[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7679-7680]
[FR Doc No: 2014-02765]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0039 (Formerly 2006D-0408)]

Annual Reports for Approved Premarket Approval Applications,
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Annual Reports for Approved
Premarket Approval Applications (PMA).'' The purpose of this guidance
is to describe the information required to be included in an annual
report for an approved PMA, additional information requirements that
may be imposed by an approval order, and FDA's recommendations for the
level of detail the applicant should provide in the annual report. It
also identifies the steps FDA staff generally takes when reviewing
annual reports, the resources available to assist staff in their
reviews, and the regulatory actions they may recommend after reviewing
annual reports.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Annual Reports for Approved Premarket Approval
Applications (PMA)'' to the Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

I. Background

    In the Federal Register of October 26, 2006 (71 FR 62595), FDA
announced the availability of its draft guidance entitled, ``Annual
Reports for Approved Premarket Approval Applications (PMA),'' and
invited interested persons to comment on the document. FDA received
several comments, most of which sought additional clarification and
recommendations about the level of detail and format of annual reports.
We

considered all of the comments received and revised the guidance where
appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on annual reports for PMAs. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all Center for Device and
Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or from the Center for Biologics Evaluation
and Research (CBER) at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Annual Reports for Approved Premarket Approval Applications (PMA),''
you may either send an email request to<EMAIL_ADDRESS>to receive
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number 1585 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR 814.82(a)(7) and 814.84(b)
have been approved under OMB control number 0910-0231.
    Under section 3506(c)(2)(A) of the PRA, FDA provided a 60-day
notice concerning the proposed collection of information set forth in
the draft guidance (71 FR 62595, October 26, 2006). In response to the
notice, FDA received several comments pertaining to the information
collection.
    Comments noted that for changes previously submitted in a
regulatory submission, requiring a rationale for each change is
burdensome and duplicative because FDA already has this information. In
response to this comment, FDA modified the guidance to request only
limited information for changes that were submitted as either a PMA
supplement or 30-day notice, including supplement number and the status
of the document.
    Comments requested clarification of the type of information, data,
and level of detail that need to be provided. In response, FDA removed
columns from the proposed ``Changes Table'' in the guidance, including
columns for validation testing, implementation date, approval date, and
risk analysis.
    As a result of modifications made to the guidance in response to
comments, the guidance no longer imposes an information collection
burden additional to that previously approved in OMB control number
0910-0231. FDA is therefore no longer requesting approval of an
additional information collection.

V. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is necessary to
send only one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02765 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="30/06/2008 02:43:44 ">
<TITLE></TITLE>


From:  Self, Traci I<EMAIL_ADDRESS>Sent: Monday, April 25, 2016 3:23 PM To:  Jones, DonnaLee<EMAIL_ADDRESS>Cc: Zavoda, Rich<EMAIL_ADDRESS>Shelton, Randy E<EMAIL_ADDRESS>Hill, John R<EMAIL_ADDRESS>Self, Traci I<EMAIL_ADDRESS>Subject:  ICR TITLE V PERMIT-ArcelorMittal Monessen LLC.

Dr. Jones,   Per  U.S. EPA ICR request dated April 4[th] 2016 attached is a copy of the most recent Air permit for ArcelorMittal Monessen LLC.   If you need additional information or have any questions please contact me.

Traci Self Environmental Manager ArcelorMittal Monessen LLC.

<< 01-30-14  ArcelorMittal Monessen Title V Permit.pdf >>


[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Rules and Regulations]
[Page 54682]
[DOCID:fr23se08-10]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2008-0896]

Drawbridge Operation Regulation; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Nassau County,
NY, Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Loop Parkway Bridge, mile 0.7, across Long Creek, Nassau County, New
York. Under this temporary deviation the bridge may remain in the
closed position for three hours on two days to facilitate bridge
maintenance.

DATES: This deviation is effective from 8:20 a.m. on September 22, 2008
through 11:20 a.m. on September 30, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0896 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and the First
Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue,
Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Judy Leung-Yee, Project Officer, First Coast Guard District,
at<PHONE_NUMBER>. If you have questions on viewing the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION: The Loop Parkway Bridge, across Long Creek
at mile 0.7, at Nassau County, New York, has a vertical clearance in
the closed position of 21 feet at mean high water and 25 feet at mean
low water. The existing drawbridge operation regulations are listed at
33 CFR 117.799(f).
    The waterway has seasonal recreational vessels and fishing vessels
of various sizes. The facilities were notified regarding this closure
and no objections were received.
    The owner of the bridge, New York State Department of
Transportation, requested a temporary deviation to facilitate
electrical maintenance at the bridge.
    Under this temporary deviation the Loop Parkway Bridge at mile 0.7,
across Long Creek, may remain in the closed position between 8:20 a.m.
and 11:20 a.m. on September 22, 2008 and September 23, 2008. In the
event of inclement weather the alternate rain dates are September 29,
2008 and September 30, 2008. Vessels that can pass under the bridge
without a bridge opening may do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 11, 2008.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E8-22156 Filed 9-22-08; 8:45 am]

BILLING CODE 4910-15-P


Cooling Water Intake Structure ( CWIS) Information Data Required Rig Information Rig Name: Falcon 100 Rig Type: Semisubmersible F& G Pacesetter L 900 Total Installed Power Generation Capacity ( 7,800 HP)

Number of Cooling Water Intake Structures ( CWISs) 2 Brief description of each CWIS ( e. g., sea chest, simple pipe) Sea Chest Rough dimensions of each CWIS and indicate whether onboard CWIS has an existing flange 16" intake pipe reduced to a 10" manifold with 140' of 8" saltwater discharge piping to main deck. Screen type ( e. g., strainer, wedge wire) with mesh size Simplex Basket Strainers Total Design Specifications for Daily Maximum Water Intake Volume of each CWIS 1,151,136 gal ( 27,408 bbls) Total Daily Water Intake Volume of each CWIS ( Set up/ Drilling) 1,151,136 gal ( 27,408 bbls) Design Specs for Through Screen Velocity of each CWIS ( i. e., Q= V* A) ( Set up/ Drilling) 1.27 ft/ second List of Purposes of Cooling Water Intakes ( e. g., cool crude oil, produced water, power generators, drill pipe brakes) Winch brake cooling, Drawworks Brake Water Cooling, HPU ( High Pressure Unit) , Air Compressors & A/ C unit water cooled condenser List of Purposes of Non cooling Water Intakes ( e. g., fire water, hotel loads) Water Makers, Fire Main, Ballast, Sanitary, & Pits Total Volume of Water Intake for Ballasting, Duration of the Ballast intake, and the Through Screen Velocity of the Ballast intake 1250 GPM, max. Duration = 4 hours 299,964 gals ( 7,142 bbls) Velocity = 1.99 ft/ second. 16" sea chest inlet piping. Mitigation Measures for reducing Exotic Species Migration through Ballast water The rig does not carry much ballast water from location to location. It is taken on and dumped at the same location. Mitigation Measures for reducing Impingement and Entrainment of Aquatic Organisms, as well as Bio fouling Prevention Measures Sea chest screens, simplex baskets, cathodic protection( Al/ Cu anodes 1amp current)

