, Rotorcraft
Certification Office. If you do not find a crack, you are required to
reidentify and refinish the fitting in accordance with the specified
portion of Alert Service Bulletin (ASB) 212-10-142, dated November 24,
2010 (ASB 212-10-142).

Actions Since AD Was Issued

    Since we issued EAD 2010-25-51, additional fittings with cracks
were found using the MPI process. In response to these findings, Bell
issued ASB 212-10-142, Revision A, dated March 21, 2011, that specifies
performing an MPI for a crack on all serial-numbered fittings with the
same part number in stock or in service. We have determined that
certain fittings were not manufactured in accordance with the approved
manufacturing processes and controls. Due to the severity of a fitting
failure, this superseding AD is being issued to continue to require
replacing certain serial-numbered fittings, and to expand the
applicability to require performing an MPI for a crack on the remaining
serial numbers of the fittings with the same part number. Serial-
numbered fittings affected by this superseding AD are listed in Table 1
of the Applicability section of this AD. This superseding AD is being
issued to prevent failure of a fitting, loss of a main rotor blade, and
subsequent loss of control of the helicopter.

Relevant Service Information

    We reviewed Bell Alert Service bulletin (ASB) No. 212-10-141, dated
November 11, 2010 (ASB-212-10-141), which specified the immediate
removal of the affected fittings, S/Ns A-9956 through A-10005, from
service. We also reviewed ASB No. 212-10-141, Revision A, dated
November 18, 2010 (ASB 212-10-141 Rev. A), which incorporates
additional S/Ns of the affected fittings and specifies removing the
affected serial-numbered fittings from service. In ASB 212-10-141, Bell
states that they have determined that the fittings may not have been
manufactured in accordance with the engineering design requirements and
may fracture as a result of the nonconformance.
    We have also reviewed Bell ASB 212-10-142, initial release, dated
November 24, 2010 (ASB 212-10-142) which specifies performing an MPI on
fittings with certain S/Ns to detect a crack on those fittings.
    Finally, we have reviewed Bell ASB 212-10-142, Revision A, dated
March 21, 2011 (ASB 212-10-142 Rev. A), which includes all serial-
numbered fittings except those already inspected and marked with
``FM''. ASB 212-10-142 Rev. A specifies 1) within 25 hours time-in-
service (TIS) or 15 days, whichever comes first, for all fittings with
less than 400 hours TIS; or 2) within 100 hours TIS or 30 days,
whichever comes first, for all fittings with 400 or more hours but less
than 800 hours TIS; or 3) at the next main rotor teardown inspection or
next tension-torsion strap replacement, whichever comes first, for all
fittings with more than 800 hours TIS, performing a one-time MPI of the
fitting, P/N 212-010-103-007, with all S/Ns in stock or in service.
Finally, ASB 212-10-142 Rev. A states that all fittings, S/Ns A-11021
and subsequent, SH-053, SH-066, SH-072, SH-074 through SH-102, SH-104
through SH-111, SH-114 through SH-136, SH-138, and SH-140 and
subsequent are not affected by ASB 212-10-142 Rev. A. Bell states that
a one-time MPI of the affected fittings is required to ensure continued
airworthiness of the fittings.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other helicopters of this same type
design.

AD Requirements

    This AD supersedes EAD 2010-25-51 and requires the following:
     Before further flight, for any helicopter with a fitting,
S/N 9956 through 10005, with a prefix of ``A'', and S/N 52, 54, 55, 57
through 65, 67, 69, 70, 71, 73, 103, 112, 113, 137, and 139 with a
prefix of ``SH'', replace the fitting with an airworthy fitting. Any
fitting with a S/N identified in this paragraph is no longer eligible
for installation on any helicopter.
     Before further flight, for any helicopter with a fitting,
S/N 9911 through 9955, 10006 through 10049, 10075 through 10174, 10455
through 10460, 10581 through 10655, 10742 through 10791, and 10862
through 10946, with a prefix of ``A'', perform an MPI of each fitting
for a crack. If the fitting is cracked, replace it with an airworthy
fitting. If the fitting is not cracked, reidentify and refinish the
fitting.
     For any fitting with a serial number identified in
paragraph (h) in the Compliance section of this AD, perform an MPI of
each fitting for a crack:
    [cir] For any fitting with 400 or less hours TIS, perform an MPI
within 25

hours TIS or 15 days, whichever comes first.
    [cir] For any fitting with more than 400 hours but less than 800
hours TIS, perform an MPI within 100 hours TIS or 30 days, whichever
comes first.
    [cir] For fittings with 800 hours or more TIS, perfrom an MPI at
the next main rotor hub teardown inspection or tension-torsion strap
replacement, whichever comes first.
    [cir] If a fitting is cracked, replace it with an airworthy
fitting. If a fitting is not cracked, reidentify and refinish the
fitting.
     If a crack is found on any fitting, within 24 hours,
report the information requested in Appendix 1 of this AD to the
Manager, Rotorcraft Certification Office, FAA, 2601 Meacham Blvd, Fort
Worth, Texas 76137, or e-mail<EMAIL_ADDRESS>
Differences Between the AD and the Service Information

    This AD differs from ASB 212-10-142 Rev. A as follows:
     We do not require returning parts to Bell.
     We require performing an MPI before further flight on
certain S/N fittings included in the initial release of ASB 212-10-142.
     We require sending information to the Rotorcraft
Certification Office and not to Bell.
     Bell uses the term ``total time-in-service'' to describe
compliance times, and we use the term ``time-in-service.''
     We specify S/Ns in our AD, and Bell does not specify S/Ns
in ASB 212-10-142 Rev. A.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA finds that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because we
evaluated all the available information and determined the unsafe
condition described is likely to exist or develop in other helicopters
of this same type design. Therefore, we find that notice and
opportunity for prior public comment are impracticable because of the
short compliance times, and that good cause exists for making this
amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
the Docket Number FAA-2011-0323 and ``Directorate Identifier 2011-SW-
005-AD'' at the beginning of your comments. We specifically invite
comments on the overall regulatory, economic, environmental, and energy
aspects of this AD. We will consider all comments received by the
closing date and may amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 84 helicopters of U.S. registry.
We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost      helicopter       operators
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(a) For any fitting, S/N 9956 through   40 work-hours x $85 per           $2,367          $5,767        $415,224
 10005 and a prefix of ``A''; or a S/N   hour = $3,400.
 of 52, 54, 55, 57 through 65, 67, 69,
 70, 71, 73, 103, 112, 113, 137, 139
 with a prefix of ``SH''; replace the
 fitting with an airworthy fitting
 (assumes action affects 72 fittings).
(c) For any fitting affected by this    40 work-hours x $85 per                0           3,400          40,800
 AD with a S/N not identified in         hour = $3,400.
 paragraph (a) of this table, perform
 an MPI on each fitting for a crack
 unless documentation exists of any
 previous MPI performed during
 regularly scheduled maintenance
 (assumes action affects 12 fittings).
----------------------------------------------------------------------------------------------------------------

    We estimate a total cost of $456,024 to do the actions required by
this AD.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends Part 39 of the Federal Aviation
Regulations (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 AD:

2011-08-01 Bell Helicopter Textron, Inc. (Bell): Amendment 39-16651;
Docket No. FAA-2011-0323; Directorate Identifier 2011-SW-005-AD.

Effective Date

    (a) This AD is effective on April 21, 2011.

Other Affected ADs

    (b) This AD supersedes Emergency AD 2010-25-51, issued on
November 24, 2010, Directorate Identifier 2010-SW-096-AD.

