[Federal Register Volume 86, Number 89 (Tuesday, May 11, 2021)]
[Notices]
[Pages 25911-25913]
[FR Doc No: 2021-09882]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91773; File No. SR-BX-2021-019]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Delay the
Implementation of BX's Rule Amendment To Limit Short Term Options
Series Intervals to July 1, 2021

May 5, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 22, 2021, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to delay the implementation of BX's rule
amendment to limit Short Term Options Series intervals between strikes
which

are available for quoting and trading from ``prior to June 30, 2021''
to ``July 1, 2021.''
    The Exchange also proposes a small amendment to the table within
Supplementary Material .07 to Options 4, Section 5 to add a ``greater
than'' to the table.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    BX received approval \3\ to amend the Short Term Options Series
program, within Options 4, Section 5, ``Series of Options Contracts
Open for Trading,'' to limit the intervals between strikes for multiply
listed equity options classes that have an expiration date more than
twenty-one days from the listing date. At this time, BX proposes to
delay the implementation of BX's rule amendment to limit Short Term
Options Series intervals between strikes which are available for
quoting and trading from ``prior to June 30, 2021'' to ``July 1,
2021.'' The Exchange also proposes a small amendment to the table
within Supplementary Material .07 to Options 4, Section 5 to add a
``greater than'' to the table.
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    \3\ See Securities Exchange Act Release No. 91125 (February 12,
2021), 86 FR 10375 (February 19, 2021) (SR-BX-2020-032) (Notice of
Filing of Amendment No. 1 and Order Granting Accelerated Approval of
Proposed Rule Change, as Modified by Amendment No. 1, To Amend
Options 4, Section 5, To Limit Short Term Options Series Intervals
Between Strikes That Are Available for Quoting and Trading on BX).
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Background
    Once implemented, BX's amendment to Options 4, Section 5 will limit
the intervals between strikes in options listed as part of the Short
Term Option Series program that have an expiration date more than
twenty-one days from the listing date. Specifically, BX will limit the
intervals between strikes by utilizing the table within Supplementary
Material .07 of Options 4, Section 5 for expiration dates of option
series beyond twenty-one days.\4\
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    \4\ The table considers both the share price and average daily
volume for the option series.
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Implementation
    First, the Exchange proposes to amend the implementation date to
limit Short Term Options Series intervals between strikes which was
proposed within its Amendment No. 1 to SR-BX-2020-032.\5\ The Exchange
proposes to amend the date from ``prior to June 30, 2021'' to ``July 1,
2021.'' The Exchange will issue an Options Trader Alert to Participants
with the date of implementation.
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    \5\ See supra note 3.
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Proposal
    Second, the Exchange proposes a small amendment to the table within
Supplementary Material .07 to Options 4, Section 5. The Exchange
proposes to capitalize the word ``greater'' in Tier 1 and add the words
``Greater than'' within Tier 2. As proposed the table would appear as
follows:

                                                                       Share Price
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                $25 to less     $75 to less    $150 to less       $500 or
                 Tier                         Average daily volume         Less than $25     than $75        than $150       than $500        greater
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.....................................  Greater than 5,000..............           $0.50           $1.00           $1.00           $5.00           $5.00
2.....................................  Greater than 1,000 to 5,000.....            1.00            1.00            1.00            5.00           10.00
3.....................................  0 to 1,000......................            2.50            5.00            5.00            5.00           10.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

This non-substantive amendment is intended to bring greater clarity to
BX's rule.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by delaying the implementation to limit the intervals between strikes
for multiply listed equity options classes within the Short Term
Options Series program to allow the Exchange additional time to
implement related functionality. The Exchange notes that the delay is
one day after the time period of the initial planned implementation.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    BX's proposed amendment to the table within Supplementary Material
.07 to Options 4, Section 5 is consistent with the Act because it
clarifies the tiers by adding the words ``greater than'' to Tier 2. The
amendment will bring greater clarity to the Exchange's rule.

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 not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
delay the implementation to limit the intervals between strikes for
multiply listed equity options classes within the Short Term Options
Series program does not impose an undue burden on competition. The
delay allows the Exchange additional time to implement related
functionality. Also, the delay is one day after the time period of the
initial planned implementation.
    The proposed amendment to the table within Supplementary Material
.07 to Options 4, Section 5 does not impose an undue burden on
competition. The amendment will bring greater clarity to the Exchange's
rule.

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

    No written comments were either solicited or received.

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) \8\ of the Act and Rule 19b-4(f)(6) thereunder.\9\
Because the foregoing proposed rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A)(iii) of the Act and subparagraph (f)(6) of Rule
19b-4 thereunder.\10\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of its intent to file the
proposed rule change at least five business days prior to the date
of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2021-019 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2021-019. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2021-019, and should be submitted on
or before June 1, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09882 Filed 5-10-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Rules and Regulations]
[Pages 40490-40492]
[FR Doc No: 2012-16698]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0129; Airspace Docket No. 12-AWA-3]
RIN 2120-AA66

Revocation and Modification of Multiple Domestic, Alaskan, and
Hawaiian Compulsory Reporting Points

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action removes eighteen Domestic and Alaskan compulsory
reporting points defined by navigation aids previously decommissioned,
removed, or shutdown and taken out of the FAA aeronautical database as
compulsory reporting points. Additionally, this action also requires
changes to the name of four navigation aids that define associated
compulsory reporting points. The FAA is removing the outdated Part 71
compulsory reporting points since they are no longer valid, and
amending those Part 71 compulsory reporting points that require name
changes, to be consistent with the FAA's aeronautical database.

DATES: Effective date 0901 UTC July 10, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    After a recent review of aeronautical data, the National Flight
Data Center (NFDC) identified eighteen compulsory reporting points,
defined by navigation aids, listed in FAA Order (FAAO) 7400.9, Airspace
Designations and Reporting Points that are no longer valid and are not
contained in the FAA's aeronautical database as reporting points. The
reporting points included five Domestic Reporting Points, ten Alaskan
Low Altitude Reporting Points, and three Alaskan High Altitude
Reporting Points. Additionally, NFDC identified four other reporting
points that require updates to match the current navigation aid name
that defines the reporting point, as reflected in the aeronautical
database. These include two Alaskan Low Altitude Reporting Points, one
Alaskan High Altitude Reporting Point, and one Hawaiian Reporting
Point.
    No regulatory actions were taken when the navigation aids, which
define these compulsory reporting points, were removed or renamed in
the FAA aeronautical database. To overcome confusion and remove flight
safety issues associated with publishing outdated compulsory reporting
point information, the FAA is removing

eighteen reporting points, from Part 71, and FAAO 7400.9. Also, the FAA
is updating the names of four reporting points, in Part 71, and FAAO
7400.9. Accordingly, since this is an administrative change and simply
brings current regulations in concert with the FAA's aeronautical
database, notice and public procedures under Title 5 U.S.C. 553(b) are
unnecessary.

