[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68788-68789]
[FR Doc No: 2012-27934]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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. This meeting is being rescheduled due to the
postponement of the November 1, 2012, meeting due to unanticipated
weather conditions caused by hurricane Sandy.
    Name of Committee: Neurological 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 December 10, 2012, from
8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Grand Ballroom, Gaithersburg, MD 20877. The hotel's telephone number is
301-977-8900.
    Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1544, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>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 December 10, 2012, the committee will discuss current
knowledge about the safety and effectiveness of the CoAxia NeuroFlo
Catheter device for the intended use of diverting cardiac output to the
cerebral vasculature via partial occlusion of the descending aorta,
including in patients with acute ischemic stroke within 14 hours of
symptom onset.
    The CoAxia NeuroFlo Catheter is a 7F multilumen device with two
balloons mounted near the distal tip. The proximal end has a multiport
manifold that provides access for the guidewire, monitoring of blood
pressure, and independent inflation of the individual balloons. The
device is placed in the descending aorta. On March 30, 2005, a
humanitarian device exemption application for the CoAxia NeuroFlo
Catheter was approved for the following indication for use: The CoAxia
NeuroFlo Catheter is intended for the treatment of cerebral ischemia
resulting from symptomatic vasospasm following aneurismal subarachnoid
hemorrhage, secured by either surgical or endovascular intervention for
patients who have failed maximal medical management.
    Of note, the CoAxia NeuroFlo Catheter is identical in design to the
CoAxia FloControl, which is currently cleared for the following general
indications for use:
    1. The CoAxia FloControl Catheter is intended for use in
selectively stopping or controlling flow in the peripheral vasculature
(K023914).
    2. The CoAxia FloControl Catheter is intended for use in
selectively stopping or controlling flow in the peripheral vasculature,
which includes the descending aorta (K090970).
    CoAxia has submitted a de novo application for the NeuroFlo for the
following indication: The CoAxia NeuroFlo Catheter is intended for use
in diversion of cardiac output via partial occlusion of the descending
aorta, including patients with acute ischemic stroke within 14 hours of
symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in
selectively stopping or controlling blood flow in the peripheral
vasculature, which includes the descending aorta.
    FDA is convening this committee to seek expert scientific and
clinical opinion on the risks and benefits of this device based on the
available premarket and postmarket data. In particular, the committee
will be asked to discuss the safety and effectiveness data from the
``Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke''
(SENTIS) clinical trial as they relate to the proposed indications for
use.
    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
December 4, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 November 26, 2012. 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 November 28, 2012.
    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 AnnMarie Williams,
Committee Management Staff,<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: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27934 Filed 11-15-12; 8:45 am]
BILLING CODE 4160-01-P


including continuous
                            emissions monitoring
                            system, and operating
                            parameter monitoring
                            systems, were out-of-
                            control as specified in
                            Sec.   63.8(c)(7), a
                            statement that there
                            were no periods during
                            which the CMSs were out-
                            of-control during the
                            reporting period; and.
                           c. If you have a
                            deviation from any
                            emission limitation
                            (emission limit and
                            operating limit) or
                            work practice standard
                            during the reporting
                            period, the report must
                            contain the information
                            in Sec.   63.10031(d).
                            If there were periods
                            during which the CMSs,
                            including continuous
                            emissions monitoring
                            systems and continuous
                            parameter monitoring
                            systems, were out-of-
                            control, as specified
                            in Sec.   63.8(c)(7),
                            the report must contain
                            the information in Sec.
                              63.10031(e)..
------------------------------------------------------------------------

0
28. Revise Table 9 to subpart UUUUU of part 63 to read as follows:

