[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11854-11856]
[FR Doc No: 2019-05948]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-2008-0355; FMCSA-
2010-0203; FMCSA-2012-0050; FMCSA-2014-0379; FMCSA-2015-0323]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

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

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

SUMMARY: FMCSA announces its decision to renew exemptions for eight
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before April 29,
2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2006-24278; FMCSA-2006-25854;
FMCSA-2008-0355; FMCSA-2010-0203; FMCSA-2012-0050; FMCSA-2014-0379;
FMCSA-2015-0323 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the

online 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: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

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 W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-2008-0355;
FMCSA-2010-0203; FMCSA-2012-0050; FMCSA-2014-0379; FMCSA-2015-0323),
indicate the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation.
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,
put the docket number, FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-2008-
0355; FMCSA-2010-0203; FMCSA-2012-0050; FMCSA-2014-0379; FMCSA-2015-
0323, in the keyword box, and click ``Search.'' When the new screen
appears, click on the ``Comment Now!'' button and type your comment
into the text box on the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit.
    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.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-
2008-0355; FMCSA-2010-0203; FMCSA-2012-0050; FMCSA-2014-0379; FMCSA-
2015-0323, in the keyword box, and click ``Search.'' Next, click the
``Open Docket Folder'' button and choose the document to review. If you
do not have access to the internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years 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 five-year period. FMCSA
grants exemptions from the FMCSRs for a two-year period to align with
the maximum duration of a driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
    The eight individuals listed in this notice have requested renewal
of their exemptions from the epilepsy and seizure disorders prohibition
in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable two-
year period.

III. Request for Comments

    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.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315, each of the eight
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The
eight drivers in this notice remain in good standing with the Agency,
have maintained their medical monitoring and have not exhibited any
medical issues that would compromise their ability to safely operate a
CMV during the previous two-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System (CDLIS) and the Motor Carrier Management
Information System (MCMIS) are searched for crash and violation data.
For non-CDL holders, the Agency reviews the driving records from the
State Driver's Licensing Agency (SDLA). These factors provide an
adequate basis for predicting each driver's ability to continue to
safely operate a CMV in interstate

commerce. Therefore, FMCSA concludes that extending the exemption for
each renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.
    As of January 1, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual has satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers: Jordan
M. Hyster (OH).
    This driver was included in docket number FMCSA-2015-0323. The
exemption is applicable as of January 1, 2019, and will expire on
January 1, 2021.
    As of January 7, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual has satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers: Edgar
Snapp (IN).
    This driver was included in docket number FMCSA-2014-0379. The
exemption is applicable as of January 7, 2019, and will expire on
January 7, 2021.
    In accordance with 49 U.S.C. 31136(e) and 31315, the following
groups of drivers received renewed exemptions in the month of January
and are discussed below.
    As of January 15, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following six individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Daniel Forth (NY)
Steven L. Hunsaker (ID)
Brian J. Porter (PA)
Wayne C. Sorenson (MN)
Michael W. Thomas (KS)
Paul Warren (ME)

    The drivers were included in docket numbers FMCSA-2006-24278;
FMCSA-2006-25854; FMCSA-2008-0355; FMCSA-2010-0203; FMCSA-2012-0050.
Their exemptions are applicable as of January 15, 2019, and will expire
on January 15, 2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the two-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy of his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official. The exemption will be rescinded if: (1) The person fails to
comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the eight exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in 49 CFR 391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two
years unless revoked earlier by FMCSA.

    Issued on: March 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-05948 Filed 3-27-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Rules and Regulations]
[Page 16205]
[FR Doc No: 2019-07600]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0787; Airspace Docket No. 18-ASW-12]
RIN 2120-AA66

Establishment of Class E Airspace; Coushatta, LA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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

SUMMARY: This action corrects a final rule published in the Federal
Register of March 1, 2019, that establishes Class E airspace at The Red
River Airport, Coushatta, LA. The geographic coordinates of the airport
will be amended to be in concert with the FAA's aeronautical database.

DATES: Effective date 0901 UTC, April 25, 2019. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register for Docket
No. FAA-2018-0787 (84 FR 6965, March 1, 2019), establishing Class E
airspace at The Red River Airport, Coushatta, LA. Subsequent to
publication, the FAA identified an error that the geographic
coordinates of the airport need to be amended to be in concert with the
FAA's aeronautical database. This correction changes the coordinates
from ``(lat. 31[deg]59'25'' N, long. 093[deg]18'40'' W)'' to read
``(lat. 31[deg]59'25'' N, long. 093[deg]18'27'' W)''

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of March 1, 2019 (84 FR 6965) FR Doc. 2019-03615,
Establishment of Class E Airspace; Coushatta, LA, is corrected as
follows:

Sec.  71.1  [Amended]

ASW LA E5 Coushatta, LA [Corrected]

0
On page 6966, column 1, line 37; remove ``(lat. 31[deg]59'25'' N, long.
093[deg]18'40'' W)'' and add in its place ``(lat. 31[deg]59'25'' N,
long. 093[deg]18'27'' W)''.