Is the Rig equipped with a Radiator Cooling System for the Main Engines? Yes


[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Proposed Rules]
[Pages 9215-9218]
[FR Doc No: 2023-02938]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0164; Project Identifier MCAI-2022-01357-T]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11
airplanes. This proposed AD was prompted by a report that certain
airplane flight manuals (AFMs) contain figures with incorrect
performance charts for landing on contaminated runways. This proposed
AD would require revising the existing AFM to correct the affected
performance charts. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 30,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0164; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this NPRM, contact
Bombardier, Inc., Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email bombardier.com">[email protected]bombardier.com; internet
bombardier.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Gabriel Kim, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0164; Project Identifier
MCAI-2022-01357-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your

comments responsive to this NPRM contain commercial or financial
information that is customarily treated as private, that you actually
treat as private, and that is relevant or responsive to this NPRM, it
is important that you clearly designate the submitted comments as CBI.
Please mark each page of your submission containing CBI as ``PROPIN.''
The FAA will treat such marked submissions as confidential under the
FOIA, and they will not be placed in the public docket of this NPRM.
Submissions containing CBI should be sent to Gabriel Kim, Aerospace
Engineer, Mechanical Systems and Administrative Services Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    Transport Canada, which is the aviation authority for Canada, has
issued Transport Canada AD CF-2022-49, dated August 23, 2022 (also
referred to after this as the MCAI), to correct an unsafe condition on
certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes.
The MCAI states that it was discovered that the thrust reverser
correction factors presented in certain AFM performance charts for
landing on contaminated runways do not provide sufficient margin for
stopping distances in certain conditions. If not corrected, use of the
affected performance charts could lead to longitudinal runway
excursions. To address the unsafe condition, Transport Canada issued
Transport Canada AD CF-2021-35, dated October 26, 2021 (Transport
Canada AD CF-2021-35) mandating certain AFM revisions that incorporate
changes to the wet and contaminated runway stopping distance data.
Transport Canada AD CF-2021-35 corresponds to FAA AD 2022-24-01,
Amendment 39-22241 (88 FR 6976, February 2, 2023) (AD 2022-24-01).
    Since Transport Canada AD CF-2021-35 was issued, the MCAI states
that it was discovered that the mandated AFM changes to Figures 07-35-2
and 07-35-4 are incorrect in certain later revisions of two of the
AFMs.
    The FAA is proposing this AD to address the unsafe condition on
these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0164.

Relationship Between This NPRM and AD 2022-24-01

    Accomplishing the AFM revision required by paragraph (g) of this
proposed AD terminates the requirement in AD 2022-24-01 to incorporate
Figure 07-35-2 and Figure 07-35-4 as part of the procedures specified
in paragraphs (g)(3)(viii) and (g)(5)(viii) of AD 2022-24-01.
    Operators that revise the existing AFM to incorporate Bombardier
Global 6000 Airplane Flight Manual--Publication No. CSP 700-1V,
Revision 42, dated May 19, 2022; and Bombardier Global 5000 Featuring
Global Vision Flight Deck Airplane Flight Manual--Publication No. CSP
700-5000-1V, Revision 42, dated May 19, 2022; meet the applicable
requirements of paragraphs (g)(3)(viii) and (g)(5)(viii) of AD 2022-24-
01 and the proposed requirements of this AD.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed the following service information, which specifies
revised AFM corrections to the performance charts for landing on
contaminated runways. These documents are distinct since they apply to
different airplane models and configurations.
     Figure 07-35-2 and Figure 07-35-4 of paragraph A., Take-
off on Wet Grooved or Wet PFC Runways, of Section 6--Performance, of
Supplement 35--Operation on Wet Grooved or Wet Porous Friction Course
Runways, of Chapter 7--Supplements of Bombardier Global 6000 Airplane
Flight Manual--Publication No. CSP 700-1V, Revision 42, dated May 19,
2022. (For obtaining this section of the Bombardier Global 6000
Airplane Flight Manual--Publication No. CSP 700-1V, use Document
Identification No. GL 6000 AFM.)
     Figure 07-35-2 and Figure 07-35-4 of paragraph A., Take-
off on Wet Grooved or Wet PFC Runways, of Section 6--Performance, of
Supplement 35--Operation on Wet Grooved or Wet Porous Friction Course
Runways, of Chapter 7--Supplements of Bombardier Global 5000 Featuring
Global Vision Flight Deck Airplane Flight Manual--Publication No. CSP
700-5000-1V, Revision 42, dated May 19, 2022. (For obtaining this
section of the Bombardier Global 5000 Featuring Global Vision Flight
Deck Airplane Flight Manual--Publication No. CSP 700-5000-1V, use
Document Identification No. GL 5000 GVFD AFM.)
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with this State of Design Authority,
it has notified the FAA of the unsafe condition described in the MCAI
and service information described above. The FAA is issuing this NPRM
after determining that the unsafe condition described previously is
likely to exist or develop on other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require revising the existing AFM to correct
the affected performance charts.

Compliance With AFM Revisions

    Transport Canada AD CF-2022-49, dated August 23, 2022, requires
operators to ``advise all flight crews'' of revisions to the AFM, and
thereafter to ``operate the aeroplane accordingly.'' However, this
proposed AD would not specifically require those actions as those
actions are already required by FAA regulations. FAA regulations
require operators furnish to pilots any changes to the AFM (for
example, 14 CFR 121.137), and to ensure the pilots are familiar with
the AFM (for example, 14 CFR 91.505). As with any other flight crew
training requirement, training on the updated AFM content is tracked by
the operators and recorded in each pilot's training record, which is
available for the FAA to review. FAA regulations also require pilots to
follow the procedures in the existing AFM including all updates.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 204 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85          $17,340
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

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

Bombardier, Inc.: Docket No. FAA-2023-0164; Project Identifier MCAI-
2022-01357-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 30, 2023.

