[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82115-82117]
[FR Doc No: 2010-32787]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63604; File No. SR-NSCC-2010-18]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing of Proposed Rule Change Relating to the
Insurance and Retirement Processing Services To Incorporate a New
Analytics Reporting Service

December 23, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on December 10, 2010, the
National Securities Clearing Corporation (``NSCC'') 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 primarily by NSCC. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
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I. Self-Regulatory Organization's Statement of Terms of Substance of
the Proposed Rule Change

    NSCC is proposing to expand its Insurance and Retirement Processing
Service (``IPS'') by providing a new Analytics Reporting Service in
order to provide greater transparency to the insurance market.

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

    In its filing with the Commission, NSCC 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. NSCC 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 Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Background
    Currently, service providers that make insurance information
available to the insurance industry generally utilize a combination of
publicly accessible financial information, responses provided by market
participants to optional surveys, and proprietary analytical tools.
These services also rank the various market participants and products
in the insurance market to provide relative rankings by revenue or
other criteria. Reliance on survey results and the aggregation and
analysis of those results often makes the information several months
old by the time it is distributed to subscribers.
2. Proposed Amendments
    NSCC proposes to add a new Section 12 to NSCC Rule 57 to provide an
Analytics Reporting Service.\2\ The Analytics Reporting Service would
use actual transaction information currently used by NSCC in processing
IPS transactions rather than survey results. NSCC believes that this
would allow IPS to provide more efficient, cost-effective, and timely
benchmarking and other market information about the insurance market.
The Analytics Reporting Service would assist NSCC Members and Limited
Members in better understanding their business and the broader market
for insurance products; would help them to better understand investor
needs; would support the efficient development of products that meet
investor needs; and would assist them in making decisions related to
sales, marketing, and product development.
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    \2\ The text of proposed new Section 12 to NSCC Rule 57 can be
viewed at http://www.dtcc.com/downloads/legal/rule_filings/2010/nscc/2010-18.pdf.
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3. Overview
    The Analytics Reporting Service would provide NSCC Members and
Limited Members with the ability to perform market analysis based on
IPS data. This market analysis (commonly referred to as
``benchmarking'') would allow users of this service to obtain and
compare aggregated data from different perspectives including, but not
limited to, geographic location, type of transaction, and other
criteria that NSCC and the NSCC Members and Limited Members determine
to be most useful. The benchmarking portion of the service would
provide information on an aggregate basis and would not reveal the
confidential or proprietary information of any NSCC Member or Limited
Member. The service would permit NSCC Members and Limited Members to
monitor and to analyze their business through benchmarking relative
performance by comparing their own transactional information against
the overall market's and by conducting market research and analyzing
market trends.
    Additionally, NSCC would provide information that attributes
aggregated transaction information to specific NSCC Members and Limited
Members for the purposes of providing a relative ranking of products
and market participants (i.e., league tables). This aspect of the
Analytics Reporting Service would allow NSCC Members and Limited
Members to conduct peer analysis and to understand their performance
relative to other NSCC Members or Limited Members. Although service
providers already provide league tables on the basis of surveys and
other tools, this information may be considered confidential or
proprietary information by NSCC or the individual NSCC Members or
Limited Members to which it pertains.
    NSCC would offer the Analytics Reporting Service through a
proprietary online service.

