[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42779-42781]
[FR Doc No: 2016-15500]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78155; File No. SR-NYSEMKT-2016-64]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change for a Temporary
Suspension of Those Aspects of Rules 36.20--Equities and 36.21--
Equities That Would Not Permit Floor Brokers To Use Personal Portable
Phone Devices on the Trading Floor Due to the Unavailability of Floor
Broker Telephone Services

June 24, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 24, 2016, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes a temporary suspension of those aspects of
Rules 36.20--Equities and 36.21--Equities that would not permit Floor
brokers to use personal portable phone devices on the Trading Floor due
to the unavailability of Floor broker telephone services on June 24,
2016. The proposed rule change is available on the Exchange's Web site
at www.nyse.com, at the principal office of the Exchange,

and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
    The Exchange proposes to temporarily suspend those aspects of Rules
36.20--Equities (``Rule 36.20'') and 36.21--Equities (``Rule 36.21'')
that would not permit Floor brokers to use personal portable phone
devices on the Trading Floor.\4\ As proposed, all other aspects of Rule
36--Equities (``Rule 36'') remain applicable and the temporary
suspensions of the applicable Rule 36 requirements are in effect on
June 24, 2016 only.\5\
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    \4\ Pursuant to Rule 6A--Equities, the Trading Floor is defined
as the restricted-access physical areas designated by the Exchange
for the trading of securities.
    \5\ The Exchange provided Floor brokers with notice of this rule
filing, including the applicable recordkeeping and other
requirements related to using personal cell phones during the
temporary suspension of Rule 36.
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    On June 24, 2016, the third-party carrier that provides service for
the wired phone lines for Floor brokers experienced an issue that
affected the availability of those phone lines. This suspension of
service only impacted the service for telephone service for Floor
brokers and did not impact phone service for Designated Market Makers.
The Exchange is working closely with the third-party carrier to restore
such phone service.
    Rules 36.20 and 36.21 govern the type of telephone communications
that are approved for Floor brokers. Pursuant to Rule 36.20, Floor
brokers may maintain a telephone line on the Trading Floor and use
Exchange authorized and provided portable phones while on the Trading
Floor. The use of such Exchange authorized and provided portable phones
is governed by Rule 36.21. Because of the issues with the third-party
carrier, Floor brokers are unable to reach their customers via their
third-party carrier wired telephone lines. While Exchange-provided
portable phones are operating, not all Floor brokers have Exchange-
provided and authorized portable phones. However, the personal cell
phones of Floor brokers are operational on the Trading Floor. The
Exchange believes that because communications with customers is a vital
part of a Floor broker's role as agent and therefore contributes to
maintaining a fair and orderly market, during the period when the phone
lines are non-operational, Floor brokers who do not have Exchange
authorized and provided portable phones should be permitted to use
personal cell phone devices in lieu of the non-operational wired phone
lines.\6\
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    \6\ To the extent that the wired phone lines are operational,
Floor brokers must use those phone lines rather than use a personal
cell phone.
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    The Exchange therefore proposes to temporarily suspend the
limitations in Rules 36.20 and 36.21 that permit Floor brokers to use
only Exchange authorized and provided portable phones so that Floor
brokers who do not have an Exchange authorized and portable phone may
use personal cell phones on the Trading Floor. The Exchange proposes
that pursuant to this temporary suspension, Floor brokers must provide
the Exchange with the names of all Floor-based personnel who used
personal portable phones during this temporary suspension period,
together with the phone number and applicable carrier for each number.
Floor broker member organizations must maintain in their books and
records all cell phone records that show both incoming and outgoing
calls that were made during the period that a personal portable phone
was used on the Trading Floor. To the extent the records are
unavailable from the third-party carrier, the Floor brokers must
maintain contemporaneous records of all calls made or received on a
personal portable phone while on the Trading Floor. As with all member
organization records, such cell phone records must be provided to
Exchange regulatory staff on request.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\8\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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    In particular, because of issues experienced by a third-party phone
carrier, wired phone lines are not functional. The Exchange believes
that the proposed temporary suspensions from those aspects of Rule 36
that restrict Floor broker's use of personal portable phones on the
Trading Floor removes impediments to and perfects the mechanism of a
free and open market and national market system because the proposed
relief will enable Floor brokers who do not have an Exchange authorized
and provided portable phone to conduct their regular business,
notwithstanding the ongoing issues with telephone service. The Exchange
further believes that without the requested relief, Floor brokers would
be compromised in their ability to conduct their regular course of
business on the Trading Floor. In particular, for Floor brokers,
because they operate as agents for customers, their inability to
communicate with customers could compromise their ability to represent
public orders on the Trading Floor.

