[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56900-56902]
[FR Doc No: 2018-24858]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2018-0054]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 11 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 operate CMVs in interstate commerce.

DATES: The exemptions were applicable on October 17, 2018. The
exemptions expire on October 17, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], 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. 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-2018-0054, 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.

B. 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

    On September 10, 2018, FMCSA published a notice announcing receipt
of applications from 11 individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (83 FR 45724). The public comment
period ended on October 10, 2018, and two comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to or greater than the level that would be
achieved by complying with the current regulation 49 CFR 391.41(b)(8).
    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 \1\ 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.]
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received two comments in this proceeding. These comments
supported granting these exemptions.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
for up to five years from the epilepsy and seizure disorder prohibition
in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an
equivalent or greater level of safety than would be achieved without
the exemption. The exemption allows the applicants to operate CMVs in
interstate commerce. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    In reaching the decision to grant these exemption requests, FMCSA
considered the 2007 recommendations of the Agency's Medical Expert
Panel (MEP). The January 15, 2013, Federal Register notice (78 FR 3069)
provides the current MEP recommendations which is the criteria the
Agency uses to grant seizure exemptions.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. In addition, the Agency
reviewed the treating clinician's medical opinion related to the
ability of the driver to safely operate a CMV with a history of seizure
and each applicant's driving record found in the Commercial Driver's
License Information System (CDLIS) for commercial driver's license
(CDL) holders, and interstate and intrastate inspections recorded in
the Motor Carrier Management Information System (MCMIS). For non-CDL
holders, the Agency reviewed the driving records from the State
Driver's Licensing Agency (SDLA). A summary of each applicant's seizure
history was discussed in the September 10, 2018, Federal Register
notice (83 FR 45724) change) and will not be repeated in this notice.
    These 11 applicants have been seizure-free over a range of 31 years
while taking anti-seizure medication and maintained a stable medication
treatment regimen for the last two years. In each case, the applicant's
treating physician verified his or her seizure history and supports the
ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in 49 CFR
391.41(b)(8) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (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.

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 upon its evaluation of the 11 exemption applications, FMCSA
exempts the following drivers from the epilepsy and seizure disorder
prohibition, 49 CFR 391.41(b)(8), subject to the requirements cited
above:

    Jonthon A. Arrieta (FL)
    Jose F.J. Cabrera Maciel (CA)
    Pietro Capobianco (NJ)
    Armando B. Castro Jr. (NV)
    Joshua Cirilo (MN)
    Barbara A. Cruz (IN)
    Gail A. Hackathorn (IA)
    Jose G. Lara-Ramirez (NV)
    Bryan F. Sheehan (FL)
    Christopher A. Steinke (WI)
    Francis L. Stimpson (ID)

    In accordance with 49 U.S.C. 31315(b)(1), each exemption will be
valid for two years from the effective date unless revoked earlier by
FMCSA. The exemption will be revoked if the following occurs: (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 prior to being granted; or (3) continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136 and 31315.

    Issued on: November 5, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-24858 Filed 11-13-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Pages 23068-23071]
[FR Doc No: 2016-08934]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32070; 812-14450]

Newtek Business Services Corp.; Notice of Application

April 13, 2016.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 23(a), 23(b) and 63 of the Act; under sections 57(a)(4) and
57(i) of the Act and rule 17d-1 under the Act permitting certain joint
transactions otherwise prohibited by section 57(a)(4) of the Act; and
under section 23(c)(3) of the Act for an exemption from section 23(c)
of the Act.

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Summary of the Application: Newtek Business Services Corp.
(``Applicant'' or ``Company'') requests an order that would permit
Applicant to (a) issue restricted shares of its common stock
(``Restricted Stock'') as part of the compensation package for certain
participants in its 2015 Stock Incentive Plan (the ``Plan''), (b)
withhold shares of the Applicant's common stock or purchase shares of
Applicant's common stock from participants to satisfy tax withholding
obligations relating to the vesting of Restricted Stock or the exercise
of options to purchase shares of Applicant's common stock
(``Options''), and (c) permit participants to pay the exercise price of
Options with shares of Applicant's common stock.

Filing Dates: The application was filed on April 28, 2015, and amended
on October 28, 2015 and February 9, 2016.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicant with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on May 9, 2016, and should be accompanied by proof of service
on applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicant, 212 West 35th Street,
2nd Floor, New York, New York 10001.

FOR FURTHER INFORMATION CONTACT: Jill Ehrlich, Senior Counsel, at (202)
551-6819, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER> (Chief
Counsel's Office, Division of Investment Management).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicant's Representations: 1. Applicant is an internally managed
closed-end investment company that has elected to be regulated as a
business development company (``BDC'') under the Act.\1\ Applicant
represents that it is