4. NSCC's Right to Release Clearing Data
    ``Clearing Data'' as defined in NSCC's Rule 49 includes data
received by NSCC for inclusion in the clearance and settlement process
of NSCC or such data, reports, or summaries produced as a result of
NSCC processing such transaction data. Rule 49 generally prohibits the
release of Clearing Data relating to a transaction to parties other
than the NSCC Members or Limited Members that are involved in the
transaction.
    The use of IPS-related Clearing Data as part of the Analytics
Reporting Service for purposes of providing benchmarking data does not
violate this general prohibition of Rule 49. Rule 49 explicitly permits
NSCC to utilize Clearing Data in a form that prevents the disclosure of
proprietary or confidential financial, operational, or trading data of
a particular NSCC Member or Limited Member. Thus, Rule 49 permits the
sharing of cleansed or aggregate reporting of transaction information
or Clearing Data. The Analytics Reporting Service would utilize
Clearing Data for benchmarking purposes in a manner that is consistent
with existing NSCC rules because it would provide only cleansed or
aggregated reporting data that would not reveal the proprietary or
confidential information of any NSCC Member or Limited Member.
    Because the league tables that provide a relative ranking of NSCC
Members and Limited Members and their products may be considered by
some NSCC Members and Limited Members to be the release of confidential
or proprietary information, NSCC is providing notice of its intent to
release this data in accordance with NSCC Rule 49(c). NSCC Rule 49(c)
provides that an NSCC Member or Limited Member may request the release
of any Clearing Data whose release is not otherwise permitted under
Rule 49 either in writing or by written agreement. NSCC intends this
proposed rule change and the addition of the Analytics Reporting
Service to serve as the written agreement providing for the release of
the Clearing Data under Rule 49(c). NSCC believes that this proposed
rule change, the amendment to its rules, and NSCC's Important Notice to
NSCC Members and Limited Members \3\ (a notice issued to NSCC Members
and Limited Members in relation to every rule filing submitted to the
Commission by NSCC) provides NSCC Members and Limited Members with
reasonable and sufficient notice of its intent to distribute cleansed
and aggregated IPS related Clearing Data.
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    \3\ NSCC Important Notices are notices issued to NSCC Members
and Limited Members in relation to, among other things, every rule
filing submitted to the Commission by NSCC.
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5. Right to Opt-Out
    Due to potential concerns that the attribution of aggregated
transactions to specific NSCC Members and Limited Members within league
tables may potentially reveal confidential data, NSCC Members and
Limited Members that utilize IPS (``IPS Members'') would be able to
request that NSCC not attribute and not include their respective
transaction information with respect to league tables in the Analytics
Reporting Service. That is, they may ``opt-out.'' By opting-out, the
IPS Member would prohibit NSCC from associating their transactions in
any discernible manner (e.g., listing the IPS Member in a league
table). However, opting-out would not prohibit NSCC from including the
information for purposes of describing the market in a particular
geographic location or in accordance with other criteria that does not
identify a specific IPS Member for purposes of benchmarking. This opt-
out provision would provide an IPS Member with the ability to prevent
disclosure of potentially confidential or proprietary information
attributable to its activity, just as it may prevent the disclosure of
its individual transactions. Yet, it would not prevent NSCC from
providing the marketplace with useful information regarding the overall
insurance market.
    In order to opt-out of the Analytics Reporting Service prior to the
service becoming available, IPS Members would have to notify NSCC in
writing during the initial ninety (90) day opt-out period. NSCC would
announce the beginning of this ninety (90) day period through an
Important Notice. A new IPS Member would be allowed to opt-out by
providing NSCC with written notice of their election to opt-out at any
time prior to account activation. Once the Analytics Reporting Service
commences to include the information of an IPS Member, the IPS Member
would be allowed to opt-out by providing NSCC with thirty (30) days'
written notice.
    By opting-out, the IPS Member would authorize NSCC to disclose that
the league tables and other information that compares IPS Members and
their insurance products do not include information from that IPS
Member. This would clarify the content of the benchmarking data that
NSCC would provide.
    Finally, an IPS Member that opts-out would forfeit any portion of
NSCC's annual refund, if any, that is directly attributable to the
revenue generated by the Analytics Reporting Service.
6. Prohibiting Disclosures Prior to Earnings Reports
    The Analytics Reporting Service would allow IPS Members to prevent
the disclosure or attribution of transactions to a specific IPS Member
in order to permit compliance with the laws and regulations governing
disclosure of such information prior to earnings reporting. Based on
discussions with IPS Members, NSCC has established a policy that
applies an embargo period of sixty (60) days after the end of the
first, second, and third calendar quarters and ninety (90) days after
the end of the calendar year.
7. Fees
    NSCC intends to propose fees for the Analytics Reporting Service in
a subsequent proposed rule filing. Until then, NSCC Members and Limited
Members would be able to use the Analytics Reporting Service without
any additional charge to the current Financial Activity Reporting fees.
Parties that are not NSCC Members or Limited Members would not be able
to use the Analytics Reporting Service until appropriate fees for non-
members have become effective.
    NSCC states that the proposed change will permit NSCC Members and
Limited Members to enhance their monitoring and analysis of their
respective businesses. NSCC further states that the proposed rule
change is consistent with the requirements set forth under Section 17A
of the Act \4\ that require the rules of a clearing agency be designed
to foster cooperation and coordination with persons engaged in the
clearance and settlement of securities transactions, to remove
impediments to and perfect the mechanism of a national system for the
prompt and accurate clearance and settlement of securities
transactions, and, in general, to protect investors and the public
interest.
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    \4\ 15 U.S.C. 78q-1.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NSCC does not believe that the proposed rule change will have any
impact or impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    NSCC has not solicited and does not intend to solicit comments
regarding this proposed rule change. NSCC has not received any
unsolicited written comments from members or other interested parties.
However, NSCC has worked with NSCC Members and Limited Members in
designing this service.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:
     Electronic comments may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NSCC-2010-18 on the subject line.
     Paper comments should be sent 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 No. SR-NSCC-2010-18. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at NSCC's principal office and NSCC's Web site
(http://www.dtcc.com/legal/rule_filings/nscc/2010.php). 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 No. SR-NSCC-2010-18 and should be
submitted by January 19, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-32787 Filed 12-28-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24261-24263]
[FR Doc No: 2023-08191]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0032]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 15 individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with a clinical diagnosis
of epilepsy or any other condition that is likely to cause a loss of
consciousness or any loss of ability to control a commercial motor
vehicle (CMV) to drive in interstate commerce. If granted, the
exemptions would enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before May 19, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2023-0032 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2023-0032) in the keyword box and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click on the ``Comment'' button. Follow
the online instructions for submitting comments.
     Mail: Dockets Operations; 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 20590-0001 between 9 a.m. and
5 p.m. ET Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    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, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are 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 Dockets
Operations,<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-2023-0032), 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 www.regulations.gov/docket?D=FMCSA-2023-0032. Next, sort the results by ``Posted (Newer-
Older),'' choose the first notice listed, click the ``Comment'' 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. FMCSA will consider all comments and
material received during the comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2023-0032) in the keyword box and click ``Search.'' Next,
sort the results by ``Posted (Newer-Older),'' choose the first notice
listed, and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.
ET Monday through Friday, except Federal holidays. To be sure someone
is there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER>
before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. 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 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-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 statutes also allow the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The 15 individuals listed in this notice have requested an
exemption from the epilepsy and seizure disorders

prohibition in 49 CFR 391.41(b)(8). Accordingly, the Agency will
evaluate the qualifications of each applicant to determine whether
granting the exemption will achieve the required level of safety
mandated by statute.
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  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 \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
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    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The criteria states that if an individual has had a sudden episode
of a non-epileptic seizure or loss of consciousness of unknown cause
that did not require anti-seizure medication, the decision whether that
person's condition is likely to cause the loss of consciousness or loss
of ability to control a CMV should be made on an individual basis by
the ME in consultation with the treating physician. Before
certification is considered, it is suggested that a 6-month waiting
period elapse from the time of the episode. Following the waiting
period, it is suggested that the individual have a complete
neurological examination. If the results of the examination are
negative and anti-seizure medication is not required, then the driver
may be qualified.
    In those individual cases where a driver has had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has recovered fully from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
    Drivers who have a history of epilepsy/seizures, off anti-seizure
medication, and seizure-free for 10 years, may be qualified to operate
a CMV in interstate commerce. Interstate drivers with a history of a
single unprovoked seizure may be qualified to drive a CMV in interstate
commerce if seizure-free and off anti-seizure medication for a 5-year
period or more.
    As a result of MEs misinterpreting advisory criteria as regulation,
numerous drivers have been prohibited from operating a CMV in
interstate commerce based on the fact that they have had one or more
seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified ME based on
the physical qualification standards and medical best practices.
    On January 15, 2013, FMCSA announced in a notice of final
disposition titled, ``Qualification of Drivers; Exemption Applications;
Epilepsy and Seizure Disorders,'' (78 FR 3069), its decision to grant
requests from 22 individuals for exemptions from the regulatory
requirement that interstate 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.'' Since that time, the Agency has published additional
notices granting requests from individuals for exemptions from the
regulatory requirement regarding epilepsy found in Sec.  391.41(b)(8).
    To be considered for an exemption from the epilepsy and seizure
disorders prohibition in Sec.  391.41(b)(8), applicants must meet the
criteria in the 2007 recommendations of the Agency's Medical Expert
Panel (78 FR 3069).