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. The Exchange does not
believe that the proposed rule change will impose any burden on
competition because the proposed change only impacts Floor brokers and
has no change in operations for other market participants or other
market centers. To the contrary, the Exchange believes that without the
proposed relief, Floor brokers would be compromised in their ability to
conduct their regular course of business on the Trading Floor, thereby
placing a burden on the Floor brokers' ability to compete.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
Because the 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 prior to
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, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\11\
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    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give 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 Commission has determined to waive the five-day prefiling period
in this case.
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    A proposed rule change filed under Rule 19b-4(f)(6) under the Act
\12\ normally does not become operative prior to 30 days after the date
of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. In support
of the request, the Exchange states that waiver the 30-day operative
delay will allow the Exchange to invoke the relief immediately upon
filing, which is necessary so that Floor brokers may be able to
communicate with their customers on a day with significantly increased
volumes of trading due both to the United Kingdom referendum vote to
leave the European Union and the rebalancing of the Russell Investment
Group indices after the close of trading on June 24, 2016. Based on the
above, the Commission believes that waiver of the 30-day operative
delay is consistent with the protection of investors and the public
interest because it will permit Floor brokers to remain in
communication with customers while wired phone lines are unavailable.
Accordingly, the Commission designates the proposed rule change as
operative upon filing with the Commission.\14\
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ 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).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \15\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \15\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2016-64 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2016-64. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2016-64, and should
be submitted on or before July 21, 2016.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2016-15500 Filed 6-29-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 181 (Wednesday, September 20, 2023)]
[Notices]
[Page 64902]
[FR Doc No: 2023-20358]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2639-028]

Northern States Power Company--Wisconsin; Notice of Waiver Period
for Water Quality Certification Application

    On September 11, 2023, Northern States Power Company--Wisconsin
submitted to the Federal Energy Regulatory Commission (Commission) a
copy of its application for a Clean Water Act section 401(a)(1) water
quality certification filed with the Wisconsin Department of Natural
Resources (Wisconsin DNR), in conjunction with the above captioned
project. Pursuant to section 401 of the Clean Water Act \1\ and section
4.34(b)(5) of the Commission's regulations,\2\ a State certifying
agency is deemed to have waived its certifying authority if it fails or
refuses to act on a certification request within a reasonable period of
time, which is one year after the date the certification request was
received. Accordingly, we hereby notify Wisconsin DNR of the following:
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    \1\ 33 U.S.C. 1341(a)(1).
    \2\ 18 CFR 4.34(b)(5) (2022).
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    Date of Receipt of the Certification Request: September 11, 2023.
    Reasonable Period of Time to Act on the Certification Request: One
year (September 11, 2024).
    If Wisconsin DNR fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: September 14, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-20358 Filed 9-19-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Rules and Regulations]
[Page 38412]
[FR Doc No: 2010-16114]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0520]

Drawbridge Operation Regulations; Chicago River, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: Commander, Ninth Coast Guard District, issued a temporary
deviation from the regulation governing the operation of the Lake Shore
Drive Bridge at Mile 0.32, Columbus Drive Bridge at mile 0.62, Michigan
Avenue Bridge at Mile 0.85, State Street Bridge at Mile 1.05, LaSalle
Street Bridge at Mile 1.29, and the Franklin Street Bridge at Mile 1.47
over the Main Branch of the Chicago River, Monroe Street Bridge at Mile
1.99, Adams Street Bridge at Mile 2.08, Halsted Street Bridge at Mile
4.47 over the South Branch of the Chicago River, at Chicago, IL. This
deviation will temporarily change the operating schedule of the bridges
to accommodate the City's Bank of America Shamrock Shuffle 8K Run, Rock
N Roll Chicago Half Marathon, Illinois Special Olympics Rubber Duck
Race, Chicago Triathlon, Ready to Run Chicago Marathon, Bank of America
Chicago Marathon, Men's Health Urbanathlon, and the Magnificent Mile
Lights Festival events. This temporary deviation allows the bridges to
remain secured to masted navigation on the dates and times listed.

DATES: This deviation is effective on August 1, 2010 from 6 a.m. to 9
a.m., August 12, 2010 from noon to 1:30 p.m., August 29, 2010 from 6
a.m. to 1 p.m., September 19, 2010 from 7 a.m. to 10 a.m., September
29, 2010 from 6 a.m. to 1 p.m., October 10, 2010 from 4:30 a.m. to
11:30 a.m., October 16, 2010 from 7:30 a.m. to 9:30 a.m., and on
November 20, 2010 from 6 p.m. to 8 p.m..

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0520 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0520 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Lee D. Soule, Bridge Management Specialist, Ninth
Coast Guard District; telephone<PHONE_NUMBER>, e-mail;
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION: The City of Chicago, Illinois, who owns and
operates these drawbridges, requested a temporary deviation from the
current operating regulations set forth in 33 CFR 117.391. The purpose
of this request is to facilitate efficient management of all
transportation needs and provide timely public safety services during
these special events. The most updated and detailed current marine
information for this event, and all bridge operations, is found in the
Local Notice to Mariners and Broadcast Notice to Mariners issued by the
Ninth District Commander. In accordance with 33 CFR 117.35(e), the
drawbridge must return to its regular operating schedule immediately at
the end of the designated time periods. These deviations from the
operating regulations are authorized under 33 CFR 117.35.