a leading capital provider to small- and medium-sized businesses
(``SMBs''). Applicant originates loans through a variety of sourcing
channels and, through a rigorous underwriting process, seeks to achieve
attractive risk-weighted returns. In addition, Applicant and its
controlled portfolio companies provide comprehensive lending, payment
processing, managed technology, personal and commercial insurance and
payroll solutions to over 100,000 SMB accounts, across all industries.
Shares of Applicant's common stock are traded on the Nasdaq Global
Market under the symbol ``NEWT.'' As of December 31, 2015, there were
14,503,927 shares of Applicant's common stock outstanding. As of that
date, Applicant had 146 employees.
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    \1\ Applicant was incorporated under the laws of the state of
New York in June 1999 as Whitestone Holdings, Inc., completed an
initial public offering in September 2000, and changed its name to
Newtek Business Services, Inc. in November 2002. In November 2014,
Newtek Business Services, Inc. merged with and into Newtek Business
Services Corp. (the ``Reincorporation Transaction'') for the purpose
of reincorporating in the state of Maryland. Upon completion of the
Reincorporation Transaction, Applicant elected to be regulated as a
BDC. Section 2(a)(48) of the Act defines a BDC to be any closed-end
investment company that operates for the purpose of making
investments in securities described in sections 55(a)(1) through
55(a)(3) of the Act and makes available significant managerial
assistance with respect to the issuers of such securities.
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    2. Applicant currently has a five-member board of directors (the
``Board'') of whom three are not ``interested persons'' of Applicant
within the meaning of section 2(a)(19) of the Act, and two are
considered ``interested persons'' of Applicant.
    3. Applicant believes that, because the market for superior
investment professionals is highly competitive, Applicant's successful
performance depends on its ability to offer fair compensation packages
to its professionals that are competitive with those offered by other
investment management businesses. Applicant states that the ability to
offer equity-based compensation to its employees and non-employee
directors (``Non-Employee Directors''), which both aligns employee and
Board behavior with stockholder interests and provides a retention
tool, is vital to Applicant's future growth and success.
    4. Effective October 22, 2014, Applicant adopted the Newtek
Business Services Corp. 2014 Stock Incentive Plan (the ``2014 Plan''),
which provides for the grant of Options. As of February 8, 2016, there
were no Options outstanding. Applicant proposes to amend and restate
the 2014 Plan by adopting the Plan, which will supersede the 2014 Plan,
subject to the issuance of the requested order and stockholder
approval. The Plan authorizes the issuance of Options and Restricted
Stock to the Company's directors, including Non-Employee Directors,
officers and other employees (``Participants'').\2\
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    \2\ Options will not be granted to Non-Employee Directors.
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    5. The Plan will authorize the issuance of Options and Restricted
Stock subject to certain forfeiture restrictions. The restrictions may
relate to continued employment or service on the Board, the performance
of the Applicant pursuant to performance goals as set forth in the
Plan, or other restrictions deemed by the Required Majority,\3\ the
Compensation, Corporate Governance, and Nominating Committee \4\ or the
Board from time to time to be appropriate and in the best interests of
Applicant and its stockholders. Unless otherwise determined by the
Board, a Participant granted Restricted Stock will have all of the
rights of a stockholder including, without limitation, the right to
vote Restricted Stock and the right to receive dividends, including
deemed dividends, thereon, although such rights may be deferred during
the restricted period applicable to these awards. Restricted Stock may
not be transferred, pledged, hypothecated, margined, or otherwise
encumbered by the Participant during the restricted period, except for
disposition by will or intestacy. Except as otherwise determined by the
Board under the Plan, upon termination of a Participant's employment or
director relationship with the Company during the applicable
restriction period, the Participant's Restricted Stock and any accrued
and unpaid dividends that are then subject to restrictions shall
generally be forfeited.\5\
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    \3\ Section 57(o) of the Act provides that the term ``required
majority,'' when used with respect to the approval of a proposed
transaction, plan, or arrangement, means both a majority of a BDC's
directors or general partners who have no financial interest in such
transaction, plan, or arrangement and a majority of such directors
or general partners who are not interested persons of such company.
    \4\ The ``Compensation, Corporate Governance, and Nominating
Committee'' is composed of ``non-employee directors'' within the
meaning of rule 16b-3, and ``outside directors'' within the meaning
of section 162(m) of the Internal Revenue Code of 1986, as amended.
    \5\ If any shares subject to an award granted under the Plan are
forfeited, cancelled, exchanged or surrendered or if an award
terminates or expires without an issuance of shares, those shares
will again be available for awards under the Plan.
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    6. A maximum of twenty percent (20%) of Applicant's total shares of
common stock issued and outstanding (as of the Effective Date) \6\ will
be available for awards under the Plan. Under the Plan, no more than
fifty percent (50%) of the shares of stock reserved for the grant of
awards under the Plan may be Restricted Stock awards at any time during
the term of the Plan. The maximum amount of Restricted Stock that may
be outstanding at any particular time will be ten percent of the
Applicant's voting securities.\7\ Under the Plan, the aggregate number
of shares of common stock deliverable pursuant to awards will not
exceed 3,000,000.\8\
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    \6\ Effective Date is defined in section 2(p) of the Plan as the
date on which the Plan is approved by Applicant's stockholders.
    \7\ For purposes of calculating compliance with this limit, the
Company will count as Restricted Stock all shares of its common
stock that are issued under the Plan less any shares that are
forfeited back to the Company and cancelled as a result of
forfeiture restrictions not lapsing.
    \8\ If the Company does not receive the order to issue
Restricted Stock, all shares granted under the Plan may be subject
to Options. All Option awards will be issued to employees in
accordance with the statutory provisions set forth in section 61 and
will not be granted to Non-Employee Directors.
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    7. The Plan will be administered by the Compensation, Corporate
Governance, and Nominating Committee with respect to Participants
employed by Applicant and by the Board with respect to Non-Employee
Directors, and the Board will have the responsibility to ensure that
the Plan is operated in a manner that best serves the interests of
Applicant and its stockholders. Restricted Stock will be awarded to
certain employees, officers and directors, including Non-Employee
Directors, from time to time as part of the employees', officers' or
directors' compensation based on their actual or expected performance
and value to the Company. All awards of Restricted Stock to employees
and Non-Employee Directors will be approved by the Required Majority.
Awards of Restricted Stock to Non-Employee Directors will be made on
the schedule described below.
    8. Under the Plan, Non-Employee Directors will each receive a grant
of up to 2,000 shares of Restricted Stock at the beginning of each one-
year term of service on the Board, for which forfeiture restrictions
will lapse as to one-third of such shares each year for three years.
Each grant of Restricted Stock to Non-Employee Directors will be made
pursuant to this schedule and will not be changed without Commission
approval.
    9. The Plan provides that the Company is authorized to withhold
stock (in whole or in part) from any award of Restricted Stock granted
in satisfaction of a Participant's tax obligations. In addition, as
discussed more fully in the application, the exercise of Options will
result in the recipient being deemed to have received compensation in
the amount by which the fair market value of the shares of the
Company's common stock, determined as of the date of exercise, exceeds
the

exercise price. Accordingly, Applicant requests relief to withhold
shares of its common stock or purchase shares of its common stock from
Participants to satisfy tax withholding obligations related to the
exercise of Options granted under the 2014 Plan or the vesting of
Restricted Stock or exercise of Options that will be granted pursuant
to the Plan. Applicant also requests an exemption to permit
Participants to pay the exercise price of Options that were granted
under the 2014 Plan or will be granted to them pursuant to the Plan
with shares of the Company's common stock.
    10. The Plan was approved on April 27, 2015 by the Compensation,
Corporate Governance and Nominating Committee and the Board, including
the Required Majority. The Plan will be submitted for approval to the
Company's stockholders, and will become effective upon such approval,
subject to and following receipt of the requested order.

