[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24106-24107]
[FR Doc No: 2016-09449]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0539]

Assay Development and Validation for Immunogenicity Testing of
Therapeutic Protein Products; Revised Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Assay Development and Validation for Immunogenicity Testing of
Therapeutic Protein Products.'' This guidance provides recommendations
to facilitate industry's development and validation of immune assays
for assessment of the immunogenicity of therapeutic protein products
during clinical trials. The guidance for assay development and
validation provided in this document applies to assays for detection of
anti-drug antibodies (ADA). This document includes guidance regarding
the development and validation of screening assays, confirmatory
assays, titering assays, and neutralization assays. This guidance
revises the draft guidance for industry entitled ``Assay Development
for Immunogenicity Testing of Therapeutic Proteins'' issued in December
2009. This revised draft guidance includes new information on titering
and confirmatory assays.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the
revised draft guidance by June 24, 2016.

ADDRESSES: 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-2009-D-0539 for ``Assay Development and Validation for
Immunogenicity Testing of Therapeutic Protein Products; Revised Draft
Guidance for Industry; Availability.'' 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.
    Submit written requests for single copies of the revised draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002; or the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002; or the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the revised
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993, 301-796-
0281; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Peter Hudson,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G434 (HFZ-410),
Silver Spring, MD, 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Assay Development and Validation for Immunogenicity
Testing of Therapeutic Protein Products.'' Patient immune responses to
therapeutic protein products have the potential to affect product
safety and efficacy. The clinical effects of patient immune responses
are highly variable, ranging from no effect at all to extreme harmful
effects to patient health. Detection and analysis of ADA formation is a
helpful tool in understanding potential patient immune responses.
Information on immune responses observed during clinical trials,
particularly the incidence of ADA induction and the implications of ADA
responses for drug safety and efficacy, is crucial for any therapeutic
product development program. Accordingly, such information, if
applicable, should be included in the prescribing information as a
subsection of the ADVERSE REACTIONS section entitled
``Immunogenicity.''
    In general, assays for detection of ADA facilitate understanding of
the immunogenicity, safety, and efficacy of therapeutic protein
products. However, the detection of ADA is dependent on key operating
parameters of the assays (e.g., sensitivity, specificity), which vary
between assays. Therefore, the development of valid, sensitive,
specific, and selective assays to measure ADA responses is a key aspect
of therapeutic protein product development.
    This guidance revises the draft guidance for industry entitled
``Assay Development for Immunogenicity Testing of Therapeutic
Proteins'' issued in December 2009. The information in the draft
guidance has been reorganized for clarity, and the revised draft
guidance includes new information on titering and confirmatory assays.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
assay development and validation for immunogenicity testing of
therapeutic protein products. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved
collections of information that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 314 have been approved under
OMB control numbers 0910-0001 and 0910-0230; the collections of
information in 21 CFR part 58 have been approved under OMB control
number 0910-0119; and the collections of information in 21 CFR part 601
have been approved under OMB control numbers 0910-0338 and 0910-0719.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09449 Filed 4-22-16; 8:45 am]
BILLING CODE 4164-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, September 19, 2018 4:20 PM
To:
Eric Stuart<EMAIL_ADDRESS>Subject:
draft map, list

See if this looks Ok to you. We incorporated your comments into the list, as far as names go and deleted Indiana Harbor.

_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< EAF-Map-2018.pdf >>


[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Proposed Rules]
[Pages 10413-10415]
[FR Doc No: 2012-4160]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0146; Directorate Identifier 2011-NM-115-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and
CL-604 Variants) airplanes. This proposed AD was prompted by reports of
deformation at the neck of the pressure regulator body on the oxygen
cylinder and regulator assemblies (CRAs), and an electrical wiring
harness in the area of the oxygen cylinder had no protective conduit
sleeving. This proposed AD would require inspecting to determine if
certain oxygen pressure regulators are installed and replacing oxygen
CRAs containing pressure regulators that do not meet the required
material properties. This proposed AD would also require inspecting for
damaged wiring and repairing or replacing wiring if necessary. We are
proposing this AD to prevent rupture of the oxygen cylinder, which in
the case of cabin depressurization, oxygen would not be available when
required; and to detect and correct unprotected wiring that could chafe
against the oxygen system components or surrounding structure in the
area, which could lead to electrical arcing and an oxygen-fed fire.

DATES: We must receive comments on this proposed AD by April 9, 2012.

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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0146;
Directorate Identifier 2011-NM-115-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on 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 proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), has issued Canadian
Airworthiness Directive CF-2011-11, dated May 25, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    During a routine inspection, deformation was found at the neck
of the pressure regulator body on the oxygen Cylinder and Regulator
Assemblies (CRA) of a BD-700-1A11 aeroplane.
    An investigation by the vendor, Avox Systems Inc., revealed that
the deformation was attributed to two (2) batches of raw material
that did not meet the required tensile strength. This may cause
elongation of the pressure regulator neck, which could result in
rupture of the oxygen cylinder, and in the case of cabin
depressurization, oxygen would not be available when required.
    Although there have been no reported failures to date on any CL-
600-2B16 aeroplanes, oxygen pressure regulators, Part Numbers (P/N)
806370-12, could be part of the affected batches.
    It has also been found that the electrical wiring harness in the
area of the oxygen cylinder has been installed without protection.
Unprotected wiring could chafe against the oxygen system components
or surrounding structure in the area, which could lead to electrical
arcing and an oxygen fed fire.
    This [TCCA] directive mandates [an inspection to determine if a
certain oxygen CRA is installed and] the replacement of oxygen CRAs
containing pressure regulators that do not meet the required
material properties and to [do a general visual inspection of] and
protect the affected wiring.