Table 9 to Subpart UUUUU of Part 63--Applicability of General Provisions
                            to Subpart UUUUU
   [As stated in Sec.   63.10040, you must comply with the applicable
             General Provisions according to the following:]
------------------------------------------------------------------------
                                                     Applies to subpart
          Citation                   Subject                UUUUU
------------------------------------------------------------------------
Sec.   63.1.................  Applicability.......  Yes.
Sec.   63.2.................  Definitions.........  Yes. Additional
                                                     terms defined in
                                                     Sec.   63.10042.
Sec.   63.3.................  Units and             Yes.
                               Abbreviations.
Sec.   63.4.................  Prohibited            Yes.
                               Activities and
                               Circumvention.
Sec.   63.5.................  Preconstruction       Yes.
                               Review and
                               Notification
                               Requirements.
Sec.   63.6(a), (b)(1)        Compliance with       Yes.
 through (5), (b)(7), (c),     Standards and
 (f)(2) and (3), (h)(2)        Maintenance
 through (9), (i), (j).        Requirements.
Sec.   63.6(e)(1)(i)........  General Duty to       No. See Sec.
                               minimize emissions.   63.10000(b) for
                                                     general duty
                                                     requirement.
Sec.   63.6(e)(1)(ii).......  Requirement to        No.
                               correct
                               malfunctions ASAP.
Sec.   63.6(e)(3)...........  SSM Plan              No.
                               requirements.
Sec.   63.6(f)(1)...........  SSM exemption.......  No.
Sec.   63.6(h)(1)...........  SSM exemption.......  No.
Sec.   63.6(g)..............  Compliance with       Yes. See Sec.  Sec.
                               Standards and          63.10011(g)(4) and
                               Maintenance           63.10021(h)(4) for
                               Requirements, Use     additional
                               of an alternative     requirements.
                               non-opacity
                               emission standard.
Sec.   63.7(e)(1)...........  Performance testing.  No. See Sec.
                                                     63.10007.
Sec.   63.8.................  Monitoring            Yes.
                               Requirements.
Sec.   63.8(c)(1)(i)........  General duty to       No. See Sec.
                               minimize emissions    63.10000(b) for
                               and CMS operation.    general duty
                                                     requirement.
Sec.   63.8(c)(1)(iii)......  Requirement to        No.
                               develop SSM Plan
                               for CMS.
Sec.   63.8(d)(3)...........  Written procedures    Yes, except for last
                               for CMS.              sentence, which
                                                     refers to an SSM
                                                     plan. SSM plans are
                                                     not required.
Sec.   63.9.................  Notification          Yes, except (1) for
                               Requirements.         the 60-day
                                                     notification prior
                                                     to conducting a
                                                     performance test in
                                                     Sec.   63.9(e);
                                                     instead use a 30-
                                                     day notification
                                                     period per Sec.
                                                     63.10030(d), (2)
                                                     the notification of
                                                     the CMS performance
                                                     evaluation in Sec.
                                                      63.9(g)(1) is
                                                     limited to RATAs,
                                                     and (3) the
                                                     information
                                                     required per Sec.
                                                     63.9(h)(2)(i);
                                                     instead provide the
                                                     information
                                                     required per Sec.
                                                     63.10030(e)(1)
                                                     through (e)(6) and
                                                     (e)(8).
Sec.   63.10(a), (b)(1),      Recordkeeping and     Yes, except for the
 (c), (d)(1) and (2), (e),     Reporting             requirements to
 and (f).                      Requirements.         submit written
                                                     reports under Sec.
                                                      63.10(e)(3)(v).
Sec.   63.10(b)(2)(i).......  Recordkeeping of      No.
                               occurrence and
                               duration of
                               startups and
                               shutdowns.
Sec.   63.10(b)(2)(ii)......  Recordkeeping of      No. See Sec.
                               malfunctions.         63.10001 for
                                                     recordkeeping of
                                                     (1) occurrence and
                                                     duration and (2)
                                                     actions taken
                                                     during malfunction.
Sec.   63.10(b)(2)(iii).....  Maintenance records.  Yes.
Sec.   63.10(b)(2)(iv)......  Actions taken to      No.
                               minimize emissions
                               during SSM.
Sec.   63.10(b)(2)(v).......  Actions taken to      No.
                               minimize emissions
                               during SSM.
Sec.   63.10(b)(2)(vi)......  Recordkeeping for     Yes.
                               CMS malfunctions.
Sec.   63.10(b)(2)(vii)       Other CMS             Yes.
 through (ix).                 requirements.
Sec.   63.10(b)(3) and        ....................  No.
 (d)(3) through (5).
Sec.   63.10(c)(7)..........  Additional            Yes.
                               recordkeeping
                               requirements for
                               CMS--identifying
                               exceedances and
                               excess emissions.
Sec.   63.10(c)(8)..........  Additional            Yes.
                               recordkeeping
                               requirements for
                               CMS--identifying
                               exceedances and
                               excess emissions.
Sec.   63.10(c)(10).........  Recording nature and  No. See Sec.
                               cause of              63.10032(g) and (h)
                               malfunctions.         for malfunctions
                                                     recordkeeping
                                                     requirements.
Sec.   63.10(c)(11).........  Recording corrective  No. See Sec.
                               actions.              63.10032(g) and (h)
                                                     for malfunctions
                                                     recordkeeping
                                                     requirements.
Sec.   63.10(c)(15).........  Use of SSM Plan.....  No.
Sec.   63.10(d)(5)..........  SSM reports.........  No. See Sec.
                                                     63.10021(h) and (i)
                                                     for malfunction
                                                     reporting
                                                     requirements.
Sec.   63.11................  Control Device        No.
                               Requirements.
Sec.   63.12................  State Authority and   Yes.
                               Delegation.
Sec.  Sec.   63.13 through    Addresses,            Yes.
 63.16.                        Incorporation by
                               Reference,
                               Availability of
                               Information,
                               Performance Track
                               Provisions.

Sec.  Sec.                    Reserved............  No.
 63.1(a)(5),(a)(7) through
 (9), (b)(2), (c)(3) and
 (4), (d), 63.6(b)(6),
 (c)(3) and (4), (d),
 (e)(2), (e)(3)(ii), (h)(3),
 (h)(5)(iv), 63.8(a)(3),
 63.9(b)(3), (h)(4),
 63.10(c)(2) through (4),
 (c)(9)..
------------------------------------------------------------------------

0
29. Appendix A to subpart UUUUU of part 63 is amended by revising
paragraphs <IP_ADDRESS>.1, <IP_ADDRESS>, and <IP_ADDRESS>, table A-1, paragraphs
<IP_ADDRESS>, <IP_ADDRESS>.2, <IP_ADDRESS>, and <IP_ADDRESS>, table A-2, and paragraphs
5.2.1, <IP_ADDRESS>, and <IP_ADDRESS> and adding paragraph <IP_ADDRESS> to read as
follows:

Appendix A to Subpart UUUUU of Part 63--Hg Monitoring Provisions

* * * * *

3. Mercury Emissions Measurement Methods

* * * * *
    <IP_ADDRESS>.1 NIST Traceability. Only NIST-certified or NIST-traceable
calibration gas standards and reagents (as defined in paragraphs 3.1.4
and 3.1.5 of this appendix), and including, but not limited to, Hg gas
generators and Hg gas cylinders, shall be used for the tests and
procedures required under this subpart. Calibration gases with known
concentrations of Hg\0\ and HgCl2 are required. Special
reagents and equipment may be needed to prepare the Hg\0\ and
HgCl2 gas standards (e.g., NIST-traceable solutions of
HgCl2 and gas generators equipped with mass flow
controllers).
* * * * *

