[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Rules and Regulations]
[Pages 63195-63200]
[FR Doc No: 2020-22039]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0049; Product Identifier 2017-CE-031-AD; Amendment
39-21222; AD 2020-18-01]
RIN 2120-AA64

Airworthiness Directives; Textron Aviation Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Textron Aviation Inc. (Textron) Model 172N, 172P, 172Q, 172RG,
F172N, F172P, FR172K, R172K, 182E, 182F, 182G, 182H, 182J, 182K, 182L,
182M, 182N, 182P, 182Q, 182R, T182, F182P, F182Q, FR182, R182, TR182,
206, P206, P206A, P206B, P206C, P206D, P206E, TP206A, TP206B, TP206C,
TP206D, TP206E, U206, U206A, U206B, U206C, U206D, U206E, U206F, U206G,
TU206A, TU206B, TU206C, TU206D, TU206E, TU206F, TU206G, 207, 207A,
T207, T207A, 210-5 (205), 210-5A (205A), 210B, 210C, 210D, 210E, 210F,
and T210F airplanes. This AD was prompted by cracks found in the lower
area of the forward cabin doorpost bulkhead. This AD requires
repetitively inspecting the lower area of the forward cabin doorposts
at the strut attach fitting for cracks and repairing any cracks. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective November 12, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 12,
2020.

ADDRESSES: For service information identified in this final rule,
contact Textron Aviation Inc., Textron Aviation Customer Service, One
Cessna Blvd., Wichita, Kansas 67215; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>internet: https://support.cessna.com. You may
review this referenced service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0049.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0049; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations (phone:<PHONE_NUMBER>) is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Bobbie Kroetch, Aerospace Engineer,
Wichita ACO Branch, 1801 Airport Road, Room 100, Wichita, Kansas 67209;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>or fbac929893928f9ad6b8b4a8bb9d9a9ad59c948d.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 by adding an AD that would apply to certain
serial-numbered Textron Aviation Inc. (Textron) (type certificate
previously held by Cessna Aircraft Company) Model 172N, 172P, 172Q,
172RG, F172N, F172P, FR172K, R172K, 182E,

182F, 182G, 182H, 182J, 182K, 182L, 182M, 182N, 182P, 182Q, 182R, T182,
F182P, F182Q, FR182, R182, TR182, 206, P206, P206A, P206B, P206C,
P206D, P206E, TP206A, TP206B, TP206C, TP206D, TP206E, U206, U206A,
U206B, U206C, U206D, U206E, U206F, U206G, TU206A, TU206B, TU206C,
TU206D, TU206E, TU206F, TU206G, 207, 207A, T207, T207A, 210-5 (205),
210-5A (205A), 210B, 210C, 210D, 210E, 210F, and T210F airplanes. The
SNPRM published in the Federal Register on May 29, 2020 (85 FR 32308).
    The FAA preceded the SNPRM with a notice of proposed rulemaking
(NPRM) that published in the Federal Register on February 1, 2018 (83
FR 4605). The NPRM was prompted by reports of cracks in the lower area
of the forward cabin doorpost bulkhead on more than four dozen Textron
100 and 200 airplanes. The NPRM proposed to require repetitively
inspecting the lower area of the forward cabin doorposts at the strut
attach fitting for cracks and repairing any cracks found by modifying
the area with the applicable service kit. The SNPRM proposed to modify
the estimated costs of the proposed AD, the repetitive inspection
intervals, and the credit allowed for previous actions; clarify the
inspection instructions for airplanes with the service kit installed;
correct the contact information for obtaining the service information;
and add a reporting requirement to collect the inspection results. The
SNPRM also changed some of the model designations listed in the
applicability in order to match the models as they are listed in the
type certificate data sheet.
    The FAA is issuing this AD to detect and address cracking of the
wing strut attach point. The unsafe condition, if not addressed, could
result in failure of the wing in operation, which could result in loss
of control of the airplane.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the SNPRM and the FAA's response to each comment.

Support for the SNPRM

    Patrick Imperatrice expressed support for the proposed AD.

Request To Extend or Remove Calendar Compliance Time

    Kermit Bunde expressed support for the 1,000-hour time-in-service
(TIS) inspection interval but requested the FAA remove the 36-month
calendar time inspection interval. The commenter stated that the 36-
month interval is too often and that cracking is a function of usage
and not only elapsed time. The commenter provided examples of Cessna
maintenance actions that have no calendar time limit.
    The FAA disagrees. Both the manufacturer's guidance, which is
published in the supplemental inspection documents (SIDs) for certain
airplanes, and fleet history support the 36-month interval for
inspecting this location. Loading conditions outside of flight, such as
ground loads, handling loads, and tie down loads, may also cause
cracking at this location. Therefore, the FAA determined the inspection
interval of 36 calendar months or 1,000 hours TIS, whichever occurs
first, is necessary to address the unsafe condition. The FAA did not
change this AD based on this comment.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Cessna Single Engine Service Bulletin SEB93-5,
Revision 2, dated May 29, 2019 (SEB93-5R2) and Cessna Single Engine
Service Bulletin SEB95-19, dated December 29, 1995 (SEB95-19). For the
applicable model airplanes, the service information contains procedures
for repetitively inspecting the lower area of the forward cabin
doorposts for cracks and repairing any cracks found by modifying the
area with the applicable Cessna service kit.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Cessna Single Engine Service Kit SK172-147, dated
December 29, 1995. This service kit provides instructions to add a
channel to each forward cabin doorpost bulkhead. The FAA also reviewed
Cessna Single Engine Service Kit SK182-115, dated December 29, 1995;
Cessna Single Engine Service Kit SK206-42D, dated May 29, 2019; and
Cessna Single Engine Service Kit SK210-156, dated December 29, 1995.
For the applicable model airplanes, these service kits provide
instructions to add a doubler and a channel to each forward cabin
doorpost bulkhead. In addition, the FAA reviewed Cessna Single Engine
Service Kit SK207-19A, dated May 29, 2019. The service information
contains procedures to reinforce the lower forward doorpost bulkhead
and wing strut fitting by adding a doubler and a channel to each
forward cabin doorpost bulkhead.

Costs of Compliance

    The FAA estimates that this AD affects 14,653 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Inspect the lower area of the       1.5 work-hours x $85   Not applicable.......         $127.50   $1,868,257.50
 forward cabin doorposts for         per hour = $127.50.
 cracks.
Reporting requirement.............  1 work-hour x $85 per  Not applicable.......              85       1,245,505
                                     hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary repairs
that would be required based on the results of the inspection.
Reference the applicable Cessna single engine service bulletin for kit
applicability. The FAA has no way of determining the number of
airplanes that might need this repair.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Install Cessna Single-Engine Service Kit SK172- 36 work-hours x $85 per hour =            $3,415          $6,475
 147.                                            $3,060.
Install Cessna Single-Engine Service Kit SK182- 36 work-hours x $85 per hour =             7,490          10,550
 115.                                            $3,060.
Install Cessna Single-Engine Service Kit SK206- 36 work-hours x $85 per hour =             3,115           6,175
 42D.                                            $3,060.
Install Cessna Single-Engine Service Kit SK207- 36 work-hours x $85 per hour =             4,957           8,017
 19A.                                            $3,060.
Install Cessna Single-Engine Service Kit SK210- 36 work-hours x $85 per hour =             7,020          10,080
 156.                                            $3,060.
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Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. Public reporting for this collection of information is estimated
to be approximately 1 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, completing and reviewing the collection of
information. All responses to this collection of information are
mandatory. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: Information Collection Clearance Officer,
Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX
76177-1524.