Corrective actions include repairing or replacing any damaged wiring.
You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier, Inc. has issued Service Bulletin 605-24-005, dated
January 31, 2011; and Bombardier Service Bulletin 605-35-001, Revision
01, dated February 28, 2011. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This Proposed AD and the MCAI or Service
Information

    This proposed AD differs from the MCAI and/or service information
as follows: The MCAI and service information do not specify corrective
actions if damaged wiring is found; this proposed AD requires repairing
or replacing any damaged wiring. This proposed AD also includes serial
numbers (S/N) 5824 and subsequent in the applicability. Those airplanes
are included in paragraph (j) of the proposed AD, which prohibits the
installation of certain regulators.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 72 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $6,120, or $85 per product.
    In addition, we estimate that certain follow-on actions (wiring
protection) would take about 2 work-hours and require parts costing $0,
for a cost of $170 per product. We have no way of determining the
number of products that may need these actions.
    We have received no definitive data that would enable us to provide
cost estimates for certain other on-condition actions (repairing or
replacing damaged wiring) specified in this proposed 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

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Bombardier, Inc.: Docket No. FAA-2012-0146; Directorate Identifier
2011-NM-115-AD.

(a) Comments Due Date

    We must receive comments by April 9, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B16 (CL-601-
3A, CL-601-3R, & CL-604 Variants) airplanes; certificated in any
category; serial numbers 5701 through 5802 inclusive, 5804 through
5808 inclusive, 5810 through 5816 inclusive, 5819, 5822, 5823 and
subsequent.

(d) Subject

    Air Transport Association (ATA) of America Codes 24: Electrical
power; and 35: Oxygen.

(e) Reason

    This AD was prompted by reports of deformation at the neck of
the pressure regulator body on the oxygen cylinder and regulator
assemblies (CRAs), and an electrical wiring harness in the area of
the oxygen cylinder had no protective conduit sleeving. We are
issuing this AD to prevent rupture of the oxygen cylinder, which in
the case of cabin depressurization, oxygen would not be available
when required; and to detect and correct unprotected wiring that
could chafe against the oxygen system components or surrounding
structure in the area, which could lead to electrical arcing and an
oxygen-fed fire.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspect and Replace the Oxygen CRA

    For airplanes with serial numbers 5701 through 5802 inclusive,
5804 through 5808 inclusive, 5810 through 5816 inclusive, 5819,
5822, and 5823: Within 750 flight hours after the effective date of
this AD, but no later than 6 months after the effective date of this
AD, inspect the serial number of oxygen pressure regulators having
part number (P/N) 806370-12, in accordance with the Accomplishment
Instructions, Section 2.B.(3), of Bombardier Service Bulletin 605-
35-001, Revision 01, dated February 28, 2011. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
part number of the oxygen pressure regulator can be conclusively
determined from that review.
    (1) If any serial number is found that is listed in table 2 of
Bombardier Service Bulletin 605-35-001, Revision 01, dated February
28, 2011, before further flight, replace the affected oxygen CRA in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 605-35-001, Revision 01, dated February 28, 2011.
    (2) If any serial number is found that is not listed in table 2
of Bombardier Service Bulletin 605-35-001, Revision 01, dated
February 28, 2011, no further action is required by this paragraph.

(h) Inspection and Corrective Action of the Oxygen CRA Wiring Harness

    For airplanes with serial numbers 5701 through 5778 inclusive,
5780 through 5796 inclusive, 5798, 5800 through 5802 inclusive,
5804, 5805, 5808, 5811, and 5813: At the compliance times specified
in paragraphs (h)(1) and (h)(2) of this AD, do a detailed inspection
for damaged wiring (i.e., signs of damaged insulation, abrasion, or
chafing) of the electrical wiring harness for the oxygen CRA, and
protect the electrical wiring harness, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 605-24-
005, dated January 31, 2011. If any damaged wiring is found, before
further flight, repair or replace any damaged wiring in accordance
with a method approved by the Manager, New York Aircraft
Certification Office (ACO), FAA; or Transport Canada Civil Aviation
(TCCA) (or its delegated agent).
    (1) For airplanes on which the oxygen CRA must be replaced as
required by paragraph (g)(1) of this AD: At the time the oxygen CRA
is replaced.
    (2) For airplanes other than those identified in paragraph
(h)(1) of this AD: Within 800 flight hours after the effective date
of this AD.

(i) Credit for Actions Accomplished in Accordance With Previous Service
Information

    Actions accomplished before the effective date of this AD
accordance with Bombardier Service Bulletin 605-35-001, dated
January 31, 2011, are considered acceptable for compliance with the
corresponding actions specified in this AD.

(j) Parts Installation

    For all airplanes: As of the effective date of this AD, no
person may install an oxygen pressure regulator (P/N 806370-12)
having any serial number listed in table 2 of Bombardier Service
Bulletin 605-35-001, Revision 01, dated February 28, 2011, on any
airplane, unless a suffix ``-A'' is beside the serial number.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax:<PHONE_NUMBER>. 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. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(l) Related Information

    Refer to MCAI Canadian Airworthiness Directive CF-2011-11, dated
May 25, 2011, and the service bulletins identified in paragraphs
(l)(1) and (l)(2) of this AD, for related information.
    (1) Bombardier Service Bulletin 605-24-005, dated January 31,
2011.
    (2) Bombardier Service Bulletin 605-35-001, Revision 01, dated
February 28, 2011.