4. Certification and Recertification Requirements

* * * * *
    <IP_ADDRESS> 7-Day Calibration Error Test. Perform the 7-day calibration
error test on 7 consecutive source operating days, using a zero-level
gas and either a high-level or a mid-level calibration gas standard (as
defined in paragraphs 3.1.8, 3.1.10, and 3.1.11 of this appendix). Use
a NIST-traceable elemental Hg gas standard (as defined in paragraphs
3.1.4 of this appendix) for the test. If your Hg CEMS lacks an
integrated elemental Hg gas generator, you may continue to use NIST-
traceable oxidized Hg gases for the 7-day calibration error test (or
the daily calibration error check) until such time as NIST-traceable
compressed elemental Hg gas standards, at appropriate concentration
levels, are available from gas vendors. If moisture is added to the
calibration gas, the dilution effect of the moisture and/or chlorine
addition on the calibration gas concentration must be accounted for in
an appropriate manner. Operate the Hg CEMS in its normal sampling mode
during the test. The calibrations should be approximately 24 hours
apart, unless the 7-day test is performed over non-consecutive calendar
days. On each day of the test, inject the zero-level and upscale gases
in sequence and record the analyzer responses. Pass the calibration gas
through all filters, scrubbers, conditioners, and other monitor
components used during normal sampling, and through as much of the
sampling probe as is practical. Do not make any manual adjustments to
the monitor (i.e., resetting the calibration) until after taking
measurements at both the zero and upscale concentration levels. If
automatic adjustments are made following both injections, conduct the
calibration error test such that the magnitude of the adjustments can
be determined, and use only the unadjusted analyzer responses in the
calculations. Calculate the calibration error (CE) on each day of the
test, as described in Table A-1 of this appendix. The CE on each day of
the test must either meet the main performance specification or the
alternative specification in Table A-1 of this appendix.
* * * * *
    <IP_ADDRESS> Three-Level System Integrity Check. Perform the 3-level
system integrity check using low, mid, and high-level calibration gas
concentrations generated by a NIST-traceable source of oxidized Hg. If
your Hg CEMS lacks an integrated elemental Hg gas generator, you may
continue to use NIST-traceable oxidized Hg gases for the 7-day
calibration error test (or the daily calibration error check) until
such time as NIST-traceable compressed elemental Hg gas standards, at
appropriate concentration levels, are available from gas vendors.
Follow the same basic procedure as for the linearity check. If moisture
and/or chlorine is added to the calibration gas, the dilution effect of
the moisture and/or chlorine addition on the calibration gas
concentration must be accounted for in an appropriate manner. Calculate
the system integrity error (SIE), as described in Table A-1 of this
appendix. The SIE must either meet the main performance specification
or the alternative specification in Table A-1 of this appendix.

               Table A-1--Required Certification Tests and Performance Specifications for Hg CEMS
----------------------------------------------------------------------------------------------------------------
                                                                     The alternate
 For this required certification test    The main performance         performance         And the conditions of
                . . .                   specification \1\ is .   specification \1\ is .       the alternate
                                                 . .                      . .            specification are . . .
----------------------------------------------------------------------------------------------------------------
7-day calibration error test 2 6.....  [verbar]R - A[verbar]    [verbar]R - A[verbar]    The alternate
                                        <= 5.0% of span value,   <= 1.0 [mu]g/scm.        specification may be
                                        for both the zero and                             used on any day of the
                                        upscale gases, on each                            test.
                                        of the 7 days..
Linearity check 3 6..................  [verbar]R - Aavg         [verbar]R - Aavg         The alternate
                                        [verbar] <= 10.0% of     [verbar] <= 0.8 [mu]g/   specification may be
                                        the reference gas        scm.                     used at any gas level.
                                        concentration at each
                                        calibration gas level
                                        (low, mid, or high)..
3-level system integrity check \4\...  [verbar]R - Aavg         [verbar]R - Aavg         The alternate
                                        [verbar] <= 10.0% of     [verbar] <= 0.8 [mu]g/   specification may be
                                        the reference gas        scm.                     used at any gas level.
                                        concentration at each
                                        calibration gas level..

RATA.................................  20.0% RA...............  [verbar]RMavg -          RMavg < 2.5[mu]g/scm
                                                                 Cavg[verbar] +
                                                                 [verbar]CC[verbar] <=
                                                                 0.5 [mu]g/scm \7\.
Cycle time test \5\..................  15 minutes where the
                                        stability criteria are
                                        readings change by <
                                        2.0% of span or by <=
                                        0.5 [mu]g/scm, for 2
                                        minutes..
----------------------------------------------------------------------------------------------------------------
\1\ Note that [verbar]R - A[verbar] is the absolute value of the difference between the reference gas value and
  the analyzer reading. [verbar]R - Aavg[verbar] is the absolute value of the difference between the reference
  gas concentration and the average of the analyzer responses, at a particular gas level.
\2\ Use elemental Hg standards; a mid-level or high-level upscale gas may be used.
\3\ Use elemental Hg standards.
\4\ Use oxidized Hg standards.
\5\ Use elemental Hg standards; a high-level upscale gas must be used. The cycle time test is not required for
  Hg CEMS that use integrated batch sampling; however, those monitoring systems must be capable of recording at
  least one Hg concentration reading every 15 minutes.
\6\ If your Hg CEMS lacks an integrated elemental Hg gas generator, you may continue to use NIST-traceable
  oxidized Hg gases until such time as NIST-traceable compressed elemental Hg gas standards, at appropriate
  concentration levels, are available from gas vendors.
\7\ Note that [verbar]RMavg - Cavg[verbar] is the absolute difference between the mean reference method value
  and the mean CEMS value from the RATA; CC is the confidence coefficient from Equation 2-5 of Performance
  Specification 2 in appendix B to part 60 of this chapter.