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.
    The FAA is 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

    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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive (AD):

2020-18-01 Textron Aviation Inc.: Amendment 39-21222; Docket No. FAA
2018-0049; Product Identifier 2017-CE-031-AD.

(a) Effective Date

    This AD is effective November 12, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Textron Aviation Inc. (type
certificate previously held by Cessna Aircraft Company) model
airplanes, certificated in any category:
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR07OC20.000

[GRAPHIC] [TIFF OMITTED] TR07OC20.001

BILLING CODE 4910-13-C

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report of cracks found in the lower
area of the forward cabin doorpost bulkhead. The FAA is issuing this
AD to detect and address cracking of the wing strut attach point.
The unsafe condition, if not addressed, could result in failure of
the wing in operation, which could result in loss of control of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Initial Inspections

    (1) For airplanes without a lower forward doorpost bulkhead and
wing strut fitting reinforcement service kit (service kit) installed
in accordance with Cessna Single Engine Service Bulletin SEB95-19,
dated December 29, 1995 (SEB95-19), or Cessna Single Engine Service
Bulletin SEB93-5, Revision 2, dated May 29, 2019 (SEB93-5R2): At the
applicable compliance time specified in paragraph (g)(1)(i) or (ii)
of this AD, do a visual inspection of the lower forward doorpost at
the strut attach fitting for cracks in accordance with steps 1.A.,
1.B., 1.C., and 1.B. (the step following step 1.C.) of the
Accomplishment Instructions in SEB95-19; or steps 1.A. and 1.B. of
the Accomplishment Instructions in SEB93-5R2; as applicable to your
model airplane.
    (i) For airplanes that have accumulated less than 4,000 hours
time-in-service (TIS) as of the effective date of this AD: Initially
inspect prior to the accumulation of 4,000 hours TIS or within the
next 200 hours TIS after the effective date of this AD, whichever
occurs later.
    (ii) For airplanes that have accumulated 4,000 or more hours TIS
as of the effective date of this AD: Initially inspect within 200
hours TIS after the effective date of this AD or within 12 calendar
months after the effective date of this AD, whichever occurs first.
    (2) For airplanes with a service kit installed in accordance
with SEB95-19 or SEB93-5R2: At the later of the times specified in
paragraphs (g)(2)(i) and (ii) of this AD, do a visual inspection of
the lower forward doorpost at the strut attach fitting for cracks in
accordance with steps 1.A., 1.B., 1.C., and 1.B. (the step following
step 1.C.) of the Accomplishment Instructions in SEB95-19; or steps
1.A. and 1.B. of the Accomplishment Instructions in SEB93-5R2; as
applicable to your model airplane. Do not remove the installed
service kit; instead, inspect for cracking that extends beyond the
modified parts.
    (i) At the applicable time specified in paragraph (g)(1)(i) or
(ii) of this AD.
    (ii) Within 1,000 hours TIS or 36 calendar months, whichever
occurs first, since installing the service kit.

(h) Repetitive Inspections

    (1) If no cracks are found during the initial inspection
required by paragraph (g)(1) or (2) of this AD, thereafter repeat
the inspection at intervals not to exceed 36 calendar months or
1,000 hours TIS, whichever occurs first from the last inspection, as
long as no cracks are found.
    (2) If cracks are found during any inspection required by
paragraph (g)(1) or (h)(1) of this AD, do the inspection specified
in paragraph (g)(2) of this AD within 36 calendar months or 1,000
hours TIS, whichever occurs first after installing the service kit
required by paragraph (i)(1) of this AD. Thereafter, repeat the
inspection at intervals not to exceed 36 calendar months or 1,000
hours TIS, whichever occurs first from the last inspection, as long
as no additional cracks are found.

(i) Corrective Actions

    (1) If cracks are found during any inspection required by
paragraph (g)(1) or paragraph (h)(1) of this AD, before further
flight, install a service kit in accordance with step 1.D. of the
Accomplishment Instructions in SEB95-19; or step 1.C. of the
Accomplishment Instructions in SEB93-5R2; as applicable to your
model airplane.
    (2) If cracks are found during any inspection required by
paragraph (g)(2) or (h)(2) of this AD, before further flight, repair
the area using a method approved by the Manager, Wichita ACO Branch,
FAA. For a repair method to be approved by the Manager, Wichita ACO
Branch as required by this paragraph, the Manager's approval letter
must specifically refer to this AD. You may use the contact
information in paragraph (n)(1) of this AD to obtain FAA approval of
your repair method.

(j) Reporting Requirement

    Within 30 days after the effective date of this AD, or within 30
days after completing the initial inspection required by paragraph
(g) of this AD, whichever occurs later, report the findings of the
initial inspection (regardless if cracks were found or not) to the
FAA at<EMAIL_ADDRESS>Thereafter, within 30 days after
completing each repetitive inspection required by paragraph (h) of
this AD, if any crack was found, report the crack findings to the
FAA at<EMAIL_ADDRESS>Include in your reports the following
information:

    (1) Name and address of the owner;
    (2) Date of the inspection;
    (3) Name, address, telephone number, and email address of the
person submitting the report;
    (4) Airplane serial number and total hours TIS on the airplane
at the time of the inspection; and
    (5) If any crack was found during the inspection, provide
detailed crack information as specified below:
    (i) A sketch or picture detailing the crack location;
    (ii) Measured length of the crack(s) found;
    (iii) Installation of a Cessna service kit or any other kit or
repair before the inspection; and
    (iv) Installation of any supplemental type certificates (STCs),
alterations, repairs, or field approvals affecting the area of
concern or affecting gross weight.

(k) Credit for Previous Actions

    (1) You may take credit for the initial inspection required by
paragraph (g) of this AD if you performed the inspection before the
effective date of this AD using Cessna Single Engine Service
Bulletin SEB93-5, dated March 26, 1993; or Cessna Single Engine
Service Bulletin SEB93-5, Revision 1, dated September 8, 1995.
    (2) You may take credit for the installation required by
paragraph (i)(1) of this AD as follows.
    (i) For Model 207, T207, 207A, and T207A airplanes with a
service kit installed using SK206-42, SK206-42A, SK206-42B, or
SK206-42C: You may take credit for the installation if done before
the effective date of this AD using Cessna Single Engine Service
Bulletin SEB93-5, dated March 26, 1993, or Cessna Single Engine
Service Bulletin SEB93-5, Revision 1, dated September 8, 1995; if
the reinforcement of the lower forward doorpost bulkhead and wing
strut fitting specified in Cessna Single Engine Service Kit SK207-
19A, dated May 29, 2019, is also accomplished within 200 hours TIS
after the effective date of this AD.
    (ii) For all other models: You may take credit for the
installation if done before the effective date of this AD using
Cessna Single Engine Service Bulletin SEB93-5, dated March 26, 1993;
or Cessna Single Engine Service Bulletin SEB93-5, Revision 1, dated
September 8, 1995.