III. Qualifications of Applicants

Jeffrey Baker

    Jeffrey Baker is a 36-year-old class CM1 license holder in
California. They have a history of epilepsy and have been seizure free
since February 2015. They take anti-seizure medication with the dosage
and frequency remaining the same since February 2015. Their physician
states that they are supportive of Jeffrey Baker receiving an
exemption.

Robert Bennett

    Robert Bennett is a 37-year-old class AM commercial driver's
license holder in New York. They have a history of focal epilepsy and
have been seizure free since January 2014. They take anti-seizure
medication with the dosage and frequency remaining the same since
January 2014. Their physician states that they are supportive of Robert
Bennett receiving an exemption.

Karl Bohmuller

    Karl Bohmuller is a 24-year-old class C license holder in North
Carolina. They have a history of generalized idiopathic epilepsy and
have been seizure free since October 2012. They take anti-seizure
medication with the dosage and frequency remaining the same since 2012.
Their physician states that they are supportive of Karl Bohmuller
receiving an exemption.

David Brown

    David Brown is a 69-year-old class E license holder in Florida.
They have a history of seizure disorder and have been seizure free
since 2003. They take anti-seizure medication with the dosage and
frequency remaining the same since 2018. Their physician states that
they are supportive of David Brown receiving an exemption.

John Carroll

    John Carroll is a 35-year-old class 3 license holder in Hawaii.
They have a history of epilepsy and have been seizure free since 2007.
They take anti-seizure medication with the dosage and frequency
remaining the same since January 2007. Their physician states that they
are supportive of John Carroll receiving an exemption.

Jean Daza

    Jean Daza is a 55-year-old class D license holder in New Jersey.
They have a history of focal epilepsy and have been seizure free since
July 2013. They take anti-seizure medication with the dosage and
frequency remaining the same since April 2014. Their physician states
that they are supportive of Jean Daza receiving an exemption.

Jerrid Hielscher

    Jerrid Hielscher is a 41-year-old class A license holder in South
Dakota. They have a history of seizures and have been seizure free
since April 1999. They take anti-seizure medication with the dosage and
frequency remaining the same since April 1999. Their physician states
that they are supportive of Jerrid Hielscher receiving an exemption.

Brandon Kirby

    Brandon Kirby is a 23-year-old class D license holder in
Connecticut. They have a history of seizures and have been seizure free
since 2012. They take anti-seizure medication with the dosage and
frequency remaining the same since 2012. Their physician states that
they are supportive of Brandon Kirby receiving an exemption.

Alexander Kumm

    Alexander Kumm is a 47-year-old class D license holder in Illinois.
They have a history of idiopathic generalized epilepsy and have been
seizure free since 2013. They take anti-seizure medication with the
dosage and

frequency remaining the same since 2013. Their physician states that
they are supportive of Alexander Kumm receiving an exemption.

Armando Leandry

    Armando Leandry is a 41-year-old class D license holder in New
Jersey. They have a history of epilepsy and have been seizure free
since 2014. They take anti-seizure medication with the dosage and
frequency remaining the same since October 2016. Their physician states
that they are supportive of Armando Leandry receiving an exemption.

Nicholas Liebe

    Nicholas Liebe is a 28-year-old class D license holder in
Wisconsin. They have a history of complex partial epileptic seizure and
have been seizure free since 2013. They take anti-seizure medication
with the dosage and frequency remaining the same since 2020. Their
physician states that they are supportive of Nicholas Liebe receiving
an exemption.

Sheldon Martin

    Sheldon Martin is a 40-year-old class A license holder in New York.
They have a history of idiopathic generalized epilepsy and have been
seizure free since July 2008. They take anti-seizure medication with
the dosage and frequency remaining the same since January 2013. Their
physician states that they are supportive of Sheldon Martin receiving
an exemption.

Robert Moseler

    Robert Moseler is a 65-year-old class C chauffeur license holder in
Michigan. They have a history of seizure disorder and have been seizure
free since 1996. They take anti-seizure medication with the dosage and
frequency remaining the same since 1996. Their physician states that
they are supportive of Robert Moseler receiving an exemption.

Tammy Snyder

    Tammy Snyder is a 51-year-old class A license holder in North
Carolina. They have a history of an unprovoked seizure and have been
seizure free since July 2013. They take anti-seizure medication with
the dosage and frequency remaining the same since March 2021. Their
physician states that they are supportive of Tammy Snyder receiving an
exemption.

Michael Urbshot

    Michael Urbshot is a 38-year-old class 23 license holder in Hawaii.
They have a history of partial complex seizures and have been seizure
free since 2012. They take anti-seizure medication with the dosage and
frequency remaining the same since 2009. Their physician states that
they are supportive of Michael Urbshot receiving an exemption.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated under the DATES
section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-08191 Filed 4-18-23; 8:45 am]
BILLING CODE 4910-EX-P


SUPPORTING STATEMENT
                          EXTENSION OF OMB APPROVAL
                  DEFECT/NONCOMPLIANCE REPORT (CG 4917) AND
                       CAMPAIGN UPDATE REPORT (CG-4918)

A.  JUSTIFICATION:

1.  CIRCUMSTANCES WHICH MAKE COLLECTION OF INFORMATION NECESSARY:

The Recreational Boating Product Assurance Branch (BSX 23) in the Office of Boating Safety develops and enforces compliance with U.S. Coast Guard safety standards and regulations under the authority of 46 U.S.C. Chapter 43.