* * * * *
    <IP_ADDRESS> Relative Accuracy Test Audit (RATA). Perform the RATA of
the Hg CEMS at normal load. Acceptable Hg reference methods for the
RATA include ASTM D6784-02 (Reapproved 2008), ``Standard Test Method
for Elemental, Oxidized, Particle-Bound and Total Mercury in Flue Gas
Generated from Coal-Fired Stationary Sources (Ontario Hydro Method)''
(incorporated by reference, see Sec.  63.14) and Methods 29, 30A, and
30B in appendix A-8 to part 60 of this chapter. When Method 29 or ASTM
D6784-02 is used, paired sampling trains are required and the
filterable portion of the sample need not be included when making
comparisons to the Hg CEMS results for purposes of a RATA. To validate
a Method 29 or ASTM D6784-02 test run, calculate the relative deviation
(RD) using Equation A-1 of this section, and assess the results as
follows to validate the run. The RD must not exceed 10 percent, when
the average Hg concentration is greater than 1.0 [mu]g/dscm. If the RD
specification is met, the results of the two samples shall be averaged
arithmetically.
[GRAPHIC] [TIFF OMITTED] TR06AP16.008

Where:

RD = Relative Deviation between the Hg concentrations of samples
``a'' and ``b'' (percent),
Ca = Hg concentration of Hg sample ``a'' ([mu] g/dscm),
and
Cb = Hg concentration of Hg sample ``b'' ([mu] g/dscm).
* * * * *
    <IP_ADDRESS>.2 Calculation of RATA Results. Calculate the relative
accuracy (RA) of the monitoring system, on a [mu] g/scm basis, as
described in section 12 of Performance Specification (PS) 2 in appendix
B to part 60 of this chapter (see Equations 2-3 through 2-6 of PS2)
including the option to substitute the emission limit value (in this
case the equivalent concentration) in the denominator of Equation 2-6
in place of the average RM value when the average emissions for the
test are less than 50 percent of the applicable emissions limit. For
purposes of calculating the relative accuracy, ensure that the
reference method and monitoring system data are on a consistent basis,
either wet or dry. The CEMS must either meet the main performance
specification or the alternative specification in Table A-1 of this
appendix.
* * * * *

5. Ongoing Quality Assurance (QA) and Data Validation

* * * * *
    <IP_ADDRESS> Calibration error tests of the Hg CEMS are required daily,
except during unit outages. Use a NIST-traceable elemental Hg gas
standard for these calibrations. If your Hg CEMS lacks an integrated
elemental Hg gas generator, you may continue to use NIST-traceable
oxidized Hg gases for the 7-day calibration error test (or the daily
calibration error check) until such time as NIST-traceable compressed
elemental Hg gas standards, at appropriate concentration levels, are
available from gas vendors. Both a zero-level gas and either a mid-
level or high-level gas are required for these calibrations.
* * * * *
    <IP_ADDRESS> Perform a single-level system integrity check weekly, i.e.,
once every 7 operating days (see the third column in Table A-2 of this
appendix).
* * * * *

                              Table A-2--On-Going QA Test Requirements for Hg CEMS
----------------------------------------------------------------------------------------------------------------
                                                                       With these
  Perform this type of QA test . . .   At this frequency . . .     qualifications and    Acceptance criteria . .
                                                                    exceptions . . .                .
----------------------------------------------------------------------------------------------------------------
Calibration error test \5\...........  Daily..................   Use either a    [verbar]R - A[verbar]
                                                                 mid- or high-level gas.  <= 5.0% of span value
                                                                 Use elemental   or
                                                                 Hg.                     [verbar]R - A[verbar]
                                                                 Calibrations     <= 1.0 [mu]g/scm.
                                                                 are not required when
                                                                 the unit is not in
                                                                 operation..
Single-level system integrity check..  Weekly \1\.............   Use oxidized    [verbar]R -
                                                                 Hg--either mid- or       Aavg[verbar] <= 10.0%
                                                                 high-level.              of the reference gas
                                                                                value
                                                                                or
                                                                                [verbar]R -
                                                                                Aavg[verbar] <= 0.8
                                                                                [mu]g/scm.
Linearity check or 3-level system      Quarterly \3\..........   Required in     [verbar]R - Aavg
 integrity check.                                                each ``QA operating      [verbar] <= 10.0% of
                                                                 quarter'' \2\ and no     the reference gas
                                                                 less than once every 4   value, at each
                                                                 calendar quarters.       calibration gas level
                                                                 168 operating   or
                                                                 hour grace period       [verbar]R -
                                                                 available.               Aavg[verbar] <= 0.8
                                                                 Use elemental    [mu]g/scm.
                                                                 Hg for linearity check.
                                                                 Use oxidized
                                                                 Hg for system
                                                                 integrity check.
RATA.................................  Annual \4\.............   Test deadline   <=20.0% RA when Cavg >=
                                                                 may be extended for      2.5 [mu]g/scm
                                                                 ``non-QA operating      or
                                                                 quarters,'' up to a     [verbar]RMavg -
                                                                 maximum of 8 quarters    Cavg[verbar] +
                                                                 from the quarter of      [verbar]CC[verbar] <=
                                                                 the previous test..      0.5 [mu]g[mu]/scm, if
                                                                 720 operating    RMavg < 2.5 [mu]g/scm.
                                                                 hour grace period
                                                                 available.
----------------------------------------------------------------------------------------------------------------
\1\ ``Weekly'' means once every 7 operating days.
\2\ A ``QA operating quarter'' is a calendar quarter with at least 168 unit or stack operating hours.
\3\ ``Quarterly'' means once every QA operating quarter.
\4\ ``Annual'' means once every four QA operating quarters.
\5\ If your Hg CEMS lacks an integrated elemental Hg gas generator, you may continue to use NIST-traceable
  oxidized Hg gases until such time as NIST-traceable compressed elemental Hg gas standards, at appropriate
  concentration levels, are available from gas vendors.