(l) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW, Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (n)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(n) Related Information

    (1) For more information about this AD, contact Bobbie Kroetch,
Aerospace Engineer, Wichita ACO Branch, 1801 Airport Road, Room 100,
Wichita, Kansas 67209; telephone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>or aef9c7cdc6c7dacf83ede1fdeec8cfcf80c9c1d8.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Cessna Single Engine Service Bulletin SEB93-5, Revision 2,
dated May 29, 2019.
    (ii) Cessna Single Engine Service Bulletin SEB95-19, dated
December 29, 1995.
    (3) For service information identified in this AD, contact
Textron Aviation Inc., Textron Aviation Customer Service, One Cessna
Blvd., Wichita, Kansas 67215; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>internet: https://support.cessna.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 24, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-22039 Filed 10-6-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11533-11534]
[DOCID:fr11mr10-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-73-000]

TGGT Holdings, LLC; Notice of Petition for Declaratory Order

March 4, 2010.
    Take notice that on February 26, 2010, under Rule 207(a)(2) of the
Commission's Rules of Practice and Procedure, 18 CFR 385.207(a)(2)
(2009), TGGT Holdings, LLC (TGGT) filed a petition for a declaratory
order requesting that the Commission declare TGGT's proposed expansion
facilities

will be non-jurisdictional gathering facilities, and the completion of
its proposed expansion facilities will not affect the non-
jurisdictional gathering status of TGGT's existing facilities, because
such facilities will perform a gathering function exempt from the
Commission's jurisdiction under section 1(b) of the Natural Gas Act.
    Any person desiring to intervene in or 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 and 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 date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not 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 14 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time March 26, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-5211 Filed 3-10-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Page 1051]
[FR Doc No: X10-230108]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-27-000]

Christian County Generation, LLC; Notice of Filing

December 30, 2009.
    Take notice that on December 23, 2009, Christian County Generation,
LLC pursuant to section 207 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure, 18 CFR
385.207 (2009), filed a petition for declaratory order requesting the
Commission to confirm the reasonableness of their proposed 11.5 percent
return on equity and hypothetical capital structure of 55 percent debt
and 45 percent equity in connection with a levelized or deferred
capital recovery method under formula rates to be filed at a later date
for power sales from their proposed new Taylorville Energy Center.
    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 14 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 22, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-61 Filed 1-7-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 21, 2008 (Volume 73, Number 204)]
[Notices]
[Page 62495]
[DOCID:fr21oc08-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13285-000]

The Nevada Hydro Company, Inc.; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene and Competing Applications

October 14, 2008.
    On September 10, 2008, The Nevada Hydro Company, Inc. filed an
application, pursuant to section 4(f) of the Federal Power Act (FPA),
proposing to study the feasibility of the Blue Diamond Pumped Storage
Project to be located in Clark County, Nevada. The proposed project
would be closed loop and would not be located on any existing water
body.
    The proposed project would consist of: (1) An upper reservoir with
a maximum elevation of 4,810 feet MSL, a storage capacity of 4,900
acre-feet, and a surface area of 150 acres; (2) a lower reservoir with
a maximum elevation of 3,320 feet MSL, a storage capacity of 4,900
acre-feet, and a surface area of 75 acres; (3) a 21-foot diameter,
4,300-foot long concrete and steel penstock; (4) a powerhouse
containing two turbine/pump units with a total installed capacity of
450 MW; (5) a 132-kV, 3.5-mile long transmission line and; (6)
appurtenant facilities. The annual production would be 1170 GWh which
would be sold to a local utility.
    Applicant Contact: Rexford Wait, 2416 Cades Way, Vista, CA 92083
(760) 599-0086.
    FERC Contact: Steven Sachs<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
    Comments, motions to intervene, notices of intent and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    For more information on how to submit these types of filings please
go to the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13285) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-24953 Filed 10-20-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18589-18591]
[FR Doc No: 2011-7836]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64143; File No. SR-NASDAQ-2011-037]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change to Modify Chapter VI, Section
8 of the Exchange's Rules

March 29, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 15, 2011, The NASDAQ Stock Market LLC (``NASDAQ''), filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by NASDAQ. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ proposes to modify Chapter VI, Section 8 of the Exchange's
rules, dealing with the Nasdaq Opening Cross. Additionally, NASDAQ is
proposing to establish a Halt Cross that is nearly identical to the
modified Opening Cross on NOM. The Exchange proposes to implement these
changes on or about May 31, 2011.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    Nasdaq proposes to modify Chapter VI, Section 8 of the rules
governing NOM, and in particular governing the opening of trading at
the start of the trading day and at the resumption of trading following
a halt. Since NOM was launched on March 31, 2008 Nasdaq has monitored
the operation of the market to identify instances where market
efficiency can be enhanced.\3\ NASDAQ believes that the opening of the
market, while currently quite effective, can be further enhanced, and
that a Halt Cross would create a more orderly opening following a
trading halt.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 60905 (Oct. 30,
2009), 74 FR 57544 (Nov. 6, 2009)) (SR-NASDAQ-2009-033); Securities
Exchange Act Release No. 57822 (May 15, 2008), 73 FR 29800 (May 22,
2008)) (SR-NASDAQ-2008-045); Securities Exchange Act Release No.
57977 (June 17, 2008), 73 FR 35429 (June 23, 2008) (SR-NASDAQ-2008-
052).
---------------------------------------------------------------------------

    First, NOM currently employs a series of tie-breakers that resolve
instances where multiple prices satisfy the conditions for executing
the cross. These tie-breakers govern the calculation of the Current
Reference Price that is disseminated to market participants prior to
the execution of a cross. The tie-breakers also govern the calculation
of the actual cross price. The tiebreakers are criteria that operate in
a hierarchy. If one and only one price satisfies the first criterion,
the system has no need to move to the second. Conversely, if multiple
prices satisfy the first criterion, the algorithm turns to the second
criteria and if multiple prices satisfy the second criterion, the
algorithm then turns to the third criterion.
    NASDAQ is proposing to eliminate what currently serves as the
second tie-breaker that NOM employs to establish the Current Reference
Price as set forth in Chapter VI, Section 8(a)(2(A)(ii) [sic] and the
Cross price as set forth in subsection (b)(2)(B) of that Rule. This
tie-breaker resolves price disputes based on minimizing order
imbalances. In other words, under the current system, when more than
one price satisfies equally the first condition for the Opening Cross,
the system will choose that price which minimizes the order imbalance
remaining if the cross were to be executed.
    NASDAQ has determined to eliminate this tie-breaker because it has
not proven useful in augmenting price discovery prior to the cross or
in

operating an effective opening cross. NASDAQ initially adopted the
imbalance-based tie-breaker based upon its successful use in the
equities opening cross. The imbalance-based tie-breaker has not
performed well in the options cross during NASDAQ's experience. First,
imbalances occur less often in the options market. Additionally, in
NASDAQ's experience, such imbalances that do exist generally are much
smaller in size than in the equities market. As a result, the size of
an imbalance in an options cross rarely provides a meaningful basis for
distinguishing between multiple prices at which a cross could occur.
NASDAQ believes that elimination of this tie breaker will not hinder
price discovery and will allow NASDAQ to focus the cross on the most
relevant criteria.
    NASDAQ is also proposing to modify the ``mid-point'' tie-breaker
for the price dissemination and cross calculation which are set forth
in modified subsections 8(a)(2(A)(iii) [sic] and the Cross price as set
forth in subsection (b)(2)(C). Rather than choosing the midpoint of the
NBBO, as happens today, the exchange will choose a price that more
accurately represents the supply and demand in the market at the time
of reference price dissemination and/or auction execution. A minimum
threshold price, based on the higher of the last crossed NOM offer or
the NBB, will be chosen and a maximum threshold price, based on the
lower of the last crossed NOM bid or the NBO. The midpoint (in $0.01
increments) of the minimum threshold price and maximum threshold price
will be the price if this tiebreaker is reached.
    NASDAQ poses the following illustrations, each based on the
assumption that other markets are open and NASDAQ is not:

Example 1:
NBBO: $1.80 x $1.90
Pre Open NOM Book:

------------------------------------------------------------------------
                                            Buy        Sell       Sell
             Buy  contracts                prices     prices   contracts
------------------------------------------------------------------------
20.....................................      $2.00      $1.82         10
                                         .........       1.86         10
------------------------------------------------------------------------

Opening Auction/Reference Price: $1.88--The midpoint of $1.86 and $1.90
    --The last crossed NOM offer of $1.86 is used as the minimum price
threshold because it is higher than the NBB of $1.80
    --The NBO of $1.90 is used as the maximum price threshold because
it is lower than the last crossed NOM bid of $2.00

Example 2:
NBBO: $1.80 x $1.90
Pre Open NOM Book:

------------------------------------------------------------------------
                                            Buy        Sell       Sell
             Buy  contracts                prices     prices   contracts
------------------------------------------------------------------------
10.....................................       $MKT       $MKT         10
------------------------------------------------------------------------

Opening Auction Price: $1.85--The midpoint of $1.80 and $1.90
    --For the purpose of this tie-breaker, a price of $MKT is
essentially infinity for buy orders and zero for sell orders
    --The NBB of $1.80 is used as the minimum price threshold because
it is higher than the last crossed NOM offer at $MKT
    --The NBO of $1.90 is used as the maximum price threshold because
it is lower than the lass [sic] crossed NOM bid at $MKT

Example 3:
NBBO: $1.80 x $1.90
Pre Open NOM Book:

------------------------------------------------------------------------
                                            Buy        Sell       Sell
             Buy  contracts                prices     prices   contracts
------------------------------------------------------------------------
10.....................................      $1.84      $1.75         10
------------------------------------------------------------------------

Opening Auction Price: $1.82--The midpoint of $1.80 and $1.84
    --The NBB of $1.80 is used as the minimum price threshold because
it is higher than the last crossed NOM offer of $1.75
    --The last crossed NOM bid of $1.84 is used as the maximum
threshold because it is lower than the NBB of $1.90

NASDAQ believes that this formulation will improve price discovery and
execution quality.
    Additionally, NASDAQ is proposing to modify subsection
(a)(2)(E)(iii) which governs when an indicative message is disseminated
with a price of ``market.'' First, such message will be disseminated
when there is trading interest with a market price that is not offset,
not when there is marketable interest. Second, whether NOM disseminates
an indicative price of ``market'' will not depend upon the available
interest being priced lower or higher than the near or far clearing
prices. NASDAQ believes that this formulation of ``market'' will reduce
potential confusion about NASDAQ's dissemination practices.
    NASDAQ is also proposing to modify subsection (b)(1) of Section 8
to provide increased calibration of the time at which imbalance and
indicative price data will begin to be disseminated. Generally, NASDAQ
has had positive experience and feedback in beginning indicative data
dissemination at 9:25 a.m. EST. Occasionally, however, NASDAQ has
received participant feedback that an options class or classes would
benefit from a different dissemination period due to the trading
characteristics of that option. Accordingly, NASDAQ is proposing to
calibrate the start time for data dissemination between 9:20 a.m. and
9:28 a.m. The initial default time for dissemination to being will
remain at 9:25. NASDAQ believes that this calibration could benefit
investors and poses little risk. When NASDAQ does change the start time
for data dissemination, which will be rare, the new time of imbalance
dissemination commencement would be published in advance and with equal
access on the NASDAQ Trader Web site.
    Moreover, NASDAQ is proposing to modify subsection (b)(5) to
clarify when an Order Imbalance Indicator will be disseminated just
prior to the opening cross. Currently, any time an imbalance remains
just prior to the opening cross, NASDAQ disseminates a final Order
Imbalance Indicator. Under the proposed modified rule, NASDAQ will
disseminate this final Order Imbalance Indicator only when the
imbalance contains routable trading interest that is marketable against
the NBBO. The exchange believes that non-routable interest is best
served by being posted on the exchange after execution of the opening
cross.\4\ Once the cross is executed and the order is posted, that
trading interest will be disseminated as part of the exchange best bid
or offer via the consolidated data feed. This broad dissemination will
better advertise the trading interest and thereby increase the
likelihood of an execution. Additionally, the exchange proposes to
clarify that after the opening cross is executed, all orders in the
imbalance will be cancelled, routed, or posted in accordance with the
entering party's instructions.
---------------------------------------------------------------------------

    \4\ NASDAQ states that the goal of NOM's open is to attract as
much liquidity as possible to interact with any orders that are
marketable at the time of the open. NASDAQ believes that the change
to post non-routable orders (at the NBBO) rather than disseminating
additional imbalance messages provides more advertisement for the
order because it is broadcast over the consolidated quote feed
rather than just NASDAQ's proprietary market data feeds. For
routable orders NOM is continuing the current process of advertising
the order(s) via an imbalance message on NASDAQ's proprietary market
data feeds rather than opening immediately and routing the order
away. By doing this, NASDAQ's goal is to get the order a price that
is equal to or better than the away quoted price. See email from
Jeffrey S. Davis, Vice President and Deputy General Counsel, NASDAQ
OMX Group, Inc., to Carl E. Tugberk, Special Counsel, Division of
Trading and Markets, Commission, dated March 29, 2011.

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

    Finally, NASDAQ is proposing to re-establish an Opening Cross to be
executed upon the termination of a trading halt.\5\ Having operated NOM
for almost two years, NASDAQ has determined in its experience that an
auction will provide a more orderly opening of the market after a halt.
This is particularly true because NOM has attracted significantly
higher levels of liquidity, an important ingredient for a successful
cross. Accordingly, NASDAQ is proposing to modify Chapter V, Section 4
(Resumption of Trading After a Halt) and various subsections of Chapter
VI, Section 8. The Opening Cross will operate in the same manner
following a trading halt as it operates at the start of the trading
day, including dissemination of the Order Imbalance Indicator, matching
algorithm, and posing or routing of interest that remains unexecuted
following execution of the opening cross. The Opening Cross for halted
options will differ only in the time at which it occurs and the fact
that that time is determined pursuant to Chapter V, Section 4.
---------------------------------------------------------------------------

    \5\ When Nasdaq first proposed its options trading rules, it
planned to resume trading by operating a ``Halt Cross,'' which it
originally described in Chapter VI, Section 8. Nasdaq later amended
the proposed rules to remove the Halt Cross. See Securities Exchange
Act Release Nos. 57478 (March 12, 2008), 73 FR 14521 (March 18,
2008) (SR-NASDAQ-2007-004 and SR-NASDAQ-2007-080) (approval order
regarding NOM Rules including Chapters III and XIV).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
Nasdaq believes that the proposal is consistent with this standard
because the proposed rule change is designed to improve execution
quality at the critical opening of the market both at the start of the
trading day and following a trading halt.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve or disapprove such proposed rule change, or
    B. institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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-NASDAQ-2011-037 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-NASDAQ-2011-037. 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 on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices 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-NASDAQ-2011-037, and should be submitted on or before
April 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-7836 Filed 4-1-11; 8:45 am]
BILLING CODE 8011-01-P


Vickie Patton < vpatton@ environmentaldef ense. org>

01/ 19/ 2006 10: 42 AM To Vickie Patton < vpatton@ environmentaldefense. org> cc Subject Fresno Bee: Groups gasping over air proposal Groups gasping over air proposal By MICHAEL G. MOONEY BEE STAFF WRITER and MARK GROSSI THE FRESNO BEE People in the Central Valley might breathe dirtier air if a proposed rule ends federal dust monitoring in rural areas, local air officials said Wednesday.

The Bush administration proposal, through the U. S. Environmental Protection Agency, would establish a new dust standard and provide a national exemption for farming and mining in rural areas.