(b) Affected ADs

    This AD affects AD 2022-24-01, Amendment 39-22241 (88 FR 6976,
February 2, 2023) (AD 2022-24-01).

(c) Applicability

    This AD applies to Bombardier, Inc., airplanes identified in
paragraphs (c)(1) and (2) of this AD, certificated in any category.
    (1) Model BD-700-1A10 airplanes, serial numbers 9381, 9432
through 9860 inclusive, 9863 through 9867 inclusive, 9869 through
9871 inclusive, 9873, 9875 through 9878 inclusive, 60005, 60024,
60030, 60032, 60037, 60043, 60045, 60049, 60056, 60057, 60061, 60068
and 60072.
    (2) Model BD-700-1A11 airplanes, serial numbers 9386, 9401, and
9445 through 9997 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Unsafe Condition

    This AD was prompted by a report that certain airplane flight
manuals (AFMs) contain figures with incorrect performance charts for
landing on contaminated runways. The FAA is issuing this AD to
address incorrect AFM performance charts, which if not corrected,
could lead to longitudinal runway excursions.

(f) Compliance

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

(g) AFM Revision

    Within 30 days after the effective date of this AD: Do the
applicable actions specified in paragraph (g)(1) and (2) of this AD.
    (1) For Model BD-700-1A10 airplanes with a Global 6000 marketing
designation: Revise the existing AFM to incorporate the information
specified in Figure 07-35-2 and Figure 07-35-4 of paragraph A.,
Take-off on Wet Grooved or Wet PFC Runways, of Section 6--
Performance, of Supplement 35--Operation on Wet Grooved or Wet
Porous Friction Course Runways, of Chapter 7--Supplements of
Bombardier Global 6000 Airplane Flight Manual--Publication No. CSP
700-1V, Revision 42, dated May 19, 2022.
    Note 1 to paragraph (g)(1): For obtaining this section of the
Bombardier Global 6000 Airplane Flight Manual--Publication No. CSP
700-1V, use Document Identification No. GL 6000 AFM.
    (2) For Model BD-700-1A11 airplanes with a Global 5000 featuring
Global Vision Flight Deck (GVFD) marketing designation: Revise the
existing AFM to incorporate the information specified in Figure 07-
35-2 and Figure 07-35-4 of paragraph A., Take-off on Wet Grooved or
Wet PFC Runways, of Section 6--Performance, of Supplement 35--
Operation on Wet Grooved or Wet Porous Friction Course Runways, of
Chapter 7--Supplements of Bombardier Global 5000 Featuring Global
Vision Flight Deck Airplane Flight Manual--Publication No. CSP 700-
5000-1V, Revision 42, dated May 19, 2022.
    Note 2 to paragraph (g)(2): For obtaining this section of the
Bombardier Global 5000 Featuring Global Vision Flight Deck Airplane
Flight Manual--Publication No. CSP 700-5000-1V, use Document
Identification No. GL 5000 GVFD AFM.

(h) Terminating Action for Certain Requirements of AD 2022-24-01

    Accomplishing the AFM revision required by paragraph (g) of this
AD terminates the requirement in AD 2022-24-01 to incorporate Figure
07-35-2 and Figure 07-35-4 as part of the procedures specified in
paragraphs (g)(3)(viii) and (g)(5)(viii) of AD 2022-24-01.

(i) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.

    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Additional Information

    (1) Refer to Transport Canada AD CF-2022-49, dated August 23,
2022, for related information. This TCCA AD may be found in the AD
docket at regulations.gov under Docket No. FAA-2023-0164.
    (2) For more information about this AD, contact Gabriel Kim,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Figure 07-35-2 and Figure 07-35-4 of paragraph A., Take-off
on Wet Grooved or Wet PFC Runways, of Section 6--Performance, of
Supplement 35--Operation on Wet Grooved or Wet Porous Friction
Course Runways, of Chapter 7--Supplements of Bombardier Global 6000
Airplane Flight Manual--Publication No. CSP 700-1V, Revision 42,
dated May 19, 2022.
    Note 3 to paragraph (k)(2)(i): For obtaining this section of the
Bombardier Global 6000 Airplane Flight Manual--Publication No. CSP
700-1V, use Document Identification No. GL 6000 AFM.
    (ii) Figure 07-35-2 and Figure 07-35-4 of paragraph A., Take-off
on Wet Grooved or Wet PFC Runways, of Section 6--Performance, of
Supplement 35--Operation on Wet Grooved or Wet Porous Friction
Course Runways, of Chapter 7--Supplements of Bombardier Global 5000
Featuring Global Vision Flight Deck Airplane Flight Manual--
Publication No. CSP 700-5000-1V, Revision 42, dated May 19, 2022.
    Note 4 to paragraph (k)(2)(ii): For obtaining this section of
the Bombardier Global 5000 Featuring Global Vision Flight Deck
Airplane Flight Manual--Publication No. CSP 700-5000-1V, use
Document Identification No. GL 5000 GVFD AFM.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email bombardier.com">[email protected]bombardier.com; internet
bombardier.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 7, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-02938 Filed 2-10-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Notices]
[Pages 55833-55834]
[FR Doc No: 2012-22344]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2012-0035; FRL-9726-8]

Announcement of Public Meeting on the Consumer Confidence Report
(CCR) Rule Retrospective Review and Request for Public Comment on
Potential Approaches to Electronic Delivery of the CCR

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a public meeting and request for public comments.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) will be holding
a public meeting on October 1, 2012, to listen to stakeholder comments
on potential approaches for providing Consumer Confidence Reports (CCR)
via electronic delivery. EPA plans to discuss its analysis of
electronic delivery and present potential approaches and considerations
for stakeholders to evaluate when pursuing electronic delivery of CCRs.
EPA invites the public to participate in this listening session. EPA
has posted the draft CCR Electronic Delivery Approaches document for
public comment on its Web site at http://water.epa.gov/lawsregs/rulesregs/sdwa/ccr/. The instructions for registration for the meeting
are located in the SUPPLEMENTARY INFORMATION section of this notice.