Applicability

    (c) This AD applies to Model 212 helicopters certificated in any
category, with a main rotor hub inboard strap fitting (fitting),
part number (P/N) 212-010-103-007, installed, with the serial
numbers (S/Ns) listed in the following Table 1:

                                 Table 1
------------------------------------------------------------------------
                    Serial numbers with a prefix of:
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``A'' or ``A-FS'': 7 through 10946.
``A1'': 430 through 7606.
``DI'': 22296 through 22681.
``EA'': 333 through 381.
``LK'': 4619 through 4631.
``MB'': 11908 through 11916.
``SH'': 52, 54, 55, 57 through 65, 67, 69, 70, 71, 73, 103, 112, 113,
 137, and 139.
``WR'': 275 through 319.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD is prompted by a recent accident that resulted in
several fatalities. During the investigation of the accident, a
crack was found on a fitting. We have determined that certain
fittings were not manufactured in accordance with approved
manufacturing processes and controls. Due to the severity of a
fitting failure, we are requiring replacing certain serial-numbered
fittings, and we are expanding the applicability to require
performing a magnetic particle inspection (MPI) for a crack on the
remaining serial numbers of the fittings with the same part number.
The actions specified by this AD are intended to prevent failure of
a fitting, loss of a main rotor blade, and subsequent loss of
control of the helicopter.

Compliance

    (e) Required as indicated, unless accomplished previously.
    (f) Before further flight, for any helicopter with a fitting,
serial number (S/N) 9956 through 10005 with a prefix of ``A'', and
S/N 52, 54, 55, 57 through 65, 67, 69, 70, 71, 73, 103, 112, 113,
137, and 139 with a prefix of ``SH'' installed, replace the fitting
with an airworthy fitting. Any fitting with a S/N identified in this
paragraph is no longer eligible for installation on any helicopter.
    (g) Before further flight, for any helicopter with a fitting, S/
N 9911 through 9955, 10006 through 10049, 10075 through 10174, 10455
through 10460, 10581 through 10655, 10742 through 10791, and 10862
through 10946 with a prefix of ``A'', perform an MPI of each fitting
for a crack. If a fitting is cracked, replace it with an airworthy
fitting. If a fitting is not cracked, reidentify and refinish the
fitting using a vibrating stylus (not to exceed 0.005 inch depth nor
to extend within 0.10 inch of part edge) by adding ``FM'' at the end
of the P/N. Touch up the reworked area with brush cadmium plating or
zinc chromate primer. Reidentify the historical service records with
``FM'' at the end of the P/N.

    Note 1:  The Bell Model 212 Component, Repair, and Overhaul
Manual, which is not incorporated by reference, contains additional
information about MPI procedures.

    (h) For any fitting with a S/N identified in Table 1 of the
Applicability section of this AD, and not identified in paragraph
(f) or (g) of this AD, perform an MPI of each fitting for a crack as
follows:
    (1) For a fitting with 400 or less hours time-in-service (TIS),
perform an MPI within 25 hours TIS or 15 days, whichever comes
first.
    (2) For a fitting with more than 400 but less than 800 hours
TIS, perform an MPI within 100 hours TIS or 30 days, whichever comes
first.
    (3) For a fitting with 800 or more hours TIS, perform an MPI at
the next main rotor hub teardown inspection or tension-torsion strap
replacement, whichever comes first.
    (4) If a fitting is cracked, replace it with an airworthy
fitting.
    (5) If a fitting is not cracked, reidentify and refinish the
fitting in accordance with the instructions in paragraph (g) of this
AD.
    (i) Within 24 hours after finding any cracked fitting, report
the information requested in Appendix 1 of this AD to the Manager,
Rotorcraft Certification Office, to the address, fax number, or
email specified in the Appendix.

Paperwork Reduction Act Burden Statement

    (j) A federal agency may not conduct or sponsor, and a person is
not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid Office of
Management and Budget (OMB) Control Number. Under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the OMB has
approved the information collection requirements contained in this
AD and has assigned OMB Control Number 2120-0056. Public reporting
for this collection of information is estimated to be approximately
5 minutes per response, including the time for reviewing
instructions, completing and reviewing the collection of
information. All responses to this collection of information are
mandatory. Comments concerning the accuracy of this burden and
suggestions for reducing the burden should be directed to the FAA
at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Subject

    (k) The Joint Aircraft System Component/Air Transport
Association of America Code is 6220: Main rotor hub.

Alternative Methods of Compliance (AMOCs)

    (l) The Manager, Rotorcraft Certification Office, 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 ACO, send it to the attention of the
person identified in the ``Additional Information'' section of this
AD.

    Note 2:  Before using any approved AMOC, we request that you
notify your appropriate principal inspector, or if you have no
principal inspector, your local Flight Standards District Office.

Additional Information

    (m)(1) For service information identified in this AD, contact
Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX 76101,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.bellcustomer.com/files/.
    (2) You may review copies of the service information at the FAA,
Office of the Regional Counsel, Southwest Region, 2601 Meacham
Blvd., Room 663, Fort Worth, Texas.
    (3) Bell Helicopter Alert Service Bulletin No. 212-10-141,
Revision A, dated November 18, 2010, and Alert Service Bulletin No.
212-10-142, Revision A, dated March 21, 2011, contain additional
guidance pertaining to the subject of this AD but are not
incorporated by reference. A picture of a crack indication on an
actual fitting is shown in Figure 1 of Bell Alert Service Bulletin
212-10-142, Rev. A.

Appendix 1 to AD 2011-08-01

AD Compliance Inspection Report (Sample Format)

    Provide the following information and mail, fax, or e-mail
report to: Manager, Rotorcraft Certification Office, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137, fax<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

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

------------------------------------------------------------------------
Aircraft Registration No.
------------------------------------------------------------------------
Helicopter Serial No.
------------------------------------------------------------------------
Helicopter Owner/Operator.
------------------------------------------------------------------------
Contact Phone No.
------------------------------------------------------------------------
Fitting Part Number.
------------------------------------------------------------------------
Fitting Serial Number.
------------------------------------------------------------------------
Hours Time-in-Service on Fitting at
 Time of Inspection.
------------------------------------------------------------------------
Description of Findings.
------------------------------------------------------------------------
Who Performed the Inspection?
------------------------------------------------------------------------
Date and Location the Inspection was
 Performed.
------------------------------------------------------------------------
Describe the crack size, location,
 orientation (provide a sketch or
 pictures with the fitting part and
 serial numbers).
------------------------------------------------------------------------
Provide any other comments.
------------------------------------------------------------------------

    Issued in Fort Worth, Texas, on March 29, 2011.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-8133 Filed 4-5-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41528-41530]
[FR Doc No: 2015-17297]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75409; File No. SR-BX-2015-038]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Exchange Rule 7018