The EPA proposal, announced Tuesday, would stop federal monitoring for larger particle pollution in rural places, said officials.

The move could mean some loss of federal muscle  financial sanctions  in enforcing dust cleanup in the San Joaquin Valley, one of the nation's worst areas for air quality.

For the valley, sanctions include the temporary loss of $ 2 billion in federal road building money for missing cleanup deadlines.

Jaime Holt, a spokeswoman for the San Joaquin Valley Air Pollution Control District, said the agency learned of the Bush administration's plan late Tuesday.

While the district still is investigating the proposal, Holt pointed out Wednesday that the dust plan  if adopted  would set different standards for rural and urban areas. " We feel public health should be treated equally in both areas," Holt said. " We have some questions. What parts of the valley would be defined as urban and what parts rural?"

Holt said it was not clear Wednesday whether dust rules set by the California Air Resources Board would remain in force should the federal standards be changed.

" That's ( one of the things) we're looking at," Holt said. " This is not a done deal. We're curious to see where this goes at the federal level."

Brent Newell, staff attorney at the Center for Race, Poverty and the Environment, said the proposal to exempt mining and farming operations from federal standards for " coarse particulate matter" such as dust raises a constitutional issue.

" If this proposal goes through," Newell said, " rural residents will have lesser protection under the law than urban residents.

" That raises the issue of ' equal protection under the law,' which is guaranteed in the Constitution."

Newell said pollution standards for dust and other particulate matter set by California law would remain in effect.

" State laws can be stricter than federal laws," he said. " The ( federal) EPA does not have the power to pre empt the states."

Still, Newell said he would be filing comments to the federal EPA proposal on behalf of his group, raising some of the same issues.

" This is par for the Bush EPA," he said, " caving to powerful industries like mining and agriculture."

Mary Michal Rawling, program manager for the Merced Mariposa Asthma Coalition, believes the Bush proposal would make matters worse for everybody in the Central Valley, not just those already suffering from respiratory diseases.

" I just don't think this would be beneficial at all," Rawling said. " There would be significant health effects."

Rawling and Newell said various studies have shown that agricultural operations account for more than 50 percent of the dust and coarse particulate matter in the valley.

Is valley considered rural?

Relaxing standards for dust, Rawling said, would lead to more coughing, more irritated airways, more inflamed air passages, more bronchitis, more asthma attacks.

Studies show, Rawling said, that " about 1,300 people die prematurely every year in the valley from particulate matter pollution."

Tom Orvis, an Oakdale area cattle rancher who has been involved in the dust issue, said he did not yet know enough about the proposal to comment in detail. He did say farmers already have done much to control dust.

" I think agriculture has come to the table, and essentially, we're trying to be in compliance and be good stewards," he said.

The measures have included nut harvesting machines that stir up little dust, as well as improved tilling of fields and controls on dirt roads.

State officials disagree with the local air district's interpretation of the federal rule, saying the valley's rural areas should not be affected by an EPA rule change, because the region's 3.7 million residents make it too populated to be considered rural.

But exemptions for farming and mining might affect places like the Owens Valley or northern Sacramento Valley, officials said.

" That's our biggest concern," said spokesman Jerry Martin of the California Air Resources Board. " Some parts of the state might not be protected."

Disagreement, outrage Federal officials, who have been working on the proposal for years, said they consulted thousands of studies. They concluded that rural pollution sources, mainly farming and mining, do not create urban pollution.

In California, home of the nation's dirtiest air basins, the proposal raised disagreement and outrage. State Sen. Dean Florez, D Shafter, announced that he wanted a resolution opposing the new rule.

" I condemn the U. S. EPA action as bad for public health and wrong on the science," he said in a written statement Wednesday. " The fact is, particulate matter from dust has been shown to be a potential carcinogen and very harmful to the lungs of kids and the elderly."

Farming is the biggest source of dust in the valley, which is among the three dirtiest air basins in the country. In 2003, Florez sponsored Senate Bill 700, requiring broad controls on farm pollution. Agriculture has complied.

Experts said the EPA rule would not trump SB 700, but the state has no sanctions to enforce the law. The federal government has had the power to sanction for many years.

But establishing a new air standard usually takes years because of legal challenges.

Said local district planning director Nester, " There probably would be a lawsuit from someone on this." Bee staff writer John Holland contributed to this story.

Posted on 01/ 19/ 06 00: 00: 00 http:// www. modbee. com/ local/ story/ 11703155p 12428933c. html


[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35005-35006]
[FR Doc No: 2018-15779]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]

Regulatory Perspectives on Otic and Vestibular Toxicity:
Challenges in Translating Animal Studies to Human Risk Assessment;
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Regulatory Perspectives on Otic
and Vestibular Toxicity: Challenges in Translating Animal Studies to
Human Risk Assessment.'' The purpose of the public workshop is to
identify the challenges involved in the translation of toxicities from
animal studies to clinical trials, to highlight potential endpoints
that can be used in both nonclinical and clinical phases of drug
development, and to provide a platform for engaging discussions to
improve safety assessments for drugs impacting auditory and vestibular
functions. This public workshop will bring together regulatory medical
and toxicologist reviewers, veterinary and clinical neurologists, and
experts in evaluating auditory and vestibular endpoints.

DATES: The public workshop will be held on August 21, 2018, from 9 a.m.
until 12 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Deepa B. Rao, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4235, Silver Spring, MD 20993, 240-402-
6544, [email protected] or Christopher D. Toscano, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4145, Silver Spring, MD 20993, 301-796-
1122, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Although multiple drugs are known to cause hearing loss, otic and
vestibular toxicities remain a neglected component in routine drug
development. In drug safety evaluations, comparative clinical
assessments for auditory and vestibular systems between animals and
humans remain largely unexplored. The objective of this public workshop
is to identify the challenges involved in the translation of toxicities
from animal toxicology studies to clinical trials, to highlight
potential endpoints that can be used in nonclinical and clinical phases
of drug development, and to provide a platform for engaging discussions
to improve safety assessments for ototoxic drugs. This public workshop
will bring together regulatory medical and toxicologist reviewers,
veterinary and clinical neurologists, and experts in evaluating
auditory and vestibular endpoints.

II. Topics for Discussion at the Public Workshop

    A regulatory perspective of drug development and the occurrence of
otic and vestibular toxicity will be presented, with a focus on the
current regulatory recommendations on assessment of the auditory and
vestibular systems in clinical and nonclinical studies. Relevant
endpoints of vestibular and auditory function (clinical evaluation,
non-invasive electrophysiological measurements, and histopathology)
will be discussed from a clinical and nonclinical perspective. The
public workshop will end with an open platform discussion between the
audience and panelists regarding the adequacy of the current evaluation
and potential future approaches towards improving safety assessments
for agents impacting auditory and vestibular functions. We support the
principles of the ``3Rs,'' to reduce, refine, and replace animal use in
testing when feasible. We encourage sponsors to consult with us if it
they wish to use a non-animal testing method they believe is suitable,
adequate, validated, and feasible. We will consider if such an
alternative method could be assessed for equivalency to an animal test
method.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website to register: https://www.eventbrite.com/e/fda-public-
workshop-regulatory-perspectives-on-

otic-vestibular-toxicity-tickets-47223962142. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by August 20, 2018, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
    For any participant in need of sign language interpretation, please
send an email request to [email protected]. For all
other reasonable accommodations, please contact FDA's Office of Equal
Employment Opportunity at<PHONE_NUMBER>.
    Streaming webcast of the public workshop: This public workshop will
also be webcast at https://collaboration.fda.gov/ovtw/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