Compliance enforcement includes monitoring defect notification and recall campaigns which boat and engine manufacturers conduct in accordance with 46 U.S.C. 4310 for failures to comply with applicable U.S. Coast Guard safety standards or regulations, and for defects which in the words of the Federal statutes, "create a substantial risk of personal injury to the public." This authority is delegated by the Secretary to the Coast Guard via the Department of Homeland Security Delegation No. 0170.1, Revision No. 01.2. (II)(92)(b). Boat and "designated" associated equipment (inboard engine, outboard motor, sterndrive engine or an inflatable personal flotation device approved under 46 CFR 160.076) manufacturers use the Defect/Noncompliance Report (CG-4917) and Campaign Update Report (CG-4918) forms to provide an initial report and to report their progress in conducting recall campaigns.

Defect/Noncompliance Report (CG-4917):

According to 46 U.S.C. 4310(d) and (e) and 33 CFR 179.13(a)(2) the manufacturer shall provide the Commandant of the Coast Guard with an initial report consisting of certain information about the defect notification and recall campaign being conducted.  Upon receipt of information from a manufacturer indicating the initiation of a recall, the Recreational Boating Product Assurance Branch assigns a recall campaign number, and sends the manufacturer a CG-4917 form for supplying the information.  The CG-4917 form describes:

   (1) the manufacturer's reason for conducting defect notification,
   (2) the units affected by the defect or failure to comply,
   (3) the degree of danger to the public with continued use of the affected product,
   (4) the extent of the problem, and
   (5) what corrective action the manufacturer plans to take.

Alternatively, manufacturers are allowed the option of supplying the required information without using the form; however, a majority of manufacturers choose to use the form..

Campaign Update Report (CG-4918):

According to 33 CFR 179.15(a), a manufacturer who makes an initial report required by 33 CFR 179.13 shall send to the Commandant of the Coast Guard a follow-up report within 60 days after the initial report.  The follow-up report must contain at least the following information:

  "(1) A positive identification of the initial report;
   (2) The number of units in which the defect was discovered as of the date of the follow-up report;
   (3) The number of units in which corrective action has been completed as of the date of the follow-up report;
   (4) The number of first purchasers not notified because of an out of date name or address or both; and
   (5) An updating of the information required by Section 179.13."

Section 179.15 also states "Each manufacturer shall submit any additional follow-up reports requested by the Commandant."  The Recreational Boating Product Assurance Branch furnishes the manufacturer with CG-4918 forms for supplying the information.

Per an agreement with OMB, the first Campaign Update Report form (CG-4918) must be submitted within 60 days after the manufacturer submits the Defect Noncompliance Report.  Additional CG-4918 forms must be submitted within 90-day intervals thereafter, until the recall campaign reaches an acceptable level of completion.

Alternatively, manufacturers are allowed the option of supplying the required information without using the form; however, a majority of manufacturers choose to use the form.

2.  HOW, BY WHOM, HOW FREQUENTLY, AND FOR WHAT PURPOSE IS THE INFORMATION USED AND ACTUAL USE THE COAST GUARD HAS MADE OF THE INFORMATION FROM THE CURRENT COLLECTION?

The Recreational Boating Product Assurance Branch uses the information collected with the CG-4917 and CG-4918 forms to:

	   (1) Assess the severity of defects and failures to comply with applicable safety standards and regulations in boats and designated associated equipment (designated in 33 CFR 179.03);

	   (2) Determine the degree of danger to the public with continued use of the product without correction of the defect or noncompliance;

	   (3) Determine whether a manufacturer's proposed method for correction of the defect or noncompliance is appropriate; and

	   (4) Monitor the progress of manufacturer notifications of owners and corrections of affected units and determine whether the manufacturer is exercising reasonable diligence in performing those responsibilities.

Once the Coast Guard receives the Defect/Noncompliance Report (CG-4917), the information is entered into a database.  The Recreational Boating Product Assurance Branch uses the database for the purposes of monitoring when Campaign Update Reports (CG-4918) are due; to quickly gather significant information about specific recall campaigns; to evaluate a manufacturer's diligence in conducting a campaign; and in evaluating the need for safety standards addressing specific problems.

The Coast Guard Office of Boating Safety has a contractor-run website (http://www.uscgboating.org) where visitors can access a variety of recreational boating safety information.  One of the popular features of the site is access to a database where owners can access information concerning defect notification and recall campaigns.

 3.  CONSIDERATION GIVEN TO THE USE OF IMPROVED INFORMATION TECHNOLOGY

Manufacturers are not required to use the CG-4917 and 4918 forms.  The Federal defect notification regulations in 33 CFR 179.13 and 179.15 specify the information the manufacturer must provide in an initial report  -  the Defect/Noncompliance Report (CG-4917) and in any follow-up reports  -  the Campaign Update Report (CG-4918).   The Recreational Boating Product Assurance Branch believes use of the forms is the easiest way to collect the necessary information.  However, the Coast Guard accepts information provided in other formats such as:

 Narrative form such as in a letter;
 Via electronic mail; or
 Via facsimile.

90% of the active recall campaigns as of December 2021 send the CG-4917 and CG 4918 forms electronically. The forms are provided to the manufacturers in either Adobe Acrobat.

4.  EFFORTS TO IDENTIFY DUPLICATION?

A search of the USCG data collections revealed no duplications of this information collection. There is no similar data collected

5.  IF THE COLLECTION OF INFORMATION INVOLVES SMALL BUSINESSES OR OTHER SMALL ENTITIES, WHAT METHODS USED TO MINIMIZE THE BURDEN?

Small businesses manufacture fewer units annually, therefore minimizing burdens.  At the same time, however, many small businesses or small entities might not have computers or facsimile machines and might not be able to take advantage of reductions in burdens by filing electronically.

6.  CONSEQUENCE TO COAST GUARD BOATING STANDARDS PROGRAM IF CG-4917 AND CG ARE WITHDRAWN OR INFORMATION IS COLLECTED LESS FREQUENTLY.
The information is collected quarterly from manufacturers conducting recalls of their products. A manufacturer conducting a recall campaign submits one CG-4917 form or some other type of initial report such as a letter containing the information required by 46 U.S.C. 4310(d) and 179.13.  The manufacturer is then required to submit the first Campaign Update Report form within 60 days of the initial report, and additional reports every 90 days thereafter, until an acceptable number of owners have been notified and an acceptable number of units have been corrected.  If the Recreational Boating Product Assurance Branch did not collect the information or collected the information less frequently, the Coast Guard would not be able to determine:

   (1) Whether owners of boats, inboard engines, outboard motors or sterndrive units which failed to comply with applicable U.S. Coast Guard safety standards or contained defects which create a substantial risk of personal injury to the public were being notified by the manufacturers of those products about the existence of the recalls and potential danger with continued use of the defective products; and

   (2) Whether manufacturers subject to 46 U.S.C. 4310 and 33 CFR 179 were carrying out their statutory and regulatory responsibilities.

