[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]
[Page 55596-55597]
[DOCID:fr28oc09-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60855; File No. SR-NYSEArca-2009-92]

 Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change Amending
Obligations of Lead Market Makers

October 21, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on October 14, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III, 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\ 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 make changes to NYSE Arca Rule 6.82(c)--
Obligations of Lead Market Makers. The text of the proposed rule change
is available at the Exchange, the Commission's Public Reference Room,
and www.nyse.com.

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 amend NYSE Arca Options Rule 6.82(c)(5) to
remove the requirement that an LMM designate a back-up LMM and add a
provision obligating an LMM to notify a Trading Official in the event
the LMM is not accessible. In addition, the Exchange proposes that if
such LMM is not accessible, the Exchange may designate a back-up LMM.
    The requirement that each LMM designates a back-up LMM was
initially established to help ensure that there would be adequate
liquidity in a given issue in the event the appointed LMM was
unavailable. At the time, the NYSE Arca options market was strictly
floor-based, many Lead Market Makers were individuals, and there may
have only been a few Market Makers in any given issue. Therefore, it
was necessary to have a designated back-up LMM ready to take over as
LMM, should the appointed LMM be unable to fulfill its obligations. In
return for fulfilling the obligations of the LMM, the back-up LMM (when
acting in that capacity) would also be entitled to all rights afforded
to the assigned LMM.
    The rationale underlying this rule has since become antiquated
because today's electronic-based trading results in fewer absences and
there are a sufficient number of Market Maker firms assigned to each
issue that are able to provide liquidity in the event of a LMM's
temporary absence. Also, since nearly all option issues traded on NYSE
Arca are traded on multiple exchanges, the historical risk to be
managed by the current rule (namely, the ability of the Exchange to
foster the provision of liquidity for investors) is no longer present.
    Pursuant to the changes proposed to Rule 6.82(c)(5), an LMM must
promptly notify a Trading Official if it is not accessible during the
trading day. In the event an LMM is not accessible, it will not be
eligible to receive any of the rights afforded to LMMs as contained in
Rule 6.82(d). In those instances, the Exchange may designate an
approved LMM \3\ to act as a back-up LMM. In selecting an approved LMM
to act in a back-up capacity, the Exchange will select an LMM that
appears best able to perform the functions of the LMM. In designating a
back-up LMM, the Exchange will use criteria consistent with LMM
allocation procedures contained in Rule 6.82(e). The Exchange believes
that this process is more beneficial to all market participants because
the Exchange is in the best position to identify an appropriate back-up
LMM.
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    \3\ An ``approved LMM'' is an individual or entity that has been
deemed qualified to be an LMM pursuant to Rule 6.82.
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    It should be noted that the Exchange intends to designate a back-up
LMM only in situations where the incumbent LMM is temporarily not
accessible. In the event of a long-term absence, or permanent vacancy,
the Exchange may either designate an Interim LMM pursuant to Rule
6.82(b)(4) or reallocate the issue to another LMM pursuant to Rule
6.82(f).
    Upon the operative date of this rule change, all previously
executed agreements between LMMs and back-up LMMs will be considered
null and void. In addition, OTP Holders will no longer be required to
designate a back-up LMM when applying to become an LMM. This rule
change does not in any way revise or amend any other Exchange rules,
including those rules pertaining to qualifications, obligations, and
rights of LMMs.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \4\ of the Act, in general, and furthers the
objectives of Section 6(b)(5),\5\ in particular, in that it is designed
to facilitate transactions in securities, to promote just and equitable
principles of trade, to enhance competition, and to protect investors
and the public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the 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 \6\ and Rule 19b-
4(f)(6) thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 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 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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    A proposed rule change filed under Rule 19b-4(f)(6) of the Act \8\
normally does not become operative prior to 30 days after the date of
the filing. However, Rule 19b-4(f)(6) \9\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ Id.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-92 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-92. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the 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-NYSEArca-2009-92 and should
be submitted on or before November 18, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-25829 Filed 10-27-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Notices]
[Pages 25747-25749]
[FR Doc No: 2013-10394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastroenterology and Urology Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on June 27, 2013, from 8
a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's phone number is<PHONE_NUMBER>.
    Contact Person: Shanika Craig<EMAIL_ADDRESS>Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: On June 27, 2013, during session I, the committee will
discuss and make recommendations regarding the proposed classification
of sorbent hemoperfusion systems, one of the remaining preamendments
class III devices. The class III sorbent hemoperfusion system is a
device intended for the treatment of poisoning, drug overdose, hepatic
coma, and metabolic disturbances. It consists of an extracorporeal
blood system and a container filled with adsorbent material that
removes a wide range of substances, both toxic and normal, from blood
flowing through it. The adsorbent materials are usually activated
carbon or resins, which may be coated or immobilized to prevent fine
particles from entering the patient's blood. The generic type of device
may include lines and filters specifically designed to connect the
device to the extracorporeal blood system. Sorbent hemoperfusion
systems may also include the machine or instrument used to drive and
manage blood and fluid flow within the extracorporeal circuit, as well
as any accompanying controllers, monitors, or sensors.
    On April 4, 2013 (78 FR 20268), FDA issued a proposed order which,
if made final, would reclassify sorbent hemoperfusion systems labeled
for the treatment of poisoning and drug overdose class II subject to
premarket notification [510(k)] and special controls, while sorbent
hemoperfusion systems labeled for the treatment of hepatic coma and
metabolic disturbances would remain class III requiring premarket
approval (PMA) applications. The committee's discussion will involve
making recommendations regarding the regulatory classifications noted
above. The committee will also discuss whether the proposed special
controls are adequate to reasonably ensure the safety and effectiveness
of sorbent hemoperfusion devices labeled for the treatment of poisoning
and drug overdose. The regulatory history of sorbent hemoperfusion has
been discussed as part of a previously published proposed rule (77 FR
9610).
    During session II on June 27, 2013, the committee will discuss and
make recommendations regarding the proposed classification of implanted
blood access devices for hemodialysis from class III to class II. The
class III implanted blood access devices for hemodialysis include
various flexible or rigid tubes, such as catheters, cannulae or hollow
needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic
catheters that have a subcutaneous ``cuff''' for tissue ingrowth. They
are placed in a central vein to allow blood access. Chronic
hemodialysis catheters serve as conduits for the removal of blood from
the patient, delivery to a hemodialysis machine for filtering, and
return of filtered blood to the patient. They have no moving parts,
consisting, essentially, of flexible tubing terminating in rigid Luer
lock connectors for attachment to a dialysis machine. Subcutaneous
catheters are totally implanted below the skin surface with no external
communication. Arteriovenous shunts and vessel tips are tubing with
tapered tips that are inserted into the artery and vein. The tubing is
attached to the roughened or etched outer surface of the tip. The
tubing is external to the skin and can be accessed with needles. They
are similar to subcutaneous catheters.
    On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which,
if made final, would make the class III implanted blood access devices
class II subject to premarket notification [510(k)] and special
controls. The regulatory history of implanted blood access devices has
been discussed as part of the proposed rule (77 FR 36951).
    The committee's discussion will involve making recommendations
regarding regulatory classification to either reaffirm class III or
reclassify these devices into class II and comment on whether special
controls are adequate to reasonably ensure the safety and effectiveness
of this device.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
11, 2013. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 10 a.m. for session I and session II will
start immediately after lunch between approximately 1:30 p.m. and 2:30
p.m. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
3, 2013. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 4, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Committee Management Staff, at<EMAIL_ADDRESS>or<PHONE_NUMBER>
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on public conduct during advisory
committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-10394 Filed 5-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Rules and Regulations]
[Page 46546-46547]
[DOCID:fr11au08-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0450; Directorate Identifier 2007-SW-39-AD;
Amendment 39-15634; AD 2008-16-16]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada (BHTC)
Model 230 Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for BHTC
Model 230 helicopters. This AD results from mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
Canada which indicates that the existing rigging procedures for the
tail rotor pitch change mechanism have to be changed due to the
possibility of parts interference. The cumulative effect of individual
part tolerances resulting in the total assemblage of those parts being
out of tolerance could result in the tail rotor yoke striking another
part other than the flapping stop (parts interference) as cited in the
MCAI. Also, the misalignment of the tail rotor counterweight bellcrank
may result in higher tail rotor pedal forces and a higher pilot
workload after failure of the No. 1 hydraulic system. Both parts
interference and the misaligned counterweight bellcrank create an
unsafe condition. This AD requires actions that are intended to address
these unsafe conditions.