    Date: June 16, 2010.
M.N. Parks,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2010-16114 Filed 7-1-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Proposed Rules]
[Page 35260]
[FR Doc No: 2015-14993]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0909; Directorate Identifier 96-ANE-24-AD]
RIN 2120-AA64

Airworthiness Directives; AlliedSignal Inc. and Rajay Inc. Oil
Scavenge Pumps

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The FAA is withdrawing a notice of proposed rulemaking (NPRM).
The NPRM proposed a new airworthiness directive (AD) that had applied
to AlliedSignal oil scavenge pumps, part numbers (P/Ns) 101633-01 and -
02 and Rajay Inc. oil scavenge pumps, P/Ns 1025-1 and -2 installed on
Continental Motors, Inc. (CMI) IO-470 and TSIO-520 reciprocating
engines and on Lycoming Engines, Inc., (Lycoming) IO-360, IO-540, and
O-360 reciprocating engines. We have found no service difficulties with
these model oil scavenge pumps when installed on the affected engines.
Accordingly, we withdraw the proposed rule.

DATES: As of June 19, 2015, the proposed rule published February 20,
1997 at 62 FR 7730 is withdrawn.

FOR FURTHER INFORMATION CONTACT: Richard McCauley, Aerospace Engineer,
Seattle Aircraft Certification Office, FAA, Transport Directorate, 1601
Lind Avenue SW., Renton, WA 98055-4056; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39
with a proposed AD (62 FR 7730, February 20, 1997). The proposed AD had
applied to AlliedSignal oil scavenge pumps, P/Ns 101633-01 and -02 and
Rajay Inc. oil scavenge pumps, P/Ns 1025-1 and -2 installed on CMI IO-
470 and TSIO-520 reciprocating engines and on Lycoming IO-360, IO-540,
and O-360 reciprocating engines. The NPRM proposed to require initial
and repetitive inspections of the oil scavenge pump for the security of
the snap ring installation, snap ring and washer wear, and shaft groove
wear, and their replacement, if necessary, with serviceable parts. The
proposed action was prompted by reports of severe wear on the end plate
of the oil scavenge pump. The proposed actions were intended to prevent
oil scavenge pump snap ring failure causing severe wear on the pump end
plate, which could result in loss of engine oil and subsequent engine
shutdown.
    Since we issued the NPRM (62 FR 7730, February 20, 1997),
additional information became available after the public comment period
closed on April 21, 1997.
    Upon further consideration, we hereby withdraw the proposed rule
for the following reason:
     We reviewed service difficulty reports, AD databases, and
airplane manufacturer's data and found no unsafe condition in the last
19 years of service history associated with these oil scavenge pumps
installed on the affected engines.
    Withdrawal of the NPRM (62 FR 7730, February 20, 1997) constitutes
only such action, and does not preclude the agency from issuing another
notice in the future, nor does it commit the agency to any course of
action in the future.
    Since this action only withdraws a notice of proposed rulemaking,
it is neither a proposed nor a final rule. Therefore, Executive Order
12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979) do not cover this
withdrawal.

List of Subjects in 14 CFR Part 39

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

The Withdrawal

    Accordingly, the notice of proposed rulemaking, Docket No. FAA-
2015-0909; Directorate Identifier 96-ANE-24-AD, published in the
Federal Register on February 20, 1997 (62 FR 7730), is withdrawn.

    Issued in Burlington, Massachusetts, on June 10, 2015.
Ann C. Mollica,
Acting Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-14993 Filed 6-18-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Rules and Regulations]
[Pages 52778-52783]
[FR Doc No: 2019-20524]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0138; FRL-9999-72]

Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-; Exemption
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert
ingredient (surfactant) applied to animals. Exponent, on behalf of
LNouvel, Inc., submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- when
used in accordance with the terms of the exemption in EPA regulations.

DATES: This regulation is effective October 3, 2019. Objections and
requests for hearings must be received on or before December 2, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0138, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William

Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0138 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 2, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0138, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of May 13, 2019 (84 FR 20843) (FRL-9991-
91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11248) by
Exponent, on behalf of LNouvel, Inc., 4657 Courtyard Trail, Plano, TX
75024-2114. The petition requested that 40 CFR 180.930 be amended by
establishing an exemption from the requirement of a tolerance for
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy)disiloxanyl)propyl)-[omega]-hydroxy- (CAS Reg.
No. 67674-67-3) when used as an inert ingredient in pesticide
formulations applied to animals. That document referenced a summary of
the petition prepared by Exponent, on behalf of LNouvel, Inc., the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(c)(2)(B) requires EPA to take into
account the considerations set forth in section 408(b)(2)(C) and (D),
when making this safety determination. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the