The Rule

    The FAA amends Title 14 Code of Federal Regulations (14 CFR) part
71 by removing five Domestic Reporting Points, ten Alaskan Low Altitude
Reporting Points, and three Alaskan High Altitude Reporting Points.
Specifically, the FAA removes Blue Ridge, TX, Gunnison, CO, Lewistown,
MT, and Ukiah, CA, Domestic Low Altitude Reporting Points; the Ramey,
PR, listed in Other Domestic Reporting Points; Adak NDB, AK, Barter
Island NDB, AK, Farewell NDB, AK, Hinchinbrook NDB, AK, Julius NDB, AK,
Oliktok NDB, AK, Puntilla Lake NDB, AK, Shemya NDB, AK, Umiat NDB, AK,
and Wessels NDB, AK, Alaskan Low Altitude Reporting Points; and Adak
NDB, AK, Barter Island NDB, AK, and Prudhoe Bay NDB, AK, Alaskan High
Altitude Reporting Points.
    This action also amends 14 CFR part 71 by updating the names of two
Alaskan low altitude reporting points, one Alaskan high altitude
reporting point, and one Hawaiian reporting point to match the
navigation aid names that define the reporting points. Specifically,
the FAA amends ``Chandalar NDB, AK,'' to ``Chandalar Lake, AK,'' and
``Glenallen NDB, AK,'' to ``Glennallen, AK,'' in the Alaskan Low
Altitude Reporting Points; ``St Paul NDB, AK,'' to ``St Paul Island,
AK,'' in the Alaskan High Altitude Reporting Points; and ``Upolu, HI,''
to ``Upolu Point, HI,'' in the Hawaiian Reporting Points.
    Domestic Low Altitude Reporting Points, Other Domestic Reporting
Points designated at all altitudes, Alaskan Low Altitude Reporting
Points, Alaskan High Altitude Reporting Points, and Hawaiian Reporting
Points are listed in paragraph 7001, 7003, 7004, 7005 and 7006,
respectively of FAA Order 7400.9V dated August 9, 2011, and effective
September 15, 2011, which is incorporated by reference in 14 CFR 71.1.
The reporting points listed in this document will be revised
subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it removes Domestic, Alaskan, and Hawaiian Reporting Points
contained in the NAS.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with 311a, FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures.'' This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V,
Airspace Designations and Reporting Points, signed August 9, 2011, and
effective September 15, 2011, is amended as follows:

Paragraph 7001 Domestic low altitude reporting points.

* * * * *

Blue Ridge, TX [Removed]

* * * * *

Gunnison, CO [Removed]

* * * * *

Lewistown, MT [Removed]

* * * * *

Ukiah, CA [Removed]

* * * * *

Paragraph 7003 Other domestic reporting points.

* * * * *

Ramey, PR [Removed]

* * * * *

Paragraph 7004 Alaskan low altitude reporting points.

Adak NDB, AK [Removed]

* * * * *

Barter Island NDB, AK [Removed]

* * * * *

Chandalar NDB, AK [Removed]

Chandalar Lake, AK [New]

* * * * *

Farewell NDB, AK [Removed]

* * * * *

Glenallen NDB, AK [Removed]

Glennallen, AK [New]

* * * * *

Hinchinbrook NDB, AK [Removed]

* * * * *

Julius NDB, AK [Removed]

* * * * *

Oliktok NDB, AK [Removed]

* * * * *

Puntilla Lake NDB, AK [Removed]

* * * * *

Shemya NDB, AK [Removed]

* * * * *

Umiat NDB, AK [Removed]

* * * * *

Wessels NDB, AK [Removed]

* * * * *

Paragraph 7005 Alaskan high altitude reporting points.

Adak NDB, AK [Removed]

* * * * *

Barter Island NDB, AK [Removed]

* * * * *

Prudhoe Bay NDB, AK [Removed]

* * * * *

St Paul NDB, AK [Removed]

St Paul Island, AK [New]

* * * * *

Paragraph 7006 Hawaiian reporting points.

* * * * *

Upolu, HI [Removed]

Upolu Point, HI [New]

    Issued in Washington, DC, June 28, 2012.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2012-16698 Filed 7-9-12; 8:45 am]
BILLING CODE 4910-13-P


DRAFT Page 1 of 1 12/ 20/ 2004 U. S. EPA BOARD OF SCIENTIFIC COUNSELORS Endocrine Disrupting Chemicals Subcommittee DRAFT MEETING AGENDA January 6, 2005 12: 00 pm   2: 00 pm EST CONFERENCE CALL Participation by Teleconference Only Thursday, January 6, 2005 12: 00 12: 10 pm Welcome Dr. Anna Harding  Summary of Subcommittee Activities Chair, EDC Subcommittee  Agenda for this Conference Call 12: 10 12: 15 pm Administrative Issues Dr. Neil Stiber ( EPA)  FACA, Time Sheets, etc. DFO, EDC Subcommittee 12: 15 1: 50 pm Preparation of Draft Final Report for Dr. Anna Harding Deliberation by BOSC Executive Committee  Additions and Revisions Needed  Writing and Editing Assignments 1: 50 2: 00 pm Public Comments ( if needed)

2: 00 pm Adjourn


MEMORANDUM

DATE:	4/4/00

SUBJECT:	PP#5F4469.  Prosulfuron in or on Cereal Grains (Except Rice)
and Animal Commodities.  Submissions Dated 12/22/97 Addressing Residue
Chemistry Deficiencies in Establishing Permanent Tolerances.

MRID#s 444492-04 thru -07.

DP Barcode: D242049.

Trade Name: EXCEED Herbicide (Reg.# 100-774)

PEAK Herbicide (Reg.# 100-763)

Class: Herbicide

Chemical: 129031.

Case: 014396.

40 CFR: 180.481.

TO:		James Stone/Jim Tompkins, P.M. Team 25

Herbicide Branch

Registration Division (7505C)

FROM:	G. Jeffrey Herndon, Chemist

RAB2/HED (7509C)

THRU:	Richard Loranger, Branch Senior Scientist

RAB2/HED (7509C)

BACKGROUND

Ciba-Geigy (now Novartis) had previously submitted an application for
tolerances for prosulfuron
(1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenyl
sulfonyl]-urea) and registration for Peak Herbicide on cereal grains
(except rice).  In PP#5F04469, the petitioner proposed the following
tolerances (expressed as parent only):

Cereal grains (except rice)         --  0.01 ppm

Cereal grains (except rice) forage  --  0.10 ppm

Cereal grains (except rice) fodder  --  0.01 ppm

Cereal grains (except rice) straw   --  0.02 ppm

Cereal grains (except rice) hay     --  0.20 ppm

Prior to PP#5F4469, in PP#4F04336, the petitioner proposed the following
tolerances (also expressed as parent only):

Corn, Forage   --   0.01 ppm  |  Corn, Fodder   --   0.01 ppm

Corn, Grain    --   0.01 ppm  |  Corn, K+CWHR   --   0.01 ppm

Milk           --   0.01 ppm  |

Meat, Fat, Kidney, Liver & Meat By-Products*    --    0.05 ppm

*of cattle, goats, horses, hogs and sheep

These tolerances were established on a time-limited  basis under 40 CFR
§ 180.481 pending resolution of the deficiencies outlined in the G.
Kramer review of 10/29/96.