DATES: This AD becomes effective on September 15, 2008.
    The incorporation by reference of certain publications is approved
by the Director of the Federal Register as of September 15, 2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the Docket Operations office, U.S.
Department of Transportation, M-30, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC between 9 a.m. and
5 p.m. Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from Bell
Helicopter Textron Canada, 12,800 Rue de l'Avenir, Mirabel, Quebec
J7J1R4, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Examining the Ad Docket: The AD docket contains the Notice of
proposed rulemaking (NPRM), the economic evaluation, any comments
received, and other information. The street address and operating hours
for the Docket Operations office (telephone<PHONE_NUMBER>) are in the
ADDRESSES section of this AD. Comments will be available in the AD
docket shortly after they are received.

FOR FURTHER INFORMATION CONTACT: Tyrone Millard, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Rotorcraft Standards Staff, Fort
Worth, Texas 76193-0111, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued an NPRM to amend 14 CFR part 39 to include an AD that
would apply to the BHTC Model 230 helicopters on April 14, 2008. That
NPRM was published in the Federal Register on April 23, 2008 (73 FR
21855). That NPRM proposed to require, within the next 150 hours time-
in-service (TIS) or at the next annual inspection, whichever occurs
first, adjusting the rigging of the tail rotor pitch change mechanism,
and if a gap exists between the tail rotor yoke and the flapping stop,
replacing the tail rotor yoke with an airworthy tail rotor yoke. If no
gap exists between the tail rotor yoke and the flapping stop at either
full right or full left pedal position, adjusting the tail rotor pitch
change mechanism and the tail rotor pedal forces was proposed.

Comments

    By publishing the NPRM, we gave the public an opportunity to
participate in developing this AD. However, we received no comment on
the NPRM or on our determination of the cost to the public. Therefore,
based on our review and evaluation of the available data, we have
determined that air safety and the public interest require adopting the
AD as proposed.

Related Service Information

    Bell Helicopter Textron has issued Alert Service Bulletin 230-07-
36, dated January 9, 2007. The actions described in the MCAI are
intended to correct the same unsafe condition as that identified in the
service information.

Differences Between This AD and the MCAI

    The compliance times in this AD differ from the MCAI in that
compliance is required within the next 150 hours TIS or at the next
annual inspection, whichever occurs first, instead of ``at the next 150
hour or annual inspection but no later than 31 December 2007.''

Costs of Compliance

    We estimate that this AD will affect about 20 helicopters of U.S.
registry. We also estimate that it will take 2 work-hours per
helicopter to adjust the

rigging of the tail rotor pitch change mechanism. The average labor
rate is $80 per work-hour. A replacement yoke will cost about $21,218,
assuming the part is no longer under warranty. However, because the
service information lists this part as covered under warranty, we have
assumed that there will be no charge for this part, if needed.
Therefore, as we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
assumptions and figures, we estimate the cost of the AD on U.S.
operators to be $3,200, or $160 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``subtitle VII, part A, subpart III, section 44701: General
Requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    Therefore, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-16-16 Bell Helicopter Textron Canada: Amendment 39-15634;
Docket No. FAA-2008-0450; Directorate Identifier 2007-SW-39-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective on
September 15, 2008.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bell Helicopter Textron Canada (BHTC)
Model 230 helicopters, certificated in any category.