    Issued in Fort Worth, Texas, on April 4, 2019.
John Witucki,
Acting Manager, Operations Support Group, Central Service Center.
[FR Doc. 2019-07600 Filed 4-17-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73676-73679]
[FR Doc No: 2014-29006]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73759; File No. SR-EDGA-2014-30]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the EdgeBook Cloud Service on EDGA Exchange, Inc.

December 5, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 25, 2014, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
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\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to eliminate references to and fees
for the Flex Download and Snapshot offerings available as part of the
Exchange's EdgeBook Cloud service, which are optional services that are
to be discontinued by the Exchange. The Exchange will continue to offer
the Replay portion of the EdgeBook Cloud service, but proposes to
rename it EDGA Historical Depth Data as well as amend its related fees.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.directedge.com/, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The EdgeBook Cloud is a service that allows Members and non-Members
of the Exchange to obtain and query historical trade and quote data
(``historical data'') representing the real-time data feed previously
disseminated by the Exchange.\5\ The EdgeBook Cloud currently includes
the three separate offerings: Replay, FlexDownload, and Snapshot. The
Exchange proposes to eliminate references to and fees for the Flex
Download and Snapshot offerings available as part of the Exchange's
EdgeBook Cloud service, which are optional services that are to be
discontinued by the Exchange. The

Exchange will continue to offer the Replay portion of the EdgeBook
Cloud service, but proposes to rename it EDGA Historical Depth Data as
well as amend its related fees.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 66403 (February 15,
2012), 77 FR 10593 (February 22, 2012) (SR-EDGA-2012-05) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating
to an Offering of a New Historical Data Feed Service to Members and
Non-Members).
---------------------------------------------------------------------------

Termination of FlexDownload and Snapshot
    The Exchange proposes to delete reference to and fees for the
FlexDownload and Snapshot offerings available as part of the Exchange's
EdgeBook Cloud service because it intends to discontinue offering this
products as of January 2, 2015. Therefore, reference to these products
and their fees in the Exchange's fee schedule would no longer serve any
legitimate purpose upon the product being retired by the Exchange.
FlexDownload enables subscribers to submit customized queries of trade
or quote information, specify the time and symbol parameters, as well
as other attributes to be retrieved. Snapshot provided subscribers the
ability to submit standard queries that can be accessed on-demand, or
through an Application Programming Interface (``API'') \6\ that permits
query results to be downloaded by the subscriber. Standard queries
include various quote and trade requests, as well as a combined quote
and trade view for a requested symbol. The Exchange has no subscribers
to either the FlexDownload or Snapshot offerings and, therefore,
intends to terminate these services.
---------------------------------------------------------------------------

    \6\ An API facilitates information sharing by acting as a ``go-
between'' that enables a software program to interact with other
software.
---------------------------------------------------------------------------

Harmonization of EDGE Book Cloud Replay With BATS Historical Pitch Data
    The Exchange proposes to rename the Replay portion of the EdgeBook
Cloud service as EDGA Historical Depth Data, which is similar to BATS
Historical Pitch Data,\7\ an identical product offered by BATS
Exchange, Inc. (``BATS''), an affiliate of the Exchange. The Exchange
also proposes to amend the fees charged for EdgeBook Cloud Replay
service to more closely align with those fees charged for BATS
Historical Pitch Data.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 61885 (April 9,
2010), 75 FR 20018 (April 16, 2010) (SR-BATS-2010-002) (Order
Approving Proposed Rule Change, As Amended, To Offer Certain BATS
Exchange Data Products).
---------------------------------------------------------------------------