    Dated: July 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15779 Filed 7-23-18; 8:45 am]
BILLING CODE 4164-01-P


52941 Glenview Dr Elkhart IN 46514 32500 CAPITOL ST. LIVONIA MI 48150 6531 INDUSTRIAL RD. BEAUMONT TX ' 77705' 1415 SPRING CREEK PL. SPRINGVILLE UT ' 84663' ROBERTS RD. DUDLEY MA 01571 3260 STATES RTE 90 AURORA NY 13026 1005 BLUE MOUND RD FORT WORTH TX 76131 1005 BLUE MOUND RD FORT WORTH TX 76131 8219 NORTHWEST BLVD. INDIANAPOLIS IN 46278 480 W. 5TH ST. BLOOMSBURG PA 17815 4355 N. W. 128TH ST. OPA LOCKA FL ' 33054' 4355 N. W. 128TH ST. OPA LOCKA FL ' 33054' 4355 N. W. 128TH ST. OPA LOCKA FL ' 33054' 4355 N. W. 128TH ST. OPA LOCKA FL ' 33054' 4355 N. W. 128TH ST. OPA LOCKA FL ' 33054' 1 MALIBU COURT MERCED CA 95340 2710 N. PITCHER KALAMAZOO MI 49001 2110 S. 26TH ST. MANITOWOC WI 54220 2315 CITY LINE RD. BETHLEHEM PA 18017 RTE. 443 PINE GROVE PA 17963 2500 AIDE RD. MARYLAND HEIGHTS MO 63043 214 W. TAFT AVE ORANGE CA 92865 30 INDUSTRIAL PARK RD. LEWISTOWN PA 17044 400 W. ELM HERMISTON OR ' 97838' 200 RACCOON VALLEY RD. MAYNARDVILLE TN 37807 1695 HWY. 490 CHOPIN LA 71447 1318 WASHINGTON HWY. ELBERTON GA 30635 NY NY 233 INDUSTRIAL PARKWAY RICHMOND IN 47375 3045 KINGSTON CT. NORCROSS GA ' 30071' 800 BLUE RIDGE ST. GRAMLING SC 29348 6927 LINCOLN PKY. FORT WAYNE IN ' 46804' 908 HWY. 15 N. NEW ALBANY MS 38652 2000 STERLING DR. ALBEMARLE NC 28001 2000 STERLING DR. ALBEMARLE NC 28001 6901 BOWMAN ROBERTS RD. FORT WORTH TX 76179 201 E. 18TH ST. MUNCIE IN 47302 629 S BATTLEGROUND AVE KINGS MOUNTIAN NC 28086 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 1801 MONMOUTH BLVD. GALESBURG IL ' 61402' 860 TAYLOR STATION RD. BLACKLICK OH 43004 1910 ST. LUKES CHURCH RD. SALISBURY NC ' 28146' 826 E. 4TH ST. PITTSBURG KS 66762 201 CEDAR ENNIS TX ' 75119' 6906 DIXIE ST. COLUMBUS GA 31907 5857 S. KYRENE RD. TEMPE AZ ' 85283' 16 WESTERN INDUSTRIAL # D CRANSTON RI 02921 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 338 RAMSEY ST. SULLIVAN MO 63080 1 Mercedes Dr Vance AL 35490 214 S. NEWMAN ST. HACKENSACK NJ 07601 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 W6250 PIONEER ROAD FOND DU LAC WI 53919 501 NORTHRIDGE DR. SHELBYVILLE IN 46176 29333 STEPHENSON HWY. MADISON HEIGHTS MI 48071 2400 S. WABASH AVE. CENTRALIA IL 62801 3025/ 3075 BRETON RD. S. E. KENTWOOD MI 49512 203 NORTH ST CANANDAIGUA NY 14424 5284 HWY. 42 E. CARROLLTON KY 41008 8600 COMMERCIAL BLVD. PEVELY MO 63070 1497 N. KEALY LEWISVILLE TX 75057 226 WATLINGTON INDUSTRIAL DRIV REIDSVILLE NC 273208147 226 WATLINGTON INDUSTRIAL DRIV REIDSVILLE NC 273208147 226 WATLINGTON INDUSTRIAL DRIV REIDSVILLE NC 273208147 226 WATLINGTON INDUSTRIAL DRIV REIDSVILLE NC 273208147 7555 E. ST. RTE. 69 PRESCOTT VALLEY AZ 86314 2313 BROOKLYN RD. JACKSON MI 49203 3601 PARIS RD NO LA 70129 3601 PARIS RD NO LA 70129 3601 PARIS RD NO LA 70129 1305 TRINITY AVENUE HIGH POINT NC 27261 103 CHESAPEAKE PARK PLAZA MIDDLE RIVER MD 21220 0 103 CHESAPEAKE PARK PLAZA MIDDLE RIVER MD 21220 0 4631 MENARD DR. EAU CLAIRE WI ' 54703' 4901 N. 12TH ST. QUINCY IL ' 62301' 1980 CLEMENTS FERRY RD. CHARLESTON SC ' 29492' 3000 KEFAUVER DR. MILAN TN 38358 57755 Holiday Pl. Elkhart IN 46517 1155 E. 8TH ST. WINONA MN 55987 1155 E 8TH ST. WINONA MN 55987 2523 CARL JONES RD. MOODY AL 35004 300 LUKKEN INDL. DR. W. LA GRANGE GA 30240 650 W. BANNERMAN AVE. REDGRANITE WI 54970 905 S. ANN ST. MOBILE AL 36605 2101 E. LAKE MARY BLVD. SANFORD FL 32773 INDUSTRIAL PARK WALKERTON IN 46574 2777 N. HWY. 59 MERCED CA 95348 1401 INDUSTRIAL ST. EMPORIA KS 66801 822 INDUSTRIAL DR. TRENTON MO 64683 172 INDUSTRIAL RD. FITCHBURG MA ' 01420' 2 RICHLYNN DR BELCAMP MD 210171202 2500 WIGGINS RD MUSCATINE IA 52761 300 Jamison Road East Aurora NY ' 14052 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 5005 BARNARD MILL RD. RINGWOOD IL ' 60072' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 2401 E. PRATT BLVD. ELK GROVE VILLAGE IL ' 60007' 137 FOLLY MILL RD. SEABROOK NH 03874 5724 ELDER FERRY RD. MOSS POINT MS 39563 611 Jamison Road Elma NY ' 14059 Highway 60 E Mountain View MO 65548 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 4003 PARK AVE. SAINT LOUIS MO ' 63110' 400 3RD AVE. HOUSTON MS ' 38851' 1301 COLD SPRINGS RD. FORT WORTH TX 76102 956 INDUSTRIAL BLVD. ALBERTVILLE AL 35950 957 INDUSTRIAL BLVD. ALBERTVILLE AL 35951 250 OLD BALLWIN RD. BALLWIN MO 63021 1406 E. 18TH ST. MUNCIE IN ' 47307' RTE. 549 MANSFIELD PA 16933 75 Panorama Creek Drive Rochester NY ' 14625 11582 SUSSEX HWY GREENWOOD DE 19950 11582 SUSSEX HWY GREENWOOD DE 19950 MARSHALL SPACE FLIGHT CENTER HUNTSVILLE AL 35812 MARSHALL SPACE FLIGHT CENTER HUNTSVILLE AL 35812 2101 NASA ROAD 1 HOUSTON TX 77095 2101 NASA ROAD 1 HOUSTON TX 77095 2101 NASA ROAD 1 HOUSTON TX 77095 2101 NASA ROAD 1 HOUSTON TX 77095 NOT LISTED IN 539 DUNKSFERRY RD. BENSALEM PA ' 19020' 777 INDUSTRIAL PARKWAY DR. EVERGREEN AL 36401 Oak Harbor, WA ' 98278 PSC BOX 8021 CHERRY POINT NC 28533 2121 BROOKS AVE NEENAH WI 54956 RR2 WOODARD RD. BLOOMER WI 54724 730 MAIN ST. WILMINGTON MA 01887 65 N. BEACON ST. BOSTON MA 02134 3150 IH 35 SOUTH NEW BRAUNFELS TX 78130 6200 Glenn Carlson Dr ST. CLOUD MN 56301 8852 1830 W. AIRFIELD DR. DALLAS TX 75261 983 NISSAN DR. SMYRNA TN ' 37167' 983 NISSAN DR. SMYRNA TN ' 37167' 1600 S. 18TH ST. NOBLESVILLE IN 46060 600 S. KUTHER RD. SIDNEY OH ' 45365' 14591 STATE HWY. 177 JACKSON MO ' 63755' 14591 STATE HWY. 177 JACKSON MO ' 63755' 14591 STATE HWY. 177 JACKSON MO ' 63755' 14591 STATE HWY. 177 JACKSON MO ' 63755'