Reason

    (d) This AD results from mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of Canada which
indicates that the existing rigging procedures for the tail rotor
pitch change mechanism have to be changed due to the possibility of
parts interference. This ``possibility of parts interference''
occurs because the cumulative effect of the tolerances on the
various parts may result in the total assemblage outboard of the
counterweight bellcrank being out of tolerance and the tail rotor
yoke may contact nut, part number (P/N) 222-012-737-001, before
contacting the flapping stop. Further, the manufacturer has
indicated that the tail rotor counterweight bellcranks may be
misaligned, resulting in higher tail rotor pedal forces and higher
pilot workload after failure of the No. 1 hydraulic system. Both the
parts interference and the higher pedal forces constitute unsafe
conditions.

Actions and Compliance

    (e) Within the next 150 hours time-in-service (TIS) or at the
next annual inspection, whichever occurs first, unless already done,
do the following:
    (1) Adjust the rigging of the tail rotor pitch change mechanism
in accordance with the Accomplishment Instructions, paragraphs 1 and
2, in Bell Helicopter Textron Alert Service Bulletin 230-07-36,
dated January 9, 2007 (ASB).
    (2) If either at full left pedal position or full right pedal
position a gap exists between the tail rotor yoke and the flapping
stop, replace the tail rotor yoke with an airworthy tail rotor yoke.
    (3) If no gap exists between the tail rotor yoke and the
flapping stop at either full right or full left pedal position,
measure the gap between the tail rotor yoke and nut, P/N 222-012-
731-001, adjust the tail rotor pitch change mechanism, and adjust
the tail rotor pedal forces in accordance with the Accomplishment
Instructions, paragraphs 4. through 6. of the ASB.

Differences Between This AD and the MCAI

    (f) This AD requires compliance within the next 150 hours TIS or
at the next annual inspection, whichever occurs first, instead of
``at the next 150 hour or annual inspection but no later than 31
December 2007.''

Other Information

    (g) Alternative Methods of Compliance (AMOCs): The Manager,
Safety Management Group, FAA, has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
Send information to ATTN: Tyrone Millard, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Rotorcraft Standards Staff, Fort Worth,
Texas 76193-0111, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

Related Information

    (h) MCAI Transport Canada Airworthiness Directive CF-2007-12,
dated August 24, 2007, contains related information.

Air Transport Association of America (ATA) Tracking Code

    (i) ATA Code JASC 6720, Tail Rotor Control System, Tail Rotor
Pitch Change.

Material Incorporated by Reference

    (j) You must use the specified portions of Bell Helicopter
Textron Alert Service Bulletin 230-07-36, dated January 9, 2007, to
do the actions required.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact Bell
Helicopter Textron Canada, 12,800 Rue de l'Avenir, Mirabel, Quebec
J7J1R4, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax (450) 433-
0272.
    (3) You may review copies at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call
(202) 741-6030, or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.

    Issued in Fort Worth, Texas on July 27, 2008.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
 [FR Doc. E8-17990 Filed 8-8-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40125-40126]
[FR Doc No: 2019-17343]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0140]

Agency Information Collection Activities; Extension of an
Approved Information Collection Request: Transportation of Hazardous
Materials, Highway Routing

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. FMCSA requests approval
to extend an existing ICR titled, ``Transportation of Hazardous
Materials, Highway Routing.'' The information reported by States and
Indian tribes is necessary to identify designated/restricted routes and
restrictions or limitations affecting how motor carriers may transport
certain hazardous materials on their highways, including dates that
such routes were established and information on subsequent changes or
new hazardous materials routing designations.

DATES: We must receive your comments on or before October 11, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2019-0140 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     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: U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001 between 9 a.m. and 5 p.m. e.t.,
Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments, see
the Public Participation heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal website. If you want

us to notify you that we received your comments, please include a self-
addressed, stamped envelope or postcard, or print the acknowledgement
page that appears after submitting comments online. Comments received
after the comment closing date will be included in the docket and will
be considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Ms. Suzanne Rach, Office of
Enforcement and Compliance, Hazardous Materials Division, FMCSA, West
Building 6th Floor, 1200 New Jersey Avenue SE, Washington, DC 20590.
Telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The data for the Transportation of Hazardous Materials;
Highway Routing ICR is collected under authority of 49 U.S.C. 5112 and
5125. Specifically, 49 U.S.C. 5112(c) requires that the Secretary, in
coordination with the States, ``shall update and publish periodically a
list of currently effective hazardous material highway route
designations.''
    In 49 CFR 397.73, FMCSA requires that each State and Indian tribe,
through its routing agency, provide information identifying new, or
changes to existing, hazardous materials routing designations within
its jurisdiction within 60 days after their establishment (or 60 days
of the change). That information is collected and consolidated by FMCSA
and published annually, in whole or as updates, in the Federal Register
at https://www.fmcsa.dot.gov/.
    Title: Transportation of Hazardous Materials, Highway Routing.
    OMB Control Number: 2126-0014.
    Type of Request: Extension of a currently-approved information
collection.
    Respondents: The reporting burden is shared by 50 States, the
District of Columbia, Indian tribes with designated routes, and U.S.
Territories including; Puerto Rico, American Samoa, Guam, the
Commonwealth of the Northern Mariana Islands and the U.S. Virgin
Islands.
    Estimated Number of Respondents: 57 [36 States plus the District of
Columbia, with designated hazardous materials highway routes + 19
States/U.S. Territories without designated hazardous materials highway
routes + 1 Indian tribe with a designated route = 57].
    Estimated Time per Response: 15 minutes.
    Expiration Date: April 30, 2020.
    Frequency of Response: Once every two years.
    Estimated Total Annual Burden: 7 hours [57 annual respondents x 1
response per 2 years x 15 minutes per response/60 minutes per response
= 7.125 hours rounded to 7 hours].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.
    Issued under the authority of 49 CFR 1.87 on:

    Dated: August 8, 2019.
Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2019-17343 Filed 8-12-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5384-5386]
[FR Doc No: 2011-1994]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0564]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Restaurant Menu and
Vending Machine Labeling: Registration for Small Chains Under Section
4205 of the Patient Protection and Affordable Care Act of 2010