RECOMMENDATIONS

For the purposes of this Section 3 registration of prosulfuron on cereal
grains, the residue chemistry requirements have been met.  The
tolerances proposed under PP#5F4469 by the registrant for parent
prosulfuron are appropriate.  The tolerances proposed under PP#4F4336
(corn and the animal commodity tolerances) should NOT be reestablished -
the corn tolerances are covered by the cereal grain tolerances and
animal commodity tolerances were determined to be unnecessary
[180.6(a)(3)].

Any risk issues will be addressed in the human health risk assessment,
which will be the subject of a forthcoming memo by HED.

	DETAILED CONSIDERATIONS

The following Deficiencies/Conclusions were cited by CBTS in the memo of
G.F. Kramer dated 10/29/96, concerning PP#4F4336 and 5F4469.

Deficiency 2a through f

The following deficiencies must be resolved before the nature of the
residue in corn can be considered to be understood: a) Storage
Stability- As the actual dates of sample extraction and analysis were
not provided for the field-grown samples, the sample storage interval
and state (i.e., homogenates or extracts) could not be determined.
Analysis of greenhouse-grown samples within 4 months of harvest
demonstrated substantial differences when compared to the
field-grown-samples.  These differences could be explained by
degradation of prosulfuron, CGA-300408 and hydroxylation of CGA-159902
to CGA-304060.  In order to resolve this issue, the registrant should
provide the dates of sample extraction and analysis.  The
greenhouse-grown samples (homogenates or extracts, as appropriate)
should then be reanalyzed after storage for an interval equal to or
greater than that which the field-grown samples were stored.  b)
Bridge-intact metabolites A-13 and O-6 comprised >10% of the TRR in
forage and silage.  The maximum amounts of these metabolites was below
the 0.05 ppm trigger for metabolite identification (0.013 ppm for A-13
and 0.012 ppm for O-6).  However, as these studies were performed at 1X
rather than at an exaggerated rate as required by Agency guidelines,
CBTS is requiring that the registrant identify these metabolites.  c)
During characterization of the bound residues of the field-grown stalk
samples, >10% of the TRR was released into the cellulase and NaOH
supernatants.  However, no metabolite identification of these fractions
was reported.  CBTS requests that the registrant provide the results of
analysis of these samples (i.e., HPLC and 2-D TLC).  d) The
chromatographic data for the analysis of several fractions released from
bound residues were provided.  CBTS requests that the registrant provide
a quantitative analysis of this data.  e) Metabolites CGA-188838 and
G-28533 coeluted on HPLC so that the quantitative data was reported for
a combined total of both compounds.  CBTS requests that the registrant
provide data for these metabolites individually either by quantitative
analysis of existing 2-D TLC chromatograms in which separation was
achieved or by reanalysis of the samples using HPLC methods capable off
achieving separation.  f) The phenyl-specific metabolite CGA-304060
(both free and glucose-conjugated) was found in the triazine-labelled
samples of the field study.  The registrant should provide an
explanation for this result.

Registrant's Response to Deficiency 2

Novartis Submitted the following studies to address these deficiencies:

“Uptake and Metabolism of CGA-152005 in Field Grown Corn After Spray
Treatment with Phenyl-14C-CGA-152005 and Triazine-14C-CGA-152005,
Amendment 1", R. Rezaaiyan, 5/21/97, MRID# 444492-04.

and

“Stability of CGA-152005 Metabolites in Greenhouse Grown Corn After
Spray Treatment with Phenyl-14C-CGA-152005 and Triazine-14C-CGA-152005,
Amendment 2", R. Rezaaiyan, 5/21/97, MRID# 444492-05.

Storage Stability

Novartis provided actual dates for the sample extraction and analysis of
field grown 30-day corn forage, corn silage, and corn stalks.  The
samples were stored in a freezer between 6 and  12 months before they
were analyzed.  To address the potential degradation of the stored
samples, Novartis conducted 2 studies.

The first study (MRID# 444492-05) was a new greenhouse-conducted study
in which resulting homogenates were extracted and analyzed immediately
after harvest and again after 14 months of storage in the freezer
(-20oC), an interval greater than that which the field grown samples
were stored.

Subsamples of 45-day silage stage corn were extracted 13 and 398 days
after harvest.  The amount extractable was 87.5% and 83.1%,
respectively.  A second set of subsamples of 45-day silage stage corn
were extracted 13 and 397 days after harvest.  The amount extractable
was 84.9% and 87.6%, respectively.  Each extract was partitioned with
ethyl acetate.  The organic and aqueous fractions from the extracts were
analyzed by HPLC.  HPLC recoveries ranged from 70% to 95%.  HPLC
profiles of the organic and aqueous fractions were qualitatively and
quantitatively similar, indicating CGA-152005 and its metabolites are
stable in frozen silage stage corn homogenates for a period of about 13
months.

Subsamples of mature corn stalks were extracted 9 and 406 days after
harvest.  The amount extractable was 79.3% and 77.4%, respectively.  A
second set of subsamples of mature corn stalks were extracted 9 and 401
days after harvest.  The amount extractable was 81.6% and 73.3%,
respectively.  Each extract was partitioned with ethyl acetate.  The
organic and aqueous fractions from the extracts were analyzed by HPLC.
HPLC recoveries ranged from 79% to 99%.  HPLC profiles of the organic
and aqueous fractions were qualitatively and quantitatively similar,
indicating CGA-152005 and its metabolites are stable in frozen mature
corn stalk homogenates for a period of 13+ months.

In the second study (MRID# 444492-04), several field grown corn samples
were reextracted for identification purposes.  Comparison of HPLC
profiles from these samples were used to show that CGA-152005 and its
metabolites are stable in corn homogenates.

Subsamples of 30-day corn forage were extracted 7.4 and 44 months after
harvest.  The amount extractable was 83.1% and 78.8%, respectively.  The
aqueous fractions after ethyl acetate partition were analyzed by HPLC.
Comparison of HPLC quantitation showed quantitative variances in
composition, particularly of the latest eluting region A-15.  However,
Novartis concluded that the qualitative nature of the CGA-152005
residues was preserved during the freezer storage condition employed in
this study.