July 9, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 30, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the 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.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend BX Rule 7018(a) and to eliminate the
Excess Order Fee in BX Rule 7018(d).
    While the changes proposed herein are effective upon filing, the
Exchange has designated that the amendments be operative on July 1,
2015.
    The text of the proposed rule change is also available on the
Exchange's Web site at http://nasdaqomxbx.cchwallstreet.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend BX Rule 7018(a) and to eliminate
the Excess Order Fee in BX Rule 7018(d).
    Specifically, BX Rule 7018(a) defines the criteria for a firm to
become a Qualified Market Maker (``QMM'') as by being a member that
provides through one or more of its NASDAQ OMX BX Equities System
(``System'') market participant identifiers (``MPIDs'') more than 0.15%
of consolidated volume (``Consolidated Volume'') during the month. For
a member qualifying under this method, the member must have at least
one qualified MPID (``Qualified MPID''), that is, an MPID through
which, for at least 200 securities, the QMM quotes at the national best
bid and offer (``NBBO'') an average of at least 50% of the time during
regular market hours (9:30 a.m. through 4:00 p.m. ET) during the month.
Currently, the member must also provide an average daily volume of 1.5M
shares or more using orders with midpoint pegging during the month.
    The Exchange proposes to modify this last part of the criteria such
that the member must also provide an average daily volume of 1.5M
shares or more of non-displayed liquidity (rather than using orders
with midpoint liquidity) during the month. BX believes that by
expanding the type of liquidity that allows firms to qualify as a QMM
will improve the market by incentivizing firms to provide more
liquidity and meet the other QMM criteria. Non-displayed orders, which
include midpoint liquidity, can provide price improvement and improve
the experience of members trading on the Exchange and thus provide a
benefit to all other Exchange members.
    The Exchange also proposes to delete BX Rule 7018(d), which is the
Excess Order Fee. The Excess Order Fee was designed to provide a
disincentive to member organizations to engage in order entry practices
that are inefficient and thereby burdensome on the systems of BX by
assessing a fee on member organizations if they reach a threshold of
order activity based on an Order Entry Ratio calculation.\3\ Although
not a pervasive characteristic of the market, the fee was adopted to
encourage member organizations with such practices to enhance the
efficiency of their systems and modify their order entry practices,
thus improving the market for all participants.\4\ An unwanted
consequence of the rule has been to capture beneficial, liquidity
providing order flow and thereby dissuade member organizations from
participating in BX in an effort to avoid triggering the fee. Moreover,
the Exchange has observed that the fee is not assessed on a significant
number of member organizations nor is it triggered every month, leading
the Exchange to conclude that the small number of member organizations
that may have been affected by the fee because of their inefficient
order practices have taken the steps necessary to avoid such practices.
The Exchange believes that, in light of the lack of consistent order
activity that triggers the fee and the negative effect it has had on
beneficial order flow, the Excess Order Fee should be eliminated. The
Exchange notes that, should the inefficient order entry practices that
gave rise to the fee once again arise, it may adopt the fee once again
or take other steps to provide a disincentive for such practices.
---------------------------------------------------------------------------

    \3\ See BX Rule 7018(d)(2) for a definition of ``Order Entry
Ratio.''
    \4\ See Securities Exchange Act Release No. 67272 (June 27,
2012), 77 FR 39530 (July 3, 2012) (SR-BX-2012-042) (adopting the
Excess Order Fee).
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2. Statutory Basis
    BX believes that the proposed rule change is consistent with the
provisions

of Section 6 of the Act,\5\ in general, and with Sections 6(b)(4) and
6(b)(5) of the Act,\6\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which the Exchange operates or controls, and 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 regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange proposes to amend the criteria for a firm to become a
QMM. The criteria currently states that a member may become a QMM by
providing through one or more of its System MPIDs more than 0.15% of
Consolidated Volume during the month. For a member qualifying under
this method, the member must have at least one Qualified MPID, that is,
an MPID through which, for at least 200 securities, the QMM quotes at
the NBBO an average of at least 50% of the time during regular market
hours (9:30 a.m. through 4:00 p.m.) during the month. Currently, the
member must also provide an average daily volume of 1.5M shares or more
using orders with midpoint pegging during the month.
    [sic] Exchange believes it is reasonable to modify this last part
of the criteria such that the member must provide an average daily
volume of 1.5M shares or more of non-displayed liquidity (rather than
using orders with midpoint liquidity) during the month because non-
displayed orders can provide price improvement and improve the
experience of members trading on the Exchange and thus provide a
benefit to all other Exchange members. Also, BX believes the proposed
change is reasonable because it expands the opportunity for firms to
qualify as a QMM.
    The Exchange also believes that the proposed change is equitably
allocated and not unfairly discriminatory because modifying the
criteria, as stated above, applies uniformly to all members that seek
to become a QMM. Additionally, the Exchange believes that the proposed
change further perfects the mechanism of a free and open market by
refining and making more effective the means by which a member firm may
become a QMM. Furthermore firms that currently qualify as a QMM will
not need to change behavior under the new qualification method as
midpoint liquidity is considered non-displayed liquidity.
    The Exchange believes that elimination of the Excess Order Fee is
reasonable because the fee is not triggered by a significant number of
member organizations nor is it triggered every month; however, the
Exchange believes that certain member organizations are disincentivized
from providing order activity that is beneficial to market
participants. Moreover, the Exchange may adopt the fee once again
should the issues that gave rise to it reemerge. The Exchange believes
that the proposed change is consistent with an equitable allocation of
fees and is not unfairly discriminatory because it eliminates a fee,
which applies to all member organizations and which has served as a
disincentive to certain market participants in providing beneficial
order activity while also not being assessed significantly on member
organizations. The Exchange believes that elimination of the Excess
Order Fee will not unfairly burden competition because the fee is not
relevant to competition. The Exchange notes that the fee was adopted to
deter member organizations from using inefficient order practices that
place excessive burdens on the systems of BX and, as a consequence, was
not designed to impact competition among member organizations.

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

    The Exchange does not believe that the proposed rule changes will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.\7\
BX notes that it operates in a highly competitive market in which
market participants can readily favor dozens of different competing
exchanges and alternative trading systems if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, BX must
continually adjust its fees to remain competitive with other exchanges.
Because competitors are free to modify their own fees in response, and
because market participants may readily adjust their order routing
practices, BX believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
---------------------------------------------------------------------------

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

    In this instance, the modification to part of the criteria to
become a QMM does not impose a burden on competition because it is
optional and is the subject of competition from other exchanges. The
Exchange does not believe that the proposed change will impair the
ability of members or competing order execution venues to maintain
their competitive standing in the financial markets. Moreover, because
there are numerous competitive alternatives to the use of the Exchange,
it is likely that BX will lose market share as a result of the changes
if they are unattractive to market participants.
    As noted above, the Exchange believes that elimination of the
Excess Order Fee will not unfairly burden competition because the fee
is not relevant to competition as it was adopted to deter member
organizations from using inefficient order practices that place
excessive burdens on the systems of BX. Moreover, other exchanges' fee
schedules do not restrict order activity by using a fee like the Excess
Order Fee. As noted, the practices that prompted the Exchange to adopt
the rule have subsided and, consequently, the change does not impact
the ability of any market participant or trading venue to compete.
    Accordingly, BX does not believe that the proposed rule change will
impair the ability of members or competing order execution venues to
maintain their competitive standing in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. 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.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-BX-2015-038 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2015-038. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site 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 such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-BX-2015-038,
and should be submitted on or before August 5, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-17297 Filed 7-14-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Page 47153]
[FR Doc No: 2014-19052]

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

Coast Guard

[Docket No. USCG-2011-1156]

Draft Change to Navigation and Inspection Circular 01-13,
Inspection and Certification of Vessels Under the Maritime Security
Program

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability extending comment period.

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

SUMMARY: The Coast Guard is extending the public comment period on its
draft change to Navigation and Inspection Circular (NVIC) 01-13.

DATES: Submit comments and related material by September 17, 2014.
Documents discussed in this notice should be available in the online
docket by August 15, 2014.

ADDRESSES: Submit comments using one of the listed methods, and see
SUPPLEMENTAL INFORMATION for more information on public comments.
     Online--http://www.regulations.gov following Web site
instructions.
     Fax--202-493-2251.
     Mail or hand deliver--Docket Management Facility (M-30,
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Hours
for hand delivery are 9 a.m. to 5 p.m., Monday through Friday, except
Federal holidays (telephone<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: For information about this document,
call or email Lieutenant Corydon Heard, Office of Commercial Vessel
Compliance (CG-CVC), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>For information about viewing or submitting
material to the docket, call Cheryl Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>, toll free 1-800-647-5527.