toxicity of the inert in conjunction with possible exposure to residues
of the inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for poly(oxy-1,2-ethanediyl),
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl)
propyl)-[omega]-hydroxy- including exposure resulting from the
exemption established by this action. EPA's assessment of exposures and
risks associated with poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies are discussed in this unit.
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy exhibits
low levels of acute toxicity. Acute studies in rats showed oral
LD50 of >1,600 mg/kg. The dermal LD50 in rats was
>3,200 mg/kg. No acute inhalation studies were available. Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is considered to be an eye
irritant and a mild skin irritant. However, it was not found to be a
dermal sensitizer.
    Repeat dose studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- are limited. In a combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats, effects seen at 1,000 mg/kg/day, the highest dose tested (i.e.,
800 mg/kg/day to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy-) included decreased body weight, body weight gain, and food
consumption and reduced body temperature in males. No developmental/
reproductive adverse effect attributed to the test substance were
observed in the study.
    There is no evidence that exposure to poly(oxy-1,2-ethanediyl),
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl)
propyl)-[omega]-hydroxy- suppresses or otherwise harms immune function
in humans. No signs of neurotoxicity were reported in acute or repeat-
dose oral studies. There were also no signs of carcinogenicity in the
database. Similarly, all tests were negative for genotoxicity and
mutagenicity. The available data suggests that poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is not carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment.
    PODs are developed based on a careful analysis of the doses in each
toxicological study to determine the dose at which no adverse effects
are observed (the NOAEL) and the lowest dose at which adverse effects
of concern are identified (the LOAEL). Uncertainty/safety factors are
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- used for human risk assessment
are described in this unit. The Point of Departure (POD) for all
durations of oral, dermal, and inhalation exposure is based on the
NOAEL of 300 mg/kg/day and the LOAEL of 1,000 mg/kg/day based on
decreased body weight, body weight gain, and food consumption and
reduced body temperature in males from the combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test. Once corrected for the percent inert ingredient in the test
formulation, the NOAEL was 240 mg/kg/day and the LOAEL was 800 mg/kg/
day poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-.
    A 100-fold uncertainty factor was used (10X interspecies
extrapolation, 10X for intraspecies variability, and 1X FQPA safety
factor (SF)). The FQPA SF is reduced to 1X because the reproductive and
developmental toxicity database is complete and there is no evidence of
increased risk to infants and children.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance as well as the existing tolerance exemption for this
chemical. Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is
currently approved as a food use inert ingredient under 40 CFR 180.910.
EPA assessed dietary exposures from poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- in food as follows:
    Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary. In conducting the
chronic dietary exposure assessment using the Dietary Exposure
Evaluation Model DEEM-FCID\TM\, Version 3.16, EPA used food consumption
information from the U.S. Department of Agriculture's National Health
and Nutrition Examination Survey, What we eat in America, (NHANES/
WWEIA). This dietary survey was conducted from 2003

to 2008. The Inert Dietary Exposure Evaluation Model (I-DEEM) is a
highly conservative model with the assumption that the residue level of
the inert ingredient would be no higher than the highest tolerance for
a given commodity. Implicit in this assumption is that there would be
similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. This model incorporates
all current and proposed pesticidal food uses for this inert
ingredient.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-, a conservative drinking water
concentration value of 100 ppb based on screening level modeling was
used to assess the contribution to drinking water for the chronic
dietary risk assessments for parent compound. These values were
directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). A
review of residential products containing this inert ingredient
revealed that it is currently used in fungicides, herbicides, and
insecticides applied to residential settings, mainly on lawns and turf.
In an effort to assess exposure, the EPA has conducted a conservative
screening-level assessment using high-end exposure scenarios for
pesticidal use on lawns/turf. For each residential scenario, short-term
exposure for both the handler (adult) and post-application exposure
(adult and child) is expected. Based on the use pattern (e.g., pre- and
post-harvest uses, use on lawns), intermediate-term and long-term
pesticidal exposures from residential uses are not expected.
    In addition to the proposed and current pesticidal uses of
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, poly(oxy-
1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-[omega]-hydroxy- is also used in various non-
pesticidal products; however, quantifiable exposure data are not
available for these exposure scenarios.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- to share a common mechanism of toxicity with any other
substances, and poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. A combined repeated dose
toxicity study with a reproduction/developmental toxicity screening
test showed no effect on reproductive parameters of fertility in the
absence of maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is complete.
    ii. There is no indication that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    iii. There is no evidence that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- results in increased susceptibility in in utero rats
in a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- in drinking water. EPA used similarly conservative assumptions
to assess post-application exposure of children as well as incidental
oral exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy-.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking

water. No adverse effect resulting from a single oral exposure was
identified and no acute dietary endpoint was selected. Therefore,
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is not
expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- from food
and water will utilize 29.4% of the cPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is currently used as an inert
ingredient in pesticide products that are registered for uses that
could result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 390 for adults
and 175 for children 1 to 2 years old. Because EPA's level of concern
for poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is a MOE
of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). A potential intermediate-term adverse effect was identified;
however, poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is not
currently used as an inert ingredient in pesticide products that are
registered for any use patterns that would result in intermediate-term
residential exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity, poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-residues.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.930 for poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert
ingredient (surfactant) in pesticide formulations applied to animals.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action for
purposes of Executive Order 13771, entitled ``reducing Regulations and
Controlling Regulatory Costs (82 FR 9339, February 3, 2017). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and

other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This action is not
a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 13, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
 2. In Sec.  180.930, add alphabetically the inert ingredient
``Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg.
No. 67674-67-3)'' to the table to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
                Inert ingredients                               Limits                           Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-    ..................................  Surfactant.
 tetramethyl-1-((trimethylsilyl) oxy)
 disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg.
 No. 67674-67-3).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-20524 Filed 10-2-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92949-92952]
[FR Doc No: 2016-30602]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0083; FMCSA-2010-0115; FMCSA-2010-0138; FMCSA-
2012-0108; FMCSA-2012-0109; FMCSA-2014-0016; FMCSA-2014-0017]