7.  EXPLAIN ANY SPECIAL CIRCUMSTANCES RELATED TO THIS INFORMATION COLLECTION

There are no special circumstances applicable to this information collection

8.  DESCRIBE EFFORTS TO CONSULT WITH PERSONS OUTSIDE THE AGENCY

A 60-day Notice will be published in the Federal Register to obtain public comment on this collection.

 9.  EXPLAIN ANY DECISION TO PROVIDE ANY PAYMENT OR GIFT TO RESPONDENTS, OTHER THAN REMUNERATION OF CONTRACTORS OR GRANTEES.

The Coast Guard does not provide payments or gifts to respondents in exchange for the information collected.

10.  DESCRIBE ANY ASSURANCE OF CONFIDENTIALITY PROVIDED TO RESPONDENTS

There are no assurances of confidentiality for this information collection.

11.  ADDITIONAL JUSTIFICATION FOR ANY QUESTIONS OF A SENSITIVE NATURE:

There are no questions of a sensitive nature involved in this information collection.

12.  PROVIDE ESTIMATES OF THE BURDEN OF THE COLLECTION OF INFORMATION:

Total annual first year burdens for respondents  -  166.5 hours

Total annual follow-on burdens for respondents  -  296 hours for 2 years

Grand Total burdens/average campaign for respondents  -  462.5 hours

A summary of the recall campaigns initiated annually, since 2000 is listed below:

	YEAR	NUMBER OF CAMPAIGNS

	2000	27
	2001	70
	2002	65
	2003	63
	2004	43
	2005	67
	2006	77
	2007	33
	2008	38
	2009	33
	2010	24
	2011	21
	2012	11
	2013	9
	2014	12
	2015	20
	2016	18
	2017	19
	2018	28
	2019	47
	2020	32
		757/21 = 36

An estimated average of four (4) reports is filed annually by each of 36 respondents for a total of 144 responses annually for an average three year campaign timeframe.

 one Defect/Noncompliance Report (CG-4917) and three Campaign Update Reports (CG-4918) (the first year); and
 four Campaign Update Reports/year for an average of two years.

Responses:

The Recreational Boating Product Assurance Branch estimates that it takes approximately one hour to read instructions, gather the required information and complete a CG-4917 form.

The Recreational Boating Product Assurance Branch estimates that it takes approximately one-half hour to read instructions, gather the required information and complete a CG-4918 form.

An average of 36 recall campaigns is conducted by boat, inboard engine, outboard motor and sterndrive unit manufacturers annually.

First Year Estimate:
CG-4917:  36 x 1 hour = 36 hours
CG-4918:  36 x 1 hour x 3* = 108 hours**

Follow-on Two Year Estimate:
CG-4918:  36 x 1 hour x 4 = 144 hours/yr x 2 years = 288 hours

*As stated previously, per an agreement with OMB, the Recreational Boating Product Assurance Branch collects the information in the CG-4917 within 30 days, the information in the first CG-4918 within 60 days after receipt of the DNR, and additional CG-4918s every 90 days thereafter. e.g., a total of four reports the first year and four reports each additional year the campaign remains open.

** According to OMB instructions, if the hour burden on respondents is expected to vary widely because of differences in activity, size or complexity, show the range of estimated hour burden, and explain the reasons for the variance.  Numbers of units involved in recall campaigns vary widely.  A rowboat manufacturer, who was a small business entity, and whose boat failed compliance testing, might conduct a recall campaign for 10 or fewer boats.  A Personal Watercraft (PWC) manufacturer, however, might conduct a recall campaign for as many as 35,000 boats.  While the one hour estimate for completing the CG-4917 might be somewhat high for a manufacturer recalling 10 or fewer boats, the larger manufacturers have sophisticated, computerized databases which they can use to assemble the necessary information making one hour a reasonable estimate of the time required to gather the information, even for tens of thousands of units.

In addition, the larger manufacturers may have designed their hull identification numbering systems to specifically identify affected units.  All boats are required to bear two distinct 12 character Hull Identification Numbers (HINs) (see OMB approval No. 1625-0056).  The first three characters in the HIN are the Manufacturer Identification Code (MIC).  Characters four through eight are a manufacturer serial number consisting of letters of the English alphabet or Arabic numerals or both.  A manufacturer or importer may choose any serial number sequence as long as each boat has a different HIN.  Some manufacturers use the hull serial numbers portion of their boats HINs to indicate vessel-specific information of significance to the manufacturer, such as boat type, model, type of propulsion, etc., which can help identify affected units involved in a recall campaign.   The last four characters indicate month and year of manufacture and model year, enabling a manufacturer to further delineate affected units if he or she so desires.

Records:  In order to provide Campaign Update Reports (CG-4918), the manufacturer would need to keep records of:

   (1) Number of units which might contain the problem;
   (2) Number of first purchasers notified;
   (3) Number of dealers/distributors notified;
   (4) Number of units corrected or repaired;
   (5) Number of units inspected and were not affected; and
   (6) Number of owners who refused the offer for correction.

However, there is no other specific recordkeeping requirement associated with the CG-4917 or CG-4918.

The Recreational Boating Product Assurance Branch estimates one-half hour per report form for recordkeeping.

First Year Estimate:
CG-4917: 36 x .5 hour = 18 hours
CG-4918: 36 x .5 hour x 3 = 54 hours

Follow-on Two Year Estimate:
CG-4918:  36 x .5 hour x 4 = 72 hours/yr x 2 years = 144 hours

First year burden hours:
Responses:  90 hours
Recordkeeping: 72 hours
Total:  162 hours

Follow-on burden hours:
Responses:  72 hours/yr x 2 years = 144
Recordkeeping:  72 hours/yr x 2 years = 144
Total: 288 hours

Grand total burden hours/average campaign: 450 hours

13.  PROVIDE AN ESTIMATE OF THE TOTAL ANNUAL COST BURDEN TO RESPONDENTS OR RECORDKEEPERS RESULTING FROM THE COLLECTION OF INFORMATION.