    Issued in Renton, Washington, on February 7, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-4160 Filed 2-21-12; 8:45 am]
BILLING CODE 4910-13-P


1 TABLE 1: AVERAGE ANNUAL EPA RESOURCE REQUIREMENT FOR MONITORING OF STATIONARY GAS TURBINES ( A) ( B) ( C) a ( D) ( E) b ( F) d Activity EPA Hrs/ Occurences EPA hr/ Plants/ EPA EPA Cost Occurence Plant/ yr Plant/ yr year hr/ yr $

Performance test New Plants 24.0 1.2c 28.8 50 1440 49781 Report Review:

Notified of construction 2.0 1 2.0 50 100 3457 Notified of anticip strt/ up 0.5 1 0.5 50 25 865 Notified of actual strt/ up 0.5 1 0.5 50 25 865 Notified of initial test 0.5 1.2c 0.6 50 30 1037 Notified of CMS demonst. 0.5 1 0.5 50 25 865 Quarterly Reports Excess Emission 4.0 2 8.0 625 5000 172850 SUBTOTAL ANNUAL COST TO EPA 6645 229720 Travel Expenses=( 1 person x 50 plants/ yr x 3d/ plant x $ 50 per diem)+($ 250/ pl x 50 pl/ yr) 20000 TOTAL ANNUAL COST TO EPA 524,412 a) AxB= C b) CxD= E c) Assume 20% of initial performance test must be repeated due to failure.

d) Total Burden Cost is calculated at a rate of $ 34.57+ 110% burden overhead


[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51144-51145]
[FR Doc No: 2020-18104]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-65]

Petition for Exemption; Summary of Petition Received; Vintage
Aviation LLC

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal

Aviation Regulations. The purpose of this notice is to improve the
public's awareness of, and participation in, the FAA's exemption
process. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 27, 2020. Due to the
unique circumstances and plans for this event, the FAA requests
commenters provide their feedback no later than the due date.

ADDRESSES: Send comments identified by docket number FAA-2020-0698
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brittany Newton,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 13, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0698.
    Petitioner: Vintage Aviation LLC.
    Section(s) of 14 CFR Affected: Sec. Sec.  91.319(c) and 91.9 (a).
    Description of Relief Sought: Vintage Aviation LLC requests relief
to operate experimental aircraft over densely populated areas. This
request is in support of the flyovers of the Legacy of Peace Aerial
Parade, commemorating the 75th anniversary of the end of World War II
(WWII). These flyovers will occur over Pearl Harbor, Hawaii from August
28 through September 2, 2020. Twenty-one vintage aircraft from the WWII
era will participate in the flyover.

[FR Doc. 2020-18104 Filed 8-18-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Page 53805]
[FR Doc No: 2020-19104]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF20-5-000]

Southeastern Power Administration; Notice of Filing

    Take notice that on August 21, 2020, Southeastern Power
Administration submitted tariff filing per: 300.10: Kerr-Philpott 2020
Rate Adjustment to be effective 10/1/2020.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    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://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 the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 21, 2020.

    Dated: August 25, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-19104 Filed 8-28-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13901-13905]
[FR Doc No: 2017-05082]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80193; File No. SR-FINRA-2017-006]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
Rule 6191 To Implement an Anonymous, Grouped Masking Methodology for
Over-the-Counter Activity in Connection With Web Site Data Publication
of Appendix B Data Pursuant to the Regulation NMS Plan To Implement a
Tick Size Pilot Program

March 9, 2017.
    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 March 3, 2017, Financial Industry Regulatory Authority, Inc.
(``FINRA'') 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 FINRA. 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

    FINRA is proposing to amend Rule 6191 to implement an anonymous,
grouped masking methodology for over-the-counter (``OTC'') activity in
connection with Web site data publication of Appendix B data pursuant
to the Regulation NMS Plan to Implement a Tick Size Pilot Program
(``Plan'').
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Rule 6191(b) (Compliance with Data Collection Requirements) \3\
implements the data collection and Web site publication requirements of
the Plan.\4\ Rule 6191(b)(2)(B) provides, among other things, that
FINRA will publish data pursuant to Appendix B.I. and B.II. of the Plan
on its Web site within 120 calendar days following month end at no
charge,\5\ and that such publication will not identify the Trading
Center that generated the data. Rule 6191(b)(3)(C) provides, among
other things, that FINRA will publish data pursuant to Appendix B.IV.
to the Plan on its Web site within 120 calendar days following month
end at no charge, and that such publication will not identify the OTC
Trading Center that generated the data.
---------------------------------------------------------------------------

    \3\ See, e.g., Securities Exchange Act Release No. 76484
(November 19, 2015), 80 FR 73858 (November 25, 2015) (Notice of
Filing of File No. SR-FINRA-2015-048); see also Securities Exchange
Act Release No. 77164 (February 17, 2016), 81 FR 9043 (February 23,
2016) (Notice of Filing of Partial Amendment No. 1 and Order
Granting Accelerated Approval of File No. SR-FINRA-2015-048)
(``Accelerated Approval Order'').
    \4\ The Participants filed the Plan to comply with an order
issued by the Commission on June 24, 2014. See Letter from Brendon
J. Weiss, Vice President, Intercontinental Exchange, Inc., to
Secretary, Commission, dated August 25, 2014 (``SRO Tick Size Plan
Proposal''). See Securities Exchange Act Release No. 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014). See also Securities Exchange Act
Release No. 74892 (May 6, 2015), 80 FR 27513 (May 13, 2015)
(``Approval Order'').
    \5\ On November 30, 2016, the SEC granted exemptive relief to
the Participants, and FINRA filed proposed rule changes, to, among
other things, delay the publication of Web site data pursuant to
Appendices B and C to the Plan until February 28, 2017, and to delay
the ongoing Web site publication by ninety days such that it would
be published within 120 calendar days following the end of the
month. See, e.g., Letter from David S. Shillman, Associate Director,
Division of Trading and Markets, Commission, to Marcia E. Asquith,
Senior Vice President and Corporate Secretary, FINRA dated November
30, 2016; see also Securities Exchange Act Release No. 79424
(November 29, 2016), 81 FR 87603 (December 5, 2016) (Notice of
Filing and Immediate Effectiveness of File No. SR-FINRA-2016-042).
FINRA recently filed a proposed rule change to revert to the 30-day
delay with regard to Appendix C data Web site publication. See File
No. SR-FINRA-2017-005 (Proposed Rule Change to Amend FINRA Rule 6191
to Modify the Date of Appendix B Web site Data Publication Pursuant
to the Regulation NMS Plan to Implement a Tick Size Pilot Program).
---------------------------------------------------------------------------