Qualification of Drivers; Exemption Applications; Diabetes

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

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

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

SUMMARY: FMCSA announces its decision to renew the exemptions of 174
individuals from its rule prohibiting persons with insulin-treated
diabetes mellitus (ITDM) from operating commercial motor vehicles
(CMVs) in interstate commerce. FMCSA has statutory authority to exempt
individuals from this rule if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these CMV drivers.

DATES: Each group of renewed exemptions was effective from the dates
stated in the discussions below. Comments must be received on or before
January 19, 2017.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. FMCSA-2010-0083; FMCSA-
2010-0115; FMCSA-2010-0138; FMCSA-2012-0108; FMCSA-2012-0109; FMCSA-
2014-0016; FMCSA-2014-0017, using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m. e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m. e.t, Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

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

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the Federal Motor Carrier Safety Regulations 2-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 174 individuals listed
in this notice have recently become eligible for a renewed exemption
from the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to
drivers of CMVs in interstate commerce. The drivers remain in good
standing with the Agency, have maintained their required medical
monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period.

Exemption Decision

    This notice addresses 174 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. These 174 drivers
remain in good standing with the Agency, have maintained their required
medical monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period. Therefore, FMCSA has decided to extend each
exemption for a renewable two-year period. Each individual is
identified according to the renewal date.

    The exemptions are renewed subject to the following conditions: (1)
That each individual submit a quarterly monitoring checklist completed
by the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) that each individual reports
within 2 business days of occurrence, all episodes of severe
hypoglycemia, significant complications, or inability to manage
diabetes; also, any involvement in an accident or any other adverse
event in a CMV or personal vehicle, whether or not it is related to an
episode of hypoglycemia; (3) that each individual submit an annual
ophthalmologist's or optometrist's report; and (4) that each individual
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy in his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the certification when driving, for presentation to
a duly authorized Federal, State, or local enforcement official.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. The following groups of
drivers received renewed exemptions in the month of July and are
discussed below.
    As of July 2, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 30 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (75 FR 25919; 75 FR
28677; 75 FR 38597; 75 FR 38598):

Spencer W. Alexander (UT)
Cody R. Anderson (MT)
Ronnie L. Barker (GA)
Joseph P. Beagan (RI)
Brian C. Blevins (VA)
John M. Charlton (UT)
Stuart A. Dietz (KS)
Michael G. Eikenberry (IN)
Francisco K. Gallardo (AZ)
Devin S. Gibson (UT)
Jason C. Green (MS)
Kimmy D. Hall (AR)
Edward G. Harbin (AR)
Lewis M. Hendershott (NJ)
Mark E. Henning (NY)
Christopher M. Hultman (WI)
Duane K. Kohls (MN)
John F. Lohmuller (IN)
Jerry A. McMurdy (PA)
Steven L. Miller (ND)
H. A. Miller (OR)
Andrew D. Monson (MN)
Timothy J. Nowak (FL)
Peter J. Pendola (VA)
Ross R. Romano (MI)
Max S. Sklarski (NM)
Jason D. Sweet (CA)
Robert M. Thomson (IL)
James P. Tomasik (PA)
Joseph H. Watkins (IN)

    The drivers were included in Docket No. FMCSA-2010-0083; FMCSA-
2010-0115. Their exemptions are effective as of July 2, 2016 and will
expire on July 2, 2018.
    As of July 22, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 44 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (79 FR 29484; 79 FR
42628):

Curtis D. Andersen (MT)
Thomas E. Armburst (IL)
Michael A. Barrett (MI)
Jerry G. Clise Jr. (MD)
Richard K. Cressman (ND)
Steven W. Dahl (ND)
Shannon D. Eck (KS)
Manuel Fernandez (PA)
Kevin J. Franje (IA)
Michael E. Goldsberry (VA)
Jared P. Greene (OH)
Michael L. Jobe (PA)
Edwin P. Jonas, II (PA)
David W. Jones (MD)
John T. Katcher (CO)
Glenn T. Keller (PA)
Michael G. Keller (CA)
Jay T. Kirschmann (ND)
James L. Laufenberg (ND)
James R. Longo (MD)
Erik M. Mardesen (IA)
Earl W. Meadows (WV)
Ralph H. Mills (MA)
Matthew C. Moberly (KY)
Brant S. Perry (TX)
Zachary A. Petitt (TX)
James W. Restuccio Jr. (NJ)
Pedro Saavedra Garcia (CA)
David Salmond (UT)
Jerry J. Shipley (KS)
Glenn A. Skonberg (SD)
Douglas R. Smith (KS)
Cheryl G. Stephens (DE)
James F. Stewart (PA)
Martin T. Struthers (NE)
Dennis C. Svec (MI)
Larry L. Taff (AR)
Filbert J. Torres (NM)
Jennifer A. Tyson (PA)
Burdette Walker (PA)
Jacob D. Walter (PA)
Richard E. Watkins (NY)
Harold W. Wilson Jr. (SC)
Ronald D. Young (GA)