Subsamples of corn silage were extracted 10.7 and 44 months after
harvest.  The amount extractable was 79.1% and 70.3%, respectively.  The
aqueous fractions after ethyl acetate partition were analyzed by HPLC.
The HPLC profiles were qualitatively and quantitatively similar, showing
the stability of CGA-152005 and its metabolites in frozen corn silage
homogenates.

Additional Metabolite Characterization/Identification/Quantitation

Metabolites in regions [A-1], [A-13], and [O-6] were isolated and
purified.  Mass spectral analysis of the metabolites in regions [A-13]
and [O-6] confirmed that [O-6] is the aglycone of [A-13] and region
[A-13] is the glucose conjugate of hydroxy CGA-325030.  Region [A-1] was
separated into 2 peaks by HPLC and identified as G-28533 (10.2% TRR) and
CGA-188838 (12.2% TRR).  These structures are shown in the memo of G.
Kramer dated 2/22/95, concerning PP#4F4336.

Quantitation of Released Radioactivity from Bound Residues

Data were provided which show that all the released metabolites from
bound residue were less than or equal to 0.002 ppm.

RAB2's Comments and Conclusions Concerning Deficiency 2

The additional storage stability data and metabolite
characterization/identification/quantitation data submitted resolves the
questions/deficiencies surrounding the corn metabolism study.  The corn
metabolism study is now complete and acceptable.  Deficiency 2 has been
resolved.

Deficiency 3a and b

For the ruminant metabolism study, CBTS requests that the registrant :
a) Provide the actual dates of sample extraction and analysis for the
samples; b) If samples were stored longer than 6 months, provide further
evidence of storage stability.  If analysis were not performed within 6
months of collection, then CBTS is willing to consider storage data for
the parent compound in animal RACs, as prosulfuron was the predominant
residue in milk and tissue samples.

Registrant's Response to Deficiency 3

Novartis Submitted the following studies to address this deficiency:

“Response to EPA Review of Prosulfuron: Nature of the Residue in Corn
and Ruminants", 10/23/97, MRID# 444492-06.

and

“Stability of CGA-152005 Fortified into Meat, Milk, and Eggs Under
Freezer Storage Conditions", L. Eudy, 4/30/97, MRID# 444492-07.

Novartis provided actual dates from the goat metabolism study for the
goat sacrifice, extraction of samples, and analysis of samples.  Samples
were held up to 27 months from slaughter to analysis.  Novartis had
previously shown that CGA-152005 and CGA-273437 were stable in goat
liver for 8 months and that CGA-152005, CGA-273437, and CGA-150829 were
stable in milk for 17 months.

In order to address the stability of prosulfuron (CGA-152005) over
longer frozen intervals, Novartis conducted a separate storage stability
study using cold (non-radiolabeled) prosulfuron spiked into samples of
beef muscle, beef liver, milk, and eggs.  The samples were stored frozen
for a period of 25 months (16 months for the egg samples) and analyzed.
Storage stability recoveries corrected for procedural recoveries
indicated no degradation over the intervals tested (essentially 0%
degradation).

RAB2 Comments and Conclusions Concerning Deficiency 3

The additional storage stability data submitted resolves the
questions/deficiencies surrounding the goat metabolism study.  The goat
metabolism study is now complete and acceptable.  Deficiency 3 has been
resolved.

Deficiency 4

CBTS will refer to the Metabolism Committee on the toxicological
significance of metabolites once the deficiencies associated with plant
metabolism have been addressed.  A decision by CBTS concerning which
residues to regulate will then follow.  A tolerance based on the parent
only may not be appropriate; in such an instance a revised Section F and
additional field studies, analytical methodology, animal feeding studies
and storage stability data may be needed.

Registrant’s Response to Deficiency 4

None

RAB2's Comments and Conclusions Concerning Deficiency 4

Prosulfuron has not been presented to the Metabolism Assessment Review
Committee (MARC).  Based in a 1X radiolabeled corn metabolism study, the
TRR of all direct human food items was below the limit of detection (TRR
in corn grain from the phenyl-labeled prosulfuron was < 0.002 ppm, from
the triazine-labeled prosulfuron was < 0.003 ppm).  Therefore, no
metabolites (either singly or in combination) would be expected to be
found in corn grain at levels above 0.003 ppm.

In the animal (goat and hen) metabolism studies, a majority of the
radioactivity was identified as unchanged prosulfuron (60-90% TRR in
tissues/milk of goats and 65-94% TRR in tissues/egg white of hens).
Based on the cow and chicken feeding studies, meat, milk, poultry, and
egg tolerances were determined to not be required (Category 180.6(a)(3)
- see memo of G. Kramer dated 2/22/95).

RAB2 performed a “worst-case” risk assessment from the use of
prosulfuron on cereal grains.  The assessment was performed using TRR
values from the corn metabolism study, 100% crop treated, and the
toxicological endpoints chosen by Hazard Identification Assessment
Review Committee (report dated 1/24/00) coupled with the FQPA factor (3X
- FQPA Safety Factor Committee, report dated 2/10/00).  The maximum
acute dietary risk was a maximum of 6 % of the aPAD and 2 % of the cPAD
for any population of concern.  The inputs used in these risk
assessments will be outlined in a forthcoming Dietary Exposure memo.

Based on the above information coupled with the regulation of most
sulfonyl-urea herbicides as parent only (9 out of 12), prosulfuron will
be regulated as parent only in cereal grains.  If, in the future, new
uses require the submission of new metabolism data which show detectable
residues on direct human foods, or the livestock dietary burden is
increased enough to remove prosulfuron from category 180.6(a)(3), then
MARC may need to make a call as to the residue to be regulated.

For the proposed use of prosulfuron on cereal grains, Deficiency 4 has
been resolved.

Deficiency 5

ACL reports that the prosulfuron standard is not available from the EPA
repository in RTP.  The petitioner should submit standards of
prosulfuron to the EPA repository in RTP along with the MSDS and then
provide CBTS with the Repository ordering codes.  Until the receipt of
the standard and MSDS and ordering codes, the requirements for
analytical enforcement methodology will remain unfulfilled.

Registrant’s Response to Deficiency 5

None

RAB2's Comments and Conclusions Concerning Deficiency 5

A prosulfuron standard is available from the Ft. Meade laboratory
(personal communication between Chuck Stafford and Jeffrey Herndon on
3/15/00).  Deficiency 5 has been resolved.

Deficiency 7

HED notes that the Food Quality Protection Act of 1996 has amended and
strengthened the standard for establishing tolerances under the FFDCA.
OPP is still assessing the full impact of this change in the law on the
tolerance-setting process and plans to issue guidelines concerning the
establishment of tolerances under the amended statute.  All tolerance
petitions have to meet the requirements of the FFDCA as amended by the
FQPA and OPP may require additional data to determine if the terms of
the amended statute are met.