    In consultation with SEC staff, FINRA is proposing new
supplementary material to Rule 6191 to implement the aggregation
methodology described further below. Specifically, FINRA is proposing
to provide for an anonymous, grouped masking methodology for Appendix
B.I., B.II. and B.IV. data in furtherance of the Plan's requirement
that the data made publicly available will not identify the Trading
Center that generated the data.\6\ The proposed methodology also is
intended to mitigate confidentiality concerns previously raised by
commenters \7\ regarding the publication of data related to OTC
activity. Chicago Stock Exchange, Inc. (``CHX'') is the designated
examining authority (``DEA'') for a relatively small number of OTC
Trading Centers; thus, FINRA also will incorporate the firms for which
CHX is the DEA into the anonymous, grouped masking methodology and
publish OTC-wide statistics for Appendix B.I., B.II. and B.IV. data on
the FINRA Web site.\8\
---------------------------------------------------------------------------

    \6\ See Section VII.(A) of the Plan (Collection of Trading
Center Pilot Data).
    \7\ See infra note 20.
    \8\ In connection with the instant filing, FINRA and CHX
requested exemptive relief from the Plan to permit the publication
on the FINRA Web site of data relating to OTC activity pursuant to
Appendix B.I., B.II. and B.IV. on an aggregated basis using an
anonymous, grouped masking methodology. See Letter from Marcia E.
Asquith, Executive Vice President, Board and External Relations,
FINRA, to Robert W. Errett, Deputy Secretary, Commission, dated
March 2, 2017.
---------------------------------------------------------------------------

Grouping Methodology
    For purposes of the data to be made available on the FINRA Web site
pursuant to the Plan, FINRA proposes to aggregate individual OTC
Trading Center Appendix B data within groupings of Trading Centers by
ATS and non-ATS categories, using an undisclosed methodology for
assigning each Trading Center to a group. FINRA believes that an
anonymous, grouped masking methodology for purposes of publishing the
required data related to OTC activity will support the Plan's
requirement that the data to be made publicly available will not
identify the Trading Center that generated the data.\9\ In furtherance
of this objective, the details of the methodology used to formulate the
anonymous groupings will not be disclosed. FINRA believes that the
proposed approach strikes an appropriate balance between mitigating
confidentiality concerns while supporting the public availability of
useful Plan data.
---------------------------------------------------------------------------

    \9\ See Section VII.(A) of the Plan.
---------------------------------------------------------------------------

    Trading Center group assignments will not be published and
generally will remain unchanged for the duration of the data
publication period, with the exception of the entrance of a new Trading
Center (new FINRA member). The anonymized identifier used for each
group will remain unchanged for the duration of the data publication
period and the same groups and group identifiers will be used for all
Appendix B data sets. The number of Trading Centers assigned to each
group will not specifically be disclosed; however, each group will
contain between five and 25 market participant identifiers (MPIDs). In
addition, for each day's statistics, the number of MPIDs in each group
with activity in any Pilot Security for that day will be disclosed.
Disclosing the number of active MPIDs each day is intended to inform
evaluators of the data of whether the number of Trading Centers
reflected in the statistics each day has changed--for example, because
a Trading Center in the group didn't register activity on a given
day.\10\
---------------------------------------------------------------------------

    \10\ FINRA will disclose the number of MPIDs in each group with
activity in any Pilot Security for that day either within each
Appendix B data set or in an associated file.
---------------------------------------------------------------------------

Appendix B.I. Data Aggregation Methodology
    FINRA proposes to aggregate the Appendix B.I. data to be made
publicly available on the FINRA Web site by aggregating statistics
within each group by Pilot Security for each trading day. The
methodology used for computing the statistics at the group level will
be the same methodology used to compute these statistics at the Trading
Center level in the non-public version of the data (and in the public
version of the exchange data).\11\ Specifically, FINRA would calculate
group-level sums for statistics that are quantity counts \12\ and use
all underlying data within a group to calculate statistics requiring
averages or weighted averages.\13\ Data will be aggregated separately
for each order

type and subcategory, and will not be aggregated across order types or
subcategories.
---------------------------------------------------------------------------

    \11\ See Tick Size Appendix B and C Statistics FAQs (available
at http://www.finra.org/sites/default/files/Tick-Size-Pilot-Appendix-B-and-C-FAQ.pdf).
    \12\ See, e.g., Appendix B.I.a(7) (cumulative number of orders).
    \13\ See, e.g., Appendix B.I.a(28) (the share weighted average
realized spread for executions of orders); and Appendix B.I.a(29)
(the received share-weighted average percentage for shares not
displayable as of order receipt). FINRA will calculate averages for
all price variables and percentages.

                                                  Table 1--Illustrative Sample B.I. Data Aggregation 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Share
                                                                                Cumulative       weighted
                                                             Number of                                                       number of        average
                                                           active MPIDs                     Cumulative      Cumulative       shares of       realized
             Date                 Trading       Ticker       in masked      Order type       number of       number of        orders        spread for
                                   center       symbol     group across                       orders         shares of      executed at    execution of
                                                             all pilot                                        orders          an away        orders on
                                                              stocks                                                          trading         trading
                                                                                center        center only
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Unmasked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160926......................  ABCD         ZZZZ                    n/a              18               2         100,000          75,000           -0.01
20160926......................  EFGH         ZZZZ                    n/a              18               2         100,000         100,000            0.01
20160926......................  IJKL         ZZZZ                    n/a              18               4         750,000          35,000           0.011
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Masked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160926......................  G1           ZZZZ                      5              18               8         950,000         210,000          0.0090
--------------------------------------------------------------------------------------------------------------------------------------------------------

Appendix B.II. Data Aggregation Methodology
    Appendix B.II. data includes order-level statistics; thus, FINRA
proposes that all individual orders be displayed for all Trading
Centers within a group, with each order attributed to the group rather
than the underlying Trading Center. In addition, Appendix B.II. order
information would be displayed in pure chronological order based on
time of order receipt to help minimize confidentiality concerns that
may occur if other ordering methods were used, such as showing the
original chronological order per Trading Center.
---------------------------------------------------------------------------

    \14\ For purposes of illustration, this table reflects only a
sample of the data--specifically, the fields described in Appendix
B.I.a.(1), (2), (3), (7), (8), (13) and (28). The published data
would reflect all fields described in Appendix B.I. to the Plan and
as further specified in FINRA Rule 6191 and related rule filings,
the Tick Size Appendix B and C Statistics FAQs (available at http://www.finra.org/sites/default/files/Tick-Size-Pilot-Appendix-B-and-C-FAQ.pdf), and in FINRA's Appendix B and C Requirements and Finra.org
File Specifications document (available at http://www.finra.org/sites/default/files/Appendix-B-and-C-Reporting-Specifications.pdf).