DATES: The listening session will be held on October 1, 2012, from 1:00
p.m. to 4:00 p.m., Eastern Standard Time. The 30-day public comment
period starts September 11, 2012 and will end on October 11, 2012.

ADDRESSES: The meeting will be held at the EPA's Potomac Yards North
(Bldg. 2), 2733 S. Crystal Drive, Arlington, VA 22202, and will be open
to the public.
    How to Access Information: Meeting materials, including the draft
CCR Electronic Delivery Approaches document, will be emailed to
registrants or they can be accessed through EPA Docket ID No. EPA-HQ-
OW-2012-0035 and EPA's Web site at http://water.epa.gov/lawsregs/rulesregs/sdwa/ccr/; background information (including the CCR and
Public Notification Rules) is available in this docket. Comments
received on the ``Preliminary Plan for Periodic Retrospective Reviews
of Existing Regulations'' are available for viewing in EPA's Docket No.
EPA-HQ-OA-2011-0154. Publicly available docket materials are available
either electronically through www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave.
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Adrienne Harris, Drinking Water
Protection Division, Office of Ground Water and Drinking Water
(MC4606M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460 at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Public Meeting Registration

    Individuals planning on participating in the public meeting must
register for the meeting at https://www.horsleywitten.com/ccrretroreview. Registration for this meeting will end on September 26,
2012, or earlier if the meeting room capacity is reached. If there is
additional space, on-site registration will be allowed on a first-come,
first-served basis.

Meeting Information

    The session will begin with a brief presentation by the EPA Office
of Ground Water and Drinking Water. Copies of EPA's presentation will
be available at the meeting and posted on EPA's Web site following the
meeting at http://water.epa.gov/lawsregs/rulesregs/sdwa/ccr/. An oral
comment session will follow the presentation. Oral comments will be
limited to three (3) minutes each, and it is preferred that only one
person present the statement on behalf of a group or organization to
accommodate as many participants as possible. Registered attendees
requesting to make an oral presentation will be placed on the
commenting schedule. Time slots are limited and will be filled on a
first-come, first-served basis. EPA may ask clarifying questions during
the oral presentations, but will not respond to the presentations. A
facilitated participant discussion of the potential CCR Electronic
Delivery Approaches will follow the oral comment session. You may
present oral comments during the meeting and/or submit written comments
and supporting information directly to EPA up until the close of the
public comment period on October 11, 2012, to provide an opportunity
for participants to respond to what they heard at the meeting. Written
statements and supporting information submitted during the comment
period will be considered in the same manner as any oral comments and
supporting information presented at the public meeting. Written
comments may be submitted to<EMAIL_ADDRESS>If
participants are finished before 4:00 p.m., the meeting may come to a
close before the scheduled 4:00 p.m. end time. All attendees must go
through a metal detector, sign in with the security desk and show
government-issued photo identification to enter the building.

Special Accommodations

    For information on access or accommodations for individuals with
disabilities, please contact Adrienne Harris at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>Please allow at least five business
days prior to the meeting to give EPA time to process your request.

Background

    Consumer Confidence Reports are a key part of the public right-to-
know as established in the 1996 Amendments to the Safe Drinking Water
Act (SDWA, section 1414(c)). The Consumer Confidence Report, or CCR, is
an annual water quality report that a community water system is
required by Federal regulations (63 FR 44512, August 19, 1998) to
provide to its customers by July 1 each year. Community Water Systems
(CWSs) serving more than 10,000 persons are required to mail or
otherwise directly deliver these reports. States may allow CWSs serving
fewer than 10,000 persons to provide these reports by other means. The
report lists the regulated contaminants found in the drinking water, as
well as health effects information related to violations of the
drinking water standards. CCRs often allow for informed choices and
increases dialogue between water systems and their customers. More
information on CCRs can be accessed on EPA's Web site at http://water.epa.gov/lawsregs/rulesregs/sdwa/ccr/index.cfm.
    In August 2011, EPA finalized its ``Plan for Periodic Retrospective
Reviews of Existing Regulations.'' Since 1998, when the CCR rule was
finalized, the communication of information and the speed with which
information can be shared have greatly expanded, along with a
corresponding increase in the diversity of communication tools. EPA
included the CCR Rule in its retrospective review plan to explore ways
to promote greater transparency and public participation in protecting
the nation's drinking water. Through the Agency's CCR retrospective
review, EPA is evaluating opportunities to improve the effectiveness of
communicating drinking water information to the public, while lowering
the burden of CCR requirements for water systems and states. One
example suggested by water systems is to allow electronic delivery
through email, thereby reducing mailing charges. As EPA evaluates
electronic delivery approaches, the Agency will consider impacts on
consumer burden, environmental justice and state implementation. By
improving communication, customers are better prepared to make informed
decisions and the readership of CCRs also may increase.

    Dated: September 4, 2012.
Nancy K. Stoner,
Acting Assistant Administrator, Office of Water.
[FR Doc. 2012-22344 Filed 9-10-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73755-73756]
[FR Doc No: 2015-30098]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9939-30-Region 2]

Prevention of Significant Deterioration of Air Quality (PSD)
Final Determinations in New Jersey, Puerto Rico, and the Virgin Islands

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final actions.

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

SUMMARY: The purpose of this notice is to announce that between April
16, 2014 and Oct 1, 2015, the Region 2 Office of the Environmental
Protection Agency (EPA), issued one final agency action and the New
Jersey Department of Environmental Protection (NJDEP) issued three
final agency actions pursuant to the Prevention of Significant
Deterioration of Air Quality (PSD) regulations codified at 40 CFR
52.21.

DATES: The effective dates for the above determinations are delineated
in the chart in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Mr. Frank Jon, Environmental Engineer
of the Permitting Section, Air Programs Branch, Clean Air and
Sustainability Division, Environmental Protection Agency, Region 2
Office, 290 Broadway, 25th Floor, New York, NY 10007-1866, at (212)
637-4085.