Registrant’s Response to Deficiency 7

None

RAB2's Comments and Conclusions Concerning Deficiency 7

The implementation of FQPA has not affected the residue chemistry
conclusions in PP#4F4336 and PP#5F4469.  However, FQPA considerations
may affect the human health risk assessment (to be completed in the near
future) and therefore, the establishment of the tolerances proposed in
PP#4F4336 and PP#5F4469.  Deficiency 7 has been resolved.

cc:  PP#s 4F04336, PP#5F04469, RAB2 RF, Herndon.

 Of the %TRR in egg yolk, only 23% was identified as prosulfuron.

 PAGE  2


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

General Comment:I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I smoked tobacco for 45 years and over that past ten years have stop smoking with the aid of  gum, patches and pills and until I discovered e-cigarettes I continued to smoke.  I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions for you to take my comment into account. I understand that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.


[Federal Register Volume 84, Number 167 (Wednesday, August 28, 2019)]
[Notices]
[Pages 45209-45212]
[FR Doc No: 2019-18487]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0082]

Agency Information Collection Activities; Notice and Request for
Comment; Drivers' Use of Camera-Based Rear Visibility Systems Versus
Traditional Mirrors

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments on a proposed collection of
information.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
announces our intention to request the Office of Management and
Budget's (OMB) approval of a proposed collection of certain information
by the Agency. Before a Federal agency can collect certain information
from the public, it must receive approval from OMB. Procedures
established under the Paperwork Reduction Act of 1995 (the PRA) require
Federal agencies to publish a notice in the Federal Register concerning
each proposed collection of

information and to allow 60 days for public comment in response to the
notice. The proposed collection of information supports research
addressing safety-related aspects of drivers' use of camera-based rear
visibility systems intended to serve as a replacement for traditional
outside rearview mirrors.

DATES: Comments must be received on or before October 28, 2019.

ADDRESSES: You may submit comments identified by the docket number in
the heading of this document or by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments on
the electronic docket site by clicking on ``Help'' or ``FAQ''.
     Mail: Docket Management Facility. M-30, U.S Department of
Transportation. 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590.
     Hand Delivery: U.S Department of Transportation, 1200 New
Jersey Avenue SE, West Building, Ground Floor, Room W12-140,
Washington, DC 20590 between 9 a.m. and 5 p.m. Eastern Time, Monday
through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Each submission must include the Agency name and the
Docket number for this Notice. Note that all comments received will be
posted without change to www.regulations.gov, including any personal
information provided. Please see the Privacy heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://www.dot.gov/privacy.html .
    Docket: For access to the docket to read comments received, go to
http://www.regulations.gov, or the street address listed above. Follow
the online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Elizabeth Mazzae, Applied Crash
Avoidance Research Division, Vehicle Research and Test Center, NHTSA,
10820 State Route 347--Bldg. 60, East Liberty, Ohio 43319; Telephone
(937) 666-4511; Facsimile:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520), before an agency submits a proposed collection
of information to OMB for approval, it must first publish a document in
the Federal Register providing a 60-day comment period and otherwise
consult with members of the public and affected agencies concerning
each proposed collection of information. The OMB has promulgated
regulations describing what must be included in such a document. Under
OMB's regulation (at 5 CFR 1320.8(d)), an agency must ask for public
comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collection of information:
    Title: Drivers' Use of Camera-Based Rear Visibility Systems Versus
Traditional Mirrors.
    Type of Request: New collection.
    Type of Review Requested: Regular.
    OMB Clearance Number: New Collection.
    Form Number: None.
    Requested Expiration Date of Approval: Three years from date of
approval.
    Summary of the Collection of Information:
    NHTSA proposes to perform research involving the collection of
information from the public as part of a multi-year effort to learn
about drivers' use of camera-based systems designed to replace
traditional outside rearview mirrors. Initial research will focus on
light vehicles and be followed by research examining camera-based
visibility systems on heavy trucks.
    For the light vehicle research, all camera-based visibility systems
to be tested will be foreign production or prototype systems fitted
onto U.S. or European specification vehicles. At least two test
vehicles will be equipped with both camera and mirror technologies,
while the other test vehicles will be equipped with camera-based
visibility systems and no outside mirrors. Systems to be tested with
heavy trucks have yet to be finalized.
    Research participants will be members of the public who are
licensed car drivers and/or truck drivers. Participants will drive a
test vehicle equipped with a camera-based system in place of outside
rearview mirrors, an original equipment outside rearview mirror system,
or a combination of both. The research will involve track-based and on-
road, semi-naturalistic driving in which participants will drive
vehicles in multi-lane traffic scenarios while using the outside
rearview mirrors or alternative system during lane changes and other
typical driving situations. A portion of testing will take place in
dark (i.e., nighttime or early morning) driving conditions to permit
examination of system performance and drivers' use of systems in those
conditions. Vehicles will be fitted with instrumentation for recording
driver eye glance behavior, as well as vehicle speed, position,
steering angle, and turn signal status. Separate, but similar data
collections will be conducted for passenger cars and heavy trucks.
Questions will be asked during the course of the research to assess
individuals' suitability for study participation, to obtain feedback
regarding participants' use of the camera-based rear visibility
systems, and to gauge individuals' level of comfort with and confidence
in the technologies' performance and safety.
    Description of the Need for the Information and Proposed Use of the
Information:
    The National Highway Traffic Safety Administration's (NHTSA)
mission is to save lives, prevent injuries, and reduce healthcare and
other economic costs associated with motor vehicle crashes. As new
vehicle technologies are developed, it is prudent to ensure that they
do not create any unintended decrease in safety. The safety of passive
visibility-related technologies depends on both the performance of the
systems and on drivers' ability to effectively and comfortably use the
systems. This work seeks to examine and compare drivers' eye glance
behavior and aspects of driving behavior and lane change maneuver
execution for traditional mirrors and camera-based systems intended to
replace outside rearview mirrors.
    The collection of information will consist of: (1) Question Set 1,
Driving Research Study Interest Response Form, (2) Question Set 2,
Screening Questions,