    The drivers were included in Docket No. FMCSA-2014-0016. Their
exemptions are effective as of July 22, 2016 and will expire on July
22, 2018.
    As of July 24, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 18 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (77 FR 33554; 77 FR
43417):

Jack D. Alt (NH)
Tony O. Billman (PA)
Tracy M. Dowton (MT)
Anil D. Gharmalker (KS)
Larry A. Hamilton (MO)
Allen K. Kates (NJ)
Andrew L. Lyman (PA)
Nancy A. Plunk (MO)
Victor C. Port (ND)
Scott D. Roles (MN)
Jeffrey A. Ryan (IA)
Keith A. Siekmeier (AK)
Tom L. Simmons (IA)
James H. Stichberry, Jr. (MD)
Loyd J. Wagner (MO)
John F. Watson (IN)
Melvin E. Welch (NJ)
Leroy R. Wille (IA)

    The drivers were included in Docket No. FMCSA-2012-0109. Their
exemptions are effective as of July 24, 2016 and will expire on July
24, 2018.
    As of July 25, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 55 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (79 FR 35844; 79 FR
51223):

Todd Y. Albright (MT)
John H. Ascheman (MN)
Robert M. Borunda (CA)
Alan F. Brown Jr. (IN)
Theodore W. Burnette (CA)
John Canal (NY)
Anthony C. Cole (WY)
Kevin G. Comstock (MN)
Jacob S. Crawford (GA)
Christopher Dave (MI)
Anthony J. Davis (IN)
Justin J. Day (SD)
Charles G. Denegal (WA)
Wayne H. Dirks (WA)
Charles G. Elliott (IN)
Joseph S. Farrow (MN)
James R. Fiecke (ND)
Eric C. Gambill (OH)
Mark P. Gerrits (WI)
Michael Gilon (NH)
Chance A. Gooch (GA)
Robert L. Harris (IN)
Darrell S. Haynes (PA)
Joseph D. Helget (OR)
Charles D. Henderson (NY)
Marvin S. Howard (OH)
Eric A. Knox (KY)
Erik M. Lindquist (WA)
Thomas K. Linkel (IN)
Christine I. Llewellyn (IL)

Ryan A. Malandrone (WI)
Thomas J. Manning (MN)
Steve A. Meharry (WA)
Robert A. Miller Jr. (WV)
Ben G. Moore (IL)
Chad M. Morris (NY)
Paul C. Mortenson (WI)
William D. Murray (AL)
Jacob D. Nafziger (OH)
Edward T. Nauer (VA)
Keith W. Nichols (TX)
Colin R. Parmelee (IN)
Matthew P. Sczpanski (OH)
Anthony S. Sobreiro (NJ)
Colby E. Starner (PA)
Daniel E. Stephens (NY)
Bartholomew Taliaferro (PA)
Johnathan D. Truitt (IL)
Rylan P. Wheeler (IL)
Gordon J. White (MO)
Kelly L. Whitley (NC)
Jerry R. Williams (GA)
Charles L. Wojton (PA)
Michelle L. York (WA)
Steven L. Zimmer (OH)

    The drivers were included in Docket No. FMCSA-2014-0017. Their
exemptions are effective as of July 25, 2016 and will expire on July
25, 2018.
    As of July 26, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 15 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (77 FR 33551; 77 FR
43901):

Larry J. Anderson (MN)
Wade D. Calvin (WA)
Carl A. Candelaria (NM)
Owen R. Dossett (AL)
Jennifer A. Ferguson (SC)
Michael E. Fritz (NV)
Lee A. Haerterich (WI)
Eric W. Holland (CO)
Richard P. Holmen (MN)
Edward Jones (GA)
Paul A. Lacina (ND)
Bradley J. Moore (MO)
Ross W. Petermann (MN)
Randall J. Tatum (MA)
Curtis J. Young (FL)

    The drivers were included in Docket No. FMCSA-2012-0108. Their
exemptions are effective as of July 26, 2016 and will expire on July
26, 2018.
    As of July 27, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 12 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce. (75 FR 34206; 75 FR
44049):

Clinton R. Carlson II (RI)
Brandon L. Cheek (NC)
Richard A. Dufton, Jr. (NH)
Kenneth Dunn (IN)
Robert J. Dyxin (IL)
Michael H. Hayden (NY)
John T. Jones (OK)
Blake A.S. Keeten (NE)
Randall L. Koegel (NY)
Worden T. Price (NC)
Gary L. Sager (IL)
Darrel D. Schroeder (KS)