                                                 Table 2--Illustrative Sample B.II. Data Aggregation 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Number of
                                                           active MPIDs
                                  Trading                    in masked    Order received                   Order shares
             Date                  center       Issue      group across        time         Order type       quantity        B/S code       Limit price
                                                             all pilot
                                                              stocks
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Unmasked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160906......................  ABCD         ZZZZ                    n/a       93,605.41              10             500               B          (null)
20160906......................  ABCD         ZZZZ                    n/a       94,114.99              11             100               S           52.45
20160906......................  ABCD         ZZZZ                    n/a      101,140.05              11             900               S           52.31
20160906......................  EFGH         ZZZZ                    n/a       93,605.42              10             600               B          (null)
20160906......................  EFGH         ZZZZ                    n/a       94,114.99              11             100               S           52.45
20160906......................  EFGH         ZZZZ                    n/a      101,140.07              11             700               S           52.37
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Masked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160906......................  G1           ZZZZ                      5       93,605.41              10             500               B          (null)
20160906......................  G1           ZZZZ                      5       93,605.42              10             600               B          (null)
20160906......................  G1           ZZZZ                      5       94,114.99              11             100               S           52.45
20160906......................  G1           ZZZZ                      5       94,114.99              11             100               S           52.45
20160906......................  G1           ZZZZ                      5      101,140.05              11             900               S           52.31
20160906......................  G1           ZZZZ                      5      101,140.07              11             700               S           52.37
--------------------------------------------------------------------------------------------------------------------------------------------------------

Appendix B.IV. Data Aggregation Methodology
    FINRA proposes to aggregate Appendix B.IV. data by aggregating
statistics within each group by trading day by summing the statistics
of all market maker activity represented within the group. The number
of market makers would be displayed as the unique number of market
makers \16\ across all Trading Centers within the group.
---------------------------------------------------------------------------

    \15\ For purposes of illustration, this table reflects only a
sample of the data--specifically, the fields required by items a.
through h. of Appendix B.II. The published data would reflect all
fields described in Appendix B.II. to the Plan and as further
specified in FINRA Rule 6191 and related rule filings, the Tick Size
Appendix B and C Statistics FAQs (available at http://www.finra.org/sites/default/files/Tick-Size-Pilot-Appendix-B-and-C-FAQ.pdf), and
in FINRA's Appendix B and C Requirements and Finra.org File
Specifications document (available at http://www.finra.org/sites/default/files/Appendix-B-and-C-Reporting-Specifications.pdf).
    \16\ As provided in FINRA Rule 6191.11, FINRA will provide a
count of the number of Market Makers used in the participation
calculations. Thus, if a single unique Market Maker traded on
multiple Trading Centers within the same masking group, for the
Appendix B.IV. count of unique Market Makers on a given trading day,
FINRA will count this activity as attributed to one unique Market
Maker.

                                                 Table 3--Illustrative Sample B.IV. data aggregation 17
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
                                                                           active MPIDs
                                                                             in masked     Number unique   Number unique      Shares          Shares
                    Date                            Trading center         group across    MMs buy side    MMs sell side   participation   participation
                                                                             all pilot                                         (buy)          (sell)
                                                                              stocks
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Unmasked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160906....................................  ABCD                                   n/a               2               1         700,000         225,000
20160906....................................  EFGH                                   n/a               1               1             200           5,000
20160906....................................  IJKL                                   n/a               4               1          35,000         500,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Masked Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
20160906....................................  G1                                       5               5               2         735,200         730,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    If the Commission approves the proposed rule change, the effective
date of the proposed rule change will be 120 days following Commission
approval.
---------------------------------------------------------------------------

    \17\ For purposes of illustration, this table reflects only a
sample of the data--specifically, the fields required by items a.
and b. of Appendix B.IV and FINRA Rule 6191.11. The published data
would reflect all fields described in Appendix B.IV. to the Plan and
as further specified in FINRA Rule 6191 and related rule filings,
the Tick Size Appendix B and C Statistics FAQs (available at http://www.finra.org/sites/default/files/Tick-Size-Pilot-Appendix-B-and-C-FAQ.pdf), and in FINRA's Appendix B and C Requirements and Finra.org
File Specifications document (available at http://www.finra.org/sites/default/files/Appendix-B-and-C-Reporting-Specifications.pdf).
---------------------------------------------------------------------------

2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\18\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(9) of the Act,\19\ which requires
that FINRA rules not impose any burden on competition that is not
necessary or appropriate.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78o-3(b)(6).
    \19\ 15 U.S.C. 78o-3(b)(9).
---------------------------------------------------------------------------

    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stock of small-
capitalization companies. FINRA consulted extensively with SEC staff in
connection with the instant proposal to design a grouped masking
methodology that is consistent with the objectives of Section VII(A) of
the Plan to make Appendix B data publicly available while not
identifying the Trading Center that generated the data.