(3) passive observation of driving behavior, and (4) Question Set 3,
Post-Drive Questionnaire.
    The information to be collected will be used for the following
purposes:
     Question Set 1, Driving Research Study Interest Response
Form will be used to determine individuals' willingness to participate
in the study and whether an individual qualifies for participation in
this study based on certain information. For example, participants
must:
    [cir] Be at least 25 years of age
    [cir] For drivers of passenger cars: Hold a valid U.S. or Canadian
driver's license
    [cir] For drivers of heavy trucks: Hold a valid U.S. commercial
driver's license
    [cir] Drive at least 11,000 miles annually
    [cir] Provide their contact information for the purposes of
coordinating participation.
     Question Set 2, Screening Questions will be primarily used
to ensure that participants meet certain minimum health qualifications,
are free of recent criminal convictions, and have reasonable
availability to participate in the study. The objective of the health
screening questions is to identify candidate participants whose
physical and health conditions may be deemed ``average'' and are
compatible with being able to drive continuously for up to 3 hours a
vehicle equipped with only original equipment components.
     Question Set 3, Post-Drive Questionnaire will be used to
get information about the participants' experiences during the
experimental drive, including their degree of comfort in using the
camera-based system. There will be different versions of the
questionnaire for light vehicle and truck drivers, but both will be
designed to require not more than 15 minutes to complete all questions.
Participants will complete the Question Set 3 post-drive questionnaire
one time for mirrors and one time for the camera-based rear visibility
system.
    Affected Public (Respondents): Research participants will be
licensed drivers aged 25 years or greater who drive at least 11,000
miles annually, are in good health, and do not require assistive
devices to safely operate a vehicle and drive continuously for a period
of 3 hours.
    Estimated Number of Respondents: Information will be collected in
an incremental fashion to permit the determination of which individuals
have the necessary characteristics for study participation. All
interested candidates will complete Question Set 1, Driving Research
Study Interest Response Form. A subset of individuals meeting the
criteria for Question Set 1 will be asked to complete Question Set 2,
Screening Questions. From the individuals found to meet the criteria
for both Questions Sets 1 and 2, a subset will be chosen with the goal
of achieving a sample providing a balance of age and sex to be
scheduled for study participation. A summary of the estimated numbers
of individuals that will complete the noted question sets is provided
in the following table.

                     Estimated Number of Respondents
------------------------------------------------------------------------
                        Questions                             Total N
------------------------------------------------------------------------
Question Set 1, Driving Research Study Interest Response             750
 Form...................................................
Question Set 2, Screening Questions.....................             300
Question Set 3, Post-Drive Questionnaire................             160
------------------------------------------------------------------------

    Estimated Time per Response: Completion of Question Set 1, Driving
Research Study Interest Response Form is estimated to take
approximately 5 minutes and completion is estimated to take
approximately 7 minutes for Question Set 2, Screening Questions.
Completion of Question Set 3, Post-Drive Questionnaire is estimated to
take 15 minutes per participant and each participant will compete the
questionnaire two times. The estimated annual time and cost burdens are
summarized in the table below. The number of respondents and time to
complete each question set are estimated as shown in the table. The
time per question set is calculated by multiplying the number of
respondents by the time per respondent and then converting from minutes
to hours. The hour value for each question set is multiplied by the
latest average hour earning estimate from the Bureau of Labor
Statistics to obtain an estimated burden cost per question set.\1\
---------------------------------------------------------------------------

    \1\ Bureau of Labor Statistics Feb. 2019 Average Hourly Earnings
data for ``Total Private,'' $27.66 (Accessed 3/8/2019 at https://www.bls.gov/news.release/empsit.t19.htm.) The Bureau of Labor
Statistics estimates that for private industry workers, wages
represent 70.1% of total compensation. Employer Costs for Employee
Compensation-March 2019, (Assessed 7/31/2019 at https://www.bls.gov/news.release/pdf/ecec.pdf).

                                                       Estimated Time per Response and Total Time
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Time per
             Question Set                            Topic                 Participants      response       Total time      Total time      Total cost
                                                                                (minutes)       (minutes)        (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1....................................  Driving Research Study Interest               750               5           3,750            62.5       $2,466.12
                                        Response Form.
2....................................  Screening Questions..............             300               7           2,100            35.0        1,381.03
3a...................................  Post-Drive Questionnaire,                      80              30           2,400            40.0        1,578.32
                                        Passenger Vehicle.
3b...................................  Post-Drive Questionnaire, Heavy                80              30           2,400            40.0        1,578.32
                                        Truck.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr------------------------------------------------------------------------------------------------------------------
    Total Estimated Burden..............................................................  ..............  ..............           177.5        7,003.78
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Burden: 177.5 hours.
    Frequency of Collection: The data collection described will be
performed once to obtain the target number of valid test participants.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1.95.

    Issued in Washington, DC.
Tim J. Johnson,
Acting Associate Administrator for Vehicle Safety Research.
[FR Doc. 2019-18487 Filed 8-27-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54720-54722]
[FR Doc No: 2013-21539]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Registration and Financial Security Requirements for Brokers of
Property and Freight Forwarders

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

ACTION: Notice.

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

SUMMARY: FMCSA announces guidance concerning the implementation of
certain provisions of the Moving Ahead for Progress in the 21st Century
Act (MAP-21) concerning persons acting as a broker or a freight
forwarder. Section 32915 of MAP-21 requires anyone acting as a broker
or a freight forwarder and subject to FMCSA jurisdiction, including
motor carriers, to register and obtain broker or freight forwarder
authority from FMCSA. Section 32918 amended the financial security
requirements applicable to property brokers and created new
requirements for freight forwarders. FMCSA provides guidance for
brokers and freight forwarders on how to comply with the new
requirements and information regarding FMCSA's enforcement of these
provisions.

DATES: This guidance is effective October 1, 2013.

FOR FURTHER INFORMATION CONTACT: Jeffrey Secrist or Gerald Folsom,
Office of Registration and Safety Information, Federal Motor Carrier
Safety Administration, 1200 New Jersey Ave. SE., Washington, DC 20590-
0001,<PHONE_NUMBER>/2405 regarding financial security requirements or
Kenneth Rodgers, Office of Enforcement and Compliance, Federal Motor
Carrier Safety Administration, 1200 New Jersey Ave. SE., Washington, DC
20590-0001,<PHONE_NUMBER> regarding enforcement.

SUPPLEMENTARY INFORMATION: On July 6, 2012, the President signed MAP-21
(Pub. L. 112-141, 126 Stat. 405 (2012)) into law, which included a
number of mandatory, non-discretionary changes to FMCSA programs. Some
of these changes amended the financial security requirements applicable
to property brokers and freight forwarders operating under FMCSA's
jurisdiction. Others required motor carriers to register as brokers if
they were also performing brokerage functions. The FMCSA provides
guidance to ensure that all interested parties are aware of the self-
executing statutory provisions that take effect on October 1, 2013, and
how those subject to the requirements can achieve compliance with the
law.