    The drivers were included in Docket No. FMCSA-2010-0138. Their
exemptions are effective as of July 27, 2016 and will expire on July
27, 2018.
    Each of the 174 drivers in the aforementioned groups qualifies for
a renewal of the exemption. They have maintained their required medical
monitoring and have not exhibited any medical issues that would
compromise their ability to safely operate a CMV during the previous 2-
year exemption period.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each of the
174 drivers for a period of two years is likely to achieve a level of
safety equal to that existing without the exemption. The drivers were
included in docket numbers FMCSA-2010-0083; FMCSA-2010-0115; FMCSA-
2010-0138; FMCSA-2012-0108; FMCSA-2012-0109; FMCSA-2014-0016; FMCSA-
2014-0017.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by January 19, 2017.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 174 individuals from rule
prohibiting persons with ITDM from operating CMVs in interstate
commerce in 49 CFR 391.41(b)(3). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the medical condition of each applicant for an exemption from
rule prohibiting persons with ITDM from operating CMVs in interstate
commerce. That information is available by consulting the above cited
Federal Register publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2010-0083; FMCSA-
2010-0115; FMCSA-2010-0138; FMCSA-2012-0108; FMCSA-2012-0109; FMCSA-
2014-0016; FMCSA-2014-0017 and click the search button. When the new
screen appears, click on the blue ``Comment Now!'' button on the right
hand side of the page. On the new page, enter information required
including the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation. If
you submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number

FMCSA-2010-0083; FMCSA-2010-0115; FMCSA-2010-0138; FMCSA-2012-0108;
FMCSA-2012-0109; FMCSA-2014-0016; FMCSA-2014-0017 and click ``Search.''
Next, click ``Open Docket Folder'' and you will find all documents and
comments related to this notice.

    Issued on: December 8, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-30602 Filed 12-19-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66880-66881]
[FR Doc No: 2012-27132]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17f-1(c) and Form X-17F-1A; SEC File No. 270-29, OMB
Control No. 3235-0037.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget a
request for approval of extension of the existing collection of
information provided for in the following rule: Rule 17f-1(c) (17 CFR
240.17f-1(c) and Form X-17F-1A (17 CFR 249.100) under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'').
    Rule 17f-1(c) requires approximately 26,000 entities in the
securities industry to report lost, stolen, missing, or counterfeit
securities certificates to the Commission or its designee, to a
registered transfer agent for the issue, and, when criminal activity is
suspected, to the Federal Bureau of Investigation. Such entities are
required to use Form X-17F-1A to make such reports. Filing these
reports fulfills a statutory requirement that reporting institutions
report and inquire about missing, lost, counterfeit, or stolen
securities. Since these reports are compiled in a central database, the
rule facilitates reporting institutions to access the database that
stores information for the Lost and Stolen Securities Program.
    We estimate that 26,000 reporting institutions will report that
securities certificates are either missing, lost, counterfeit, or
stolen annually and that each reporting institution will submit this
report 50 times each year. The staff estimates that the average amount
of time necessary to comply with Rule 17f-1(c) and Form X17F-1A is five
minutes per submission. The total burden is 108,333 hours annually for
the entire industry (26,000 times 50 times 5 divided by 60).
    Rule 17f-1(c) is a reporting rule and does not specify a retention
period. The rule requires an incident-based reporting requirement by
the reporting institutions when securities certificates are discovered
to be missing, lost, counterfeit, or stolen. Registering under Rule
17f-1(c) is mandatory to obtain the benefit of a central database that
stores information about missing, lost, counterfeit, or stolen
securities for the Lost and Stolen Securities Program. Reporting
institutions required to register under Rule 17f-1(c) will not be kept
confidential; however, the Lost and Stolen Securities Program database
will be kept confidential.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget (OMB) control number.
    Background documentation for this information collection may be
viewed at the following Web site: www.reginfo.gov. Comments should be
directed to: (i) Desk Officer for the Securities and Exchange
Commission,

Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10102, New Executive Office Building, Washington, DC 20503
or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas
Bayer, Director/Chief Information Officer, Securities and Exchange
Commission, c/o Remi Pavlik-Simon, 6432 General Green Way, Alexandria,
VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be
submitted within 30 days of this notice.

    Dated: October 29, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-27132 Filed 11-6-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3729-3731]
[DOCID:fr22ja08-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2008N-0005]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical Current Good
Manufacturing Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information resulting from the guidance to manufacturers of veterinary
and human drugs, including human biological drug products, on how to
resolve disputes of scientific and technical issues relating to current
good manufacturing practice (CGMP).