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
2, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0664.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

I. Background

    Restaurant Menu and Vending Machine Labeling: Registration for
Small Chains Under Section 4205 of the Patient Protection and
Affordable Care Act of 2010--(OMB Control Number 0910-0664)--Revision.
    On March 23, 2010, the President signed into law the Patient
Protection and Affordable Care Act of 2010 (Affordable Care Act) (Pub.
L. 111-148). Section 4205 of the legislation, which principally amends
sections 403 and 403A of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 343 and 343-1, respectively), requires chain
restaurants and similar retail food establishments (SRFE) with 20 or
more locations, as well as operators of 20 or more vending machines, to
disclose certain nutrition information on certain food items offered
for sale so that consumers can make more informed choices about the
food they purchase. Section 4205 preempts State and local governments
from establishing menu labeling requirements in restaurants and calorie
declarations for food in vending machines that are not ``identical to''
the section 4205 requirements.
    In addition to restaurant menu and vending machine labeling,
section 4205 of the Affordable Care Act provides that persons or firms
not subject to the disclosure of nutrition information required by this
legislation, such as restaurants with fewer than 20 locations or
vending machine operators with fewer than 20 vending machines, may
elect to be subject to the requirements provided in section 4205 by
registering biannually with FDA. As required by section 4205, FDA
published a notice in the Federal Register of July 23, 2010 (75 FR
43182) (the July 23, 2010, notice) to explain how retail food
establishments and vending machine operators not otherwise subject to
the provisions of section 4205 may voluntarily elect to become subject
to them. The information collection requirements of FDA's program of
voluntary registration under section 4205 of the Affordable Care Act
were approved under OMB control number 0910-0664.
    Voluntary registration allows companies with outlets or machines
regulated by local or State calorie labeling requirements to opt
instead for the requirements of section 4205 of the Affordable Care
Act. The information provided to FDA will help Federal, State or local
officials to determine which jurisdiction's requirements apply to the
firm.
    Description of Respondents: Respondents to this collection of
information include retail food establishments and vending machine
operators with fewer than 20 outlets or machines.
    FDA's July 23, 2010, notice requires that retail food
establishments and vending machine operators register with FDA using
the Agency's Form FDA 3757 available at http://www.fda.gov/menulabeling. FDA prefers that the information be submitted by email by
typing complete information into the form (PDF), saving it on the
registrant's computer, and sending it by email to<EMAIL_ADDRESS>If email is not available, the
registrant can either fill in the form (PDF) and print it out (or print
out the blank PDF and fill in the information by hand or typewriter),
and send it to FDA either by faxing the completed form to<PHONE_NUMBER>
or mailing it to the Center for Food Safety and Applied Nutrition,
Compliance Information Branch (HFS-681), 5600 Fishers Lane, Rockville,
MD 20857.
    Information FDA requires on the registration form for restaurants
and similar retail food establishments includes the following:
     The name, address, phone number, email address, and
contact information for the authorized official;
     The name, address, and email address of each restaurant or
similar retail food establishment being registered, as well as the name
and contact information for an official onsite, such as the owner or
manager, for each specific restaurant or similar retail food
establishment;
     All trade names the restaurant or similar retail food
establishment uses;
     Preferred mailing address (if different from location
address for each establishment) for purposes of receiving
correspondence; and
     Certification that the information submitted is true and
accurate, that the person or firm submitting it is

authorized to do so, and that each registered restaurant or similar
retail food establishment will be subject to the requirements of
section 4205.
    Information FDA requires on the registration form for vending
machine operators includes includes the following:
     The name, address, phone number, email address, and
contact information for the vending machine operator;
     The address of each vending machine owned or operated by
the vending machine operator, and the name and contact information,
including email address, of the location in which each vending machine
is located;
     Preferred mailing address (if different from location
address), for purposes of receiving correspondence; and
     Certification that the information submitted is true and
accurate, that the person or firm submitting it is authorized to do so,
and that each registered restaurant or similar retail food
establishment will be subject to the requirements of section 4205 of
the Affordable Care Act.
    In addition to the initial registration, the authorized official
must register every other year with FDA, and the registration will
automatically expire if not renewed.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of
November 4, 2010 (75 FR 67978), FDA published a 60-day notice
requesting public comment on the proposed collection of information.
FDA received one letter, which contained multiple comments in response
to the notice.
    (Comments) One comment suggested that FDA underestimated the number
of affected businesses in the United States, particularly with regard
to the number of affected convenience stores, and their rate of growth.
Another comment suggested that FDA provide estimated burden hours
individualized for each industry (i.e., convenience stores,
restaurants, and grocery stores).
    (Response) FDA appreciates the data and suggestions provided in the
comments and will consider them in the upcoming rulemakings. However,
the Agency stands by its preliminary estimate of the paperwork burden
resulting from section 4205 of the Affordable Care Act. Thus, FDA has
not changed the burden estimates in table 1 of this document.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual                         Hours per
       Type of respondent            Number of     frequency per   Total annual      response       Total hours
                                    respondents      response        responses       (average)
----------------------------------------------------------------------------------------------------------------
Restaurant initial..............             103               1             103               2             206
Grocery initial.................             167               1             167               2             334
Convenience store initial.......              11               1              11               2              22
Other SRFE initial..............              81               1              81               2             162
                                 -------------------------------------------------------------------------------
    Total initial hours.........  ..............  ..............  ..............  ..............             724
                                 -------------------------------------------------------------------------------
New registrations...............               7               1               7               1               7
Re-registrations................             355               1             355            0.25              89
                                 -------------------------------------------------------------------------------
    Total recurring hours.......  ..............  ..............  ..............  ..............              96
                                 -------------------------------------------------------------------------------
    Total burden hours..........  ..............  ..............  ..............  ..............             820
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates the reporting burden of this information collection
to be 724 hours in the first year and 96 hours each year thereafter.
The registration burden will be an ongoing, semiannual reporting of
firm contact and location information to FDA. FDA bases its per
respondent burden on the PRA analysis for section 415 of the FD&C Act
(21 U.S.C. 350d) as laid out for the proposed rule ``Registration of
Food Facilities under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002'' (68 FR 5378, February 3, 2003)
(Ref. 1). FDA estimates that the initial collection of the information,
and presentation of it in a format that will meet the Agency's
registration regulations, will require a burden of approximately 2
hours per registration for the first year because the registration
system will not be fully automated.
    FDA estimates that renewal registrations after the first year will
require substantially less time because firms are expected to be able
to affirm or edit the existing information in an online account in a
way similar to other FDA firm registration systems. Therefore, FDA
estimates that re-registration will take 0.25 hours for each
registrant. Because there will be entry and exit from this set of
firms, there will also be new registrations once the system is fully
operational. FDA estimates that initial registration under the fully
operational system will take 1 hour.
    The pool of potential registrants will be restaurants and SRFE with
outlets in jurisdictions that have their own menu labeling regulations
and that are not explicitly regulated under section 4205 of the
Affordable Care Act. Of the existing State and local regulations, the
minimum number of outlets for which any of them currently apply is 15,
and section 4205 applies explicitly to firms with 20 or more outlets.
Therefore, only firms with between 15 and 19 outlets, inclusive, have
any explicit incentive to register. However, chains with fewer outlets
may choose to register, either because they are growing quickly, or
because they are concerned about possible regulation, therefore, for
the purposes of this analysis we include chains with between 10 and 19
outlets, inclusive. The primary source of potential registrants will be
restaurant and specialty food chains, but there are significant numbers
of convenience stores and grocery stores that prepare food onsite and
have a partial function as a take-away, or quick-service, restaurant.
In addition, small chains of similar retail food establishments that
operate in retail, hotel, corporate, educational, military, or
entertainment settings may want to register.
    Because the statute preempts State and local regulations on vending
machine labeling, no vending machine operators will have an incentive
to