A. General Broker/Freight Forwarder Information

    FMCSA has received a number of requests from motor carriers and
other transportation companies requesting additional information about
when registration as a broker or freight forwarder is required. The
Agency has compiled a list of the most common questions and our
responses and presents the information below in question-and-answer
format.
    Question 1: What is a broker?
    Answer: A broker is a person or an entity that, for compensation,
arranges, or offers to arrange, for the transportation of property by a
motor carrier. A broker does not transport the property and does not
assume responsibility for the property. Although MAP-21 left in place
the previous statutory definition of ``broker,'' which expressly
excludes motor carriers and their agents and employees (49 U.S.C.
13102(2)), the new law separately prohibits motor carriers from
brokering transportation services unless they are registered as a
broker (49 U.S.C. 13902(a)(6)).
    Question 2: What is a freight forwarder?
    Answer: A freight forwarder is a person or entity that holds itself
out to the general public as providing transportation of property for
compensation, and in the ordinary course of its business:
     Assembles and consolidates, or provides for assembling and
consolidating, shipments and performs or provides for break-bulk and
distribution operations of the shipments;
     Assumes responsibility for the transportation from the
place of receipt to the place of destination; and
     Uses for any part of the transportation a rail, motor or
water carrier subject to the jurisdiction of either FMCSA or the
Surface Transportation Board.
    Question 3: Are freight forwarders and brokers required to register
with FMCSA?
    Answer: Yes. Freight forwarders and brokers that are involved in
interstate commerce and subject to FMCSA jurisdiction are required to
register with FMCSA. Freight forwarders that perform both freight
forwarder services and motor carrier services (beyond the scope of
their freight forwarding operations) must register both as freight
forwarders and as motor carriers. Additionally, as noted in Q1 above,
MAP-21 requires motor carriers that broker loads, even occasionally, to
register both as motor carriers and as brokers.
    Question 4: How would a motor carrier that also brokers loads apply
for broker authority?
    Answer: Anyone seeking broker authority must file a Form OP-1 and
submit it to FMCSA. Companies with existing motor carrier authority
should include their current USDOT Number on the OP-1 form but leave
the MC Number field blank. FMCSA will issue a separate MC Number for
the broker authority. While MAP-21 requires FMCSA to establish an
indicator of the type of transportation or service for which the USDOT
registration number is issued, including whether the

registration number is issued for registration of a motor carrier,
freight forwarder, or broker, FMCSA will implement this provision at a
later time.
    Question 5: What is freight interlining?
    Answer: To interline a shipment is to transfer the property between
two or more carriers for movement to its final destination. For
example, where the point of origin of the shipment is Washington, DC,
and the final destination is Los Angeles, CA, Motor Carrier ``A'' may
transport the shipment from Washington, DC, and then interline with
Motor Carrier ``B'' in San Antonio, TX. Motor Carrier ``B'' will then
complete the transportation of the shipment from San Antonio to Los
Angeles.
    Question 6: Does FMCSA require an interline carrier to obtain
operating authority?
    Answer: FMCSA requires all non-exempt for-hire motor carriers to
obtain operating authority to provide transportation in interstate
commerce. However, a motor carrier that is performing part of a single
continuous transportation movement as an interline operation can
perform that service under either (1) its own operating authority or
(2) the authority of the originating motor carrier.
    Question 7: Is a broker required to process loss and damage claims?
    Answer: No. A claim for cargo loss and damage must be filed with
the appropriate motor carrier, which usually would be the originating
carrier responsible for transporting and delivering the freight or the
carrier causing the loss and/or damage to the freight. Brokers may,
however, assist shippers in filing claims with the responsible motor
carrier.
    Question 8: What is the civil penalty for a broker or freight
forwarder who engages in interstate operations without the required
operating authority (registration)?
    Answer: A broker or freight forwarder who knowingly engages in
interstate brokerage or freight forwarding operations without the
required operating authority is liable to the United States for a civil
penalty not to exceed $10,000 and can be liable to any injured third
party for all valid claims regardless of the amount (49 U.S.C.
14916(c)). The penalties and liability to injured parties apply jointly
and severally to all corporations or partnerships involved in the
transportation and individually to all officers, directors, and
principals of these business forms (49 U.S.C. 14916(d)). Under 49
U.S.C. 14901(d)(3), a broker of household goods (HHG) who engages in
interstate operations without the required operating authority is
liable to the United States for a civil penalty of not less than
$25,000 for each violation.

B. Financial Security Requirements

    FMCSA has received a number of requests from brokers, freight
forwarders, bonding companies and other financial institutions
requesting additional information about how to comply with these new
requirements. The Agency has compiled a list of the most common
questions and our responses and presents the information below in
question-and-answer format.
    Question 1: What is the minimum level of financial security that a
broker or freight forwarder must maintain on file with FMCSA?
    Answer: Beginning October 1, 2013, all FMCSA regulated brokers and
freight forwarders must obtain and file with FMCSA a surety bond or
trust fund agreement in the amount of $75,000.
    Question 2: May I use group surety bonds or trust funds to satisfy
FMCSA's financial responsibility requirement?
    Answer: No. Although FMCSA is authorized, pursuant to 49 U.S.C.
13906(b) and (c), to accept group financial security products to meet
property broker and freight forwarder financial responsibility
requirements on the condition that those products otherwise meet the
requirements set forth in 49 U.S.C. 13906 and 49 CFR part 387, the
Agency is not required to accept these group financial security
products. At this time, FMCSA is considering the enforcement
implications of group sureties as well as the effect on small entities
and new entrants. FMCSA is committed to reexamining this issue as part
of its enforcement phase-in plan described under section C, FMCSA
Implementation and Enforcement Timelines, below.
    Question 3: If my surety bonding company or trustee previously
filed Forms BMC-84 or BMC-85, do I need to file a new one reflecting
the new $75,000 minimum financial security requirement?
    Answer: Yes. All brokers and freight forwarders subject to FMCSA
jurisdiction must file new BMC-84 or BMC-85 forms reflecting the new
minimum financial security amount of $75,000 as of October 1, 2013.
FMCSA will develop new BMC forms for use by surety bonding companies
and trust fund institutions in advance of the October 1, 2013,
deadline.
    Question 4: My company has both broker and freight forwarder
authority. Is one $75,000 bond or trust fund sufficient or do I need 2
separate bonds/trust funds?
    Answer: One $75,000 bond or trust fund is sufficient as long as the
legal entity holding the authorities is the same. Your company will
need to file separate BMC-84/BMC-85 forms for the broker and freight
forwarder operations. However, the underlying bond or trust fund can be
the same for both operations. If your broker and freight forwarder
operations are conducted under separate but affiliated companies, each
entity must have a separate bond or trust fund.
    Question 5: What happens if my bonding company or trust fund
institution does not file new BMC-84 or BMC-85 forms reflecting the new
$75,000 minimum financial security requirement beginning October 1,
2013?
    Answer: See ``Section C: FMCSA Implementation and Enforcement
Timelines'' below.
    Question 6: MAP-21 says that I have to use a surety bond company
that is approved by the U.S. Treasury Department. How do I know whether
my surety bond company is approved by the Treasury Department?
    Answer: The Treasury Department's Financial Management Service
maintains a list of certified surety bond companies at http://fms.treas.gov/c570/index.html. This and other information about
certified surety bond companies can be obtained from the U.S.
Department of the Treasury, Financial Management Service, Surety Bond
Branch, 3700 East West Highway, Room 6F01, Hyattsville, MD 20782,
Telephone<PHONE_NUMBER> or Fax<PHONE_NUMBER>.
    Question 7: MAP-21 revised 49 U.S.C. 13906(c)(3)(C) to state that
FMCSA may require freight forwarders to provide cargo insurance. How do
I know if this applies to me?
    Answer: Existing regulations at 49 CFR 387.403 require household
goods freight forwarders to obtain cargo insurance in the amount of
$5,000 for loss of, or damage to, household goods carried on any one
motor vehicle; and $10,000 for loss of, or damage to, or the aggregate
of losses or damages of, or to, household goods occurring at any one
time and place. Non-household goods freight forwarders are not required
to obtain cargo insurance. FMCSA did not make any changes to these
requirements as a result of MAP-21.
    Question 8: MAP-21 instituted a new requirement that surety bond
and trust fund institutions ``provide electronic notification'' to
FMCSA at least 30 days before a surety bond or trust fund is cancelled.
How do these institutions provide this electronic notice?