1400 13TH ST. W. GLENCOE MN 55336 891 COUNTY RD. U HUDSON WI 54016 HWY. 11W BEAN STATION TN 37708 2800 S. BROAD ST. CHATTANOOGA TN 37408 4959 S. DIXIE HWY. DALTON GA 30721 11536 S. CENTRAL ALSIP IL 60803 Grand Sidney NY ' 13838 701 RANNEY DR. GREENVILLE MI 48838 100 Epic Drive Lexington Park MD ' 20653 RTE. 892 DUPONT RD. WASHINGTON WV ' 26181' 1750 W. DOWNS DR. WEST CHICAGO IL ' 60185' 258 MAIN ST. WADSWORTH OH 44281 61 Emery St. Sanford ME 04073 100 CANAL ST. PUTNAM CT ' 06260' 1714 S. W. 17TH ST. OCALA FL 34478 1884 MINES RD. PULASKI TN ' 38478' 795 GA. HWY. 33 S. MOULTRIE GA ' 31768' 497 INDUSTRIAL DR. MOULTRIE GA ' 31768' 6259 THOMPSON RD. SYRACUSE NY 13206 14615 N. E. 91ST ST. REDMOND WA 98052 NY NY NY 3200 REACH RD. WILLIAMSPORT PA 17701 909 S. 12TH ST. CORSICANA TX 75110 905 S. DOWNING ST. FREMONT NE ' 68025' 1601 YANCEYVILLE ST. GREENSBORO NC 27405 4601 FARNAM OMAHA NE 68132 4601 FARNAM OMAHA NE 68132 4601 FARNAM OMAHA NE 68132 300 E. CHICAGO ST. SYRACUSE IN ' 46567' 300 E. CHICAGO ST. SYRACUSE IN ' 46567' 300 E. CHICAGO ST. SYRACUSE IN ' 46567' 609 13TH ST. CADILLAC MI ' 49601' 609 13TH ST. CADILLAC MI ' 49601' 925 FRISBIE ST. CADILLAC MI ' 49601' 925 FRISBIE ST. CADILLAC MI ' 49601' 165 S. CLEVELAND AVE. MOGADORE OH 44260 7 MOBILE AVE. SAUGET IL 62201 36325 MAGNOLIA RD. UNDERWOOD IA ' 51576' 505 GENTRY MEMORIAL HWY. EASLEY SC 29640 23 INDUSTRIAL PARK RD. LEWISTOWN PA 17044 9008 GOVERNORS ROW DALLAS TX ' 75247' 5200 N. SECOND ST. SAINT LOUIS MO 63147 126 NEW PACE RD. NEWCOMERSTOWN OH 43832 500 COLORADO KELSO WA ' 98626' 9759 DISTRIBUTION AVE. SAN DIEGO CA 92121 1333 2ND ST. BERKELEY CA ' 94710' 12424 EMERSON DR. BRIGHTON MI 48116 1800 PIKE RD. LONGMONT CO 80501 1870 JAMES PKY. HEATH OH ' 43056' 635 S. WASHINGTON ST. RIPLEY TN ' 38063'


[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32220-32221]
[FR Doc No: 2011-13778]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Gastrointestinal Drugs 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.
    Name of Committee: Gastrointestinal Drugs 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 July 21, 2011, from 8
a.m. to 4 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910. The hotel's phone number is
301-589-5200.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On July 21, 2011, the committee will discuss the results
from a clinical trial of supplement biologics license application
103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in
the treatment of pediatric patients with moderately to severely active
ulcerative colitis.
    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 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 July
6, 2011. 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 June 27, 2011. 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 28, 2011.
    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 Kristine T. Khuc 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: May 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-13778 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P


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

EPA Registration Division contact: [PV Shah, Branch Chief Inert Assessment Branch (IAB)<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

[Croda, Inc.]

[IN-10834]

	EPA has received a pesticide petition ([IN-10834]) from [Croda, Inc., 315 Cherry Lane, New Castle DE, 19720] 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 180.960 to establish an exemption from the requirement of a tolerance for polyamide ester polymers having a number-average molecular weight greater than 10,000 Daltons, used as dispersants, emulsifiers, surfactants, and related adjuvants of surfactants in food use pesticide formulations in or on raw agricultural commodities. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FFDCA; 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 to include the following Chemical Abstracts Services Registry numbers:

                                  CAS NO.'S
                                   CAS. NAME
                                  678991-29-2
Fatty acids, C18-unsatd., dimers, hydrodenated, polymers with
       Ethylenediamine, neopentyl glycol and stearyl alcohol
                                  363162-42-9
Fatty acids, C18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol
                                  951153-32-5
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol
                                 1699751-19-3
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine
                                 1699751-23-9
Fatty acids, C18-unsatd., dimers, polymers with cetyl alc., neopentyl glycol and trimethylenediamine
                                 1699751-24-0
Fatty acids, C18-unsatd., dimers, polymers hexamethylenediamine and stearyl alc.
                                 1699751-25-1
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with cetyl alc. and ethylenediamine
                                 1699751-28-4
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alc. and trimethylenediamine
                                 1699751-29-5
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine
                                 1699751-31-9
 Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid and sorbitol
                                 1685271-04-8
Fatty acids, C18-unsatd., dimers, hydrogenated,  polymers with docosanol, hexamethylenediamine and neopentyl glycol

   A. Residue Chemistry

1. Plant metabolism. [NA-Remove based on the fact that this information is
not required for the establishment of a tolerance exemption.]

2. Analytical method. [NA-Remove based on the fact that this information is
not required for the establishment of a tolerance exemption.]

3. Magnitude of residues. [NA-Remove based on the fact that this information
is not required for the establishment of a tolerance exemption.]

   B. Toxicological Profile

   1. Acute toxicity.  [Polyamide Ester Polymers conform to the definition of a polymer given in 40 CFR 723.250(b) and meets the following 40 CFR 723.250 criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its composition, except
as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MWn) greater than or equal to 10,000 Daltons.
7. The minimum number average molecular weight of all the polymers listed above is greater 1,000 Daltons.  The oligomer content is less than 10% (w/w) below a number average molecular weight of 500 and less than 25 % (w/w) below a number average molecular weight of 1,000.