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

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

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

    The Commission previously received comment letters from FIF and
Citadel Securities expressing concern over FINRA's intent to publish
Appendix B data on a Trading Center-by-Trading Center basis.\20\ FIF
stated that publishing Appendix B.I. and B.II. statistics on FINRA's
Web site in a disaggregated format does not satisfy the requirements of
the Plan or Rule 6191 that the publicly available data will not
identify the trading center that generated the data.\21\ Similarly,
Citadel Securities stated that market participants would be able to
determine the identity of Trading Centers in violation of the Plan if
the Appendix B data were to be published in a disaggregated format.\22\
---------------------------------------------------------------------------

    \20\ See Letters from William Hebert, Managing Director,
Financial Information Forum (``FIF''), to Robert W. Errett, Deputy
Secretary, Commission, dated December 21, 2016 (``FIF letter''); and
Adam C. Cooper, Senior Managing Director and Chief Legal Officer,
Citadel Securities, to Brent J. Fields, Secretary, Commission, dated
December 21, 2016 (``Citadel letter''). See also Securities Exchange
Act Release No. 79424 (November 29, 2016), 81 FR 87603 (December 5,
2016) (Notice of Filing and Immediate Effectiveness of File No. SR-
FINRA-2016-042).
    \21\ See FIF letter.
    \22\ See Citadel letter.
---------------------------------------------------------------------------

    In consultation with SEC staff, FINRA is filing the instant
proposed rule change to mitigate the confidentiality concerns raised by
commenters by providing for an anonymized, grouped masking methodology
for Appendix B data for all OTC activity in furtherance of the
objectives of the Plan.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2017-006 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-FINRA-2017-006. 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 the filing also will be available for inspection
and copying at the principal office of FINRA. 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-FINRA-2017-006, and should be submitted
on or before April 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-05082 Filed 3-14-17; 8:45 am]
 BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I don't feel the media and government are explaining to people the huge amount of research and science that shows all the benefits of electronic cigarettes and vaporizers. The information seems to be cherry picked to serve the purpose of making ecigs and vaporizers look harmful or mysterious. There have been over 155 clinical studies done by doctors and researchers that have shown how safe and effective they are and a safer alternative to smoking. People need to know the good and ecigs and vaporizers need to be available to all consumers the same way that coffee makers are available. There seems to be a scare tactic about "Think of the children". We are thinking of the children. We don't want children to have to watch their friends and family die of cancer from smoking cigarettes. There is no evidence anywhere that vaping is a gate way to smoking. There is no evidence. This is just a concept someone came up with based on no facts. The myths about eliquid poisoning children is also being blown far out of proportion. The calls of children being poisoned by eliquid have rose to one a month. Well, honestly why are we  not reporting stories of how over 3,000 children are poisoned a year by energy drinks from caffeine? Or how 4,000 children a year are poisoned by laundry detergent packets? We are hearing reports that use of ecigs has risen in teens… but we aren't hearing the evidence being promoted that this past year, for the first time in decades, the percentage of teens smoking cigarettes has gone down. It's the first time that figure has gone down. I don't believe that ecigs should be available to anyone under 18 years of age and I do think they need child proof caps and ingredients listed, however a lot of the fine print in these documents regarding ecigs will put thousands of people out of jobs and many eliquid companies and device manufactures out of business because they won't be able to afford all the expensive fees to have products reviewed (and without promise of being accepted). These regulations are forcing ecigs into a tobacco shaped drawer and hurting lives and jobs. Vaporizers are no different than the coffee industry. Vape Shops are the new coffee shops. There are lots of flavors in coffee shops that appeal to children. Chocolate and whipped cream and caramel. We don't fear that children are being lured to start drinking coffee. Caffeine and Nicotine area almost the same molecularly. Both are natural chemicals plants make to ward off insects. Coffee shops and coffee culture have a variety of low to high end devices and endless amounts of accessories. From Mr. Coffee to Kcups to expensive italian espresso machines… there is a wide market and interest in coffee as a hobby as well as a thing to consume and enjoy. Vaping is the exact same way. These regulations could stop innovation and americans the financial means to start companies.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


For the Docket

Revisions to the Total Coliform Rule; Proposed Rule
Docket ID No. OW-2008-0878

Meeting with Representatives from the American Water Works Association (AWWA)

      October 28, 2010

In Attendance:

	EPA  -   Pam Barr, Office of Ground Water and Drinking Water (OGWDW)
		Crystal Rodgers-Jenkins, OGWDW
		Sean Conley, OGWDW
		Tom Grubbs, OGWDW
		Julie Javier, OGWDW
		Karl Anderson, OGWDW
		Sandyha Parshionikar, OGWDW (by phone)
		Jennifer Best, OGWDW (by phone)

       AWWA  -  Alan Roberson
		Steve Via

Summary:

AWWA requested the meeting to describe their comments on the proposed revisions to the Total Coliform Rule (TCR) and provide an opportunity for EPA to ask questions if necessary to better understand the comments.  Specifically, AWWA reviewed their comments on:

   * The process to review the TCR analytical methods
   * Concerns about where they believe that the proposed rule differs from the recommendations of the advisory committee as documented in their Agreement in Principle
   * State flexibility for determining compliance with the treatment technique requirements for assessment and corrective action
   * Guidance and training and possible stakeholder involvement in both
   * State concerns with the proposed rule
   * Repeat sampling locations
   * Invalidation of E. coli samples
   * The variance and exemption provisions relating to biofilm

AWWA did not submit any new comments.  EPA asked questions but did not provide any information about EPA positions regarding addressing comments received or possible final rule requirements.


[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48521-48522]
[FR Doc No: 2015-19887]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-1721-000]

Energy.Me Midwest LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Energy.Me Midwest LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 19, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.