    Answer. Surety bond and trust fund institutions should send their
electronic notification of cancellation through: http://li-public.fmcsa.dot.gov.
    Question 9: Will existing surety bonds be cancelled and replaced by
the new surety bonds? Alternatively, will the existing surety bonds
remain in place and be revised by rider or endorsement?
    Answer. Pursuant to 49 CFR 387.307(a), a surety bond ``for the full
limits of liability prescribed'' must be in effect before FMCSA will
issue property broker or household goods broker operating authority.
Riders/endorsements are a permissible means of complying with the new
$75,000 financial responsibility requirement, provided that a new BMC-
84 form for the full limits of liability is on file with FMCSA.

C. FMCSA Implementation and Enforcement Timelines

    Companies providing broker or freight forwarder services, including
motor carriers, are required to obtain the appropriate operating
authorities and, as of October 1, 2013, are required to meet the new
minimum financial responsibility requirements. FMCSA will be providing
a 60-day phase-in period beginning October 1, 2013, to allow the
industry to complete all necessary filings. Beginning November 1, 2013,
FMCSA will mail notifications to all brokers and freight forwarders
that have not met the $75,000 minimum financial security requirement.
FMCSA will provide 30 days advance notice before revoking the freight
forwarder and broker operating authority registrations.
    FMCSA acknowledges there are motor carriers that occasionally
broker loads that have not previously been required to obtain operating
authority registration from FMCSA as brokers. However, FMCSA is unable
to determine at this time how many motor carriers may be engaged in
some brokering activities, making implementation of a comprehensive
enforcement program difficult. Therefore, FMCSA will phase in its
enforcement of the broker registration requirements for motor carriers
that also broker loads. During the first phase-in period, FMCSA will
accept complaints regarding unregistered brokerage activities of motor
carriers through our National Consumer Complaint Database (see http://nccdb.fmcsa.dot.gov/). FMCSA will work with industry groups to use this
complaint information and other data to ascertain the extent of the
unlicensed broker population subset within the motor carrier industry.
The agency will then work toward developing a comprehensive enforcement
program.
    FMCSA strongly encourages all motor carriers not to accept loads
from unregistered brokers or freight forwarders, as these entities
might not have the financial security mandated by MAP-21. FMCSA also
notes that motor carriers brokering loads without properly registering
with FMCSA as brokers may be subject to private civil actions pursuant
to 49 U.S.C. 14707.

    Issued on: August 29, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-21539 Filed 9-4-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Pages 13338-13339]
[FR Doc No: 2017-04717]

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ENVIRONMENTAL PROTECTION AGENCY

[9956-84-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, Mecklenburg County, State of North Carolina

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of Mecklenburg County's
request to revise/modify certain of its EPA-authorized programs to
allow electronic reporting.

DATES: EPA's approval is effective March 10, 2017.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, US Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements. Once an authorized
program has EPA's approval to accept electronic documents under certain
programs, CROMERR Sec.  3.1000(a)(4) requires that the program keep EPA
apprised of any changes to laws, policies, or the electronic document
receiving systems that have the potential to affect the program's
compliance with CROMERR Sec.  3.2000.
    On June 30, 2016, the Mecklenburg County Land Use & Environmental
Services Agency (LUESA) submitted an application titled ``GovOnline
System'' for revisions/modifications to its EPA-approved programs under
title 40 CFR to allow new electronic reporting. EPA reviewed LUESA's
request to revise/modify its EPA-authorized programs and, based on this
review, EPA determined that the application met the standards for
approval of authorized program revisions/modifications set out

in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this
notice of EPA's decision to approve North Carolina's request to revise/
modify its following EPA-authorized programs to allow electronic
reporting under 40 CFR parts 50 through 52, 61, 63, 65, and 70 is being
published in the Federal Register.
    LUESA was notified of EPA's determination to approve its
application with respect to the authorized programs listed above.

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2017-04717 Filed 3-9-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]
[Page 67188-67189]
[DOCID:fr13no08-50]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0581]

Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representative on Public Advisory Committees and Request for
Nominations for Nonvoting Industry Representative on Public Advisory
Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on its public advisory
committees for the Center for Biologics Evaluation and Research (CBER)
notify FDA in writing. FDA is also requesting nominations for nonvoting
industry representatives to serve on CBER's public advisory committees.
A nominee may either be self-nominated or nominated by an organization
to serve as a nonvoting industry representative. Nominations will be
accepted for upcoming vacancies effective with this notice.

DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating the interest to FDA by December
15, 2008, for vacancies listed in the notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by December
15, 2008.

ADDRESSES: All letters of interest and nominations should be submitted
in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20892,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The agency requests nominations for
nonvoting industry representatives to the following advisory
committees.

I. CBER Advisory Committees

A. The Cellular, Tissue and Gene Therapies Advisory Committee

    The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies and xenotransplantation products which
are intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in the reconstruction, repair or replacement of tissues for various
conditions. The Committee also considers the quality and relevance of
FDA's research program which provides scientific support for the
regulation of these products, and makes appropriate recommendations to
the Commissioner of Food and Drugs (the Commissioner).

B. Vaccines and Related Biological Products Advisory Committee

    The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other product for
which FDA has regulatory responsibility. The Committee as considers the
quality and relevance of FDA's research program which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner.

C. Transmissible Spongiform Encephalopathies Advisory Committee

    The Committee reviews and evaluates available scientific data
concerning the safety of products which may be at risk for transmission
of spongiform encephalopathies having an impact on the public health as
determined by the Commissioner. The Committee will make recommendations
to the Commissioner regarding the regulation of such products.

II. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a

complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular committee. The interested organizations are
not bound by the list of nominees in selecting a candidate. However, if
no individual is selected within 60 days, the Commissioner will select
the nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee of interest should be sent to the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within the 30 days (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.)
    FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26963 Filed 11-12-08; 8:45 am]

BILLING CODE 4160-01-S