Applicant's Legal Analysis

Sections 23(a) and (b), Section 63

    1. Under section 63 of the Act, the provisions of section 23(a) of
the Act generally prohibiting a registered closed-end investment
company from issuing securities for services or for property other than
cash or securities are made applicable to BDCs. This provision would
prohibit the issuance of Restricted Stock as a part of the Plan.
    2. Section 23(b) of the Act generally prohibits a registered
closed-end investment company from selling any common stock of which it
is the issuer at a price below its current net asset value. Section
63(2) of the Act makes section 23(b) applicable to BDCs unless certain
conditions are met. Because Restricted Stock that would be granted
under the Plan would not meet the terms of section 63(2), sections
23(b) and 63 would prevent the issuance of Restricted Stock.
    3. Section 6(c) provides, in part, that the Commission may, by
order upon application, conditionally or unconditionally exempt any
person, security, or transaction, or any class or classes thereof, from
any provision of the Act, if and to the extent that the exemption is
necessary or appropriate in the public interest and consistent with the
protection of investors and the purposes fairly intended by the policy
and provisions of the Act.
    4. Applicant requests an order pursuant to section 6(c) of the Act
granting an exemption from the provisions of sections 23(a), 23(b) and
63 of the Act. Applicant states that the Plan would not violate the
concerns underlying these sections, which include: (a) Preferential
treatment of investment company insiders and the use of options and
other rights by insiders to obtain control of the investment company;
(b) complication of the investment company's structure that made it
difficult to determine the value of the company's shares; and (c)
dilution of shareholders' equity in the investment company. Applicant
asserts that the Plan does not raise concerns about preferential
treatment of Applicant's insiders because the Plan is a bona fide
compensation plan of the type that is common among corporations
generally. In addition, section 61(a)(3)(B) of the Act permits a BDC to
issue to its directors, officers, employees, and general partners
warrants, options, and rights to purchase the BDC's voting securities
pursuant to an executive compensation plan, subject to certain
conditions. Applicant states that, for reasons that are unclear,
section 61 and its legislative history do not address the issuance by a
BDC of restricted stock as incentive compensation. Applicant believes,
however, that the issuance of Restricted Stock is substantially
similar, for purposes of investor protection under the Act, to the
issuance of warrants, options, and rights as contemplated by section
61. Applicant also asserts that the issuance of Restricted Stock would
not become a means for insiders to obtain control of Applicant because
the maximum amount of Restricted Stock that may be issued under the
Plan at any one time will be ten percent of the outstanding shares of
common stock of Applicant. Moreover, no single Participant will be
granted more than 25% of the shares of stock reserved for issuance
under the Plan.
    5. Applicant further states that the Plan will not unduly
complicate Applicant's capital structure because equity-based incentive
compensation arrangements are widely used among corporations and
commonly known to investors. Applicant notes that the Plan will be
submitted for approval to the Company's stockholders. Applicant
represents that the proxy materials submitted to Applicant's
stockholders will contain a concise ``plain English'' description of
the Plan and its potential dilutive effect. Applicant also states that
it will comply with the proxy disclosure requirements in Item 10 of
Schedule 14A under the Securities Exchange Act of 1934. Applicant
further notes that the Plan will be disclosed to investors in
accordance with the requirements of the Form N-2 registration statement
for closed-end investment companies and pursuant to the standards and
guidelines adopted by the Financial Accounting Standards Board for
operating companies. Applicant also will comply with the disclosure
requirements for executive compensation plans applicable to BDCs.\9\
Applicant thus concludes that the Plan will be adequately disclosed to
investors and appropriately reflected in the market value of
Applicant's shares.
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    \9\ See Executive Compensation and Related Party Disclosure,
Securities Act Release No. 8655 (Jan. 27, 2006) (proposed rule);
Executive Compensation and Related Party Disclosure, Securities Act
Release No. 8732A (Aug. 29, 2006) (final rule and proposed rule), as
amended by Executive Compensation Disclosure, Securities Act Release
No. 8756 (Dec. 22, 2006) (adopted as interim final rules with
request for comments).
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    6. Applicant acknowledges that awards granted under the Plan may
have a dilutive effect on the stockholders' equity per share in
Applicant, but believes that effect would be outweighed by the
anticipated benefits of the Plan to Applicant and its stockholders.
Moreover, based on the manner in which the issuance of Restricted Stock
pursuant to the Plan will be administered, the Restricted Stock will be
no more dilutive than if Applicant were to issue only Options to
Participants who are employees, as is permitted by section 61(a)(3) of
the Act. Applicant asserts that it needs the flexibility to provide the
requested equity-based compensation in order to be able to compete
effectively with other venture capital firms for talented
professionals. These professionals, Applicant suggests, in turn are
likely to increase Applicant's performance and stockholder value.
Applicant also asserts that equity-based compensation would more
closely align the interests of Applicant's employees and Non-Employee
Directors with those of its stockholders. In addition, Applicant states
that its stockholders will be further protected by the conditions to
the requested order that assure continuing oversight of the operation
of the Plan by the Board.

Section 57(a)(4), Rule 17d-1

    7. Section 57(a) proscribes certain transactions between a BDC and
persons related to the BDC in the manner described in section 57(b)
(``57(b) persons''), absent a Commission order. Section 57(a)(4)
generally prohibits a 57(b) person from effecting a transaction in
which the BDC is a joint participant absent such an order. Rule 17d-1,
made applicable to BDCs by section 57(i), proscribes participation in a
``joint enterprise or other joint arrangement or

profit-sharing plan,'' which includes a stock option or purchase plan.
Employees and directors of a BDC are 57(b) persons. Thus, the issuance
of shares of Restricted Stock could be deemed to involve a joint
transaction involving a BDC and a 57(b) person in contravention of
section 57(a)(4). Rule 17d-1(b) provides that, in considering relief
pursuant to the rule, the Commission will consider (a) whether the
participation of the BDC in a joint enterprise is consistent with the
policies and purposes of the Act and (b) the extent to which such
participation is on a basis different from or less advantageous than
that of other participants.
    8. Applicant requests an order pursuant to sections 57(a)(4) and
57(i) of the Act and rule 17d-1 under the Act to permit Applicant to
issue Restricted Stock under the Plan. Applicant acknowledges that its
role is necessarily different from the other participants because the
other participants are its directors and employees. It notes, however,
that the Plan is in the interest of the Company's stockholders, because
the Plan will help align the interests of Applicant's employees with
those of its stockholders, which will encourage conduct on the part of
those employees designed to produce a better return for Applicant's
stockholders. Additionally, section 57(j)(1) of the Act expressly
permits any director, officer or employee of a BDC to acquire warrants,
options and rights to purchase voting securities of such BDC, and the
securities issued upon the exercise or conversion thereof, pursuant to
an executive compensation plan which meets the requirements of section
61(a)(3)(B) of the Act. Applicant submits that the issuance of
Restricted Stock pursuant to the Plan poses no greater risk to
stockholders than the issuances permitted by section 57(j)(1) of the
Act.