register. Therefore, FDA estimates that zero vending machine operators
will register with FDA under section 4205 of the Affordable Care Act.
    According to The NPD Group's Spring 2010 ReCount report, there were
579,416 sole purpose eating and drinking establishments in the United
States in the winter of 2010 (Ref. 2). Of these, 40 percent will be
explicitly subject to FDA rulemaking for the Affordable Care Act
because they are part of chains with 20 or more outlets (Ref. 2). Of
the remaining 350,000 outlets, only those that would be subject to
local or State rules concerning menu labeling would have any incentive
to register. Approximately 7.5 percent of restaurant outlets are in
States or localities with currently operational menu labeling
regulation, principally New York City, Oregon, Philadelphia, and some
New York State counties (Ref. 3). NPD's Spring 2010 ReCount report
shows a total of 20,000 outlets are part of chains with between 10 and
19 establishments. If outlets are evenly distributed geographically,
then 1,500 outlets and 103 restaurant firms may have an incentive to
register with FDA. The hourly burden for restaurant chains is 206 hours
(=100 chains x 1 responses/chain/year x 2 hours/response).
    From the U.S. Census County Business Patterns data, FDA estimates
that there are approximately 62,000 grocery stores in 2010. Of these,
approximately 6,500 are ``independents'' which means that they are part
of chains with fewer than 11 outlets (Ref. 4), and 35,000 are known to
belong to chains with more than 20 outlets (Ref. 5). We round the
remaining 20,523 outlets up to 21,000 to account for those outlets in
chains with 10 or 11 establishments. County Business Patterns show that
11.5 percent of all grocery stores are in jurisdictions that have
relevant menu labeling regulations. Taking 11.5 percent of 21,000
yields approximately 2,400 stores run by 167 firms. The hourly burden
for grocery chains is 334 hours (= 167 chains x 1 responses/chain/year
x 2 hours/response).
    According to Stagnito Media, there are 144,000 convenience store
outlets in the United States (Ref. 6). Of these, 64,000 are defined as
very small ``mom and pop'' locations. Approximately 60,000 outlets are
controlled by 1 of top 100 chains, each having at least 65 outlets
(Ref. 7). Of the remaining 20,000, FDA estimates that half fall in the
10 to 19 outlet range. From County Business Patterns (Ref. 3), 1.6
percent of all convenience store outlets are in a jurisdiction with a
local or State menu labeling regulation that does not explicitly exempt
convenience stores. FDA estimates that approximately 160 convenience
store outlets from 11 firms may have an incentive to register under
this notice. The hourly burden for convenience store chains is 22 hours
(=11 chains x 1 responses/chain/year x 2 hours/response).
    Additional covered establishments, such as those operating in
lodging, corporate, entertainment, and educational settings are often
provided by very large firms with many hundreds or thousands of
outlets, and will thus be explicitly covered by section 4205 of the
Affordable Care Act rather than by the registration provisions. FDA
estimates that an additional 81 firms, controlling approximately 1,200
outlets may have an incentive to register. The hourly burden for these
additional chains is 162 hours (= 81 chains x 1 responses/chain/year x
2 hours/response).
    If all of these restaurant and similar retail food establishment
chains choose to register with FDA, then FDA estimates the number of
firms registering in the first year would be approximately 362 firms.
At 2 hours per registration, the total initial hourly burden will then
be 724 hours (= 362 firms x 2 hours/firm).
    FDA estimates that the rate of growth for chains entering the 10 to
19 outlet segment will match the rate of growth out of this segment, so
that the number of registrants will remain constant. County Business
Patterns data shows an average growth rate in the number of
establishments to be 2 percent per year over the 8 years from 1999 to
2007 for restaurants (Ref. 3). If the restaurant growth rate for
outlets of approximately 2 percent per year applies to these chains,
then new registrants will amount to approximately 7 per year, with the
remaining 355 registrants only renewing their registration. The yearly
burden for registration is estimated to be 1 hour per new registrant.
Thus, the total hour burden will be 7 hours (7 firms x 1 hour/firm).
The yearly burden for renewing registration is estimated to be 0.25
hour per continuing registrant. Thus, the total hour burden will be 89
hours (355 firms x 0.25 hour/firm = 88.75, rounded to 89). This yields
a recurring hourly burden of 96 hours per year (7 hours + 89 hours).

II. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

    1. Food and Drug Administration. 2003. ``Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002,'' 68 FR 5378, February 3,
2003.
    2. The NPD Group, ``Chains System Size Trend Report for U.S.
FDA,'' ReCount, Spring 2010.
    3. U.S. Census Bureau, 2007, County Business Patterns, http://www.census.gov/econ/cbp/index.html, 2007, version date September 22,
2009.
    4. Moran, M., J. McTaggart, and D. Chanil, ``Looking Up,
Cautiously,'' Progressive Grocer 89(3): 20-52, 2010.
    5. Food Marketing Institute, Top U.S. Supermarket & Grocery
Chains (by 2007 grocery sales), http://www.fmi.org, 2008.
    6. Stagnito Media, ``Directory of Convenience Stores: FAQ,''
http://www.conveniencestores.com/faq.html, accessed June 1, 2010.
    7. Longo, D. ``Convenience Store News: Hot Top 100'' Convenience
Store News, 45(10), pp. 27-32, August 10, 2009.

    Dated: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1994 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P


MEMO

To: Elissa Reaves, Anna Lowit, Jack Housenger, OPP

From: R. Woodrow Setzer, NCCT

Date: February 4, 2008

Subject: Error in computing BMD50s from AChE inhibition models for
N-methyl carbamates.

The model used for acetylcholine esterase inhibition N-methyl carbamate
pesticides yields the following expression for fractional inhibition y
as a function of dose, x:

It is easy to see that, when x = D, fractional inhibition is R.  Now, to
calculate the BMD, D2 for an alternative level of inhibition, R2, solve

for D2.  This gives

 , or, in terms of the estimated parameter tz:

 .  This is similar, but not identical, to the erroneous expression I
previously provided, probably due to a careless algebra error:

 , which I have here modified to follow the notation of this memo.
Notice the additional 1 – R and 1 – R2 terms in the correct formula.

I noticed the error while I was preparing graphs for the Feb 5 SAP
review of carbofuran, when I noticed that the inhibition at the BMD50
was not 50%, using the formula I had sent Anna on June 12.  For example,
here is a plot of expected inhibition versus dose in the PND11 RBC data,
with both the incorrect (red) and correct (black) BMD50s plotted as
vertical lines.  The vertical and horizontal lines should intersect if
the BMD is calculated correctly.

It would be useful to calculate confidence intervals around the ratios
of brain BMD50  to RBC BMD50, but that turns out to require that the two
compartments be modeled simultaneously, to incorporate the correlation
between RBC and brain AChE inhibition in the data.  This has not yet
been done.  However, it is possible to estimate the confidence intervals
under different assumptions about the correlations between brain and RBC
BMDs induced by the correlations in the data.

The estimate relies on asymptotic normality of estimates of model
parameters, and on the fact that the variance of the difference of two
random variables (in this case, two estimators) is the sum of the
variances of the two random variables, less twice their covariance.
That is, if lBMDrbc and lBMDbrain are the log(BMD) estimates in the two
compartments, the variance of lBMDbrain – lBMDrbc is

Var(lBMDbrain) + Var(lBMDrbc) – 2 × r(lBMDbrain, lBMDrbc) ×
SD(lBMDbrain) × SD(lBMDrbc),

where Var(x) represents the variance of the random variable x, SD(x)
represents the standard deviation of the random variable x, and r(x, y)
represents the correlation between x and y.  It is possible to estimate
the variances (and the standard deviations, the square roots of the
variances) by sampling from a multivariate normal distribution with mean
and covariances equal to the estimates from a model (say, from the
dose-response for rbc or brain AChE inhibition in PND11 animals).  Then,
95% confidence limits are calculated using the well-known formula for
confidence limits of a normally-distributed quantity.   The following
figure shows results of doing this for correlations between brain and
rbc log(BMD) of 0, .25, .5, .75, and 1.  Note that it is more likely
that the correlation would be in the lower half of this range.

The plotting point represents the correct estimate of the ratio in PND11
animals, and the horizontal line the older, incorrect estimate.

Page   PAGE  1  of   NUMPAGES  3


[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Page 56453]
[FR Doc No: 2015-23428]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF15-10-000]

Western Area Power Administration; Notice of Filing

    Take notice that on September 3, 2015 the Western Area Power
Administration submitted a tariff filing: Rate Adjustment for Salt Lake
City Area Integrated Projects Firm Power (Colorado River Storage
Project Transmission and Ancillary Services--Rate Order No. WAPA-169)
to be effective October 1, 2015.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 5, 2015.

    Dated: September 11, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-23428 Filed 9-17-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Notices]
[Pages 7611-7612]
[FR Doc No: 2020-02523]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88118; File No. SR-NYSENAT-2019-31]

Self-Regulatory Organizations; NYSE National, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Establish Fees for the NYSE
National Integrated Feed

February 4, 2020.
    On December 4, 2019, NYSE National, Inc. (``NYSE National'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to establish fees for the NYSE National Integrated
Feed. The proposed rule change was immediately effective upon filing
with the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal Register
on December 26, 2019.\4\ The Commission received two comment letters on
the proposal.\5\ On January 31, 2020, the Commission issued an order
temporarily suspending the proposed rule change pursuant to Section
19(b)(3)(C) of the Act \6\ and simultaneously instituting proceedings
under Section 19(b)(2)(B) of the Act \7\ to determine whether to
approve or disapprove the proposed rule change.\8\ On February 3, 2020,
the Exchange

withdrew the proposed rule change (SR-NYSENAT-2019-31).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ See Securities Exchange Act Release No. 87797 (December 18,
2019), 84 FR 71025.
    \5\ See letters to Vanessa Countryman, Secretary, Commission,
from Tyler Gellasch, Executive Director, The Healthy Markets
Association, dated January 16, 2020; and Robert Toomey, Managing
Director and Associate General Counsel, Securities Industry and
Financial Markets Association, dated January 21, 2020.
    \6\ 15 U.S.C. 78s(b)(3)(C).
    \7\ 15 U.S.C. 78s(b)(2)(B).
    \8\ See Securities Exchange Act Release No. 88109.
    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-02523 Filed 2-7-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42790-42791]
[FR Doc No: 2014-17241]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2014-0001: FRL 9914-13-OA]

Good Neighbor Environmental Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for Nominations to the Good Neighbor Environmental
Board.