* * * * *
    5.2.1 Each sorbent trap monitoring system shall be continuously
operated and maintained in accordance with Performance Specification
(PS) 12B in appendix B to part 60 of this chapter. The QA/QC criteria
for routine operation of the system are summarized in Table 12B-1 of PS
12B. Each pair of sorbent traps may be used to sample the stack gas for
up to 15 operating days.
* * * * *

6. Data Reductions and Calculations

* * * * *
    <IP_ADDRESS> The applicable gross output-based Hg emission rate limit in
Table 1 or 2 to this subpart must be met on a 30- (or 90-) boiler
operating day rolling average basis, except as otherwise provided in
Sec.  63.10009(a)(2). Use Equation A-5 of this appendix to calculate
the Hg emission rate for each averaging period.
[GRAPHIC] [TIFF OMITTED] TR06AP16.009

Where:

Eo = Hg emission rate for the averaging period (lb/GWh),
Eho = Gross output-based hourly Hg emission rate for unit
or stack sampling hour ``h'' in the averaging period, from Equation
A-4 of this appendix (lb/GWh), and
n = Number of unit or stack operating hours in the averaging period
in which valid data were obtained for all parameters. (Note: Do not
include non-operating hours with zero emission rates in the
average).
* * * * *

7. Recordkeeping and Reporting

* * * * *
    <IP_ADDRESS> The EGUs that constitute an emissions averaging group.
* * * * *
    <IP_ADDRESS> If applicable, a code to indicate that the default gross
output (as defined in Sec.  63.10042) was used to calculate the Hg
emission rate.
* * * * *

0
30. Appendix B to subpart UUUUU of part 63 is amended by:
0
a. Revising paragraphs 2.1 and 2.3;
0
b. Adding paragraphs 2.3.1 and 2.3.2;
0
c. Revising paragraphs 3.1 and 3.2 and adding paragraph 3.3;
0
d. Adding introductory text to section 5;
0
e. Revising paragraphs 5.1, 5.1.2, 5.2, and 5.3;
0
f. Adding paragraphs 5.4, 5.4.1, 5.4.2, <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>.1,
<IP_ADDRESS>.2, <IP_ADDRESS>, <IP_ADDRESS>.1, <IP_ADDRESS>.2, <IP_ADDRESS>.3, and 5.4.3; and
0
g. Revising section 8 introductory text and paragraph 9.3.2.
    The revisions and additions read as follows:

Appendix B to Subpart UUUUU of Part 63--HCl and HF Monitoring
Provisions

* * * * *

2. Monitoring of HCl and/or HF Emissions

    2.1 Monitoring System Installation Requirements. Install HCl and/or
HF CEMS and any additional monitoring systems needed to convert
pollutant concentrations to units of the applicable emissions limit in
accordance with Sec.  63.10010(a) and either Performance Specification
15 (PS 15) of appendix B to part 60 of this chapter for extractive
Fourier Transform Infrared Spectroscopy (FTIR) continuous emissions
monitoring systems or Performance Specification 18 (PS 18) of appendix
B to part 60 of this chapter for HCl CEMS.
* * * * *

    2.3 FTIR Monitoring System Equipment, Supplies, Definitions, and
General Operation. The following provisions apply:
    2.3.1 PS 15, Sections 2.0, 3.0, 4.0, 5.0, 6.0, and 10.0 of appendix
B to part 60 of this chapter; or
    2.3.2 PS 18, Sections 3.0, 6.0, and 11.0 of appendix B to part 60
of this chapter.

3. Initial Certification Procedures

* * * * *
    3.1 If you choose to follow PS 15 of appendix B to part 60 of this
chapter, then your HCl and/or HF CEMS must be certified according to PS
15 using the procedures for gas auditing and comparison to a reference
method (RM) as specified in sections 3.1.1 and 3.1.2 below.
* * * * *
    3.2 If you choose to follow PS 18 of appendix B to part 60 of this
chapter, then your HCl CEMS must be certified according to PS 18,
sections 7.0, 8.0, 11.0, 12.0, and 13.0.
    3.3 Any additional stack gas flow rate, diluent gas, and moisture
monitoring system(s) needed to express pollutant concentrations in
units of the applicable emissions limit must be certified according to
part 75 of this chapter.
* * * * *