SUPPLEMENTARY INFORMATION: Pursuant to the PSD regulations, the Region
2 Office of the USEPA, and the NJDEP have made final PSD determinations
relative to the facilities listed below:

----------------------------------------------------------------------------------------------------------------
             Name                  Location           Project         Agency      Final action         Date
----------------------------------------------------------------------------------------------------------------
West Deptford Energy, LLC....  West Deptford     A new project     NJDEP        New PSD Permit.  June 2, 2014.
                                Township, New     (Phase II) at
                                Jersey.           an existing
                                                  electric
                                                  generating
                                                  facility. It is
                                                  a 427 Mw
                                                  Siemens
                                                  combined-cycle
                                                  combustion
                                                  turbine unit
                                                  with duct
                                                  burners, a 40
                                                  MM Btu/hr
                                                  auxiliary
                                                  boiler, an
                                                  emergency
                                                  generator, a
                                                  fire water
                                                  pump, and a
                                                  multi-cell
                                                  cooling tower.
RC Cape May Holdings, LLC....  Beesley's Point,  BL England        NJDEP        PSD Permit       October 2,
                                New Jersey.       Repowering                     Extension        2014.
                                                  Project--18-                   Granted.
                                                  month extension
                                                  for commencing
                                                  construction of
                                                  the project.
West Deptford Energy, LLC....  West Deptford     Extension of the  NJDEP        PSD Permit       September 29,
                                Township, New     18-month                       Extension        2015.
                                Jersey.           deadline for                   Granted.
                                                  commencing
                                                  construction of
                                                  the Phase II
                                                  project listed
                                                  above.
Energy Answers, LLC..........  Arecibo, Puerto   Extension of the  EPA          PSD Permit       October 1, 2015
                                Rico.             18-month                       Extension        (effective
                                                  deadline for                   Granted.         date of the
                                                  commencing                                      PSD permit
                                                  construction of                                 extended until
                                                  the Arecibo                                     April 10,
                                                  Puerto Rico                                     2017).
                                                  Renewable
                                                  Energy Project
                                                  which consists
                                                  of two 1,050
                                                  tons per day
                                                  (each) refuse-
                                                  derived fuel
                                                  municipal waste
                                                  combustors, a
                                                  77 megawatt
                                                  steam turbine
                                                  electrical-
                                                  generator, and
                                                  other ancillary
                                                  equipment.
----------------------------------------------------------------------------------------------------------------

    This notice lists only the facilities that have received final PSD
determinations. Anyone who wishes to review these determinations and
related materials should contact the following offices:

EPA Actions

    U.S. Environmental Protection Agency, Region 2 Office, Air Programs
Branch--25th Floor, 290 Broadway, New York, New York 10007-1866, (212)
637-4085.

NJDEP Actions

    New Jersey Department of Environmental Protection, Division of
Environmental Quality, Air Quality Permitting Element, Bureau of
Preconstruction Permits, 401 East State Street, Trenton, New Jersey
08625,<PHONE_NUMBER>.
    With respect to the final PSD permit for West Deptford Energy, LLC,
pursuant to 40 CFR 124.19(l), a prerequisite to seeking judicial review
of the determination under section 307(b)(1) of the Clean Air Act (the
Act), 42 U.S.C. 7607(b)(1), is that parties must have previously filed
a petition with the

EPA Environmental Appeals Board under 40 CFR 124.19(a). If the
prerequisite has been met, review may be sought only by the filing of a
petition for review in the United States Court of Appeals for the
appropriate circuit within 60 days from the date on which the
determination is published in the Federal Register. With respect to the
PSD permit extensions, pursuant to section 307(b)(1) of the Clean Air
Act, judicial review of this extension decision may be sought by filing
a petition for review in the United States Court of Appeals for the
appropriate circuit within 60 days from the date on which these
determinations are published in the Federal Register. Under section
307(b)(2) of the Act, the determinations in this Notice shall not be
subject to later judicial review in civil or criminal proceedings for
enforcement.

    Dated: November 6, 2015.
Judith A. Enck,
Regional Administrator, Region 2.
[FR Doc. 2015-30098 Filed 11-24-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46623]
[DOCID:fr11au08-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR08-27-000]

Duke Energy Kentucky, Inc.; Notice of Petition for Rate Approval

August 5, 2008.
    Take notice that on July 25, 2008, Duke Energy Kentucky, Inc. (DE-
Kentucky) filed a petition for rate approval pursuant to section
284.123 and 284.224 of the Commission's regulations. DE-Kentucky is
proposing a new maximum monthly reservation charge of $0.2781 per Dth
of demand and a commodity charge of $0.0000 per Dth for its no-notice
quality service provided under its Order 63 blanket certificate.
    Any person desiring to participate in this rate proceeding must
file a motion 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 and 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 date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Friday August 15, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-18461 Filed 8-8-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18206-18208]
[FR Doc No: 2017-07672]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-24016; FMCSA-2009-0067; FMCSA-2011-0040; FMCSA-
2011-0058; FMCSA-2013-0012; FMCSA-2013-0014; FMCSA-2014-0315; FMCSA-
2015-0057]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions of 132
individuals from its rule prohibiting persons with insulin-treated
diabetes mellitus (ITDM) from operating commercial motor vehicles
(CMVs) in interstate commerce. FMCSA has statutory authority to exempt
individuals from this rule if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these CMV drivers.

DATES: Each group of renewed exemptions are effective from the dates
stated in the discussions below. Comments must be received on or before
May 17, 2017.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. FMCSA-2006-24016; FMCSA-
2009-0067; FMCSA-2011-0040; FMCSA-2011-0058; FMCSA-2013-0012; FMCSA-
2013-0014; FMCSA-2014-0315; FMCSA-2015-0057 using any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8 a.m. to 5:30 p.m.,
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the Federal Motor Carrier Safety Regulations 2-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 132 individuals listed
in this notice have recently become eligible for a renewed exemption
from the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to
drivers of CMVs in interstate commerce. The drivers remain in good
standing with the Agency, have maintained their required medical
monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period.