    Earlier this year, the Exchange and its affiliate EDGX Exchange,
Inc. (``EDGX'') received approval to effect a merger (the ``Merger'')
of the Exchange's parent company, Direct Edge Holdings LLC, with BATS
Global Markets, Inc., the parent of BATS and the BATS Y-Exchange, Inc.
(``BYX'' together with BATS, BYX, EDGA and EDGX, the ``BGM Affiliated
Exchanges'').\8\ In the context of the Merger, the BGM Affiliated
Exchanges are working to align certain rules and services, retaining
only intended differences between the BGM Affiliated Exchanges. As part
of this effort, the Exchange proposes to: (i) Rename the Replay portion
of the EdgeBook Cloud service as EDGA Historical Depth Data, which is
like BATS Historical Pitch Data, an identical product offered by BATS;
and (ii) amend the fees charged for EdgeBook Cloud Replay service to
more closely align with those fees charged for BATS Historical Pitch
Data. Like the BATS Historical Pitch Data service, the Exchange also
proposes to specify that the EdgeBook Cloud Replay service is offered
to subscribers for internal use only.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 71449 (January 30,
2014), 79 FR 6961 (February 5, 2014) (SR-EDGX-2013-43; SR-EDGA-2013-
34).
---------------------------------------------------------------------------

    In sum, both EdgeBook Cloud Replay and BATS Historical Pitch Data
allow subscribers to access a formatted replay of each trading day,
including the exact messages that were disseminated via the EdgeBook
Depth feed for EDGA \9\ and the BATS Exchange Pitch Feed \10\
respectively, including any orders, executions, cancellations and
status messages. Therefore, renaming the Replay portion of the EdgeBook
Cloud service as EDGA Historical Depth Data, similar to the BATS
Historical Pitch Data, is designed to align the naming of identical
services offered by the BGM Affiliated Exchanges.\11\
---------------------------------------------------------------------------

    \9\ See Exchange Rule 13.8 for a description of the EDGA Book
Feed.
    \10\ See BATS Rules 11.22(a) and (c) for a description of the
BATS Exchange Pitch feeds.
    \11\ The Exchange understands that EDGX is to file a proposed
rule change with the Commission to make similar changes.
---------------------------------------------------------------------------

    While the fees for both the EdgeBook Cloud Replay and BATS
Historical Pitch Data are similar, the Exchange does proposes amend the
fees for the EdgeBook Cloud Replay service to more closely align with
those fees charged for BATS Historical Pitch Data. Currently,
subscribers to the EdgeBook Cloud Replay are charged a fee of $500/
month for a rolling thirty day replay. Subscribers may also request
data for a calendar month for a fee of $500 for each month they
request, capped at $2500 if less than or equal to 1TB of data is
requested. If a subscriber requests more than 1TB of data, it will be
charged an additional $2500 flat fee. Subscribers to the BATS
Historical Pitch Data service are charged a fee of $500/month per user
for access to 90 days of data available on a rolling basis. For data
that BATS provides on an external hard drive to a subscriber, BATS
charges 2,500 per TB drive generated by the Exchange. The Exchange
proposes to adopt the identical fee structure as BATS. As proposed, the
Exchange will charge subscribers a $500 monthly access fee per user for
access to 90 days of data available on a rolling basis. The Exchange
will no longer charge subscribers $500/per month for a rolling 30 day
replay or $500 for each calendar month requested. Like BATS, and
similar to existing EdgeBook Cloud fees, the Exchange will charge
$2,500 per TB hard drive for data downloaded by the Exchange to an
external hard drive.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\12\ in general, and
Section 6(b)(5) of the Act,\13\ in particular, in that it promotes just
and equitable principles of trade, removes impediments to, and perfects
the mechanism of, a free and open market and a national market system,
and, in general, protects investors and the public interest. The
Exchange also believes that its proposal is consistent with Section
6(b)(4) of the Act,\14\ in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
other persons using its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

Termination of FlexDownload and Snapshot
    The proposal is consistent with Section 6(b)(5) of the Act,\15\ in
that it eliminates any investor confusion by deleting references to
services, and their related fees, that are to be discontinued by the
Exchange, thereby removing impediments to and perfecting the mechanism
of a free and open market and a national market system, and, in
general, protecting investors and the public interest. In addition, the
Exchange has no subscribers to the FlexDownload and Snapshot offerings,
neither of these offerings are core product offerings by the Exchange,
nor is the Exchange required by the Act to offer such products. The
proposed rule change will not permit unfair discrimination among
customers, brokers, or dealers because the FlexDownload and Snapshot
offerings will no longer be offered by the Exchange.
---------------------------------------------------------------------------

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

    In addition, the Exchange believes that the proposed removal of the
fees for the FlexDownload and Snapshot

offerings from its fee schedule are consistent with Section 6(b)(4) of
the Act \16\ because it would delete fees for products that are to be
discontinued by the Exchange, thereby eliminating investor confusion.
Lastly, the Exchange also believes that the proposed amendment to its
fee schedule is reasonable and non-discriminatory because it will apply
uniformly to all members.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