Total annual first year cost burden to respondents = $3,780.00 (responses) + $3,024.00 (recordkeeping) + $244.80 (postage/4917) + $62.64 (postage/4918) = $7,111.44

Total annual follow-on cost burden to respondents = $6,048.00 (responses) + $6,048.00 (recordkeeping) + $88.52 (postage/4918) = $12,184.52 (two year time)

Preparation Cost for Responses:

The Recreational Boating Product Assurance Branch estimates that it takes approximately one hour to read instructions, gather the required information and complete a CG-4917 form.

The Recreational Boating Product Assurance Branch estimates that it takes approximately one to read instructions, gather the required information and complete a CG-4918 form.

First Year Estimate:
CG-4917: 36 x 1 hour = 36 hours
CG-4918: 36 x .5 hour x 3 = 54 hours

Follow-on Two Year Estimate:
CG-4918:  36 x .5 hour x 4 = 72 hours/yr x 2 years = 144 hours

Estimated $42.00 per hour cost for a secretary*

     *GS-4 outside Government per COMDTINST 7310.1V  dtd. 03 NOV 2021

First Year Estimate:
CG-4917:  36 x 1 hour x $42.00 = $1,512.00
CG-4918:  36 x .5 hour x 3 x $42.00 = $2,268.00

Follow-on Two Year Estimate:
CG-4918:  36 x .5 hour x 4 x $42.00 = $3,024.00/yr x 2 years = $6,048.00

Total annual first year preparation cost burden to respondents = $3,780.00

Total annual follow-on preparation cost burden to respondents = $3,024.00/yr for 2 years = $6,048.00

Grand Total preparation cost burden/average campaign to respondents = $9828.00

Recordkeeping Cost:

The Recreational Boating Product Assurance Branch estimates one-half hour per report form for recordkeeping.

First Year Estimate:
CG-4917:  36 x .5 hour = 18 hours
CG-4918:  36 x .5 hour x 3 = 54 hours

Follow-on Two Year Estimate:
CG-4918:  36 x .5 hour x 4 = 72 hours/yr x 2 years = 144 hours

Estimated $42.00 per hour cost for a secretary*

     *GS-4 outside Government per COMDTINST 7310.1U dtd. 03 NOV 2021

First Year Estimate:
CG-4917:  36 x .5 hour x $42.00   = $756.00
CG-4918:  36 x .5 hour x 3 x $42.00   = $2,268.00

Follow-on Two Year Estimate:
CG-4918:  36 x .5 hour x 4 x $42.00 = $3,024.00/yr x 2 years = $6,048.00

Total annual first year recordkeeping cost burden to respondents = $3,024.00

Total annual follow-on recordkeeping cost burden to respondents = $3,024.00/yr for 2 years = $6,048.00

Grand Total recordkeeping cost burden/average campaign to respondents = $9,072.00

Postage cost (if forms are mailed):

According to 179.13 and 179.15, the initial report (CG-4917) and any follow-up reports (CG-4918) to the Commandant shall be sent by first class mail or certified mail:

If first class mail = $0.58 per response*
If certified mail = $3.75 per response ($3.75 + postage)**

* ** It's not realistic to average the two, so costs computed based on more expensive method.

Three costs make up the $6.80 USPS Certified Mail rates:
1. First-Class Postage $0.58 (this is a letter size envelope, up to 1 oz in weight)
2. Certified Mail Fee $3.75
3. Return Receipt (Green Card) $3.05
Total Cost per Letter $6.80

First Year Estimate (CG Form 4917):
CG-4917:  36 x $6.80 = $244.80
First Year Follow-on:
CG-4918:  36 x 3 x $0.58 = $62.64 (Almost all reports sent first-class mail)

Follow-on Two-Year Estimate:
CG-4918:  36 x 4 x $0.58 = $88.52 (Almost all reports sent first-class mail)

14.  TOTAL ESTIMATED COST TO FEDERAL GOVERNMENT

The estimated annual cost to the Federal Government is $1,246.40.

Estimated printing costs:  $22.00 annually.
Cost of man-hours:  $1,315.60

The estimated average number of respondents annually is 36.  It takes an estimated five (5) minutes to review and enter the information collected on a Defect/Noncompliance form (CG-4917) into the records database and an estimated five (5) minutes to review and enter the information collected on each Campaign Update Report (CG-4918) into the records database:

Estimated average cost per man-hour = $98.00

36 x 22/60 = 13.20 x $98.00= $1,293.60 + $22.00 (for forms) = $1,315.60

15.  EXPLAIN REASONS FOR PROGRAM ADJUSTMENTS:  This is an ADJUSTMENT due to a decrease in burden due to a small downtick in recall campaigns over the past three years (2018-2020), with an increase in the cost of postage and an increase in labor costs.  The Coast Guard's factory inspection program has assisted in keeping boat defects/recalls down through working with manufacturers at the factory to correct possible defects at the source.

16.  OUTLINE PLANS FOR TABULATION, STATISTICAL ANALYSIS AND PUBLICATION:  The collection of this information does not involve statistical evaluation or publication.

17.  DISPLAY OF EXPIRATION DATE. USCG will display the expiration date for OMB approval of this information collection.

18.  EXPLAIN EACH EXCEPTION TO THE CERTIFICATION STATEMENT IDENTIFIED IN ITEM 19OF OMB FORM 83-1.
B.  DESCRIPTION OF COLLECTIONS OF INFORMATION THAT EMPLOY STATISTICAL METHODS:  The collection of this information does not involve statistical methods.


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Page 11775]
[FR Doc No: 2011-4710]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-2924-000]

Denver Energy, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Denver Energy, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 15, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for 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>.

    Dated: February 23, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-4710 Filed 3-2-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Proposed Rules]
[Pages 45749-45750]
[FR Doc No: 2017-20959]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0818; Airspace Docket No. 17-AGL-19]

Proposed Revocation of Class E Airspace; Pulaski, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to remove Class E airspace extending
upward from 700 feet above the surface at Carter Airport, Pulaski, WI.
The FAA is proposing this action due to the cancellation of the
instrument procedures into the airport, resulting in the airport no
longer qualifying for controlled airspace.