SUPPLEMENTARY INFORMATION: On June 19, 2014, we published a Federal
Register notice \1\ announcing the public availability of our draft
change to NVIC 01-13 and inviting public comments, by August 18, on the
draft. Today, we are extending that deadline to September 17, 2014. The
NVIC provides uniform Maritime Security Program process guidance to
assist vessel owners and operators, authorized classification
societies, and Coast Guard personnel. Please see our June notice for
further information about our proposed revisions to better facilitate
the transition of vessels to U.S. registry under the MSP.
---------------------------------------------------------------------------

    \1\ 79 FR 35177.
---------------------------------------------------------------------------

    We encourage you to submit comments or related material on the
draft change to NVIC 01-13. We will consider all submissions and may
adjust our final action based on your comments. Comments should be
marked with docket number USCG-2011-1156 and should provide a reason
for each suggestion or recommendation. You should provide personal
contact information so that we can contact you if we have questions
regarding your comments; but please note that all comments will be
posted to the online docket without change and that any personal
information you include can be searchable online.\2\ Mailed or hand-
delivered comments should be in an unbound 8\1/2\ x 11 inch format
suitable for reproduction. The Docket Management Facility will
acknowledge receipt of mailed comments if you enclose a stamped, self-
addressed postcard or envelope with your submission.
---------------------------------------------------------------------------

    \2\ See the Privacy Act notice regarding DHS public dockets, 73
FR 3316 (Jan. 17, 2008).
---------------------------------------------------------------------------

    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following the Web site's instructions. You can also view the docket at
the Docket Management Facility (see the mailing address under
ADDRESSES) between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: August 5, 2014.
Jonathan C. Burton,
Captain, U.S. Coast Guard, Director, Inspections and Compliance.
[FR Doc. 2014-19052 Filed 8-11-14; 8:45 am]
BILLING CODE 9110-04-P


US ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: April 20, 2006 MEMORANDUM SUBJECT: Didecyl Dimethyl Ammonium Chloride ( DDAC)  Report of the Antimicrobials Division Toxicity Endpoint Committee ( ADTC) and the Hazard Identification Assessment Review Committee ( HIARC).

FROM: Timothy F. McMahon, Ph. D.; Chair, ADTC Michelle Centra, Pharmacologist; Executive Secretary, ADTC Antimicrobials Division ( 7510C)

TO: Steve Malish, Ph. D., Toxicologist Kathryn Montague, Team Leader Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C) and Tracy Lantz, Chemical Review Manager Velma Noble, Team Leader Regulatory Management Branch I Antimicrobials Division ( 7510C)

PC Code: 069149 On February 10, 2000, the Health Effects Division ( HED) HIARC reviewed the recommendations of the toxicology reviewer for didecyl dimethyl ammonium chloride ( DDAC) with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to DDAC was also evaluated as required by the Food Quality Protection Act ( FQPA) of 1996. In November of 2005, members of the ADTC met with the HED Hazard Science Policy Council to discuss revision of the dermal endpoints. The conclusions drawn at this meeting are presented in this report. 3 Committee Members in Attendance HIARC members present: Willam Burnam, Vicki Dellarco, Elizabeth Doyle, Pamela Hurley, Tina Levine, Elizabeth Mendez, David Nixon, Nicole Paquette, Jess Rowland, and Brenda Tarplee. Also in attendance were: Winston Dang ( AD), Tim McMahon ( AD)

HIARC Data Evaluation/ Report Presentation: _______________________________ Jonathan Chen, Ph. D.

ADTC members: Michelle Centra, Jonathan Chen, Ph. D., Stephen Dapson, Ph. D., Roger Gardner, Karen Hamernik, Ph. D., Timothy Leighton, Tim McMahon, Ph. D., Melba Morrow, D. V. M., John Redden, Najm Shamim, Ph. D., Sanyvette Williams Foy, D. V. M.

ADTC Data Evaluation/ Report Presentation: ___________________________________ Tim McMahon, Ph. D., Chair 4 COMMITTEE MEMBERS ( Signature indicates concurrence unless otherwise stated)

Stephen Dapson _________________________________________

Jonathan Chen _________________________________________

Roger Gardner _________________________________________

Karen Hamernik _________________________________________

Tim McMahon ( Chair) _________________________________________

Melba Morrow _________________________________________

John Redden _________________________________________

SanYvette Williams _________________________________________

Michelle Centra ( Executive Secretary) _________________________________________

Najm Shamim _________________________________________

Timothy Leighton ________________________________________ 5 1. INTRODUCTION On February 10, 2000, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for didecyl dimethyl ammonium chloride ( DDAC) with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to DDAC was also evaluated as required by the Food Quality Protection Act ( FQPA) of 1996. In December of 2005, the Antimicrobials Division= s ADTC updated the dermal endpoints for DDAC based on the recently adopted use of dermal irritation as an endpoint for short term dermal risk assessments.

2. HAZARD IDENTIFICATION 2.1. Acute Reference Dose ( RfD) Subpopulation Females 13+

Study Selected: Developmental Toxicology  Rat, OPPTS 870.3700; ' 83 3 MRID No.: 41886701 Executive Summary: In a prenatal developmental toxicity study ( MRID 41886701), twenty five bred female CD 7 ( Sprague Dawley) rats per group were administered DDAC ( 80.8% a. i.) in deionized water orally by gavage at doses of 0, 1, 10, or 20 mg/ kg/ day on gestation days ( GD) 6 15, inclusive. On GD 21, dams were sacrificed, subjected to gross necropsy, and all fetuses examined externally, viscerally, and skeletally for malformations/ variations. Maternal toxicity was observed at the mid and high dose group in the form of audible respiration with the high dose presenting with other observations. Further, a treatment related decrease in body weight gain was noted during the dosing period ( gestation day= s 6 15), the dosing period plus post dosing period ( gestation days 6 21) and for the corrected body weight gains for the high dose. There was also low food efficiency compared with controls during the dosing period for the mid and high dose group. The maternal LOAEL is 10 mg/ kg/ day, based on reductions in body weight gain and clinical signs of toxicity ( audible respiration). The maternal NOAEL is 1 mg/ kg/ day. Developmental toxicity was noted at the high dose in the form of increased incidences of skeletal variations. Therefore, the developmental toxicity LOAEL is 20 mg/ kg/ day based on an increased incidence of skeletal variations, and the developmental toxicity NOAEL is 10 mg/ kg/ day.

Dose and Endpoint for Establishing RfD: Developmental NOAEL of 10 mg/ kg/ day based on increased incidences of skeletal variations at 20 mg/ kg/ day.

Uncertainty Factor ( UF): 100X ( 10X for intraspecies extrapolation; and 10X for interspecies extrapolation) 6 Acute RfD ( females 13+) = 10 mg/ kg/ day ( NOAEL) = 0.1 mg/ kg/ day 100 ( UF)

Comments about Study/ Endpoint/ Uncertainty Factor: The developmental endpoint is presumed to occur after a single exposure. Since the effect developed from in utero exposure, they are applicable for risk assessment for female 13 50 subpopulation group only.

2.2. Acute Reference Dose ( RfD) General Population Including Infants and Children+

Since the developmental endpoint selected is only applicable to Females 13+, another endpoint was considered for the general population including infants and children. However, an appropriate endpoint was not identified for this population subgroup. The maternal toxicity ( decreases in body weight gains) observed in maternal animals in the rat and rabbit studies are NOT appropriate since the effects are not attributable to a single exposure ( dose). Other oral studies did not indicate endpoints that are appropriate for this exposure period.