    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 6, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19887 Filed 8-12-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 13, 2010 (Volume 75, Number 197)]
[Notices]
[Page 62809]
[DOCID:fr13oc10-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD11-2-000]

Transmission Vegetation Management Practices; Notice of Technical
Conference

October 5, 2010.
    Take notice that the Federal Energy Regulatory Commission
(Commission) staff will hold a Technical Conference on Transmission
Vegetation Management Programs on Tuesday, October 26, 2010 from 1 p.m.
to approximately 5 p.m. This staff-led conference will be held in the
Commission Meeting Room at the Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. The conference will be
open for the public to attend and advance registration is not required.
Members of the Commission may attend the conference.
    The purpose of the conference is to discuss current vegetation
management programs and practices as required under the Commission's
Reliability Standards. In Order No. 693 the Commission approved
Reliability Standard FAC-003-1--Transmission Vegetation Management
Program.\1\ Reliability Standard FAC-003-1 applies to all transmission
lines operated at 200 kV and above, and to lower voltage lines
designated as critical to the reliability of the Bulk-Power System.\2\
---------------------------------------------------------------------------

    \1\ See Mandatory Reliability Standards for the Bulk-Power
System, Order No. 693, FERC Stats. & Regs. ] 31,242, at P 695-735;
Order on reh'g, Order No. 693-A, 120 FERC ] 61,053 at P 95-99
(2007).
    \2\ Reliability Standard FAC-003-1, section A.4.3.
---------------------------------------------------------------------------

    Certain landowners and other affected parties have raised concerns
about changes in vegetation management practices implemented following
adoption of FAC-003-1. The Commission is interested in obtaining a
better understanding of the scope of any changes in vegetation
management practices since FAC-003-1 was approved as mandatory and
enforceable, and the extent to which such changes resulted from the
requirements imposed under FAC-003-1. The Commission is also interested
in obtaining a better understanding of the range of vegetation
management practices used by transmission owners, and the reasons for
selecting a given practice or methodology over alternatives.
    The agenda for this conference will be issued at a later date.
Information on this event will be posted on the Calendar of Events on
the Commission's Web site, http://www.ferc.gov, prior to the event. The
conference will be Webcast. Anyone with Internet access who desires to
listen to this event can do so by navigating to http://www.ferc.gov's
Calendar of Events and locating this event in the Calendar. The event
will contain a link to the Webcast. The Capitol Connection provides
technical support for Webcasts and offers the option of listening to
the meeting via phone-bridge for a fee. If you have any questions,
visit http://www.CapitolConnection.org or call<PHONE_NUMBER>.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about this conference, please contact: Sarah
McKinley, Office of External Affairs, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, (202) 502-
8368<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25671 Filed 10-12-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Rules and Regulations]
[Pages 16531-16533]
[FR Doc No: 2020-05996]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1125; Product Identifier 2017-SW-078-AD; Amendment
39-19880; AD 2020-06-11]
RIN 2120-AA64

Airworthiness Directives; MD Helicopters Inc. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for MD
Helicopters Inc. (MDHI) Model 600N helicopters. This AD requires
establishing a life limit for the main rotor (M/R) blade upper control
collective/longitudinal link assembly (link assembly). This AD was
prompted by the discovery that the life limit was omitted from the
maintenance manual. The actions of this AD are intended to prevent an
unsafe condition on these products.

DATES: This AD is effective April 28, 2020.

ADDRESSES: For service information related to this final rule, contact
MD Helicopters, Inc., Attn: Customer Support Division, 4555 E. McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734; telephone 1-800-388-3378; fax
480-346-6813; or at https://www.mdhelicopters.com. You may review 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>.

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-2017-
1125; 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 AD, any comments received, and other information. The street
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: Payman Soltani, Aerospace Engineer,
Airframe Section, Los Angeles ACO Branch, Compliance and Airworthiness
Division, FAA, 3960 Paramount Blvd., Lakewood, California 90712;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to MDHI Model 600N
helicopters with a yaw stability augmentation system and with an M/R
link assembly part number (P/N) 600N7617-1 installed. The NPRM
published in the Federal Register on September 10, 2018 (83 FR 45580).
The NPRM was prompted by a report from MDHI that during a review of the
Airworthiness Limitations section of the applicable maintenance manual,
MDHI discovered that it did not include a life limit for link
assemblies installed on MDHI Model 600N helicopters with a yaw
stability augmentation system. Link assembly P/N 600N7617-1, which is
made of aluminum, is a life-limited part with a life limit of 15,000
hours time-in-service (TIS). MDHI subsequently revised the
Airworthiness Limitations section of the maintenance manual to include
the life limit. The NPRM proposed to require creating a component
history card or equivalent record for each affected link assembly, if
one does not exist, and recording a life limit of 15,000 hours TIS.
This NPRM also proposed to require determining the hours TIS of the
link assembly and removing the link assembly from service according to
the new life limit. The proposed requirements were intended to prevent
a link assembly remaining in service beyond its life limit, which could
result in fatigue failure, loss of M/R blade pitch control, and
subsequent loss of helicopter control.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request

    MDHI expressed concern that the requirements proposed by the NPRM
do not definitively eliminate the risk of a life limit being exceeded.
    MDHI stated that link assembly P/N 600N7617-1 is not serialized and
is aware that link assemblies have been installed on aircraft with
multiple serial numbers, possibly indicating that link assemblies P/N
600N7617-1 may not have a reliable TIS record. MDHI also stated if the
TIS is unknown, arbitrarily setting the TIS to the aircraft hours may
not adequately reflect the actual TIS of link assembly P/N 600N7617-1.

FAA Response

    The FAA acknowledges link assembly P/N 600N7617-1 is not serialized
and the possibility of cross-installation on multiple aircraft.
However, the FAA has determined that using the hours TIS of the
helicopter mitigates the risk to an acceptable level because there is a
small number of link assemblies P/N 600N7617-1 in-service, the usage
rate for MDHI Model 600N helicopters is similar throughout the fleet,
and the 15,000 hours TIS life limit includes a built-in life reduction
for different variabilities.

Request

    MDHI requested the FAA mandate the replacement of link assembly P/N
600N7617-1 with link assembly P/N 600N7617-5. MDHI explained that
installation of link assembly P/N 600N7617-5 is consistent with
production and field modification installations of the yaw stability
augmentation system (YSAS), which requires installation of link
assembly P/N 600N7617-5, and that link assembly P/N 600N7617-5 is not
subject to life-limiting fatigue, therefore eliminating this potential
safety risk.