DATES: Comments must be received on or before November 16, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0818; Airspace Docket No. 17-AGL-19, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would remove Class E airspace extending upward from 700 feet
above the surface at Carter Airport, Pulaski, WI.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0818/
Airspace Docket No. 17-AGL-19.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 by removing the Class E airspace area
extending upward from 700 feet above the surface within a 6.9-mile
radius of Carter Airport, Pulaski, WI.
    This action is necessary due to the cancellation of the instrument
procedures at Carter Airport. The removal of these procedures would

result in the airport no longer qualifying for controlled airspace.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL WI E5 Pulaski, WI [Removed]

    Issued in Fort Worth, Texas, on September 25, 2017.
Wayne Eckenrode,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-20959 Filed 9-29-17; 8:45 am]
 BILLING CODE 4910-13-P


Methyl Bromide Post Harvest Applicator Associations

Meeting with U.S. EPA

October 3, 2006

Tentative Agenda

Introductions and identification of applicator organizations represented

Questions about the science underlying the Agency’s regulatory decisions

Tolerances

PERFUM Model

Discussion of how the Agency accounted for benefits associated with the use of the product, including economic consequences and lack of alternatives

Risk Mitigation Measures

Buffer zones

Notification requirements

Public access to fumigation management plans/records

Status of reference manual

Posting requirements for treated commodities

Storage of treated commodities

Discussion of alternative risk mitigation measures

Next steps


[Federal Register Volume 79, Number 18 (Tuesday, January 28, 2014)]
[Notices]
[Page 4462]
[FR Doc No: 2014-01494]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR14-13-000.
    Applicants: Acacia Natural Gas, L.L.C.
    Description: Tariff filing per 284.123(e) + (g: Acacia Natural Gas
Corporation Baseline Filing to be effective 1/7/2014 Filing Type: 1280.
    Filed Date: 1/7/14.
    Accession Number: 20140107-5056.
    Comments Due: 5 p.m. ET 1/28/14.
    284.123(g) Protests Due: 5 p.m. ET 3/10/14.

    Docket Numbers: PR14-14-000.
    Applicants: Lobo Pipeline Company L.P.
    Description: Tariff filing per 284.123(e) + (g: compliance with
PR13-65-000 to be effective 1/14/2014 Filing Type: 1280.
    Filed Date: 1/14/14.
    Accession Number: 20140114-5096.
    Comments Due: 5 p.m. ET 2/4/14.
    284.123(g) Protests Due: 5 p.m. ET 3/17/14.

    Docket Numbers: RP14-369-000.
    Applicants: PGPipeline LLC.
    Description: PGPipeline, LLC Name Change in FERC Gas Tariff Filing
to be effective 2/14/2014.
    Filed Date: 1/15/14.
    Accession Number: 20140115-5064.
    Comments Due: 5 p.m. ET 1/27/14.

    Docket Numbers: RP14-370-000.
    Applicants: Bear Creek Storage Company, L.L.C.
    Description: Operational Transactions to be effective 2/14/2014.
    Filed Date: 1/15/14.
    Accession Number: 20140115-5126.
    Comments Due: 5 p.m. ET 1/27/14.

    Docket Numbers: RP14-371-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: High Plains Expansion Non-Conforming Agreement Filing
to be effective 2/15/2014.
    Filed Date: 1/15/14.
    Accession Number: 20140115-5170.
    Comments Due: 5 p.m. ET 1/27/14.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date(s). Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedlings

    Docket Numbers: RP13-941-003.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Rate Case (RP13-941) Test Period Update Filing.
    Filed Date: 1/14/14.
    Accession Number: 20140114-5083.
    Comments Due: 5 p.m. ET 1/27/14.

    Docket Numbers: RP13-1031-003.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance to TB Rate Case 2014-01-15 to be effective
1/1/2014.
    Filed Date: 1/15/14.
    Accession Number: 20140115-5143.
    Comments Due: 5 p.m. ET 1/27/14.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 16, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-01494 Filed 1-27-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 6, 2008 (Volume 73, Number 88)]
[Notices]
[Page 25061]
[DOCID:fr06my08-119]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on May 8, 2008 at 10
a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3) (5), (7), (9)(B), and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for May 8, 2008
will be:
    Formal orders of investigation;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature; and an opinion.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: May 1, 2008.
Nancy M. Morris,
Secretary.
 [FR Doc. E8-10020 Filed 5-5-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Notices]
[Page 29183]
[FR Doc No: 2014-11711]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14588-000]

Alaska Power and Telephone Company; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On February 21, 2014, the Alaska Power and Telephone Company filed
an application for a preliminary permit, pursuant to section 4(f) of
the Federal Power Act (FPA), proposing to study the feasibility of the
Lake 3160 Water Power Project (project) to be located at an unnamed
alpine lake (Lake 3160) near Evelyn Lake on the Lace River in the City
and Borough of Juneau, Alaska. The project would be located within the
Tongass National Forest. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) The
existing 451-acre Lake 3160 with 19,700 acre-feet of storage; (2)
either a siphon intake directional bore or a 20-foot-high concrete dam
with a spillway which would increase Lake 3160's surface area to 471
acres with 28,700 acre-feet of storage; (3) either a directional bore
to the lake bottom or an above-ground 20- to 24-inch-diameter, 8,800-
foot-long penstock; (4) a powerhouse containing either one or two
generating units with a total installed capacity of 4,995 kilowatts
(kW); (5) an open channel tailrace conveying powerhouse discharges to
Evelyn Lake; (6) a 7.6-mile-long, 14.4/24.9 kilovolt (kV) (or higher)
transmission line which would be built either as: (i) An overhead line;
(ii) a buried line in a conduit; (iii) submarine cable; or (iv) a
combination of all three to intertie with the existing line at a nearby
mine on Johnson Creek; and (7) appurtenant facilities. The estimated
annual generation of the project would be 40 gigawatt-hours.
    Applicant Contact: Mr. Glen D. Martin, Project Manager, Alaska
Power & Telephone Company, P.O. Box 3222, Port Townsend, WA 98363
phone:<PHONE_NUMBER>, x 122.
    FERC Contact: Suzanne Novak; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14588-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14588) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: May 14, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-11711 Filed 5-20-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Notices]
[Page 43421]
[FR Doc No: 2015-17947]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD15-11-000]