5. On-Going Quality Assurance Requirements

    On-going QA test requirements for HCl and HF CEMS must be
implemented as follows:
    5.1 If you choose to follow Performance Specification 15 (PS 15) of
appendix B to part 60 of this chapter, then the quality assurance/
quality control procedures of PS 15 shall apply as set forth in
sections 5.1.1 through 5.1.3 and 5.4.2 of this appendix.
* * * * *
    5.1.2 On a quarterly basis, you must conduct a gas audit of the HCl
and/or HF CEMS as described in section 3.1.1 of this appendix. For the
purposes of this appendix, ``quarterly'' means once every ``QA
operating quarter'' (as defined in section 3.1.20 of appendix A to this
subpart). You have the option to use HCl gas in lieu of HF gas for
conducting this audit on an HF CEMS. To the extent practicable, perform
consecutive quarterly gas audits at least 30 days apart. The initial
quarterly audit is due in the first QA operating quarter following the
calendar quarter in which certification testing of the CEMS is
successfully completed. Up to three consecutive exemptions from the
quarterly audit requirement are allowed for ``non-QA operating
quarters'' (i.e., calendar quarters in which there are less than 168
unit or stack operating hours). However, no more than four consecutive
calendar quarters may elapse without performing a gas audit, except as
otherwise provided in section <IP_ADDRESS>.1 of this appendix.
* * * * *
    5.2 If you choose to follow Performance Specification PS 18 of
appendix B to part 60 of this chapter, then the quality assurance/
quality control procedures in Procedure 6 of appendix F to part 60 of
this chapter shall apply. The quarterly and annual QA tests required
under Procedure 6 shall be performed, respectively, at the frequencies
specified in sections 5.1.2 and 5.1.3 of this appendix.
    5.3 Stack gas flow rate, diluent gas, and moisture monitoring
systems must meet the applicable on-going QA test requirements of part
75 of this chapter.
* * * * *
    5.4 Data Validation.
    5.4.1 Out-of-Control Periods. An HCl or HF CEMS that is used to
provide data under this appendix is considered to be out-of-control,
and data from the CEMS may not be reported as quality-assured, when any
acceptance criteria for a required QA test is not met. The HCl or HF
CEMS is also considered to be out-of-control when a required QA test is
not performed on schedule or within an allotted grace period. To end an
out-of-control period, the QA test that was either failed or not done
on time must be performed and passed. Out-of-control periods are
counted as hours of monitoring system downtime.
    5.4.2 Grace Periods. For the purposes of this appendix, a ``grace
period'' is defined as a specified number of unit or stack operating
hours after the deadline for a required quality-assurance test of a
continuous monitor has passed, in which the test may be performed and
passed without loss of data.
    <IP_ADDRESS> For the monitoring systems described in section 5.3 of this
appendix, a 168 unit or stack operating hour grace period is available
for quarterly linearity checks, and a 720 unit or stack operating hour
grace period is available for RATAs, as provided, respectively, in
sections 2.2.4 and 2.3.3 of appendix B to part 75 of this chapter.
    <IP_ADDRESS> For the purposes of this appendix, if the deadline for a
required gas audit/data accuracy assessment or RATA of an HCl CEMS
cannot be met due to circumstances beyond the control of the owner or
operator:
    <IP_ADDRESS>.1 A 168 unit or stack operating hour grace period is
available in which to perform the gas audit or other quarterly data
accuracy assessment; or
    <IP_ADDRESS>.2 A 720 unit or stack operating hour grace period is
available in which to perform the RATA.
    <IP_ADDRESS> If a required QA test is performed during a grace period,
the deadline for the next test shall be determined as follows:
    <IP_ADDRESS>.1 For a gas audit or RATA of the monitoring systems
described in sections 5.1 and 5.2 of this appendix, determine the
deadline for the next gas audit or RATA (as applicable) in accordance
with section 2.2.4(b) or 2.3.3(d) of appendix B to part 75 of this
chapter; treat a gas audit in the same manner as a linearity check.
    <IP_ADDRESS>.2 For the gas audit or other quarterly data accuracy
assessment of an HCl or HF CEMS, the grace period test only satisfies
the audit requirement for the calendar quarter in which the test was
originally due. If the calendar quarter in which the grace period audit
is performed is a QA operating quarter, an additional gas audit/data
accuracy assessment is required for that quarter.
    <IP_ADDRESS>.3 For the RATA of an HCl or HF CEMS, the next RATA is due
within three QA operating quarters after the calendar quarter in which
the grace period test is performed.
    5.4.3 Conditional Data Validation. For recertification and
diagnostic testing of the monitoring systems that are used to provide
data under this appendix, the conditional data validation provisions in
Sec.  75.20(b)(3)(ii) through (ix) of this chapter may be used to avoid
or minimize data loss. The allotted window of time to complete
calibration tests and RATAs shall be as specified in Sec.
75.20(b)(3)(iv) of this chapter; the allotted window of time to
complete a quarterly gas audit or data accuracy assessment shall be the
same as for a linearity check (i.e., 168 unit or stack operating
hours).
* * * * *

8. QA/QC Program Requirements

    The owner or operator shall develop and implement a quality
assurance/quality control (QA/QC) program for the HCl and/or HF CEMS
that are used to provide data under this subpart. At a minimum, the
program shall include a written plan that describes in detail (or that
refers to separate documents containing) complete, step-by-step
procedures and operations for the most important QA/QC activities.
Electronic storage of the QA/QC plan is permissible, provided that the
information can be made available in hard copy to auditors and
inspectors. The QA/QC program requirements for

the other monitoring systems described in section 5.3 of this appendix
are specified in section 1 of appendix B to part 75 of this chapter.
* * * * *