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SUMMARY: The Environmental Protection Agency (EPA) invites nominations
from a diverse range of qualified candidates to be considered for
appointment to its Good Neighbor Environmental Board (GNEB). Vacancies
are expected to be filled by March 9, 2015. Sources in addition to this
Federal Register Notice may also be utilized in the solicitation of
nominees.
    Background: GNEB is a federal advisory committee chartered under
the Federal Advisory Committee Act (FACA), Public Law 92-463. GNEB was
created in 1992 by the Enterprise for the Americas Initiative Act,
Public Law 102-532, 7 U.S.C. 5404. Implementing authority was delegated
to the Administrator of EPA under Executive Order 12916. The GNEB is
charged by statute with submitting an annual report to the President on
the need for implementation of environmental and infrastructure
projects within the states of the United States contiguous to Mexico.
The statute calls for the GNEB to have representatives from U.S.
Government agencies; the governments of the states of Arizona,
California, New Mexico and Texas; and tribal and private organizations
with experience in environmental and infrastructure issues along the
U.S./Mexico Border. Members are appointed by the EPA Administrator for
two year terms with the possibility of reappointment. The GNEB meets
approximately three times annually either in person or via video/
teleconference. The average workload for committee members is
approximately 10 to 15 hours per month. Members serve on the committees
in a voluntary capacity. Although we are unable to offer compensation
or an honorarium, members may receive travel and per diem allowances,
according to applicable federal travel regulations. The EPA is seeking
nominations from a variety of nongovernmental interests along the U.S.-
Mexico border from the private sector, including representatives from
business, academia, environmental groups, health groups, ranching and
grazing, energy, financial, and other relevant sectors. EPA values and
welcomes diversity. In an effort to obtain nominations of diverse
candidates, EPA encourages nominations of women and men of all racial
and ethnic groups.
    The following criteria will be used to evaluate nominees:
     Background and experiences that would help members
contribute to the diversity of perspectives on the committee (e.g.,
geographic, economic, social, cultural, educational, and other
considerations).
     Representative of a sector or group that helps to shape
border-region environmental policy or representatives of a group that
is affected by border region environmental policy.
     Has extensive professional knowledge and experience with
the particular issues that the GNEB examines (i.e. environmental and
infrastructure issues along the U.S.-Mexico border), including the bi-
national dimension of these issues.
     Bring senior level experience that will fill a need of the
GNEB in bringing a new and relevant dimension to its deliberations.
     Possesses a demonstrated ability to work in a consensus
building process

with a wide range of representatives from diverse constituencies.
     Ability to contribute approximately 10 to 15 hours per
month to the GNEB's activities, including face-to-face meetings,
conference calls and participation in the development of the GNEB's
annual report to the President and comment letters.
     Nominees may self-nominate by submitting a resume
describing their professional and educational qualifications, including
current business address, email and daytime telephone number.
     All nominees must demonstrate the potential for active and
constructive involvement in the GNEB's work.
    If you are interested in serving on GNEB, we will need the
following items to process your nomination package:
     Nominations must include a brief statement of interest,
resume, curriculum vitae, or a short biography (no more than two
paragraphs) describing your professional and educational
qualifications, including a list of relevant activities and any current
or previous service on advisory committees. The statement of interest,
resume, curriculum vitae, or short biography should include the
candidate's name, name and address of current organization, position
title, email address, and daytime telephone number(s). In preparing
your statement of interest, please describe how your background,
knowledge, and experience will bring value to the work of the
committee, and how these qualifications would contribute to the overall
diversity of the GNEB. Also, be sure to describe any previous
involvement with the Agency through employment, grant funding and/or
contracting sources.
     Candidates from the academic sector must also provide a
letter of recommendation authorizing the nominee to represent their
institution.
     Please be advised that federal registered lobbyists are
not permitted to serve on federal advisory boards.

ADDRESSES: Submit nominations to Ann-Marie Gantner, Acting Designated
Federal Officer, Office of Diversity, Advisory Committee Management and
Outreach (1601M), 1200 Pennsylvania Avenue NW., Washington, DC 20460.
You may also email nominations with the subject line COMMITTEE RESUME
2014 to gantner.ann-marie @epa.gov.

FOR FURTHER INFORMATION CONTACT: Ann-Marie Gantner, Acting Designated
Federal Officer, U.S. EPA, telephone<PHONE_NUMBER>, fax:<PHONE_NUMBER>.

    Dated: July 1, 2014.
Ann-Marie Gantner,
Acting Designated Federal Officer.
[FR Doc. 2014-17241 Filed 7-22-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24078-24080]
[FR Doc No: 2011-10409]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64334; File No. SR-NYSE-2011-18]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 72(d) Regarding Agency Cross Transactions

April 25, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 19, 2011, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III 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 amend Rule 72(d) with respect to agency
cross transactions. The text of the proposed rule change is available
at the Exchange, at http://www.nyse.com, at the Commission's Public
Reference Room, and at http://www.sec.gov.