Harmonization of EDGE Book Cloud Replay With BATS Historical Pitch Data
    The proposal is consistent with Section 6(b)(5) of the Act,\17\ in
that it eliminates any investor confusion because renaming the Replay
portion of the EdgeBook Cloud service as EDGA Historical Depth Data,
similar to the BATS Historical Pitch Data, an identical product offered
by BATS, is designed to align the naming of identical services offered
by the BGM Affiliated Exchanges. In addition, the Exchange believes
that its proposal to harmonize the fees charged for EdgeBook Cloud
Replay service with those fees charged for BATS Historical Pitch Data
is consistent with Section 6(b)(4) of the Act \18\ because it is also
designed to align the pricing of identical products offered across the
BGM Affiliated Exchanges. The Exchange also believes the proposed fees
for the EdgeBook Cloud Replay service are reasonable and equitable
because they mirror the fees charged for BATS Historical Pitch Data,
which have been previously approved by the Commission.\19\ The Exchange
believes that its proposed fees are reasonable in light of the benefits
to data recipients. This product is completely optional in that no
subscriber is required to purchase it and only those subscribers that
deem such product to be of sufficient overall value and usefulness will
purchase it. Lastly, the Exchange also believes that the proposed
amendment to its fee schedule is reasonable and non-discriminatory
because it will apply uniformly to all members.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b)(5).
    \18\ 15 U.S.C. 78f(b)(4).
    \19\ See supra note 7.
---------------------------------------------------------------------------

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

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \20\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change to remove references to
data products and their related fees that are to be retired by the
Exchange is not designed to have a competitive impact. Second, the
proposal to rename an existing service and amend its fees to align with
an identical service offered by BATS is also not designed to have a
burden on competition as it is merely intended to provide greater
harmonization among Exchange and BATS, alleviating investor confusion
by providing a uniform product offering across the BGM Affiliated
Exchanges. Therefore, the Exchange does not believe the proposed rule
change will have any effect on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing proposed rule change does not: (1)
Significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3) by
its terms does not become operative for 30 days after the date of this
filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest,
the proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \21\ and Rule 19b-4(f)(6) thereunder.\22\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has met this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative
immediately upon filing. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest so that the Exchange can align the names and fees
for identical services offered by the Exchange and BATS, and delete
references to data products and their fees that are to be discontinued
by the Exchange in a timely manner. In addition, the Exchange has no
subscribers to the FlexDownload and Snapshot offerings; therefore,
exchange participants will not be affected by the immediate
discontinuation of these products.\23\ Accordingly, the Commission
hereby grants the Exchange's request and designates the proposal
operative upon filing.
---------------------------------------------------------------------------

    \23\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

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-EDGA-2014-30 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGA-2014-30. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the

proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGA-2014-30, and should be
submitted on or before January 2, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-29006 Filed 12-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Notices]
[Page 55435-55436]
[DOCID:fr21se05-130]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52446; File Nos. SR-DTC-2005-04, SR-FICC-2005-10, and
SR-NSCC-2005-05]

Self-Regulatory Organizations; The Depository Trust Company,
Fixed Income Clearing Corporation, and National Securities Clearing
Corporation; Order Approving Proposed Rule Change To Establish a Fine
for Members Failing To Conduct Connectivity Testing

September 15, 2005.

I. Introduction

    On May 13, 2005, May 3, 2005, and on May 4, 2005, respectively, The
Depository Trust Company (``DTC''), the Fixed Income Clearing
Corporation (``FICC''), and the National Securities Clearing
Corporation (``NSCC'') filed with the Securities and Exchange
Commission (``Commission'') proposed rule changes SR-DTC-2005-04, SR-
FICC-2005-10, and SR-NSCC-2005-05 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'').\1\ On June 7, 2005, NSCC
amended its proposed rule change. Notice of the proposals, as amended,
was published in the Federal Register on July 21, 2005.\2\ No comment
letters were received. For the reasons discussed below, the Commission
is approving the proposed rule changes.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 52403 (July 15, 2005),
70 FR 42122.
---------------------------------------------------------------------------

II. Description

    DTC, FICC, and NSCC are imposing a fine on any member that is
required to conduct connectivity testing for business continuity
purposes and fails to do so.
    In the aftermath of September 11, 2001, and in conjunction with a
financial industry white paper, DTC, FICC, and NSCC require
connectivity testing each year for critical (``Top Tier'') members.\3\
The criteria used by DTC, FICC, and NSCC to identify their respective
Top Tier members were revenues, clearing fund contributions, settlement
amounts, and trading volumes. Connectivity testing for the Top Tier
members was initiated on January 1, 2004. Due to the critical
importance of being able to assess whether a Top Tier member has
sufficient operational capabilities, DTC, FICC, and NSCC have
determined that they need the ability to fine any Top Tier member that
does not test.\4\
---------------------------------------------------------------------------