9. Data Reduction and Calculations

* * * * *
    9.3.2 For gross output-based emission rates, first calculate the
HCl or HF mass emission rate (lb/h), using an equation that has the
general form of Equation A-2 or A-3 in appendix A to this subpart (as
applicable), replacing the value of K with 9.43 x 10-8 lb/
scf-ppm (for HCl) or 5.18 x 10-8 (for HF) and defining
Ch as the hourly average HCl or HF concentration in ppm.
Then, divide the result by the hourly gross output (megawatts) to
convert it to units of lb/MWh. If the gross output is zero during a
startup or shutdown hour, use the default gross output (as defined in
Sec.  63.10042) to calculate the HCl or HF emission rate. The default
gross output is not considered to be a substitute data value.
* * * * *
[FR Doc. 2016-06563 Filed 4-5-16; 8:45 am]
 BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Petition Number (PP#) 2E8061

EPA has received a pesticide petition, PP# 2E8061, from Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540  proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.433 by establishing a tolerance for residues of sodium salt of fomesafen (fomesafen), 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide in or on the raw agricultural commodities cantaloupe; cucumber; pea, succulent; pumpkin; squash, summer; squash, winter; and watermelon at 0.025 parts per million (ppm)  and vegetable, soybean, succulent (edamame) at 0.05 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Cotton, soybean and tomato metabolism studies were conducted using [14]C-labeled fomesafen. The major degradation pathway of fomesafen in these commodities involves ether cleavage followed by cystine conjugation. The major portion of the applied chemical is comprised of unchanged fomesafen. Metabolites, if present, are <0.01 mg/kg. Very little translocation from treated foliage tissue occurs. The nature of the residue is adequately understood.

	2. Analytical method. An analytical method using chemical derivatization followed by gas chromatography with Nitrogen-Phosphorus detection (NPD) has been developed and validated for residues of fomesafen in snap/dry beans, cotton seed and cotton gin byproducts, as well as for other crops. After homogenization, the samples are extracted with acidified acetonitrile. After addition of water and additional acid, the extract is submitted to liquid/liquid partition. The residue is transferred to dichloromethane, followed by acetone and derivatized with iodomethane in the presence of anhydrous potassium carbonate. A silica gel column cleanup is done, with dichloromethane:hexane as the eluent. The final extract is transferred to toluene and analyzed by GC-NPD. The limit of quantitation is 0.025 ppm.

	3. Magnitude of residues. Magnitude of the residue studies supporting the proposed tolerances in or on these raw agricultural commodities (cantaloupe; cucumber; pea, succulent; pumpkin; summer squash; watermelon and winter squash) were submitted with this petition.  These studies were conducted per EPA Test Guidelines Series 860.  No residues were detected above the lowest level of method validation (0.025 ppm) in any of the tested agricultural commodities.

A tolerance for vegetable, soybean, succulent (edamame) of 0.05 ppm is also proposed based on the previously established snap bean tolerance.

B. Toxicological Profile The United States Environmental Protection Agency (EPA) has evaluated the available fomesafen toxicological database and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the reliability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxicity profile of fomesafen is discussed in the March 9, 2011 Federal Register publication of the Final Rule for establishing tolerances for residues of fomesafen in or on peppers (bell and non-bell), potatoes and tomatoes [EPA-HQ-OPP-2010-0122; FRL-8858-5].

	1. Acute toxicity. [NA-Remove]

	2. Genotoxicty.  [NA-Remove]

	3. Reproductive and developmental toxicity. [NA-Remove]

      4. Subchronic toxicity.  [NA-Remove]              5. Chronic toxicity.  [NA-Remove] 	       6. Animal metabolism. [NA-Remove]

	7. Metabolite toxicology.  [NA-Remove]

	8. Endocrine disruption.  [NA-Remove]

C. Aggregate Exposure

	1. Dietary exposure. A Tier I chronic dietary exposure evaluation was performed for fomesafen using the Dietary Exposure Evaluation Model (DEEM-FCIDTM, version 2.16) from Exponent.  These exposure assessments included all currently registered uses for current fomesafen uses including dry beans, succulent snap beans, cotton, soybeans, potatoes, tomatoes, peppers, and proposed uses on cucurbit vegetables (Crop Group 9), succulent shelled and podded peas, and edamame (vegetable, soybean, succulent).  Tolerance values were used for all raw agricultural commodities; no adjustments were made for percent crop treated (%CT).  There are no expected dietary exposures as a result of residues of fomesafen in meat, milk, or eggs based upon low levels of residues in feedstuffs and low transfer factors as determined from the goat and hen metabolism studies.  Drinking water estimates were incorporated directly into the dietary exposure assessment using the higher of the estimated drinking water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure.  Acute toxicological endpoints have not been established, so acute food assessments were not performed.

Chronic Exposure.  The fomesafen chronic dietary risk assessment was performed for all population subgroups with a chronic reference dose of 0.0025 mg/kg-bw/day based on a chronic toxicity study in rats with a no observed adverse effect level (NOAEL) of 0.25 mg/kg-bw/day and an uncertainty factor of 100X.  The 100X safety factor includes intra- and inter-species variations.  No additional FQPA safety factor was applied.  For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the reference dose (%RfD).  Chronic dietary (food only) exposure to the U.S. population resulted in a MOE of 2,089, or 4.8% of the chronic RfD (Benchmark MOE = 100; cRfD = 0.0025 mg/kg-bw/day).  The most exposed sub-population was children 1-2 years old, with a MOE of 884, or 11.3% of the chronic RfD, (Benchmark MOE = 100; cRfD = 0.0025 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary (food only) exposures to residues arising from all current and proposed uses for fomesafen.