Study Selected: None MRID No.: None Executive Summary: None Dose and Endpoint for Establishing RfD: None Uncertainty Factor ( UF): None Comments about Study/ Endpoint/ Uncertainty Factor: This risk assessment is NOT required for this subpopulation.

2.3. Chronic Reference Dose ( RfD)

Study Selected: Chronic Oral Toxicity Study  Dog, OPPTS 870.4100; ' 83 1b)

MRID No.: 41970401 Executive Summary: In a chronic one year oral toxicity study ( MRID 41970401), male and female beagle dogs were given test compound at dosages of 0, 3, 10, or 20/ 30 mg/ kg/ day ( dosage at 30 mg/ kg/ day was not tolerated well and was discontinued on day 31, dosing was resumed on day 36 at 20 mg/ kg/ day). No treatment related deaths occurred during the study. The treatment related 7 clinical signs ( soft/ mucoid feces, emesis) were observed frequently in high dose animals. Hematology or urinalysis results were normal. Total cholesterol levels were significantly decreased in the high dose females. Gross and histopathological findings did not reveal any treatment related effects. The LOAEL is 20/ 30 mg/ kg/ day based on increase incidence of clinical observations ( emesis and soft/ mucoid feces) in males and females and decreased total cholesterol levels in females. The NOAEL is 10 mg/ kg/ day.

Dose and Endpoint for Establishing RfD: NOAEL of 10mg/ kg/ day based on decreased total cholesterol levels in females at 20 mg/ kg/ day ( LOAEL)

Uncertainty Factor( s): 100X ( 10X for intraspecies extrapolation; and 10X for interspecies extrapolation)

Chronic RfD = 10 mg / kg / day ( NOAEL)

100 ( UF) 0.1 mg / kg / day =

Comments about Study/ Endpoint/ Uncertainty Factor: The lowest NOAEL in the most sensitive species following chronic exposure and is appropriate for chronic dietary risk assessment.

2.4. Occupational/ Residential Exposure 2.4.1. Dermal Absorption The dermal absorption factor is not required since route specific studies are available to assess the need for endpoints.

2.4.2. Dermal Exposure NOTE: studies are available for both the technical grade active ingredient ( 80% a. i.) and two formulated products of DDAC ( 0.13% and 4% a. i.). Use of dermal irritation as an endpoint has recently been adopted as a working policy measure for the Health Effects Division and the Antimicrobials Division ( meeting of the HED Hazard Science Policy Council, November 30, 2005). Therefore, endpoints for the technical and formulated product are determined separately as needed.

2.4.3 Short term Dermal Exposure ( 1 30 days)

Study Selected: 90 Day Dermal Toxicity Study  Rat, 870.3250; ' 82 3 MRID No.: 41305901 Executive Summary: In a subchronic oral toxicity study ( MRID 41305901), fifteen Sprague Dawley rats per sex per group received repeated dermal dosing of test compound ( 80% a. i. diluted to 0.1%) at 0, 2, 6, or 12 mg/ kg/ day for 6 hours/ day, 5 days/ week for 13 weeks. No 8 treatment related effects were noticed in mortality, weight gain, food consumption, or systemic toxicity. Toxicity was limited to treated skin of mid dose females and high dose males and females. The clinical and gross findings ( erythema, edema, exfoliation, excoriation and ulceration) were confirmed by histopathological examination, where increased incidence of hyperkertosis, acanthosis, epidermitis, dermatitis and ulceration were noted beginning after 5 days of exposure. The systemic NOAEL is grater than 12 mg/ kg/ day ( highest dose tested). The dermal LOAEL for dermal toxicity is 6 mg/ kg/ day. The dermal NOAEL is 2 mg/ kg/ day.

Dose and Endpoint for Risk Assessment: Dermal toxicity NOAEL of 2 mg/ kg/ day based on increased clinical and gross findings at 6 mg/ kg/ day ( LOAEL).

Comments about Study/ Endpoint:. The HIARC and ADTC selected irritation as the short term endpoint based on the policy adopted for use of dermal irritation as a short term endpoint. It is noted from the 90 day dermal toxicity study that no systemic toxicity was seen at the highest dose tested but dermal irritation was present after 5 days of exposure. It is further noted that a second dermal toxicity study is available ( MRID 40565301 and 41105801) in which a dilution of a product containing 6% DDAC and 4% ADBAC was studied for 21 daysin guinea pigs. However, the rat study was chosen for the short term endpoint because between these two studies, the concentration evoking the irritation response was lower in the rat study ( 8 µ g/ cm2) than in the guinea pig study ( 500 µ g/ cm2) and occurred within the same time frame ( rat response observed after 5 days, guinea pig response observed after approximately 10 days).

Short term Dermal Exposure formulated product, 0.13% a. i.

Study Selected: none Comments about Study/ Endpoint: There is an available 21 day dermal toxicity study for a formulation of DDAC at 0.13% ( MRID 45656601). . This study shows no dermal irritancy or systemic effects up to and including a limit dose of 1000 mg/ kg.

2.4.4 Intermediate ( 30 days 6 months) and Long Term (> 6 months) Dermal ( Exposure Study Selected: none Comments about Study/ Endpoint: The available data show no appropriate endpoint for intermediate and long term dermal risk. Use of irritation as an endpoint for the short term is protective of any dermal or systemic effects from longer term exposures. 9 2.4.5 Inhalation Exposure ( All Durations)

When DDAC is applied with a spraying system ( e. g. sprayer), inhalation may be a potential exposure route. Since no inhalation studies are available, committee selected the oral NOAEL for this risk assessment. Since the dose identified for inhalation risk assessments are from oral studies, route to route extrapolation should be as follows:

Step I: The inhalation exposure component ( i. e., µ g a. i./ day) using a 100% ( default) absorption rate and application rate should be converted to an equivalent oral dose ( mg/ kg/ day)

Step II: To calculate the MOE =

s , the equivalent oral dose converted from Step I should then be compared to the oral NOAEL of 10 mg/ kg/ day for short term exposure study ( MRID 418867 01), and the oral NOAEL of 10 mg/ kg/ day for intermediate and chronic oral exposure based on chronic dog study ( MRID 419704 01).

3.0 Margins of Exposure for Occupational/ Residential Risk Assessments For acute and chronic dietary exposures, the standard UF of 100 is applied. The special hazardbased FQPA safety factor is reduced to 1x.

For incidental oral and dermal assessments, the MOE of 100 is applied and for inhalation assessments, an MOE of 100 is applied. An additional database UF of 10x is applied for route toroute extrapolation from an oral endpoint.

4 CLASSIFICATION OF CARCINOGENIC POTENTIAL 4.1 Combined Chronic Toxicity/ Carcinogenicity Study in Rats MRID No. 41965101 Discussion of Tumor Data: In a chronic/ carcinogenicity study ( MRID 41965101), 60 Sprague Dawley CD rats per sex per group were fed diets containing DDAC ( Batch # B 1889, 80.8% a. i.) At 0,300,750 or 1500 ppm ( mg/ kg/ day equivalents: 0,13,32, or 64 for males and 0, 16, 41, or 83 for females) for two years. High dose animals showed significant, but slight (< 10%) decreases in mean body weight during the study. Treatment related effects consisted of increased incidence of sinusoidal blood, hemosiderosis and histiocytosis in the mesenteric lymph nodes of high dose animals. In addition, a treatment related increase in the incidence of interstitial cell adenomas in testes was reported. In this study, the incidences of this tumor for control and treated animals are : Control 1 ( 5%, 3/ 60); Control 2 ( 5% 3/ 60), 300ppm ( 12.5%, 1/ 8), 750ppm ( 17.9%, 5/ 28), and 10 1500ppm ( 11.7%, 6/ 60). However, because the incidence within the historical incidence range, this chemical is not considered carcinogenic in this study. ( See Table 1)

Adequacy of the Dose Levels Tested: The high dose tested ( HDT) in the study is appropriated for carcinogenicity testing based on slight but statistically significant decrease in mean body weight (< 10%) and some histopathological changes.