Section 23(c)

    9. Section 23(c) of the Act, which is made applicable to BDCs by
section 63 of the Act, generally prohibits a BDC from purchasing any
securities of which it is the issuer except in the open market pursuant
to tenders, or under other circumstances as the Commission may permit
to ensure that the purchases are made in a manner or on a basis that
does not unfairly discriminate against any holders of the class or
classes of securities to be purchased. Applicant states that the
withholding or purchase of shares of Restricted Stock and common stock
in payment of applicable withholding tax obligations or of common stock
in payment for the exercise price of a stock option might be deemed to
be purchases by the Company of its own securities within the meaning of
section 23(c) and therefore prohibited by the Act.
    10. Section 23(c)(3) of the Act permits a BDC to purchase
securities of which it is the issuer in circumstances in which the
repurchase is made in a manner or on a basis that does not unfairly
discriminate against any holders of the class or classes of securities
to be purchased. Applicant believes that the requested relief meets the
standards of section 23(c)(3).
    11. Applicant submits that these purchases will be made in a manner
that does not unfairly discriminate against Applicant's stockholders
because all purchases of Applicant's stock will be at the closing price
of the common stock on the Nasdaq Global Market (or any primary
exchange on which its shares of common stock may be traded in the
future) on the relevant date (i.e., the public market price on the date
of grant of Restricted Stock and the date of grant of Options).
Applicant submits that because all transactions with respect to the
Plan will take place at the public market price for the Company's
common stock, these transactions will not be significantly different
than could be achieved by any stockholder selling in a market
transaction. Applicant represents that no transactions will be
conducted pursuant to the requested order on days where there are no
reported market transactions involving Applicant's shares.
    12. Applicant represents that the withholding provisions in the
Plan do not raise concerns about preferential treatment of Applicant's
insiders because the Plan is a bona fide compensation plan of the type
that is common among corporations generally. Furthermore, the vesting
schedule is determined at the time of the initial grant of the
Restricted Stock and the option exercise price is determined at the
time of the initial grant of the Options. Applicant represents that all
purchases may be made only as permitted by the Plan, which will be
approved by the Company's stockholders prior to any application of the
relief. Applicant believes that granting the requested relief would be
consistent with the policies underlying the provisions of the Act
permitting the use of equity compensation as well as prior exemptive
relief granted by the Commission under section 23(c) of the Act.

Applicant's Conditions

    Applicant agrees that the order granting the requested relief will
be subject to the following conditions:
    1. The Plan will be authorized by Applicant's stockholders.
    2. Each issuance of Restricted Stock to an officer, employee, or
Non-Employee Director will be approved by the Required Majority of
Applicant's directors on the basis that such grant is in the best
interest of Applicant and its stockholders.
    3. The amount of voting securities that would result from the
exercise of all of Applicant's outstanding warrants, options and
rights, together with any Restricted Stock issued and outstanding
pursuant to the Plan, will not at the time of issuance of any warrant,
option, right or share of Restricted Stock under the Plan, exceed 20
percent of Applicant's outstanding voting securities.
    4. The amount of Restricted Stock issued and outstanding will not
at the time of issuance of any shares of Restricted Stock exceed ten
percent of Applicant's outstanding voting securities.
    5. The Board will review the Plan at least annually. In addition,
the Board will review periodically the potential impact that the
issuance of Restricted Stock under the Plan could have on Applicant's
earnings and net asset value per share, such review to take place prior
to any decisions to grant Restricted Stock under the Plan, but in no
event less frequently than annually. Adequate procedures and records
will be maintained to permit such review. The Board will be authorized
to take appropriate steps to ensure that the issuance of Restricted
Stock under the Plan will be in the best interest of Applicant and its
stockholders. This authority will include the authority to prevent or
limit the granting of additional Restricted Stock under the Plan. All
records maintained pursuant to this condition will be subject to
examination by the Commission and its staff.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2016-08934 Filed 4-18-16; 8:45 am]
BILLING CODE 8011-01-P


Date:		2 July 2019
To: 		Jonathan Witt, U.S Environmental Protection Agency
From:		Meaghan McGrath, RTI International
		Karen Schaffner
Contact:	Greg Crist
		AdvaMed
		https://www.advamed.org/

 Participants

AdvaMed

Greg Crist, Chief Advocacy Officer and Head of External Affairs, AdvaMed
Janet Trunzo, Senior Executive Vice President, Technology and Regulatory Affairs, AdvaMed
Ellen Kondracki, Vice President, Sustainability & EHS, BD
Dan Carestio, Chief Operating Officer, STERIS
Whitney Tull, Senior Director, Government Affair, STERIS
Dianne Gibbs, Regulatory Affairs Manager, 3M Medical Solutions Division

Anguil Environmental Systems

Chris Anguil, President

U.S. Environmental Protection Agency

Jonathan Witt, Fuels and Incineration Group
Ned Shappley
Margaret Sieffert, Region 5
Tess Petesch