Cancer.  Fomesafen has been classified as not likely to be carcinogenic in humans, so cancer risk assessments were not performed.

	ii. Drinking water. The Estimated Drinking Water Concentrations (EDWCs) of fomesafen were determined for groundwater using results from a 3-year prospective groundwater (PGW) study and for surface water using the Tier II PRZM/EXAMS model which estimates pesticide concentrations in surface water.  The currently registered uses plus proposed uses on peas (succulent), cucumbers, squash, pumpkins, cantaloupes, watermelon, and edamame (vegetable, soybean, succulent) were assessed.   For ground water, the PGW monitoring concentration for fomesafen was 1 ppb (chronic).  For surface water, the currently registered use on soybeans as well as the proposed use on edamame provided the highest chronic EDWC of 7.617 ppb (adjusted for 0.91 Percent Cropped Area, PCA).  Since the surface water chronic EDWC exceeds the ground water EDWC, the surface water value was used for risk assessment purposes and will be considered protective for any ground water exposure concerns.

Chronic Exposure from Drinking Water:  The chronic EDWC of 7.617 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the chronic drinking water exposure.   Chronic drinking water exposure to the U.S. population resulted in a MOE of 1,557 or 6.4% of the cRfD (Benchmark MOE = 100; cRfD = 0.0025 mg/kg-bw/day).  The most sensitive sub-population was all infants (<1 year old), with a MOE of 475 or 21.1% of the cRfD (Benchmark MOE = 100; cRfD = 0.0025 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposures to residues arising from all current and proposed uses for fomesafen.

	2. Non-dietary exposure. There are no current or proposed uses of fomesafen that would result in residential exposures.

D. Cumulative Effects

Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity".  The EPA does not have, at this time, available data to determine whether fomesafen has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  For the purposes of this tolerance action, the EPA has not assumed that fomesafen has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. The chronic dietary exposure analysis (food plus water) showed that exposure from all current, pending, and proposed uses of fomesafen would result in a MOE of 892 (11.2% of the chronic RfD) for the general U.S. population.  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark, Syngenta believes that there is a reasonable certainty that no harm will result to the U.S. population from chronic aggregate exposures to residues arising from all current and proposed uses for fomesafen.

	2. Infants and children. The chronic dietary exposure analysis (food plus water) showed that exposure from all current, pending, and proposed uses of fomesafen would result in a MOE of 366 (27.3% of the chronic RfD) for infants <1 year old.  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark, Syngenta believes that there is a reasonable certainty that no harm will result to infants or children from chronic aggregate exposures to residues arising from all current and proposed uses for fomesafen.

F. International Tolerances

There are no Codex maximum residue levels (MRLs) established for residues of fomesafen in any commodity.  A Canadian tolerance of 0.05 ppm is established for fomesafen residues in or on soybeans, dry beans, lima beans, and snap beans.  A Mexican tolerance of 0.01 ppm is established for fomesafen residues in or on beans.


[Federal Register: August 31, 2009 (Volume 74, Number 167)]
[Notices]
[Page 44900-44901]
[DOCID:fr31au09-134]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee Meeting on Transport
Airplane and Engine Issues

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a public meeting of the FAA's Aviation
Rulemaking Advisory Committee (ARAC) to discuss transport airplane and
engine (TAE) issues.

DATES: The meeting is scheduled for Wednesday, September 23, 2009,
starting at 9 a.m. Eastern Daylight Time. Arrange for oral presentation
by September 16, 2009.

ADDRESSES: The Boeing Company, 1200 Wilson Boulevard, Room 234,
Arlington, Virginia 22209.

FOR FURTHER INFORMATION CONTACT: Ralen Gao, Office of Rulemaking, ARM-
209, FAA, 800 Independence Avenue, SW., Washington, DC 20591, Telephone
(202) 267-3168 FAX<PHONE_NUMBER>, or e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. app. III), notice is
given of an ARAC meeting to be held September 23, 2009.
    The agenda for the meeting is as follows:
     Opening Remarks, Review Agenda and Minutes;
     FAA Report;
     Airplane-level Safety Analysis WG Report;
     Task 4 Status
     EXCOM Report;
     Transport Canada Report;
     Airworthiness Assurance HWG Report;
     Ice Protection HWG Report;
     Avionics HWG Report;
     Any Other Business;
     Action Item Review.
    Attendance is open to the public, but will be limited to the
availability to meeting room space. Please confirm your attendance with
the person listed in the For Further Information Contact section no
later than September 16, 2009. Please provide the following
information. Full legal name, country of citizenship, and name of your
industry association, or applicable affiliation. If you are attending
as a public citizen, please indicate so.
    For persons participating by telephone, Please Contact Ralen Gao by
e-mail or phone for the teleconference call-in number and passcode.
Anyone calling from outside the Arlington VA, metropolitan area will be
responsible for paying long-distance charges.
    The public must make arrangements by September 16, 2009, to present
oral statements by the meeting. Written statements may be presented by
the ARAC at any time by providing 25 copies to the person listed in the
For Further Information Contact section or by providing copies at the
meeting. Copies of the documents to be presented to ARAC may be made
available by contacting the person listed in the For Further
Information Contact section.
    If you need assistance or require an reasonable accommodation for
the meeting or meeting documents, please contact the person listed in
the For Further Information Contact section. Sign and oral
interpretation, as well as a listening device, can be made available if
requested 10 calendar days before the meeting.

    Issued in Washington, DC, on August 26, 2009.
Julie Ann Lynch,
Acting Director, Office of Rulemaking.
[FR Doc. E9-20959 Filed 8-28-09; 8:45 am]

BILLING CODE 4910-13-P