Table 1: Incidence of Testicular Interstitial Adenomas in Male sprague Dawley Rats for the Studies conducted at Bushy Run Research Center since 1987 1,2 Group3 Study Dates of In Life Phase C1 C2 L M H DDAC 06/ 13/ 88 to 06/ 19/ 90 3/ 60 3/ 60 1/ 18 5/ 28 7/ 60 Historical Control # 1 03/ 22/ 88 to 03/ 27/ 90 3/ 59 1/ 60

Historical Control # 2 03/ 08/ 89 to 03/ 27/ 91 4/ 59 7/ 60

Historical Control # 3 04/ 22/ 91 to 05/ 04/ 93 1/ 60 6/ 60

1. Data provided by Bushy Run Research Center ( 1995, MRID 436138 01). 2. All rats were from Charles River Breeding Laboratories, Portage MI. 3. C1  Control Group 1; C2  Control Group 2; L  Low dose Group; M  Mid  dose Group; and H High dose group.

4.2 Carcinogenicity Study in Mice MRID No. 41802301 Discussion of Tumor Data: In a carcinogenicity study ( MRID 41802301), 60 CD 1 mice per sex per group were fed diets containing DDAC ( Batch # B 1889, 80.8% a. i.) at levels of 0,100, 500 or 1000 ppm ( mg/ kg/ day equivalents: 0, 15.0, 76.3, or 155.5 for males and 0, 18.6, 93.1, or 193.1 for females) for 78 week. No treatment related effects were noted in the incidence of clinical signs, deaths, gross and histopathological observations. Hematological values were comparable among all study groups. The NOAEL for both male and females is 500 ppm ( 76.3 mg/ kg/ day for males and 93.1 mg/ kg/ day for females), and the LOAEL is1500ppm ( 155.5 mg/ kg/ day for males; 193.1 mg/ kg/ day for females). The LOAEL is based on decreases in mean body weights and body weight gains. At the level tested, the chemical is not carcinogenic. 11 Adequacy of the Dose Levels Tested: The HDT induce statistically significant decreases ($ 10%) in mean body weight).

4.3 Classification of Carcinogenic Potential The HIARC classified DDAC as not likely to be a human carcinogen based on the lack of evidences of carcinogenicity in mice or rats.

5. FQPA CONSIDERATIONS 5.1 Adequacy of the Data Base  Acute delayed neurotoxicity study in hen ( if applicable)? No  Acute and subchronic neurotoxicity studies ( if applicable)? No  Developmental toxicity studies in Rat & Rabbits Yes  Two Generation Reproduction Study Yes  Developmental neurotoxicity study ( if applicable) No 5.2 Neurotoxicity Based on the available data, the committee concluded that there is no evidence DDAC will induce neurotoxic effects. Developmental Toxicity In the developmental toxicology  Rabbits ( MRID #: 410187 01), 16/ dose New Zealand White Rabbits were fed by gavage on gestation days 6  18 at dose level of 0,1,3 or 10 mg/ kg/ day of DDAC ( 81% a. i.). The maternal toxicity NOAEL = 1 mg/ kg/ day; LOAEL = 3 mg/ kg/ day based on increased clinical signs ( hypoactivity, labored and/ or audible respiration) and decreased body weight gain during the dosing period. The developmental toxicity NOAEL = 3 mg/ kg/ day; LOAEL = 10 mg/ kg/ day based on decreased fetal body weight and an increased number of dead fetuses were reported.

In the developmental toxicology  Rats ( MRID #: 418867 01), 25/ dose Sprague Dawley CD Rats were fed by gavage on gestation days 6  15 at dose level of 0,1,10 and 20 mg/ kg/ day of DDAC ( 80.8% a. i.). The maternal toxicity NOAEL = 1 mg/ kg/ day; LOAEL = 10 mg/ kg/ day based on decreased body weight/ weight gain. The developmental toxicity NOAEL = 10 mg/ kg/ day; 12 LOAEL = 20 mg/ kg/ day based on several variations were reported ( split anterior archof the atlas, poorly ossified thoracic centrum, bilobed thoracic centrum, unilateral short rib, poorly ossified parietal, and poorly ossified sternebrae).

5.3 Reproductive Toxicity In the two generation Reproductive toxicity  Rats ( MRID #: 418045 01), 28/ sex/ dose ( both F0 and F1) Sprague Dawley CD Rats were fed a diet containing DDAC ( 80.8% a. i.) at dosage levels of 0, 300, 750, or 1500ppm ( during premating, for males = 20, 50, or 103 mg/ kg/ day and for females = 24, 61, or 122 mg/ kg/ day). Reproductive Toxicity NOAEL = 750ppm ( 56 mg/ kg/ day); LOAEL = 1500ppm ( 113 mg/ kg/ day) based on decreased pup body weight/ weight gain and food consumption were reported.

5.4 Determination of Susceptibility There was no quantitative or qualitative evidence of increased susceptibility to rat or rabbit fetus following in utero exposure in the prenatal developmental toxicity studies or in the offspring when exposed to adults in the two generation reproductive study.

5.5 Recommendation for a Developmental Neurotoxicity Study Committee concluded that evidence do not support a need for a Developmental Neurotoxicity study.

6. HAZARD CHARACTERIZATION Didecyl dimethyl ammonium chloride ( DDAC) is an active ingredient for Z 1. Z 1 is intended to be sold as a non public health product that kills odor causing bacteria on hard to launder fabrics. DDAC is corrosive and is of moderate acute toxicity by oral, dermal, or inhalation routes of exposure. DDAC is a severe eye irritant. DDAC is a weak dermal sensitizer.

In rats and dogs subchronic oral studies, at median and high dietary doses above the limit dose, decreases in body weight and food consumption have been observed. In the dog chronic oral study, at high dosage group, emesis and soft mucoid feces were observed in males and females and deceased total cholesterol was noticed in females. In a 90 day dermal toxicity study in rats, DDAC technical ( 80% a. i.) did not produce any systemic toxicity but caused significant dermal irritation at a dose of 6 mg/ kg/ day ( 0.15 Fg/ cm2). A formulation testing 0.13% DDAC showed no evidence of dermal or systemic toxicity, while another study using a 4% DDAC formulation showed dermal irritation at 1000 13 mg/ kg/ day.

There is a battery of negative mutagenicity studies for DDAC. DDAC is negative for carcinogenicity in feeding studies in rats and mice at doses above the limit dose and was classified as " not likely" to be a human carcinogen by the HIARC. DDAC induced developmental and offspring effects in both the developmental study and reproduction study in rats, but only at dosage levels higher than those causing maternal toxicity. On the basis of this finding, the HIARC concluded that there was no evidence, to suggest that DDAC was associated with increase susceptibility to reproductive and developmental toxicity. 14 7. ACUTE TOXICITY ENDPOINTS:

Acute Toxicity of DDAC ( Didecyl dimethyl ammonium chloride)

Guideline No. Study Type MRIDs # Results Toxicity Category 81 1 Acute Oral ( 80% a. i.) 42296101 LD50 ( combined) = 238 mg/ kg II 81 2 Acute Dermal ( 65% a. i.) 42053801 LD50 (%) = 3140mg/ kg; LD50 (&) = 2730mg/ kg; LD50 ( combined) = 2930 mg/ kg III 81 3 Acute Inhalation ( purity not reported) 00145074 LC50 = 0.07mg/ L I 81 4 Primary Eye Irritation ( 80% a. i.) 42161602 Severe eye irritant I 81 5 Primary Skin Irritation ( 80% a. i.) 42161601 Severe dermal irritant I 81 6 Dermal Sensitization ( 80% a. i.) 42161603 Not a sensitizer 15 8. SUMMARY OF TOXICOLOGY ENDPOINT SELECTION DDAC The doses and toxicological endpoints selected for DDAC are summarized below.

Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE/ UF, Special FQPA SF for Risk Assessment Study and Toxicological Effects NOAEL( development al) = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intraspecies variation) Prenatal Developmental Toxicity  Rat MRID 41886701 LOAEL = 20 mg/ kg/ day based on increased incidence of skeletal variations. Acute Dietary ( Females 13+)

Acute RfD = 0.1 mg/ kg/ day ( Females age 13+)

Acute dietary ( general pop.) an acute dietary endpoint for the general population was not identified in the database for DDAC.

NOAEL = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation Chronic Toxicity Study  Dog MRID 41970401 LOAEL = 20 mg/ kg/ day based on decreased total cholesterol levels in females. Chronic Dietary ( general population)

Chronic RfD = 0.1 mg/ kg/ day Non Dietary Exposures Incidental Oral Short Term NOAEL( development al) = 10 mg/ kg/ day UF = 100 ( 10x inter species extrapolation, 10x intra species variation) FQPA SF = 1 Prenatal Developmental Toxicity  Rat MRID 41886701 LOAEL = 20 mg/ kg/ day based on increased incidence of skeletal variations.

Incidental Oral Intermediate Term NOAEL = 10 mg/ kg/ day UF = 100 ( 10x inter species extrapolation, 10x intra species variation) FQPA SF = 1 Chronic Toxicity Study  Dog MRID 41970401 LOAEL = 20 mg/ kg/ day based on decreased total cholesterol levels in females.

Dermal, Short term ( formulated product, 0.13% a. i.) No endpoint identified. No dermal or systemic effects identified in the 21 day dermal toxicity study ( MRID 45656601) up to and including the limit dose of 1000 mg/ kg/ day 16 Dermal, Short term ( TGAI 80% diluted to 0.1%) NOAEL( dermal) = 2 mg/ kg/ day ( 8 Fg/ cm2) c UF = 100 ( 10x inter species extrapolation, 10x intra species variation) 90 day Dermal Toxicity  Rat MRID 41305901 LOAEL = 6 mg/ kg/ day based on increased clinical and gross findings ( erythema, edema, exfoliation, excoriation, and ulceration) beginning on day 4 5 of treatment.

Dermal, Intermediate and Long term ( formulated product) No appropriate endpoint identified.

Inhalation, Short Term NOAEL = 10 mg/ kg/ daya UF = 100 ( 10x inter species extrapolation, 10x intra species variation, 10x route extrapolation)

DB UF an additional 10x is necessary for route extrapolation. If risk estimates are below an MOE of 1000, a confirmatory inhalation toxicity study may be required. Prenatal Developmental Toxicity  Rat MRID 41886701 LOAEL = 20 mg/ kg/ day based on increased incidence of skeletal variations.

Inhalation, Intermediate and Long Term NOAEL = 10 mg/ kg/ daya UF = 100 ( 10x inter species extrapolation, 10x intra species variation, 10x route extrapolation)

DB UF an additional 10x is necessary for route extrapolation. If risk estimates are below an MOE of 1000, a confirmatory inhalation toxicity study may be required. Chronic Toxicity Study  Dog MRID 41970401 LOAEL = 20 mg/ kg/ day based on decreased total cholesterol levels in females.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable. aAn additional uncertainty factor of 10x is applied for use of an oral endpoint for route to route extrapolation to determine if a confirmatory inhalation toxicity study is warranted. c TGAI based dermal endpoint = ( 2 mg/ kg rat x 0.2 kg rat x 1000 ug/ mg) / 50cm2 area of rat dosed = 8 µ g/ cm2 .


2000* 2001 2002 2003 00 02* 01 03 ALLEN 180030004 Fort Wayne Beacon St 15.70 14.25 14.56 14.13 14.8 14.3 ALLEN 180030014 Fort Wayne Taylor Univ 14.29 14.17 14.26 13.65 14.2 14.0 CLARK 180190005 Jeffersonville Spring St 18.59 16.85 16.02 14.68 17.2 15.8 CLARK 180190006 Jeffersonville Pfau 19.12 19.1 CLARK 180190005/ 6 Jeffersonville Combine sites 18.59 16.85 16.02 15.78 17.2 16.2 DELAWARE 180350006 Muncie Muncie Central HS 16.24 14.49 14.51 14.02 15.1 14.3 DUBOIS 180372001 Jasper 200 W 6th St 17.16 16.54 16.34 15.72 16.7 16.2 ELKHART 180390003 Elkhart Pierre Moran School 15.67 15.70 14.98 14.85 15.5 15.2 FLOYD 180431004 New Albany Green Valley School 16.27 15.73 14.62 14.44 15.5 14.9 HOWARD 180670003 Kokomo 215 W Superior St 15.59 15.01 14.72 14.26 15.1 14.7 LAKE 180890006 East Chicago Franklin School 15.76 16.11 14.92 14.60 15.6 15.2 LAKE 180890027 Highland Eldon Ready School 14.04 15.18 14.60 14.10 14.6 14.6 LAKE 180891003 Gary Ivanhoe School 15.33 14.98 15.22 14.14 15.2 14.8 LAKE 180891016 Gary Federal Bldg 16.03 16.26 15.92 16.1 monitor shut down Sep 2002 LAKE 180892004 Hammond Purdue 14.96 15.38 14.70 14.55 15.0 14.9 LAKE 180892010 Hammond Robertsdale 14.34 15.55 14.88 14.26 14.9 14.9 LA PORTE 180910011 Michigan City Marsh Elementary Sch 13.37 14.25 13.24 12.81 13.6 13.4 LA PORTE 180910012 LaPorte 1119 Lake St 12.56 14.17 13.47 13.20 13.4 13.6 * 2000 represents the highest annual average for most sites Incomplete Data Site # City Site Name Figure 1 ( Enclosure 1)

Indiana PM2.5 Summary ( 2000 2003)

Value above the Annual Standard Annual Design Values Note: The Annual Standard is 15 micrograms per cubic meter ( ug/ m3) and attainment is determined by the average of the Particulate Matter ( PM) 2.5 values over a three year period.