DATES: Submit written or electronic comments on the collection of
information by March 24, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical Current Good Manufacturing
Practice--(OMB Control Number 0910-0563)--Extension

    The guidance is intended to provide information to manufacturers of
veterinary and human drugs, including human biological drug products,
on how to resolve disputes of scientific and technical issues relating
to CGMP. Disputes related to scientific and technical issues may arise
during FDA inspections of pharmaceutical manufacturers to determine
compliance with CGMP requirements, or during FDA's assessment of
corrective actions undertaken as a result of such inspections. The
guidance provides procedures that encourage open and prompt discussion
of disputes and lead to their resolution. The guidance describes
procedures for raising such disputes to the Office of Regulatory
Affairs (ORA) and center levels and for requesting review by the
dispute resolution (DR) Panel (the DR Panel).
    When a scientific or technical issue arises during an FDA
inspection, the manufacturer should initially attempt to reach
agreement on the issue informally with the investigator. Certain
scientific or technical issues may be too complex or time-consuming to
resolve during the inspection. If resolution of a scientific or
technical issue is not accomplished through informal mechanisms prior
to the issuance of Form FDA 483, the manufacturer can formally request
DR and can use the formal two-tiered DR process described in the
guidance.
    Tier-one of the formal DR process involves scientific or technical
issues raised by a manufacturer to the ORA and center levels. If a
manufacturer disagrees with the tier-one decision, tier two of the
formal DR process would then be available for appealing that decision
to the DR Panel.
    The written request for formal DR to the appropriate ORA unit
should be made within 30 days of the completion of an inspection, and
should include all supporting documentation and arguments for review,
as described below. The written request for formal DR to the DR Panel
should be made within 60 days of receipt of the tier-one decision, and
should include all supporting documentation and arguments, as described
in the following paragraphs.
    All requests for formal DR should be in writing and include
adequate information to explain the nature of the dispute and to allow
FDA to act quickly and efficiently. Each request should be sent to the
appropriate address listed in the guidance and include the following:
     Cover sheet that clearly identifies the submission as
either a request for tier-one DR or a request for tier-two DR;
     Name and address of manufacturer inspected (from Form FDA
483);
     Date of inspection (from Form FDA 483);
     Date the Form FDA 483 issued (from Form FDA 483);
     FEI Number, if available (from Form FDA 483);
     FDA employee names and titles that conducted inspection
(from Form FDA 483);
     Office responsible for the inspection, e.g., district
office (from Form FDA 483);
     Application number if the inspection was a preapproval
inspection;
     Comprehensive statement of each issue to be resolved:
     Identify the observation in dispute.
    [ctrcir] Clearly present the manufacturer's scientific position or
rationale concerning the issue under dispute with any supporting data.
    [ctrcir] State the steps that have been taken to resolve the
dispute, including any informal DR that may have occurred before the
issuance of Form FDA 483.
    [ctrcir] Identify possible solutions.
    [ctrcir] State expected outcome.
     Name, title, telephone and fax number, and e-mail address
(as available) of manufacturer contact.
    The guidance was part of the FDA initiative ``Pharmaceutical cGMPs
for the 21st Century: A Risk-Based Approach,'' which was announced in
August 2002. The initiative focuses on FDA's current CGMP program and
covers the manufacture of veterinary and human drugs, including human
biological drug products. The agency formed the Dispute Resolution
Working Group comprising representatives from ORA, the Center for Drug
Evaluation and Research (CDER), the Center for Biologics Evaluation and
Research (CBER), and the Center for Veterinary Medicine (CVM). The
working group met weekly on issues related to the DR process and met
with stakeholders in December 2002 to seek their input.
    The guidance was initiated in response to industry's request for a
formal DR process to resolve differences

related to scientific and technical issues that arise between
investigators and pharmaceutical manufacturers during FDA inspections
of foreign and domestic manufacturers. In addition to encouraging
manufacturers to use currently available DR processes, the guidance
describes the formal two-tiered DR process explained above. The
guidance also covers the following topics.
     The suitability of certain issues for the formal DR
process, including examples of some issues with a discussion of their
appropriateness for the DR process.
     Instructions on how to submit requests for formal DR and a
list of the supporting information that should accompany these
requests.
     Public availability of decisions reached during the
dispute resolution process to promote consistent application and
interpretation of drug quality-related regulations.
    Description of Respondents: Pharmaceutical manufacturers of
veterinary and human drug products and human biological drug products.
    Burden Estimate: Based on the number of requests for tier-one and
tier-two DR received by FDA since the guidance published in January
2006, FDA estimates that approximately two manufacturers will submit
approximately two requests annually for a tier-one DR, and that there
will be one appeal of these requests to the DR Panel (request for tier-
two DR). FDA estimates that it will take manufacturers approximately 30
hours to prepare and submit each request for a tier-one DR, and
approximately 8 hours to prepare and submit each request for a tier-two
DR. Table 1 of this document provides an estimate of the annual
reporting burden for requests for tier-one and tier-two DRs.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
                      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for Tier-                 2                  1                  2                 30                 60
 One DR
----------------------------------------------------------------------------------------------------------------
Requests for Tier-                 1                  1                  1                  8                  8
 Two DR
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................                 68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through the FDMS only.

    Dated: January 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1004 Filed 1-18-08; 8:45 am]

BILLING CODE 4160-01-S


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

General Comment:Supplement No. 2 to Application of Vision Airlines, Inc.