II. Exemption Decision

    This notice addresses 132 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. These 132 drivers
remain in good standing with the Agency, have maintained their required
medical monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period. Therefore, FMCSA has decided to extend each
exemption for a renewable two-year period. Each individual is
identified according to the renewal date.
    The exemptions are renewed subject to the following conditions: (1)
That each individual submit a quarterly monitoring checklist completed
by the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) that each individual reports
within 2 business days of occurrence, all episodes of severe
hypoglycemia, significant complications, or inability to manage
diabetes; also, any involvement in an accident or any other adverse
event in a CMV or personal vehicle, whether or not it is related to an
episode of hypoglycemia; (3) that each individual submit an annual
ophthalmologist's or optometrist's report; and (4) that each individual
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy in his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the certification when driving, for presentation to
a duly authorized Federal, State, or local enforcement official.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. The following groups of
drivers received renewed exemptions in the month of May and are
discussed below.
    As of May 3, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 9 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (78 FR 16032; 78 FR
26107):

Maryland A. Chandler (KY)
Ronald D. Clark (AR)
Larry L. Eberly (PA)

Steven J. Fessler (IL)
Patrick L. Morningstar (MD)
Russell L. Stiley (CO)
Gary T. Stoutamyer (VA)
Jack K. Webster (KY)
Harry V. Wilhite, Jr. (AL)

    The drivers were included in Docket No. FMCSA-2013-0014. Their
exemptions are effective as of May 3, 2017, and will expire on May 3,
2019.
    As of May 6, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 9 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (78 FR 16758; 78 FR
26422):

Victor L. Daniels (DE)
Kenneth T. Faborito (HI)
Kevin P. Lee (MN)
Duane W. Mansur (NH)
Fritz R. McBride (WI)
Arthur H. Olsen (AZ)
Jacob D. Parnaby (OH)
Brandon P. Wilson (NC)
Peter S. Zipperer (LA)

    The drivers were included in Docket No. FMCSA-2013-0012. Their
exemptions are effective as of May 6, 2017, and will expire on May 6,
2019.
    As of May 8, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 50 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (80 FR 18681; 80 FR
37716):

Rafael M. Alvarado (TX)
Mark J. Avedisian (NY)
Timothy J. Burke (MA)
Roger D. Cassada (VA)
Leonard W. Cleaves (MA)
Larry A. Cramer (SD)
Bradford A. Davies (ME)
Larry A. DeSanno (OR)
Robert S. Doering (IL)
Michael L. Domarus (MN)
Adan A. Espinoza (CA)
Howard E. Fruehling (IA)
Michael F. Gabbianelli (NJ)
James E. Goins (NJ)
Gregory J. Goodenbour (IA)
Michael D. Howell (NC)
Mayer Indorsky (NY)
Raymond J. Jacobs (NY)
Lyle J. Kaehler (WI)
Charles F. Kennedy (PA)
Curtis G. Krichbaum (PA)
Walter P. Leck (PA)
John R. Mauney (NC)
Derrell R. McCaskill (MD)
Eric O. McLamb (NC)
Michael S. Murray (IA)
Benjamin M. Naastad (ND)
Richard G. Niemi (WI)
Kenthia E. Norfleet (AL)
Donald M. Oakes (NH)
Robert E. Piernik (FL)
Harold E. Pratt (MO)
Jack C. Reed (NE)
Fernando Rivera (IL)
William J. Schmidt (MN)
Todd J. Schoeller (WI)
Gary H. Schrot (WI)
Ryan A. Snow (PA)
Kevin L. Sundh (UT)
William H. Terry (IN)
Duane K. Torlish, Jr. (NY)
Ronald W. Truitt (PA)
Timothy E. Vanderwiele (NY)
Leo D. Vermeire (WA)
Brian W. Walls (PA)
Gary L. Webster (VT)
Lance A. Wendinger (MN)
Allan W. Widener (GA)
Shane D. Wildoner (PA)
Kyle A. Wright (WA)

    The drivers were included in Docket No. FMCSA-2014-0315. Their
exemptions are effective as of May 8, 2017, and will expire on May 8,
2019.
    As of May 9, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 38 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (76 FR 17475; 76 FR
26792; 80 FR 18928; 80 FR 37726):

James R. Bledsoe (FL)
Sammy W. Bowlin (KS)
Durwin A. Brannon (NC)
Larry J. Carril (IL)
Jimmy E. Cole (TN)
Robert S. Colosimo (ND)
Jo F. Cook (NY)
James N. Coombs (NJ)
David A. Daniels (ME)
John A. DelGiudice (RI)
Mark J. Dias (MA)
Brian A. Foss (WY)
William A.H. Gardner (CA)
Steven M. Gilmour (MA)
Ismael Gonzalez (IN)
Charles A. Gudaitis (PA)
Cory A. Harker (UT)
Clark D. Holdeman (TX)
David A. Holwenger (WA)
Conrad J. Janik (NY)
David F. Kenny (NY)
George W. Key, Jr. (AL)
Michael O. Lancial (MI)
Robert E. McKenna (NY)
Gregory O. Morton (AL)
Frank A. Mowers (IL)
Charles H. Nichols (MI)
Robert L. Rush (PA)
Derek J. Scougal (VA)
Roy Silva (IL)
James L. Skinner (IA)
Crispin Tabangcura Jr. (HI)
Robert L. Terry (TN)
Rafael Torres, Jr. (FL)
Harold E. Watters (IN)
Joseph E. Weitzel (PA)
John B. Wojcicki (OH)
Steven L. Wolvers (IA)

    The drivers were included in one of the following docket Nos:
FMCSA-2011-0058; FMCSA-2015-0057. Their exemptions are effective as of
May 9, 2017, and will expire on May 9, 2019.
    As of May 11, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 8 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (76 FR 17478; 76 FR
27376):

Peter N. Amendola (MA)
Steven V. Callison (LA)
Douglas A. Carroll (IN)
Tamara D. Folsom (SD)
Ernest Martinelli, III (RI)
Johnathon C. Morgan (TN)
David R. Smith (ME)
Adam J. Stegenga (MI)

    The drivers were included in Docket No. FMCSA-2011-0040. Their
exemptions are effective as of May 11, 2017, and will expire on May 11,
2019.
    As of May 18, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, Thomas G. Deke (MO) has satisfied the renewal conditions for
obtaining an exemption from the rule prohibiting drivers with ITDM from
driving CMVs in interstate commerce (71 FR 17558; 71 FR 28913).
    This driver was included in docket No. FMCSA-2006-24016. The
exemption is effective as of May 18, 2017, and will expire on May 18,
2019.
    As of May 22, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 17 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (74 FR 15578; 74 FR
24072):

William C. Arrington (MD)
Raymond Barajas (KS)
William N. Carpenter (KY)
Darin L. Carpenter (MT)
Jeffery W. Cotner (OR)
Juan A. Hartwell (CT)
David A. Holzbach (SC)
Joseph T. Jackson (CT)
Donald A. Lambrecht (NC)
William M. Liebert (NV)
Curtis J. Panther (MN)
Eric S. Ritter (CA)
Gary L. Robinson (TN)
Kevin J. Sears (IL)
Peter A. Storm (LA)
Don A. Wisnosky (WI)
Patrick D. Yosten (NE)

    The drivers were included in docket No. FMCSA-2009-0067. Their
exemptions are effective as of May 22, 2017, and will expire on May 22,
2019.