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 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 amend Rule 72(d) with respect to agency
cross transactions.\3\ Legacy Rule 72(b) became current Rule 72(d) when
the Exchange adopted the New Market Model Pilot. Although the rule text
was renumbered as part of the New Market Model Pilot filing, the
substance of the rule was not changed from its prior version.
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    \3\ The provisions of Rule 72 are in effect during a pilot set
to end on August 1, 2011. See Securities Exchange Act Release No.
58845 (October 24, 2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-
2008-46) (establishing the ``New Market Model Pilot'' or ``Pilot'').
See also Securities Exchange Act Release Nos. 60756 (October 1,
2009), 74 FR 51628 (October 7, 2009) (SR-NYSE-2009-100) (extending
Pilot to November 30, 2009); 61031 (November 19, 2009), 74 FR 62368
(November 27, 2009) (SR-NYSE-2009-113) (extending Pilot to March 30,
2010); 61724 (March 17, 2010), 75 FR 14221 (March 24, 2010) (SR-
NYSE-2010-25) (extending Pilot to September 30, 2010); 62819
(September 1, 2010), 75 FR 54937 (September 9, 2010) (SR-NYSE-2010-
61) (extending Pilot to January 31, 2011); and 63618 (December 29,
2010), 76 FR 617 (January 5, 2011) (SR-NYSE-2010-85) (extending
Pilot to August 1, 2011).
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    Under NYSE Rule 72(d), when a member \4\ has an order to buy and an
order to sell an equivalent amount of the same security, and both
orders are for 25,000 shares or more, the member may ``cross'' those
orders at a price at or within the Exchange best bid or offer and does
not have to break up the cross transaction to trade with any bids or
offers previously displayed at the Exchange best bid or offer,
including any interest with priority (a ``72(d) crossing
transaction'').\5\ NYSE Rule 72(d) further provides that a member can
effect a 72(d) crossing transaction only for the accounts of persons
who are not members or member organizations. Accordingly, a Floor
broker cannot use this provision for customers who are unaffiliated
NYSE members or member organizations.
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    \4\ The reference to ``member'' in Rule 72(d) and this rule
proposal means only Floor broker members. Designated Market Makers
(``DMMs''), while members of the Exchange, do not have any agency
relationships, and are therefore not able to effect this type of
cross.
    \5\ A transaction effected at the cross price in reliance on
NYSE Rule 72(d) is printed as a ``stopped stock'' to denote that the
transaction was outside of normal market procedures. See NYSE Rule
128A.16. See also Securities Exchange Act Release No. 31343 (October
21, 1992), 57 FR 48645 (October 27, 1992) (SR-NYSE-90-39). The
Exchange notes that block-sized crosses outside of the Exchange best
bid or offer are addressed under NYSE Rule 127.
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    The Exchange proposes to amend Rule 72(d) to change the required
minimum share size from 25,000 and instead require that both the order
to buy and the order to sell be ``block'' orders, which the Exchange
proposes to define for purposes of Rule 72 as at least 10,000 shares or
a quantity of stock having a market value of $200,000 or more,
whichever is less.\6\ This proposed change would more closely align
agency cross transactions with other ``block'' orders with respect to
the minimum applicable order size.\7\
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    \6\ The Exchange proposes to include the ``block'' definition as
new Supplementary Material .10 to Rule 72.
    \7\ See, e.g., NYSE Rules 104 and 127, which provide that a
``block'' shall be at least 10,000 shares or a quantity of stock
having a market value of $200,000 or more, whichever is less.
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    The Exchange further proposes to amend Rule 72(d) to modify the
current restriction that a member may not effect a 72(d) crossing
transaction for the account of a member or member organization. The
Exchange instead proposes to conform Rule 72(d) to Rule 90, and
restrict a member from effecting a 72(d) crossing transaction for the
account of such member or member organization, an account of an
associated person, or an account with respect to which the member,
member organization or associated person

thereof exercises investment discretion. This proposed change would
enable Floor brokers to effect 72(d) crossing transactions on behalf of
unaffiliated members or member organizations.
    The Exchange also proposes to update a reference to the term
``priority'' within Rule 72(d), which was included in the rule based on
the definition of the term ``priority'' under Exchange rules before
adopting the New Market Model Pilot. NYSE Rule 72(d) currently provides
that a member who is providing a better price to one side of the cross
transaction must trade with all other market interest having priority
at that price before trading with any part of the cross transaction.
The Exchange proposes to modify this requirement so that the member
seeking to provide price improvement must instead trade with all other
displayed market interest on the Exchange at that price before trading
with the cross transaction. The proposed change would expand protection
for interest on the Display Book[reg] \8\ by requiring the member who
is providing price improvement to trade not only with priority
interest, but with all displayed interest in the Display Book.\9\ The
Exchange proposes to similarly incorporate this change in Example 1
within Rule 72(d) by deleting the clause related to ``priority'' and
replacing it with a reference to ``displayed.''
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    \8\ The Display Book system is an order management and execution
facility. The Display Book receives and displays orders to the DMMs,
contains order information and provides a mechanism to execute and
report transactions and publish the results to the Consolidated
Tape. The Display Book is connected to a number of other Exchange
systems for the purposes of comparison, surveillance and reporting
information to customers and other market data and national market
systems.
    \9\ The Exchange notes that displayed interest does not include
the reserve portion of any orders on the Display Book. This proposed
amendment to Rule 72(d) does not change the obligation of the member
providing price improvement to comply with Rule 90.
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    Finally, the Exchange proposes to remove the reference to
``prevailing quotation'' within Rule 72(d) and replace it with a
reference to the ``Exchange best bid or offer.'' This change would
provide clarity regarding the price at which a member could effect a
72(d) crossing transaction, but does not alter the meaning of the
current rule or the mechanics of a 72(d) crossing transaction.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\10\ in general, and
furthers the objectives of Section 6(b)(5),\11\ 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.
Specifically, the proposed rule change would more closely align Rule
72(d) with other Exchange rules concerning block-sized orders and the
accounts for which agency orders may be crossed while also expanding
protection for interest on the Display Book by requiring that such
interest must be executed before a member could break up an agency
cross.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
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.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
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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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2011-18 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2011-18. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of 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-
NYSE-2011-18 and should be submitted on or before May 20, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-10409 Filed 4-28-11; 8:45 am]
BILLING CODE 8011-01-P