Electronic Filing Protocols for Commission Forms; Notice of
Meeting of North American Energy Standards Board

    Take notice that the North American Energy Standards Board (NAESB)
has announced that it will hold its first conference call on August 13,
2015, from 2:00 p.m. to 4:00 p.m. Eastern Time, to initiate its process
for developing standards for the submission of Commission forms in XML
format. In the Commission's April 16, 2015, Order in this proceeding,
the Commission announced it was beginning a process to develop a
revised method for natural gas pipelines, public utilities, and oil
pipelines to file forms, and asked NAESB and the electric, natural gas,
and oil industries to establish a collaborative process with Commission
staff to develop standards for filing forms.\1\ On June 10, 2015,
Commission staff held a technical conference to explore a transition to
XML format, as well as NAESB's assistance in that transition process.
---------------------------------------------------------------------------

    \1\ Electronic Filing Protocols for Commission Forms, 151 FERC ]
61,025 (2015).
---------------------------------------------------------------------------

    After the staff technical conference, the Commission received five
comments generally supportive of moving forward with the NAESB process.
NAESB has agreed to sponsor this project and the August 13, 2015
conference call is to establish procedures for moving forward. The
comments also posed certain questions that should be addressed during
the NAESB meetings.
    NAESB has posted details regarding the conference at https://www.naesb.org/pdf4/naesb_weq-wgq_ffs_081315ma.pdf. Further information
regarding participation can be obtained by contacting NAESB by phone
(713-356-0060) or email (naesb@naesb.org).
    Commission notices for future meetings will not be issued. The
Commission will post the time and dates for future meetings on its Web
site at http://www.ferc.gov/docs-filing/forms/eforms-refresh.asp,
Information also may be found on the NAESB Web site at https://www.naesb.org/ferc_forms.asp (NAESB Members) or https://www.naesb.org/committee_activities.asp (non-Members).
    For more information about this conference call or the proceeding,
please contact Robert Hudson, Office of Enforcement, at<PHONE_NUMBER>
or<EMAIL_ADDRESS>or Nicholas Gladd, Office of General Counsel,
at<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: July 16, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-17947 Filed 7-21-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4139-4141]
[FR Doc No: 2018-01638]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-6285]

Medical Devices; Cardiovascular Devices; Classification of the
Temporary Catheter for Embolic Protection During Transcatheter
Intracardiac Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the temporary catheter for embolic protection during transcatheter
intracardiac procedures into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the temporary catheter for
embolic protection during transcatheter intracardiac procedures'
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective January 30, 2018. The classification was
applicable on June 1, 2017.

FOR FURTHER INFORMATION CONTACT: Sadaf Toor, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1202, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the temporary catheter for embolic
protection during transcatheter intracardiac procedures as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation, in part
by reducing regulatory burdens by placing the device into a lower
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On September 20, 2016, Claret Medical, Inc., submitted a request
for De Novo classification of the Sentinel[supreg] Cerebral Protection
System. FDA reviewed the request in order to classify the device under
the criteria for classification set forth in section 513(a)(1) of the
FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 1, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 870.1251. We have named
the generic type of device temporary catheter for embolic protection
during transcatheter intracardiac procedures, and it is identified as a
single use percutaneous catheter system that has (a) blood filter(s) at
the distal end. This device is indicated for use while performing
transcatheter intracardiac procedures. The device is used to filter
blood in a manner that may prevent embolic material (thrombus/debris)
from the transcatheter intracardiac procedure from traveling towards
the cerebral circulation.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Temporary Catheter for Embolic Protection During Transcatheter
          Intracardiac Procedures Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Device failure leading to debris         Non-clinical performance
 embolization and stroke or death.        testing, Animal testing, and
                                          Clinical performance testing.
Impeded or disrupted blood flow leading  Non-clinical performance
 to peripheral ischemia.                  testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
Device incompatibility with              Non-clinical performance
 transcatheter intracardiac procedure     testing, Animal testing,
 device leading to prolonged treatment    Clinical performance testing,
 time or device failure.                  and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Vascular injury due to device delivery,  Non-clinical performance
 deployment, placement, or retrieval.     testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other 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 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in part 814, subparts
A through E, regarding premarket approval, have been approved under OMB
control number 0910-0231; the collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.1251 to subpart B to read as follows:

Sec.  870.1251  Temporary catheter for embolic protection during
transcatheter intracardiac procedures.

    (a) Identification. This device is a single use percutaneous
catheter system that has (a) blood filter(s) at the distal end. This
device is indicated for use while performing transcatheter intracardiac
procedures. The device is used to filter blood in a manner that may
prevent embolic material (thrombus/debris) from the transcatheter
intracardiac procedure from traveling towards the cerebral circulation.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic
model to assess the following:
    (A) Delivery, deployment, and retrieval, including quantifying
deployment and retrieval forces, and procedural time; and
    (B) Device compatibility and lack of interference with the
transcatheter intracardiac procedure and device.
    (ii) Tensile strengths of joints and components, tip flexibility,
torque strength, torque response, and kink resistance.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Characterization and verification of all dimensions.
    (2) Animal testing must demonstrate that the device performs as
intended under anticipated conditions of use. The following performance
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval, including quantifying
procedural time.
    (ii) Device compatibility and lack of interference with the
transcatheter intracardiac procedure and device.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Gross pathology and histopathology assessing vascular injury
and downstream embolization.
    (3) All patient contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device
components intended to be provided sterile.
    (5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (6) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Compatible transcatheter intracardiac procedure devices;
    (iii) A detailed summary of the clinical testing conducted; and
    (iv) A shelf life and storage conditions.
    (7) Clinical performance testing must demonstrate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to filter embolic material while not
impeding blood flow;
    (iii) Secure positioning and stability of the position throughout
the transcatheter intracardiac procedure; and
    (iv) Evaluation of all adverse events including death, stroke, and
vascular injury.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01638 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P