RTI International

Meaghan McGrath
Karen Schaffner

 Discussion
On July 2, 2019, representatives of the U.S. Environmental Protection Agency (EPA) and their contractor (RTI International) participated in a meeting with representatives of AdvaMed.  Mr. Greg Crist began the discussion by providing a brief background on AdvaMed and its association with the ethylene oxide (EtO) sterilization industry. AdvaMed is a trade association that focuses on advancing medical technology.  AdvaMed is comprised of 400 member companies, many of which are medical companies (for example, Medtronic, Bayer, STERIS, BD, etc.).  Approximately two-thirds of medical products are sterilized using EtO.
Discussions Led by BD
Ms. Ellen Kondracki provided background information on Becton Dickinson (BD), as well as BD's history within the EtO sterilization industry. Ms. Kondracki has worked in the chemical industry for 15 years, focusing mainly on regulatory compliance and has chaired AdvaMed's sterilization workgroup for the past few months. The sterilization workgroup is made up of approximately 70 members that are subject matter experts (SMEs) or manufacturers that use EtO in sterilization operations. The sterilization workgroup has been closely following the news on certain sterilization facilities that are receiving intense public scrutiny. Ms. Kondracki noted that the workgroup has focused discussions lately on the viability of alternatives to EtO sterilization, as well as focusing on the environmental health and safety effects and controls used within the industry to promote safety in the workplace and to reduce air emissions.  With respect to alternatives to EtO, one of the biggest barriers to finding a viable alternative to EtO is scalability of alternatives.
BD has approximately 80 manufacturing facilities worldwide. Of these 80 plants, there are many that conduct in-house sterilization.  BD has four sterilization facilities in the U.S. that use EtO, as well as others using gamma radiation or other forms of sterilization. Some of the BD EtO facilities are larger-scale sterilizers and some are smaller-scale sterilizers and use of sterilizers with separate aeration units is typical for their facilities.  With respect to air pollution control devices (APCD), BD EtO facilities exclusively use thermal or catalytic oxidizers; two sites use catalytic oxidizers, and two sites use thermal oxidizers. Their facilities do not operate wet scrubbers. Across these facilities, the emission sources that are controlled varies. For larger sterilizers, the chamber exhaust vents (CEV) are controlled with catalytic oxidizers, and at smaller sterilizer facilities, work practices such as increased gas washes are conducted. BD is currently working with one or two vendors to improve operation of their catalytic oxidizers.
Sterilization Cycles that Use Less EtO
BD is focused on designing sterilization cycles to use less EtO.  They have optimized and changed their sterilization cycles to use less EtO and can achieve at least a 33 percent reduction in EtO usage on average at their facilities through this reduction strategy.  BD is also working on a process with automated movement of the product from the sterilizer chamber to the aeration unit.
The steps to revise sterilization cycles requires re-validation with the U.S. Food and Drug Administration (FDA).  The sterilization cycle depends on the classification of the medical device (for example, Class I, II, or III devices, lowest risk to highest risk devices).  Based on the class of device, some sterilization cycles are easier to revise than others. It takes a good bit of work from a quality standpoint to redo validations. To comply with FDA requirements, manufacturers must have a quality management system in place that dictates how a change occurs to a sterilization cycle. For EtO sterilization cycle revisions, the FDA would review the data to make sure validation requirements are met. For small manufacturers, it is difficult to know how cost-prohibitive revising the sterilization cycle might be. EtO sterilizations tends to sterilize higher classes of devices, for example, complex or delicate medical equipment.
BD built their sterilization facilities in the U.S. in approximately 2000.  Most of the air pollution controls were designed to control the CEV, i.e., there has been no retrofitting for controls of CEVs.  Process engineers at BD have been involved with the sterilization industry from the 1980's and 1990's and were aware of the need to accurately vent to air pollution controls, as is especially important for EtO facilities.  BD shared some estimates for the cost of tying in the CEV.  The cost of ductwork, dampers, etc. for routing the CEV to a control device depends on the situation, but cost is generally in the range of $0.5 million to $1.25 million for tying the emission source into existing air pollution controls. Control of the CEV would also require use of a snubber in line prior to the oxidizer APCD to moderate concentration.
For the four U.S. BD facilities, the EtO concentration is monitored in the sterilizer chamber during gas washes. Specifically, continuous in-chamber EtO concentration monitoring is conducted at the two larger U.S. sterilizers.  BD was not certain of the measurement technique used.
Prior to initiating the CEV on the sterilizer chamber, a certain percent (%) of the lower explosive limit (LEL) or EtO concentration in the sterilizer chamber must be reached.  In addition, interlock systems are used on the sterilizer chamber door that require the EtO concentration be reduced to a certain level prior to opening.  The EtO concentration is monitored within the chamber, and this concentration is linked to the door interlock. The concentration must be less than or equal to 1 milligrams per liter (mg/L).
Smaller sterilizers emit approximately 50 pounds per year (lb/yr) of EtO from the stack. Larger sterilizers emit approximately 100 lb/yr. BD uses separate aeration units at all of their facilities.  Some of their facilities are automated, and in the future, they intend for all of their plants to be automated.
For the dwell period in the sterilizer chamber, the EtO concentration has historically been in the range of 600 mg/L, but this concentration has been declining over the last decade, and this concentration is now closer to approximately 400 mg/L.
Removal efficiencies for EtO typically range from 99.95 percent at the low end to 99.99 percent.  The destruction efficiency for a thermal oxidizer depends on the temperature maintained.
The aeration rooms have continuous monitoring and are vented to oxidizers. To ensure EtO is routed to a control device and is not being emitted as fugitive emission, EtO concentration monitors measure within the aeration room.
Recap from AdvaMed Meeting with B. Wehrum
AdvaMed met with Mr. Bill Wehrum, the EPA Assistant Air Administrator, this summer.  AdvaMed wanted to discuss fugitive emissions and how those will be considered in the future, and alternatives to EtO sterilization. Mr. Wehrum asked multiple questions about sterilization process operations, including maintaining negative pressure in room areas and issues with venting fugitives from room areas at EtO facilities to APCDs.  AdvaMed noted that the industry has long been pursuing alternatives to EtO, however the medical product industry is still reliant on EtO sterilization. A number of EtO alternatives work at the prototype level, but none of the alternatives are scalable to the size needed to replace EtO in the industry.
Discussions Led by STERIS
STERIS has nine large EtO sterilization facilities that are controlled, and the company's international facilities also meet the U.S. standards.  STERIS facilities for the most part sterilize medical devices, and approximately one-third use EtO. STERIS is a technology neutral company and is focused on using the best sterilization technology for the customer/product, whether that technology or approach uses EtO or another type of sterilization process. STERIS utilizes many different types of abatement and air pollution controls for EtO at their facilities. Two years ago, STERIS launched a Sustainable EO program, and their goal is to reduce EtO usage/inputs by 50 percent in 5 years across their organization at a global level.
All EtO sterilization operations have the same basic configuration, that includes a sterilizer vessel, aeration rooms, and EtO drum storage rooms.  At STERIS facilities, all of the emission sources are vented to control devices, including sterilizer chambers, CEV, and aeration.  Controls may vary depending on the size of the facility.  Smaller sterilizers may vent to dry bed scrubbers, while larger sterilizers may use Glygen systems, LESNI's balancer/abator system, and catalytic oxidizers as well.
APCDs at STERIS facilities typically achieve greater than 99 percent reduction of EtO.  In California, STERIS has two large facilities with controls that achieve 99.99 percent removal efficiency, and in Texas, a facility that achieves a 99.5 percent removal efficiency of EtO.
For the chamber exhaust, STERIS has retrofitted to route the CEV to existing APCDs.  It depends on the facility, but costs are likely to be $0.5 to $1.25 million. In 2008 when other facilities had major issues with explosions related to the CEV, STERIS reconfigured their facilities to control all CEV and to vent all CEV flow through wet "bubbler" systems (i.e. snubbers) prior to the APCD.  While their facilities do not run in the flammability zone, and there is no concern that the gas will reach the flashpoint, the wet system scrubber provides an added layer of safety precaution. The CEV emissions are routed to a wet bubbler system so that if a `flashback' occurs, it will not reach back to the sterilizer chamber.
Following aeration operations, sterilized product is moved to the warehouse.  STERIS facilities store products for customers for a minimum amount of time because of capacity constraints, and customers pick up their materials as soon as possible after sterilization. In the warehouse, sterilized products may be staged in outbound for approximately half a day until the customer's truck arrives for loading. STERIS facilities do not have space to warehouse products.
At some STERIS facilities, exhaust fans in the warehouse storage area handle the air and venting.  Baseline EtO monitoring is conducted in the warehouse room area, and employees wear personal protective equipment (PPE).