    \3\ The Federal Reserve, Office of the Comptroller of the
Currency, and the Commission issued ``Interagency Paper on Sound
Practices to Strengthen the Resilience of the U.S. Financial
System.'' [68 FR 17809 (April 11, 2003)]. This document provided
guidelines that required core clearing and settlement organizations,
such as DTC, FICC, and NSCC, and others in the financial industry to
manage business continuity capabilities. DTC, FICC, and NSCC
developed their testing of Top Tier firms based on the guidelines
outlined in the white paper.
    \4\ Pursuant to DTC Rule 2, ``Participants and Pledgees,''
participants must furnish, upon DTC's request, information
sufficient to demonstrate operational capability. In addition, DTC
Rule 21, ``Disciplinary Sanctions,'' allows DTC to impose fines on
participants for any error, delay or other conduct detrimental to
the operations of DTC.
    Pursuant to GSD Rule 3, ``Responsibility, Operational
Capability, and Other Membership Standards of Comparison-Only
Members and Netting Members,'' the GSD may require members to
fulfill operational testing requirements as the GSD may at any time
deem necessary. Pursuant to MBSD Rule 1, Section 3 of Article III,
all MBSD applicants and members agree to fulfill operational testing
requirements and related reporting requirements that may be imposed
to ensure the continuing operational capability of the applicant.
    Pursuant to NSCC Rule 15, ``Financial Responsibility and
Operational Capability,'' members must furnish to NSCC adequate
assurances of their financial responsibility and operational
capability as NSCC may at any time deem necessary. In addition, NSCC
Rule 48, ``Disciplinary Procedures,'' allows NSCC to impose a fine
on participants for any error, delay, or other conduct that is
determined to be detrimental to the operations of NSCC.
---------------------------------------------------------------------------

    Currently, each member of DTC, FICC, and NSCC that is designated as
Top Tier is advised of this status and is provided with information on
the testing requirements. Under DTC, FICC, and NSCC's current
procedures, if testing is not completed by a Top Tier member by the end
of June, a reminder notice is sent to the member. Thereafter, another
reminder notice is sent in October and, if necessary, again in
December.
    The reminder notice sent in December will advise that if testing is
not completed by December 31, a fine of $10,000 will be imposed. These
fines will be collected from members in January of the following year.
The Membership and Risk Management Committee will be notified of all
members that were fined for failing to complete connectivity testing.
    In the event that any member fails to complete connectivity testing
for two successive years, the fine that will be imposed at that time
will be $20,000. Failure to complete testing for more than two
successive years will result in disciplinary action, including
potential termination of membership.

III. Discussion

    Section 17A(b)(3)(F) of the Act requires that the rules of a
clearing agency be designed to assure the safeguarding of securities
and funds which are in the custody or control of the clearing agency or
for which it is responsible.\5\ The Commission finds that DTC, FICC,
and NSCC's proposed rule changes are consistent with this requirement
because the implementation of the fines should help DTC, FICC, and NSCC
to enforce compliance with their connectivity testing rules for
business continuity purposes and as a result should better enable them
to ensure the safeguarding of securities and funds which are in their
custody or control.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule changes are consistent with the requirements of the Act
and in particular Section 17A of the Act and the rules and regulations
thereunder.
    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule changes (File Nos. SR-DTC-2005-04, SR-FICC-2005-
10, and SR-NSCC-2005-05) be and hereby are approved.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
[FR Doc. 05-18763 Filed 9-20-05; 8:45 am]

BILLING CODE 8010-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 21, 2011

	On June 23rd, 2011 we held a conference call with the Hybrid
Manufacturers Regulatory Collaboration (HMRC) to discuss concerns raised
by members of the HMRC regarding heavy-duty onboard diagnostic (OBD)
requirements and timing.  Concerns were raised during the comment period
for the heavy-duty greenhouse gas notice of proposed rulemaking that
heavy-duty hybrid applications may not be able to meet the 2013
heavy-duty OBD regulations that were published in the 2009 OBD Final
Rulemaking.,  Specifically, they have requested a delay of the
application of HD OBD requirements for hybrid applications until 2020.
Attendees from the EPA and HMRC are shown below.