	2. Genotoxicty. [NA-Remove based on the fact that this polymer meets the 40
CFR 723.250 criteria that are used to identify low-risk polymers.]

	3. Reproductive and developmental toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	4. Subchronic toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	5. Chronic toxicity. [[NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	6. Animal Metabolism. .[NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	7. Metabolite toxicity. [NA-Remove based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	8. Endocrine Disruption. [Not expected based on the fact that this polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

	C. Aggregate Exposure

	1. Dietary exposure. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      i. Food. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      ii. Drinking water. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      2. Non-dietary exposure. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

D. Cumulative Effects

      	[This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

E. Safety Determination

      1. U.S. population. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

      2. Infants and children. [This polymer meets the 40 CFR 723.250 criteria that are used to identify low-risk polymers.]

F. International Tolerances

      [There are no known international tolerances for this polymer.]


[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24474-24475]
[FR Doc No: 2011-10564]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R04-OAR-2009-1011; FRL-9301-3]

Adequacy Status of the Greensboro/Winston-Salem/Highpoint North
Carolina 1997 Annual PM2.5 Maintenance Plan Motor Vehicle
Emissions Budgets for Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Adequacy.

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

SUMMARY: In this notice, EPA is notifying the public of its finding
that the direct fine particulate (PM2.5) and nitrogen oxides
(NOX) motor vehicle emissions budgets (MVEBs) in the
Greensboro/Winston-Salem/Highpoint, North Carolina area (hereafter
referred to as ``the Triad Area'') maintenance plan for the 1997 annual
PM2.5 standard, submitted on December 18, 2009, and
supplemented on December 22, 2010, by the North Carolina Department of
Environment and Natural Resources (NCDENR) are adequate for
transportation conformity purposes. The Triad Area is comprised of
Guilford and Davidson Counties in their entirety. On March 2, 1999, the
District of Columbia Circuit Court ruled that submitted state
implementation plans (SIPs) cannot be used for transportation
conformity determinations until EPA has affirmatively found them
adequate. As a result of EPA's finding, the Triad Area must use the
PM2.5 and NOX MVEBs from the submitted
maintenance plan for the Area for future conformity determinations.

DATES: The adequacy finding for the PM2.5 and NOX
MVEBs are effective May 17, 2011.

FOR FURTHER INFORMATION CONTACT: Dianna B. Smith, Environmental
Scientist, U.S. Environmental Protection Agency, Region 4, Air Planning
Branch, Air Quality Modeling and Transportation Section, 61 Forsyth
Street, SW., Atlanta, Georgia 30303. Ms. Smith can also be reached by
telephone at<PHONE_NUMBER>, or via electronic mail at
<EMAIL_ADDRESS>The finding is available at EPA's conformity Web
site: http://www.epa.gov/otaq/transp.htm (once there, click on the
``Transportation Conformity'' text icon, then look for ``Adequacy
Review of SIP Submissions'').

SUPPLEMENTARY INFORMATION: Today's notice is simply an announcement of
findings that EPA has already made. EPA Region 4 sent a letter to
NCDENR on February 2, 2011, stating that the 2011 and 2021 sub-area
PM2.5 and NOx MVEBs in the 1997 PM2.5
maintenance plan for the Triad Area, dated December 18, 2009, and
supplemented on December 22, 2010, are adequate. EPA posted the
availability of the Triad MVEBs on EPA's Web site on November 23, 2010,
as part of the adequacy process, for the purpose of soliciting
comments. The comment period ran from November 23 through December 23,
2010. EPA's findings have also been announced on EPA's conformity Web
site: http://www.epa.gov/otaq/stateresources/index.htm, (once there,
click ``Transportation Conformity'' text icon, then look for ``Adequacy
Review of SIP Submissions''). The adequate PM2.5 and
NOX MVEBs are provided in the following table:

                Triad, North Carolina Annual PM2.5 MVEBS
                            [Kilograms/year]
------------------------------------------------------------------------
                                               2011            2021
------------------------------------------------------------------------
                      Guilford County Sub-area MVEB
------------------------------------------------------------------------
NOX.....................................      11,133,605       6,309,650
PM2.5...................................         421,841         421,841
------------------------------------------------------------------------
                      Davidson County Sub-area MVEB
------------------------------------------------------------------------
NOX.....................................       4,086,413       2,148,938
PM2.5...................................         153,313         153,313
------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act, as amended in 1990. EPA's conformity rule, 40 Code of
Federal Regulations (CFR) Part 93, requires that transportation plans,
programs and projects conform to state air quality implementation plans
and establishes the criteria and procedures for determining whether or
not they do. Conformity to a SIP means that transportation activities
will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the national ambient air
quality standards (NAAQS).
    The criteria by which EPA determines whether a SIP's MVEBs are
adequate for transportation conformity purposes are outlined in 40 CFR
93.118(e)(4). EPA has described the process for determining the
adequacy of submitted SIP budgets in a May 14, 1999, memorandum
entitled ``Conformity Guidance on Implementation of March 2, 1999
Conformity Court Decision.'' EPA has followed this guidance in making
this adequacy determination. This guidance is incorporated into EPA's
July 1, 2004, final rulemaking entitled ``Transportation Conformity
Rule Amendments for the New 8-hour Ozone and PM2.5 National
Ambient Air Quality Standards and Miscellaneous Revisions for Existing
Areas; Transportation Conformity Rule Amendments: Response to Court
Decision and Additional Rule Changes'' (69 FR 40004). Please note that
an adequacy review is separate from EPA's completeness review, and it
also should not be used to prejudge EPA's ultimate approval of the SIP.
Even if EPA finds the MVEB adequate, the Agency may later disapprove
the SIP.
    Within 24 months from the effective date of this notice, the
transportation

partners will need to demonstrate conformity to the new MVEB if the
demonstration has not already been made, pursuant to 40 CFR 93.104(e).
See 73 FR 4419 (January 24, 2008).

    Authority:  42 U.S.C. 7401 et seq.

    Dated: April 18, 2011.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2011-10564 Filed 4-29-11; 8:45 am]
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[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Notices]
[Page 17925]
[FR Doc No: 2023-06050]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for New Special
Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before April 24, 2023.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.
    Copies of the applications are available for inspection in the
Records Center, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on March 6, 2023.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                 Applicant          Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
21524-N......................  TEA Technologies Inc....  180.205(c), 180.205(f),   To authorize the
                                                          180.205(g).               transportation in commerce
                                                                                of composites tubes that
                                                                                have been requalified using
                                                                                modal acoustic emission
                                                                                (MAE) in lieu of volumetric
                                                                                and internal visual
                                                                                examination. (modes 1, 2, 3,
                                                                                4, 5).
21529-N......................  Skykraft Pty Ltd........  173.302a(a)(1)..........  To authorize the one time,
                                                                                one way, transportation in
                                                                                commerce of non-DOT
                                                                                specification cylinders
                                                                                containing argon. (mode 1).
21533-N......................  Samsung SDI. Co., Ltd...  172.101(j)..............  To authorize the
                                                                                transportation in commerce
                                                                                of lithium ion batteries
                                                                                exceeding 35 kg by cargo-
                                                                                only aircraft. (mode 4).
21534-N......................  Techknowserv Corp.......  180.205(g)..............  To authorize the
                                                                                transportation in commerce
                                                                                of certain cylinders that
                                                                                have been requalified using
                                                                                acoustic emissions testing
                                                                                in lieu of hydrostatic and
                                                                                internal visual methods.
                                                                                (modes 1, 2, 3, 4, 5).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2023-06050 Filed 3-23-23; 8:45 am]
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