The aeration rooms are under engineering controls and are balanced to ensure negative pressure is maintained in the room. The facilities use baseline monitoring at leak points (such as door openings) to ensure EtO is not escaping the room. STERIS has installed Rytec doors, that are considered "zip tight" doors, in all of their facilities, which means that there is little time with the door open even when adding and removing product from the aeration room.
STERIS facilities in El Paso, TX, Spartanburg, SC, and Northborough, MA (near Boston) each have a similar design and follow typical sterilization process setup. The STERIS facilities in Grand Prairie, TX (near Dallas) and San Diego, CA use a combination-type sterilizer chamber, which STERIS refers to as "EO Express." In EO Express, all sterilization operations are conducted in all-in-one processors where preconditioning, sterilization, and aeration all are conducted in one chamber (i.e., in the sterilization chamber itself). Because these additional activities happen in the sterilizer chamber, the residence time for products in the chamber is 20 hours instead of the normal 10. STERIS is the only company that is able to operate combination sterilizers on a large, contract scale in the U.S. The pressure vacuum gradients that this process requires are not appropriate for all types of products, for example, surgical kits could not go through this process.
Use of combination sterilizers eliminates the CEV.  The combination-type sterilizer chambers tend to have hood vents over the sterilizer chamber door so that any fugitive EtO that vents from the door at the front of the chamber is captured; there are also sweep vents in the floor. Generally speaking, the EtO Express process is a cleaner process, since aeration is conducted within the chamber and there are no CEV emissions.
At STERIS facilities, most of the hoods over combination sterilizer chambers are routed to a control device, and if not, they will be routed to a control device in the near future. At some sites, the hoods over combination sterilizers are not yet tied in to the APCD but this is fairly easy to do (simply a function of installing ductwork and the time to design and implement).  These fugitive emissions consist of high air flowrates and low EtO concentration.
The ventilation air in the sterilizer chamber room area, where the sterilizer vessels are operating, is vented to a control device. The aeration room (i.e., this is referring to the emission source, not fugitives) is vented to a control device as well.
Some members of AdvaMed's EtO workgroup have in-house sterilization, others use contract sterilizers to sterilize.
Discussion Led by Anguil Environmental Systems
Anguil Environmental Systems (Anguil) is a manufacturer of thermal and catalytic oxidizers for EtO sterilization and other industries. Anguil has approximately 1,900 installations worldwide and has been providing EtO abatement since the 1990's. Anguil guarantees destruction efficiency of 99 percent plus for EtO. For high inlet concentrations of EtO, 99 percent or 1 part per million, volume (ppmv) is easy to achieve, but for lower concentration streams (e.g., aeration rooms), there are concerns regarding the outlet testing methodology (EPA Method 25A, gas chromatography, etc.) used to measure EtO destruction because there is some inaccuracy/play in the results. Anguil can guarantee 99.9 percent for high EtO concentration streams, but it is hard for a manufacturer to guarantee 1 ppmv if the inlet concentration to APCD is less than 20 ppmv.
EPA noted that EPA Methods 18 and 25A can measure EtO concentrations less than 100 ppmv, and the detection limit is understood to be approximately 0.3 ppmv.  EPA noted that a number of monitoring manufacturers are citing monitoring equipment that is more sensitive for EtO, with detection limits of approximately 1 to 20 parts per billion, volume (ppbv). Optimized Fourier Transform Infrared (FTIR), using EPA Method 320, is sensitive and has a detection limit of approximately 1 ppbv.  EPA would need to review associated test data to demonstrate the performance of the monitors.  It is anticipated that some of these newer monitoring devices will be commercially available in roughly 6-month timeframe.  Anguil also noted they are aware of the newer approaches in monitoring but do not have the data.
The Anguil oxidizers can handle emissions from sterilizer chamber vents (SCV), CEVs, and aeration room vents (ARV) depending on the facility. At older locations, it is quite common to have CEVs vented to the oxidizers. Facilities that have a peak shaver/quench snubber installed following the SCV and prior to the APCD are able to vent to an oxidizer.  High concentration flows from the sterilization chamber are directed to a water tank (i.e., peak shaver/quench snubber) where the EtO is bubbled through and absorbed in the water.  Then the EtO is stripped from the water at a constant rate and is mixed with the ARV air prior to the oxidizer.
The test method to determine the destruction efficiency (DE) of the oxidizer is selected by the end user, and a third party conducts the emission testing. Anguil noted they are not sure if a capture test was conducted in determining DE provided above.
The size of the APCD used at a facility is based on the air flow from the processes. Anguil has built small catalytic oxidizers from 100 standard cubic feet per minute (scfm) and larger ones up to 20,000 scfm. The largest catalytic oxidizer available right now is 20,000 scfm and is designed for ARVs only.
Anguil can likely share some capital and annual cost data with EPA but noted that cost really depends on the scope of the control system, as there are many variables that affect price. A higher flow system that uses more natural gas means increased capital and annual cost. For capital costs for an APCD that include capture improvements to achieve a combined capture and control of 99.9 percent, a back-of-the-envelope calculation for capital costs could be $100 million. Smaller systems could range from a few hundred thousand dollars to a couple million dollars. Hospital sterilizers could be hundreds of dollars per cfm.
Anguil has oxidizer control devices for smaller sterilizer units in California.  These sterilizer units have typical EtO usage of 25 lb/yr.  It is sometimes difficult for Anguil to provide a performance guarantee when it is not clear which test methods would be used by a state to determine the outlet EtO concentration in ppmv.
With respect to the catalyst bed replacement schedule, facilities often have their preferred approach. Some facilities replace part of catalyst beds, for example, replace one-third of the catalyst every year, and do not do a complete replacement of the catalyst at one time. Other facilities do a full replacement of the catalyst. Facilities can conduct testing on the activity of the catalyst and compare to the specification of a new batch of catalyst by measuring via x-ray or gas chromatography.  Facilities would take a sample plug of catalyst or a small core of catalyst and send to a laboratory, and often send the catalyst sample to the catalyst manufacturer for testing.  Anguil was not aware of an American Society for Testing and Materials (ASTM) method for testing the activity of catalyst. Over time, the catalyst may have a slight decrease in performance, however a small increase in the operating temperature of the catalyst bed will improve efficiency/performance; there is a tradeoff in operating costs at higher temperatures versus replacing the catalyst. In general, the catalyst life averages 5 years. Anguil offers replacement services as part of their contracts.
Anguil noted that some facilities monitor outlet EtO concentrations from the oxidizers using continuous emission monitoring systems (CEMS), but this is third party monitoring equipment.  Facilities determine the operating temperature based on the temperature during the stack test performance demonstration, and this sets the operational specification for temperature (i.e., operate the oxidizer at the temperature during the stack test).
In general, the stack test is conducted at worse case.  This is often defined as high EtO concentrations, but some industries or states may require demonstration of the emission standard at both high and low EtO concentrations.  Performance for processes with low inlet concentration are more difficult to guarantee.
Controls for Fugitive Emissions from EtO Sterilization Facilities
There has been a good bit of discussion in the industry regarding control of fugitive emissions. In the industry as a whole, there is significant variation in facility age and design. The variation in facility layout often comes from whether the facility is a commercial sterilizer or a manufacturing facility that also happens to conduct EtO sterilization. In the past, fugitive emissions have been a focus of the EtO environmental health and safety (EHS) subgroup from a worker safety or employee exposure perspective (e.g., OSHA PEL).  Today, the focus is about benchmarking what emissions occur and how emissions are currently controlled. A number of companies have been very public about improvements they are making at their facilities with respect to fugitive emissions. There are many workgroup participants who are capturing EtO emissions at the sterilizer chamber.  After the sterilizer chamber, EtO emissions occur from off-gassing from the sterilized product in the room areas, in aeration process, and from the warehouse area.  Some warehouse areas are climate-controlled in the winter as the area gets heated for operator comfort, however in the summer the room can be hot (ambient temperature).  Drum rooms, etc. could also be vented to a control device. Decreasing the initial EtO usage is also a solution.
Typically, at AdvaMed facilities there is a building management system where facility operations managers are watching concentrations, etc. in the different steps of the EtO sterilization process.
Closing
STERIS welcomed EPA to visit their Spartanburg, SC facility and possibly their Grand Prairie, TX facility. There are a number of validation/technical staff at the Texas facility who are able to discuss measurement specifics of EtO operations.