Attendee	Affiliation

Cleophas Jackson	EPA – Compliance and Innovative Strategies Division

Anthony Neam	EPA – Assessment and Standards Division

Amy Kopin	EPA – Assessment and Standards Division

Barbara Chance	Allison Transmission

Kevin Rodgers	Allison Transmission

Rob Merrion	Allison Transmission

Steve Spurlin	Allison Transmission

Justin Owens	Allison Transmission

Ian McKenzie	Eaton Corporation

Tom Apalenek	BAE Systems

Derek Matthews	BAE Systems

Dan Butler	BAE Systems

Doug Thrall	BAE Systems

Jim Lyons	Sierra Research

 U.S. EPA, NHTSA, and DOT, “Greenhouse Gas Emission Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,”
republished December 29, 2010.  Available here:
http://origin.www.gpo.gov/fdsys/pkg/FR-2010-12-29/html/2010-32726.htm

 U.S. EPA, “Control of Air Pollution from New Motor Vehicles and New
Motor Vehicles Engines; Final Rule Regulations Requiring Onboard
Diagnostic Systems on 2010 and Later Heavy-Duty Engines Used in Highway
Applications Over 14,000 Pounds; Revisions to Onboard Diagnostic
Requirements for Diesel Highway Heavy-Duty Vehicles Under 14,000
Pounds,” published February 24, 2009.  Available here:
http://www.epa.gov/otaq/regs/im/obd/regtech/hd-obd-frm-02-24-09-notice-7
4-fr-8310.pdf


[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89456-89458]
[FR Doc No: 2023-28519]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-2225]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SCEMBLIX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SCEMBLIX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and

Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 26, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 24, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2022-E-2225 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SCEMBLIX.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biological product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, SCEMBLIX
(asciminib hydrochloride). SCEMBLIX is indicated for the treatment of
adult patients with:
     Philadelphia chromosome-positive chronic myeloid leukemia
(Ph+CML) in chronic phase (CP), previously treated with two or more
tyrosine kinase inhibitors. This indication is approved under
accelerated approval based on major molecular response. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial(s).

     Ph+ CML in CP with the T315I mutation.
    Subsequent to this approval, the USPTO received a patent term
restoration application for SCEMBLIX (U.S. Patent No. 8,829,195) from
Novartis AG, and the USPTO requested FDA's assistance in determining
the patent's eligibility for patent term restoration. In a letter dated
January 10, 2023, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
SCEMBLIX represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
SCEMBLIX is 2,845 days. Of this time, 2,717 days occurred during the
testing phase of the regulatory review period, while 128 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 16, 2014. The applicant claims December 17, 2013, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was January
16, 2014, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: June 24,
2021. FDA has verified the applicant's claim that the new drug
application (NDA) for SCEMBLIX (NDA 215358) was initially submitted on
June 24, 2021.
    3. The date the application was approved: October 29, 2021. FDA has
verified the applicant's claim that NDA 215358 was approved on October
29, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 899 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28519 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36220-36222]
[FR Doc No: 2013-14285]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002; Internal Agency Docket No. FEMA-B-1322]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect

in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before September 16, 2013.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1322, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Calvert County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.rampp-team.com/md.htm
------------------------------------------------------------------------
City of North Beach....................  City Hall, 8916 Chesapeake
                                          Avenue, North Beach, MD 20714.
Town of Chesapeake Beach...............  Town Hall, 8200 Bayside Road,
                                          Chesapeake Beach, MD 20732.
Unincorporated Areas of Calvert County.  Calvert County Planning
                                          Department, 150 Main Street,
                                          Suite 300, Prince Frederick,
                                          MD 20678.
------------------------------------------------------------------------
           St. Mary's County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.rampp-team.com/md.htm
------------------------------------------------------------------------
Town of Leonardtown....................  Town Hall, 41660 Courthouse
                                          Drive, Leonardtown, MD 20650.
Unincorporated Areas of St. Mary's       St. Mary's County Planning
 County.                                  Department, 23150 Leonard Hall
                                          Drive, Leonardtown, MD 20650.
------------------------------------------------------------------------
             Jefferson County, Texas, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.riskmap6.com/Community.aspx?cid=372&sid=5
------------------------------------------------------------------------
City of Beaumont.......................  Community Development
                                          Department, 801 Main Street,
                                          Suite 201, Beaumont, TX 77701.
City of Bevil Oaks.....................  Bevil Oaks City Hall, 7525
                                          Sweetgum Road, Beaumont, TX
                                          77713.
City of Groves.........................  Public Works Building, 4925
                                          McKinley, Groves, TX 77619.
City of Nederland......................  Inspections Department, 1903
                                          Atlanta Avenue, Nederland, TX
                                          77627.
City of Nome...........................  City Hall, 1586 2nd Street,
                                          Nome, TX 77629.
City of Port Arthur....................  Planning and Zoning Department,
                                          444 4th Street, 3rd Floor,
                                          Port Arthur, TX 77640.
City of Port Neches....................  Public Works Department, 1005
                                          Merriman Street, Port Neches,
                                          TX 77651.