    Each of the 132 drivers in the aforementioned groups qualifies for
a renewal of the exemption. They have maintained their required medical
monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each of the
132 drivers for a period of two years is likely to achieve a level of
safety equal to that existing without the exemption. The drivers were
included in docket numbers FMCSA-2006-24016; FMCSA-2009-0067; FMCSA-
2011-0040; FMCSA-2011-0058; FMCSA-2013-0012; FMCSA-2013-0014; FMCSA-
2014-0315; FMCSA-2015-0057.

IV. Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by May 17, 2017.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 132 individuals from rule
prohibiting persons with ITDM from operating CMVs in interstate
commerce in 49 CFR 391.41(b)(3). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the medical condition of each applicant for an exemption from
rule prohibiting persons with ITDM from operating CMVs in interstate
commerce. That information is available by consulting the above cited
Federal Register publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

V. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2006-24016; FMCSA-
2009-0067; FMCSA-2011-0040; FMCSA-2011-0058; FMCSA-2013-0012; FMCSA-
2013-0014; FMCSA-2014-0315; FMCSA-2015-0057 and click the search
button. When the new screen appears, click on the blue ``Comment Now!''
button on the right hand side of the page. On the new page, enter
information required including the specific section of this document to
which each comment applies, and provide a reason for each suggestion or
recommendation. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the facility, please
enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

VI. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2006-24016; FMCSA-2009-0067; FMCSA-2011-0040;
FMCSA-2011-0058; FMCSA-2013-0012; FMCSA-2013-0014; FMCSA-2014-0315;
FMCSA-2015-0057 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to this
notice.

    Issued on: April 10, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-07672 Filed 4-14-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 94 (Wednesday, May 15, 2013)]
[Notices]
[Pages 28687-28688]
[FR Doc No: 2013-11508]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69543; File No. SR-FINRA-2013-021]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to an Extension of the Implementation
Date for FINRA Rule 5270 (Front Running of Block Transactions)

May 9, 2013.
    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 May 2, 2013, 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. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to establish September 3, 2013, as the
implementation date of FINRA Rule 5270 (Front Running of Block
Transactions) that the Commission approved on September 4, 2012.\4\ The
proposed rule change adopted NASD Interpretive Material (``IM'') 2110-3
(Front Running Policy) as FINRA Rule 5270 with certain changes,
including broadening the rule's scope and providing further clarity
into trading activity that FINRA believes is inconsistent with just and
equitable principles.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 67774 (September 4,
2012), 77 FR 55519 (September 10, 2012) (Order Approving SR-FINRA-
2012-025) (``Approval Order'').
---------------------------------------------------------------------------

    The proposed rule change does not make any changes to the text of
FINRA rules.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    FINRA is filing the proposed rule change to establish September 3,
2013, as the implementation date for FINRA Rule 5270 regarding front
running.
    On September 4, 2012, the SEC approved SR-FINRA-2012-025, which
adopted NASD IM-2110-3 as FINRA Rule 5270 in the Consolidated FINRA
Rulebook \5\ with certain changes, including broadening the rule's
scope and providing further clarity into trading activity that FINRA
believes is inconsistent with just and equitable principles.\6\ On
December 3, 2012, FINRA published Regulatory Notice 12-52 announcing
that the Commission approved the proposed rule change and announcing an
implementation date of June 1, 2013.
---------------------------------------------------------------------------

    \5\ The current FINRA rulebook consists of (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from NYSE (``Incorporated
NYSE Rules'') (together, the NASD Rules and Incorporated NYSE Rules
are referred to as the ``Transitional Rulebook''). While the NASD
Rules generally apply to all FINRA members, the Incorporated NYSE
Rules apply only to those members of FINRA that are also members of
the NYSE. The FINRA Rules apply to all FINRA members, unless such
rules have a more limited application by their terms. For more
information about the rulebook consolidation process, see
Information Notice, March 12, 2008 (Rulebook Consolidation Process).
    \6\ See Approval Order, supra note 4.
---------------------------------------------------------------------------

    Since the publication of the Notice, many firms and industry groups
have requested that the implementation date for Rule 5270 be delayed to
allow firms sufficient time to make necessary systems updates and
changes. Firms have noted that, because of the expansion of the rule to
include a wider range of securities and other related financial
instruments,\7\ existing vendor systems and internally-developed
controls cannot easily be revised to include the expanded securities
and instruments covered by the rule. Firms are also reconsidering, and
in some cases adjusting, the scope of existing information barriers to
account for the broader scope of the rule as well as implementing
education and training programs. Although FINRA has stated, and firms
recognize, that the underlying conduct addressed in Rule 5270 is
largely covered by existing FINRA rules, FINRA understands the need for
firms to adjust their training, education, and internal surveillance
programs in an effort to successfully comply with the expansion of Rule
5270. As a result of these discussions, and the comment letter
discussed in Item 5 below,\8\ FINRA is seeking to delay the
implementation of Rule 5270 until September 3, 2013, to give firms
sufficient time to make necessary changes to their programs and systems
to enable them to review their trading activity for compliance with the
rule.\9\ FINRA stresses, however, that much of the trading activity
prohibited by Rule 5270 may already violate other existing FINRA rules.
---------------------------------------------------------------------------

    \7\ FINRA Rule 5270(c) defines a ``related financial
instrument'' as ``any option, derivative, security-based swap, or
other financial instrument overlying a security, the value of which
is materially related to, or otherwise acts as a substitute for,
such security, as well as any contract that is the functional
economic equivalent of a position in such security.''
    \8\ The Commission notes that Item 5 is discussed in the filing,
not this Notice.
    \9\ FINRA does not anticipate providing further extensions
beyond September 3, 2013.
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ 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. FINRA believes that extending the implementation date
will ensure that firms have sufficient time to make the necessary
changes to their systems to be able to effectively surveil their
trading activity in the securities and financial instruments that are
subject to the rule. Extending the implementation date by three months
will also ensure firms have sufficient time to complete the assessment
of their existing information barriers and any needed training or
education. FINRA notes that members are already under an existing
obligation to prevent the front running of customer orders under other
FINRA rules and that these rules will continue to apply to members'
trading

activity notwithstanding the extension of the implementation date for
Rule 5270.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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. Because the proposed rule
change does not amend FINRA rules and merely extends the implementation
date for Rule 5270, FINRA does not believe the proposed rule change
imposes any unnecessary or inappropriate burden on competition.