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Proposed Rules]
[Pages 18157-18160]
[FR Doc No: 2020-06743]

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

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0143]
RIN 1625-AA08

Special Local Regulation; Upper Potomac River, National Harbor,
MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish special local
regulations for certain waters of the Upper Potomac River. This action
is necessary to provide for the safety of life on these navigable
waters located at National Harbor, MD, during a swim event on June 20,
2020. This proposed rulemaking would prohibit persons and vessels from
entering the regulated area unless authorized by the Captain of the

Port Maryland-National Capital Region or the Coast Guard Patrol
Commander. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 1, 2020.

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0143 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Ron Houck, U.S. Coast Guard
Sector Maryland-National Capital Region; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Coast Guard Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    Enviro-Sports Productions, Inc. of Stinson Beach, CA, notified the
Coast Guard that it will be conducting the Washington DC Sharkfest Swim
event from 7:30 a.m. to 10:30 a.m. on June 20, 2020. The open water
swim races consist of approximately 250 adult and youth participants
competing on a designated course with three designated swim distances,
including 1 km, 2 km, and 4 km. The course starts and finishes at the
commercial pier at National Harbor, MD. Hazards from the swim
competition include participants swimming within and adjacent to the
designated navigation channel and interfering with vessels intending to
operate within that channel, as well as swimming within approaches to
local public and private marinas and public boat facilities. The
Captain of the Port (COTP) Maryland-National Capital Region has
determined that potential hazards associated with the swim event would
be a safety concern for anyone intending to participate in this event
or for vessels that operate within specified waters of the Upper
Potomac River.
    The purpose of this rulemaking is to protect event participants,
non-participants and transiting vessels on certain waters of the Upper
Potomac River before, during, and after the scheduled event. The Coast
Guard is proposing this rulemaking under authority in 46 U.S.C. 70034
(previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region is proposing to establish
a special local regulation from 7 a.m. through 11 a.m. on June 20,
2020. There is no alternate date planned for this event. The regulated
area would cover all navigable waters of the Upper Potomac River,
within an area bounded by a line connecting the following points: From
the Rosilie Island shoreline at latitude 38[deg]47'30.30'' N, longitude
077[deg]01'26.70 W, thence west to latitude 38[deg]47'30.00'' N,
longitude 077[deg]01'37.30'' W, thence south to latitude
38[deg]47'08.20'' N, longitude 077[deg]01'37.30'' W, thence east to
latitude 38[deg]47'09.00'' N, longitude 077[deg]01'09.20'' W, thence
southeast along the pier to latitude 38[deg]47'06.30'' N, longitude
077[deg]01'02.50 W, thence north along the shoreline and west along the
southern extent of the Woodrow Wilson (I-95/I-495) Memorial Bridge and
south and west along the shoreline to the point of origin, located at
National Harbor, MD. The regulated area is approximately 1,210 yards in
length and 740 yards in width.
    The proposed duration of the rule and size of the regulated area
are intended to ensure the safety of life on these navigable waters
before, during, and after the open water swim event, scheduled from
7:30 a.m. to 10:30 a.m. on June 20, 2020. The COTP and the Coast Guard
Patrol Commander (PATCOM) would have authority to forbid and control
the movement of all vessels and persons, including event participants,
in the regulated area.
    Except for Washington DC Sharkfest Swim event participants and
vessels already at berth, a vessel or person would be required to get
permission from the COTP or PATCOM before entering the regulated area.
Vessel operators can request permission to enter and transit through
the regulated area by contacting the PATCOM on VHF-FM channel 16.
Vessel traffic would be able to safely transit the regulated area once
the PATCOM deems it safe to do so. A person or vessel not registered
with the event sponsor as a participant or assigned as official patrols
would be considered a non-participant. Official Patrols are any vessel
assigned or approved by the Commander, Coast Guard Sector Maryland-
National Capital Region with a commissioned, warrant, or petty officer
on board and displaying a Coast Guard ensign.
    If permission is granted by the COTP or PATCOM, a person or vessel
would be allowed to enter the regulated area or pass directly through
the regulated area as instructed. Vessels would be required to operate
at a safe speed that minimizes wake while within the regulated area.
Official patrol vessels will direct non-participants while within the
regulated area. Vessels would be prohibited from loitering within the
navigable channel. Only participant vessels and official patrol vessels
would be allowed to enter the swim race area.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on size, time of day
and duration of the regulated area, which would impact a small
designated area of the Upper Potomac River for 4 hours. The Coast Guard
would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the status of the regulated area. Moreover, the rule would allow
vessels to seek permission to enter the regulated area, and vessel
traffic would be able to safely transit the regulated area once the
PATCOM deems it safe to do so.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations

that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area lasting for 4 hours. Normally such
actions are categorically excluded from further review under paragraph
L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 01. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this docket, see DHS's Correspondence System
of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0143 to read as follows:

Sec.  100.T05-0143   Washington DC Sharkfest Swim, Upper Potomac River,
National Harbor, MD.