City of Taylor Landing.................  Taylor Landing Building Permits
                                          Department, 324 North Memorial
                                          Freeway, Nederland, TX 77627.
Unincorporated Areas of Jefferson        Jefferson County Courthouse,
 County.                                  1149 Pearl Street, 5th Floor,
                                          Beaumont, TX 77701.
------------------------------------------------------------------------
              Orange County, Texas, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.riskmap6.com/Community.aspx?cid=430&sid=5
------------------------------------------------------------------------
City of Bridge City....................  City Hall, 260 Rachal Avenue,
                                          Bridge City, TX 77611.
City of Orange.........................  Planning and Community
                                          Development Department, 303
                                          8th Street, Orange, TX 77630.
City of Pine Forest....................  Pine Forest City Hall, 305
                                          Nagel Drive, Vidor, TX 77662.
City of Pinehurst......................  Pinehurst City Hall, 2497
                                          Martin Luther King Jr. Drive,
                                          Orange, TX 77630.
City of Rose City......................  Secretary's Office, 370 South
                                          Rose City Drive, Rose City, TX
                                          77662.
City of Vidor..........................  Public Works Department, 1395
                                          North Main Street, Vidor, TX
                                          77662.
City of West Orange....................  City Hall, 2700 Western Avenue,
                                          West Orange, TX 77630.
Unincorporated Areas of Orange County..  Orange County Environmental
                                          Health and Code Compliance
                                          Department, 123 South 6th
                                          Street, Orange, TX 77630.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

     Dated: June 3, 2013.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2013-14285 Filed 6-14-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Proposed Rules]
[Pages 42422-42424]
[FR Doc No: 2022-15130]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0923; FRL-9882-01-R9]

Air Plan Approval; California; Mojave Desert Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Mojave Desert Air Quality Management District
(MDAQMD or ``District'') portion of the California State Implementation
Plan (SIP). This revision concerns emissions of oxides of nitrogen
(NOX) from Portland cement kilns. We are proposing to
approve a local rule to regulate these emission sources under the Clean
Air Act (CAA or the Act). We are taking comments on this proposal and
plan to follow with a final action.

DATES: Comments must be received on or before August 15, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2021-0923 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Elijah Gordon, EPA Region IX, 75
Hawthorne St. (AIR-3-2), San Francisco, CA 94105. By phone: (415) 972-
3158 or by email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the rule revision?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the dates
that it was adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
              Local agency                  Rule #            Rule title              Amended        Submitted
----------------------------------------------------------------------------------------------------------------
MDAQMD..................................       1161  Portland Cement Kilns......      01/22/2018      05/23/2018
----------------------------------------------------------------------------------------------------------------

    On November 23, 2018, pursuant to CAA section 110(k)(1)(B) and 40
CFR part 51, appendix V, the submittal for the MDAQMD Rule 1161 was
deemed complete by operation of law.

B. Are there other versions of this rule?

    We approved an earlier version of Rule 1161 into the SIP on
February 27, 2003 (68 FR 9015). The MDAQMD adopted revisions to the
SIP-approved version on January 22, 2018, and CARB submitted them to us
on May 23, 2018. If we take final action to approve the January 22,
2018 version of Rule 1161, this version will replace the previously
approved version of the rule in the SIP.

C. What is the purpose of the rule revision?

    Emissions of NOX contribute to the production of ground-
level ozone, smog and particulate matter (PM), which harm human health
and the environment. Section 110(a) of the CAA requires states to
submit plans that provide for implementation, maintenance, and
enforcement of the National Ambient Air Quality Standards (NAAQS). SIP-
approved Rule 1161 established NOX emission limits for
Portland cement kilns within the District.
    On November 17, 2017 (82 FR 54309), the EPA proposed to
conditionally approve the MDAQMD's reasonably available control
technology (RACT) demonstrations for the 1997 8-hour ozone NAAQS and
the 2008 8-hour ozone NAAQS (referred to as the 2006 and 2015 RACT
SIPs) based on deficiencies in several rules. One of the rules noted
was Rule 1161, which did not meet current RACT based on comparisons of
NOX emission limits in ozone nonattainment areas located in
other states deemed to meet or exceed RACT. The conditional approval,
finalized on February 12, 2018 (83 FR 5921), was based on commitments
from