FAA Response

    The FAA agrees that replacing link assembly P/N 600N7617-1 with
link assembly P/N 600N7617-5 is beneficial but disagrees that the
replacement is required for airworthiness. Link

assembly P/N 600N7617-5 is an upgraded part made of steel and is not
subject to a life limit. The FAA disagrees with requiring replacement
of link assembly P/N 600N7617-1 with link assembly P/N 600N7617-5
because link assembly P/N 600N7617-1 is airworthy within the life limit
of 15,000 TIS. The FAA provided additional information about this
response, which can be found in the AD docket. The FAA has added an
optional terminating action to the requirements of this AD that
specifies removing link assembly P/N 600N7617-1 from service and
installing link assembly P/N 600N7617-5 instead.

FAA's Determination

    The FAA has reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed except for the changes
described previously. These changes are consistent with the intent that
was proposed in the NPRM to address the unsafe condition and do not add
any additional burden upon the public to that already proposed in the
NPRM. The FAA has also determined that these changes will neither
increase the economic burden on any operator nor increase the scope of
this final rule.

Related Service Information

    The FAA reviewed MDHI CSP-HMI-2 MDHI Maintenance Manual, Chapter
04, Airworthiness Limitations, Revision 47, dated September 30, 2016.
This service information specifies a 15,000 hour TIS life limit for
link assembly P/N 600N7617-1 for helicopters with a yaw stability
augmentation system.

Costs of Compliance

    The FAA estimates that this AD affects 26 helicopters of U.S.
Registry. The FAA estimates that operators may incur the following
costs in order to comply with this AD. Labor costs are estimated at $85
per work-hour.
    Determining the hours TIS of each link assembly and updating the
aircraft records takes about 30 minutes, for a cost of $43 per
helicopter and $1,118 for the U.S. fleet.
    Replacing a link assembly, if needed, takes about 2 work-hours, and
parts cost about $984 for an estimated replacement cost of $1,154 per
link per helicopter.

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 adding the following new airworthiness
directive (AD):

2020-06-11 MD Helicopters Inc.: Amendment 39-19880; Docket No. FAA-
2017-1125; Product Identifier 2017-SW-078-AD.

(a) Applicability

    This AD applies to MD Helicopters Inc. (MDHI) Model 600N
helicopters, certified in any category, with a yaw stability
augmentation system and with a main rotor (M/R) blade upper control
collective/longitudinal link assembly (link assembly) part number
(P/N) 600N7617-1 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a link assembly
remaining in service beyond its fatigue life. This condition could
result in failure of the link assembly, failure of M/R blade pitch
control, and subsequent loss of helicopter control.

(c) Effective Date

    This AD becomes effective April 28, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 100 hours time-in-service (TIS):
    (1) Determine the total hours TIS of each link assembly P/N
600N7617-1. If the hours TIS are unknown, use the hours TIS of the
helicopter. Remove from service any link assembly that has 15,000 or
more hours TIS. Thereafter, remove from service any link assembly
before accumulating 15,000 hours TIS.
    (2) Create a component history card or equivalent record for
each link assembly P/N 600N7617-1 and record a life limit of 15,000
hours TIS.
    (3) As an optional terminating action to the requirements of
paragraphs (e)(1) and (2) of this AD, you may remove from service
link assembly P/N 600N7617-1 and install link assembly P/N 600N7617-
5.

(f) Special Flight Permits

    Special flight permits are prohibited.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, may approve AMOCs
for this AD. Send your proposal to: Payman Soltani, Aerospace
Engineer, Airframe Section, Los Angeles ACO Branch, Compliance and
Airworthiness Division, FAA, 3960 Paramount Blvd., Lakewood,
California 90712; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    For service information related to this AD, contact MD
Helicopters, Inc., Attn: Customer Support Division, 4555 E. McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734; telephone 1-800-388-3378;
fax<PHONE_NUMBER>; or at https://www.mdhelicopters.com. You may
review a copy of this service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101

Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

    Issued on March 17, 2020.
Gaetano A. Sciortino,
 Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-05996 Filed 3-23-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 232 (Friday, December 2, 2011)]
[Notices]
[Page 75573]
[FR Doc No: 2011-30982]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65840; File No. SR-BX-2011-071]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order
Approving Proposed Rule Change With Respect to an Amendment to the By-
Laws of The NASDAQ OMX Group, Inc.

November 28, 2011.
    On October 11, 2011, NASDAQ OMX BX, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend the by-
laws of its parent corporation, The NASDAQ OMX Group, Inc. (``NASDAQ
OMX''). The proposed rule change was published for comment in the
Federal Register on October 28, 2011.\3\ The Commission received no
comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65603 (October 21,
2011), 76 FR 67013.
---------------------------------------------------------------------------

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange \4\
and, in particular, the requirements of Section 6(b)(5) of the Act.\5\
The proposal will allow the NASDAQ OMX Board of Directors (``Board'')
to determine the size of its Audit Committee, so long as the Audit
Committee includes at least three directors, as well as the size of its
Nominating & Governance Committee, so long as the Nominating &
Governance Committee includes at least two directors. The proposal is
intended to provide greater flexibility to the NASDAQ OMX Board to
determine the appropriate size for these committees. The Commission
notes that the proposed rule change maintains compliance with the
Exchange's listing standards. The proposal does not change any other
compositional requirements of either the Audit Committee or the
Nominating & Governance Committee, including independence requirements.
Moreover, the Commission notes that the proposal does not alter the
application of Section 10A of the Exchange Act \6\ and Rule 10A-3
thereunder \7\ to the NASDAQ OMX Audit Committee. The proposal also
deletes an obsolete section from, and corrects a typographical error
in, the NASDAQ OMX by-laws, which are clarifying revisions. For the
foregoing reasons, the Commission believes that the proposed rule
change is consistent with the Act.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78j-1.
    \7\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-BX-2011-071) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-30982 Filed 12-1-11; 8:45 am]
BILLING CODE 8011-01-P