    (a) Regulated area. The regulations in this section apply to the
following area: All navigable waters of the Upper

Potomac River, within an area bounded by a line connecting the
following points: From the Rosilie Island shoreline at latitude
38[deg]47'30.30'' N, longitude 077[deg]01'26.70 W, thence west to
latitude 38[deg]47'30.00'' N, longitude 077[deg]01'37.30'' W, thence
south to latitude 38[deg]47'08.20'' N, longitude 077[deg]01'37.30'' W,
thence east to latitude 38[deg]47'09.00'' N, longitude
077[deg]01'09.20'' W, thence southeast along the pier to latitude
38[deg]47'06.30'' N, longitude 077[deg]01'02.50'' W, thence north along
the shoreline and west along the southern extent of the Woodrow Wilson
(I-95/I-495) Memorial Bridge and south and west along the shoreline to
the point of origin, located at National Harbor, MD. These coordinates
are based on datum NAD 1983.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Coast Guard Patrol Commander (PATCOM) means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means all persons and vessels registered with the event
sponsor as participating in the Washington DC Sharkfest Swim event or
otherwise designated by the event sponsor as having a function tied to
the event.
    (c) Regulations. (1) Except for vessels already at berth, all non-
participants are prohibited from entering, transiting through,
anchoring in, or remaining within the regulated area described in
paragraph (a) of this section unless authorized by the COTP Maryland-
National Capital Region or PATCOM.
    (2) To seek permission to enter, contact the COTP Maryland-National
Capital Region at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz) or the PATCOM on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). Those in the regulated area must
comply with all lawful orders or directions given to them by the COTP
Maryland-National Capital Region or PATCOM.
    (3) The COTP Maryland-National Capital Region will provide notice
of the regulated area through advanced notice via Fifth Coast Guard
District Local Notice to Mariners, broadcast notice to mariners, and
on-scene official patrols.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 7 a.m.
to 11 a.m. June 20, 2020.

    Dated: March 26, 2020.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2020-06743 Filed 3-31-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]
[Page 51351-51352]
[DOCID:fr06oc09-115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60744; File No. SR-NYSEAmex-2009-62]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Amex LLC Amending Rule
900.3NY

September 29, 2009.
    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 September 14, 2009, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposed rule change pursuant to Section 19(b)(3)(A) of the
Act \3\ and Rule 19b-4(f)(6) 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.
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    \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).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 900.3NY to (i) offer PNP Blind
orders to its Participants and (ii) make technical corrections to the
numbering of Rule 900.3NY. The text of the proposed rule change is
attached as Exhibit 5 to the 19b-4 form. A copy of this filing is
available on the Exchange's Web site at http://www.nyse.com, at the
Exchange's principal office 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 self-regulatory organization
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 those 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
    NYSE Amex has an existing order type known as PNP (Post No
Preference) \5\ which is a limit order that is only to be executed on
the Exchange, and may be ranked in the Consolidated Book if not
marketable, but is never to be routed. A PNP order that is marketable
against the NBBO when entered is cancelled back to the entering ATP
Holder.
---------------------------------------------------------------------------

    \5\ See NYSE Amex Rule 900.3NY(p).
---------------------------------------------------------------------------

    Certain ATP Holders have asked for a similar order type that will
also not route if marketable against the NBBO, but, unlike a PNP order,
will not be cancelled if similarly marketable.
    A PNP Blind order is a limit order that is to be executed on the
Exchange, but never routed to another market. The

unexecuted portion of a PNP Blind order is to be ranked in the
Consolidated Book. Unlike a conventional PNP order, a PNP Blind Order
that is marketable against the NBBO will not be cancelled; however, the
price and size will not be disseminated to OPRA. If the NBBO moves so
that the PNP Blind Order no longer locks or crosses the NBBO, the
order's price and size will be disseminated. When a PNP Blind order is
not displayed, it provides price improvement to any incoming contra-
side order. A PNP Blind order will be executed at its limit price, if
displayed, or at a price that matches the contra side of the NBBO, if
undisplayed.
    The Exchange believes that the implementation of the aforementioned
rule change modifying NYSE Amex order entry options will preserve order
execution opportunities on the NYSE Amex market, provide greater
control over the circumstances of executions, and provide an
opportunity for enhanced executions.
    The Exchange is also making technical corrections to the numbering
of the subparagraphs in Rule 900.3NY.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
and furthers the objectives of Section 6(b)(5) of the Act, in that it
is designed to promote just and equitable principles of trade, remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, to protect investors and the
public interest, by providing investors with additional order types
that allow greater flexibility in maintaining compliance with the
rules, or providing an opportunity for enhanced executions, or managing
the circumstances in which their orders are executed.

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

    The Exchange does not believe that the proposed rule change will
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

    No written comments were solicited or received with respect to 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:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, if
consistent with the protection of investors and the public interest, it
has become effective pursuant to Section 19(b)(3)(A) of the Act \6\ and
Rule 19b-4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b 4(f)(6). In addition, Rule 19b 4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission 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 provided such a notice.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay. The Commission hereby grants the Exchange's request.\8\ The
proposed rule is identical to that in use by NYSE Arca, Inc. (``NYSE
Arca'') \9\ and does not raise any novel or significant issues.
Therefore, the Commission believes that waiving the 30-day period to
allow the proposed rule change to become operative upon filing is
consistent with the protection of investors and the public interest and
designates the proposal as operative upon filing.
---------------------------------------------------------------------------

    \8\ For purposes only of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \9\ See NYSE Arca Rule 6.62(u); see also Securities Exchange Act
Release No. 59603 (March 19, 2009), 74 FR 13279 (March 26, 2009)
(amending Rule 6.62 to provide additional order types).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMEX-2009-62 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2009-62. 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 inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549-1090 on official business days between the
hours of 10 a.m. and 3 p.m. Copies of the filing will also be available
for inspection and copying at the NYSE Amex's principal office and on
its Internet Web site at http://www.nyse.com. 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-NYSEAmex-2009-62 and should be submitted
on or before October 27, 2009.

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

    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-23994 Filed 10-5-09; 8:45 am]

BILLING CODE 8011-01-P