the MDAQMD to revise and submit amendments to Rule 1161 that would meet
current RACT. Revisions to Rule 1161, submitted to the EPA on May 23,
2018, addressed this deficiency by establishing a more stringent
NOX limit for Portland cement kilns. The EPA's technical
support document (TSD) has more information about this rule.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, ozone nonattainment areas classified as Moderate or
above (see CAA sections 182(b)(2) and 182(f)) are required to submit
SIP revisions containing rules requiring RACT for each major source of
NOX. The MDAQMD regulates an ozone nonattainment area
classified as Severe-15 for the 2008 8-hr ozone NAAQS (40 CFR 81.305).
Therefore, in order for the MDAQMD to fulfill the commitments in its
2006 and 2015 RACT SIP conditional approval commitment letter, this
proposed rule must implement RACT.
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation, and rule stringency requirements
for the applicable criteria pollutant include the following:
    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January 11,
1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``State Implementation Plans; Nitrogen Oxides Supplement to the
General Preamble; Clean Air Act Amendments of 1990 Implementation of
Title I; Proposed Rule,'' (the NOX Supplement), 57 FR 55620,
November 25, 1992.
    5. ``NOX Emissions from Cement Manufacturing,'' EPA-453/
R-94-004, March 1994.
    6. ``NOX Control Technologies for the Cement Industry:
Final Report,'' EPA 457/R-00-002, September 2000.
    7. The Texas Commission on Environmental Quality in Section
117.3110--Cement Kilns, Emissions Specifications, May 23, 2007.
    8. State Implementation Plans: Response to Petition for Rulemaking;
Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings
of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying
to Excess Emissions During Periods of Startup, Shutdown and
Malfunction,'' 80 FR 33839, June 12, 2015.
    9. ``Guidance Memorandum: Withdrawal of the October 9, 2020,
Memorandum Addressing Startup, Shutdown, and Malfunctions in State
Implementation Plans and Implementation of the Prior Policy,''
September 30, 2021.

B. Does the rule meet the evaluation criteria?

    This proposed rule meets CAA requirements and is consistent with
relevant guidance regarding enforceability, RACT, and SIP revisions. We
find that the District has fulfilled the requirements in its commitment
letter for the 2006 and 2015 RACT SIP conditional approval (83 FR 5921,
February 12, 2018) to revise the rule by lowering the NOX
emission limits for Portland cement kilns in order to meet current
RACT. NOX emission limits during all periods not labeled
Startup and Shutdown for Preheater-Precalciner Kilns are reduced from
6.4 to 2.8 pounds per ton of clinker produced when averaged over any 30
consecutive day period, increasing the stringency of the rule.
Additionally, provisions clearly laid out in Sections (F), (I), and (J)
of the rule establish applicability criteria, monitoring,
recordkeeping, and reporting that can be consistently evaluated to
determine compliance. Startup and shutdown emissions limits (e.g.,
17,616 pounds of NOX per day for Preheater-Precalciner Kilns
manufactured by Allis Chalmers, whose construction was completed in
1982), duration time limits (i.e., 36 hours), and recordkeeping
requirements are found in Rule 1161. These and other alternative
emission limitations (AEL) provisions, consistent with our 2015 SSM
Policy (80 FR 33839, June 12, 2015), are found in Sections (C) and (F).
Finally, the retention of all produced and maintained on-site records
increased from two years to five years, further enhancing the
stringency of the rule. The TSD has more information on our evaluation.

C. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted proposed rule because it fulfills all
relevant requirements. We will accept comments from the public on this
proposal until August 15, 2022. If we take final action to approve the
submitted proposed rule, our final action will incorporate this rule
into the federally enforceable SIP.

III. Incorporation by Reference

    In this proposed rule, the EPA is proposing to include in a final
EPA rule regulatory text that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, the EPA is proposing to
incorporate by reference MDAQMD Rule 1161, which regulates
NOX emission limits for Portland cement kilns, as listed in
Table 1 of this preamble. The EPA has made, and will continue to make,
these materials available through https://www.regulations.gov and at
the EPA Region IX Office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described

in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed rule does not have tribal implications and
will not impose substantial direct costs on tribal governments or
preempt tribal law as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen oxides, Ozone, Reporting and recordkeeping
requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: July 10, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2022-15130 Filed 7-14-22; 8:45 am]
BILLING CODE 6560-50-P