Site Design Value Annual Means County 2/ 24/ 04 2000* 2001 2002 2003 00 02* 01 03 MADISON 180950009 Anderson 44 W 5th St 15.55 14.61 14.91 14.35 15.0 14.6 MARION 180970042 Indianapolis Mann Road 15.19 14.78 15.22 14.53 15.1 14.8 MARION 180970078 Indianapolis Washington Park 17.75 16.58 16.55 15.45 17.0 16.2 MARION 180970079 Indianapolis 7250 E. 75th St 16.36 16.25 15.68 14.67 16.1 15.5 MARION 180970081 Indianapolis W 18th St 16.78 17.14 14.24 16.21 16.1 15.9 MARION 180970083 Indianapolis E. Michigan St. 17.00 17.09 16.72 16.32 16.9 16.7 PORTER 181270020 Dunes Natl Lakeshore 13.53 13.62 13.24 13.19 13.5 13.4 PORTER 181270024 Ogden Dunes Water Treatment Plant 14.55 14.18 14.20 12.94 14.3 13.8 ST JOSEPH 181410014 South Bend Nuner Elementary Sch 13.78 14.04 14.27 13.82 14.0 14.0 ST JOSEPH 181411008 South Bend Angela & Eddy 14.10 14.72 14.39 13.80 14.4 14.3 ST JOSEPH 181412004 South Bend LaSalle HS 13.78 14.48 13.91 13.49 14.1 14.0 TIPPECANOE 181570007 Lafayette Fire Station 15.67 14.90 15.66 15.4 monitor relocated in Oct 2002 TIPPECANOE 181570008 Lafayette 3401 Greenbush St 14.07 13.97 14.1 14.0 TIPPECANOE 181570007/ 8 Lafayette Combine sites 15.67 14.90 15.26 13.97 15.2 14.7 VANDERBURGH 181630006 Evansville Civic Center 16.17 15.45 15.36 14.93 15.7 15.2 VANDERBURGH 181630012 Evansville W Mill Rd 16.17 15.15 15.27 15.27 15.5 15.2 VANDERBURGH 181630016 Evansville Univ of Evansville 15.70 16.16 15.24 15.09 15.7 15.5 VIGO 181670018 Terre Haute Lafayette St 15.72 15.18 14.55 14.11 15.2 14.6 VIGO 181670023 Terre Haute Devaney School 13.79 13.40 13.39 13.40 13.5 13.4 * 2000 represents the highest annual average for most sites Incomplete Data Value above the Annual Standard Site Design Value Indiana PM2.5 Summary ( 2000 2003)

Annual Design Values Note: The Annual Standard is 15 micrograms per cubic meter ( ug/ m3) and attainment is determined by the average of the Particulate Matter ( PM) 2.5 values over a three year period.

County Site # City Site Name Annual Means 2/ 24/ 04 2000* 2001 2002 2003 00 02* 01 03 HENRY** 180650003 Shenandoah HS 12.90 13.64 13.65 13.36 13.4 13.6 KNOX** 180830004 SW Purdue Ag Cntr 13.87 13.39 14.20 13.96 13.8 13.9 LAKE*** 180890022 Gary IITRI 17.38 18.11 16.43 16.64 17.3 17.0 LAKE*** 180890026 Gary Burr St 17.24 18.19 17.67 17.38 17.7 17.7 MARION*** 180970043 Indianapolis S. West St 18.44 17.69 17.02 17.23 17.7 17.3 MARION*** 180970066 Indianapolis English Ave 18.90 18.63 18.35 17.46 18.6 18.1 SPENCER** 181470009 Dale David Turnham Sch 16.32 14.52 14.06 14.63 15.0 14.4 * 2000 represents the highest annual average for most sites Incomplete Data ** Background/ Transport monitor site. Data collected for the daily and annual standard.

*** Monitoring sites intended to reflect air quality in a relatively small geographic area directly influenced by a specific source or sources of air pollution.

Data from these sites are intended to be used for determining attainment status under the daily standard and not intended for use in the annual standard.

Although the daily values for these sites are below the standard, the annual average values exceed the standard. IDEM will work with the source or sources that may be contributing to these values to decrease emissions and ultimately reduce the annual values.

Annual Means Site Design Value County Site # City Site Name Indiana PM2.5 Summary ( 2000 2003)

Annual Values for Background, Transport, and Source Monitors Value above the Annual Standard 2/ 24/ 04


[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Page 6860]
[FR Doc No: 2022-02498]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL22-23-000]

Citizens S-Line Transmission LLC; Notice of Institution of
Section 206 Proceeding and Refund Effective Date

    On January 28, 2022, the Commission issued an order in Docket No.
EL22-23-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e, instituting an investigation into whether Citizens S-Line
Transmission LLC's proposed rates in Docket No. ER21-2082-000 are
unjust, unreasonable, unduly discriminatory or preferential, or
otherwise unlawful. Citizens S-Line Transmission LLC, 178 FERC ] 61,067
(2021).
    The refund effective date in Docket No. EL22-23-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL22-23-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, in
accordance with Rule 214 of the Commission's Rules of Practice and
Procedure, 18 CFR 385.214 (2021), within 21 days of the date of
issuance of the order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. In lieu of electronic filing, you may submit a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Dated: February 1, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-02498 Filed 2-4-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Page 69274]
[FR Doc No: 2011-28875]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]

Draft Guidance for Industry and Food and Drug Administration
Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k)
for a Change to an Existing Device; Availability; Reopening of Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening until
November 28, 2011, the comment period for the notice entitled ``Draft
Guidance for Industry and Food and Drug Administration Staff; 510(k)
Device Modifications: Deciding When to Submit a 510(k) for a Change to
an Existing Device; Availability,'' that appeared in the Federal
Register of July 27, 2011 (76 FR 44935). In that document, FDA
announced the availability of a draft guidance for industry and FDA
staff and requested comments. The Agency is taking this action to allow
interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by November 28,
2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Michael J. Ryan, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1615,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

I. Background

    In the Federal Register of July 27, 2011 (76 FR 44935), FDA
published a notice with a 90-day comment period to request comments on
the draft guidance for industry and FDA staff entitled ``510(k) Device
Modifications: Deciding When to Submit a 510(k) for a Change to an
Existing Device.'' Comments on the draft guidance will assist FDA in
the development of a final guidance for industry and FDA staff.
    FDA is reopening the comment period for the notice until November
28, 2011. The Agency believes that this will allow adequate time for
interested persons to submit comments without significantly delaying
action by the Agency.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all Center for
Devices and Radiological Health (CDRH) guidance documents is available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or from the Center for Biologics Evaluation
and Research at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``510(k) Device Modifications: Deciding When to Submit a 510(k) for a
Change to an Existing Device'' from CDRH, you may either send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard
copy. Please use the document number 1793 to identify the guidance you
are requesting.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28875 Filed 11-7-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16250-16251]
[FR Doc No: 2019-07743]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3451-001]

Notice of Intent To File License Application, Filing of Pre-
Application Document, and Approving Use of the Traditional Licensing
Process: Beaver Falls Municipal District

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 3451-001
    c. Date Filed: February 12, 2019
    d. Submitted By: Beaver Falls Municipal District
    e. Name of Project: Townsend Water Power Project
    f. Location: On the Beaver River, in the Borough of New Brighton,
Beaver County, Pennsylvania. No federal lands are occupied by the
project works or located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Applicant Contacts: Roy Stintzi, Beaver Falls Municipal
District, P.O. Box 400, Beaver Falls, Pennsylvania, 15010; Laura Cowan,
Project Manager, Kleinschmidt Associates, 2 Thornton Hill, Ossining,
New York, 10562,<PHONE_NUMBER>, [email protected].
    i. FERC Contact: Emily Carter at<PHONE_NUMBER>; or email at
[email protected].
    j. Beaver Falls Municipal District filed its request to use the
Traditional Licensing Process on February 12, 2019. Beaver Falls
Municipal District provided public notice of its request on February
11, 2019. In a letter dated April 11, 2019, the Director of the
Division of Hydropower Licensing approved Beaver Falls Municipal
District's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR, part
402. We also are initiating consultation with the Pennsylvania

State Historic Preservation Officer, as required by section 106,
National Historic Preservation Act, and the implementing regulations of
the Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Beaver Falls Municipal
District as the Commission's non-federal representative for carrying
out informal consultation pursuant to section 7 of the Endangered
Species Act; and consultation pursuant to section 106 of the National
Historic Preservation Act.
    m. Beaver Falls Municipal District filed a Pre-Application Document
(PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(http://www.ferc.gov), using the eLibrary link. Enter the docket
number, excluding the last three digits, in the docket number field to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 3451. Pursuant to 18 CFR
16.8, 16.9, and 16.10, each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by July 31,
2022.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: April 11, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-07743 Filed 4-17-19; 8:45 am]
 BILLING CODE 6717-01-P