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

    The Securities Industry and Financial Markets Association
(``SIFMA'') submitted a written request to FINRA for a three-month
extension of the implementation date for Rule 5270.\11\ A copy of the
SIFMA Letter is attached as Exhibit 2.\12\
---------------------------------------------------------------------------

    \11\ See Letter from Sean Davy, Managing Director, Corporate
Credit Markets Division, SIFMA, to Brant K. Brown, Associate General
Counsel, Office of General Counsel, FINRA (April 22, 2013) (``SIFMA
Letter'').
    \12\ The Commission notes that Exhibit 2 is attached to the
filing, not this Notice.
---------------------------------------------------------------------------

    In its letter, SIFMA represents that, since Rule 5270 was approved,
its members ``have been actively working to update their policies and
are expanding and implementing robust education and training
programs.'' \13\ SIFMA states that, notwithstanding these efforts,
because ``existing vendor [surveillance] systems and internally-
developed controls cannot easily be revised to the new, expanded
product set'' covered by Rule 5270, firms may not be able to implement
the needed systems changes by June 1, 2013.\14\ In particular, the
expansion of firms' surveillance and supervision systems to include
other product areas, in particular fixed income securities and OTC
products, may not be completed by June 1, 2013.\15\ SIFMA also
represents that the implementation of certain provisions of the Dodd-
Frank Wall Street Reform and Consumer Protection Act, particularly
those under Title VII, are affecting many of the same systems
implicated by Rule 5270.\16\ As a result of these factors, SIFMA
requested that FINRA extend the implementation date of Rule 5270 by
three months. SIFMA acknowledges, however, that ``during this period
member firms are, and would continue to be, under an existing
obligation to prevent the frontrunning of customer orders'' and that
``much of the trading activity prohibited by new Rule 5270 may already
violate existing FINRA Rules.'' \17\
---------------------------------------------------------------------------

    \13\ Id. at 1.
    \14\ Id.
    \15\ Id.
    \16\ Id. at 2.
    \17\ Id.
---------------------------------------------------------------------------

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \18\ and Rule 19b-
4(f)(6) thereunder.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2013-021 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2013-021. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of 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-2013-021, and should
be submitted on or before June 5, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-11508 Filed 5-14-13; 8:45 am]
BILLING CODE 8011-01-P


13 31 January 2003 EPA believes that the species group approach is appropriate for the national rulemaking given the many data limitations associated with our lack of knowledge of specific fish life histories, particularly the growth and mortality rates of early life stages. However, EPA is not endorsing this approach for analyses to support individual permits related to specific water bodies and facilities. At the individual permit level, more detailed information regarding the life histories of individual species is often available and, when available, it should be used.

EPA evaluated facility I& E monitoring data for all individual fish species with losses over 1% of the facility total. EPA converted annual I& E losses for each species group into ( 1) age 1 equivalents, ( 2) fishery yield, and ( 3) biomass production foregone using standard fishery modeling techniques ( Ricker, 1975; Hilborn and Walters, 1992; Quinn and Deriso,

1999). Details of these methods are provided in Chapter A5 of Part A of the § 316( b) Phase II Case Study Document and the preamble to the NODA. Section A5 4 of Chapter A5 discusses data uncertainties. For all analyses, EPA assumed 100% entrainment mortality based on the analysis of entrainment survival studies presented in Chapter A7 of Part A of the § 316( b) Phase II Case Study Document To obtain regional I& E estimates, EPA extrapolated losses from facilities with I& E data to facilities without data. These results were then summed to obtain a regional total. Average annual results for facilities with impingement and entrainment I& E data were averaged and extrapolated on the basis of operational flow, in millions of gallons per day ( MGD), to facilities without data. The extrapolation method used, by region, is:

Total losses at case study facilities * Flow at case study facilities / Total flow in the region


[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8433-8434]
[FR Doc No: 2023-02742]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0378]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
regulatory issues. On March 7, 2023, the committee will meet in open
session to discuss and make recommendations on the selection of strains
to be included in the influenza virus vaccines for the 2023-2024
influenza season. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document.

DATES: The meeting will be held virtually on March 7, 2023, from 9 a.m.
to 3:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. The online web
conference meeting will be available at the following link on the day
of the meeting: https://youtu.be/fpZi7X29C-Q.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-0378. Please note that late, untimely
filed comments will not be considered. The docket will close on March
6, 2023. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of March 6,
2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.
    Comments received on or before February 27, 2023, will be provided
to the committee. Comments received after February 27, 2023, and by
March 6, 2023, will be taken into consideration by FDA. In the event
that the meeting is cancelled, FDA will continue to evaluate any
relevant applications or information, and consider any comments
submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-0378 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Prabhakara Atreya,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
240-506-4946, [email protected]; or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On March 7,
2023, the committee will meet in open session to discuss and make
recommendations on the selection of strains to be included in the
influenza virus vaccines for the 2023-2024 influenza season.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the time of the
advisory committee meeting, and the background material will be posted
on FDA's website after the meeting. Background material is available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Dockets (see
ADDRESSES) on or before February 27, 2023, will be provided to the
committee. Comments received after February 27, 2023, and by March 6,
2023, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled between approximately 1:30 p.m. and 2:30
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, along with their names, email addresses, and direct contact
phone numbers of proposed participants, on or before 12 p.m. Eastern
Time on February 27, 2023. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by 6 p.m.
Eastern Time March 1, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Sussan Paydar or Prabhakara Atreya (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02742 Filed 2-8-23; 8:45 am]
BILLING CODE 4164-01-P