[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Proposed Rules]
[Pages 64083-64085]
[FR Doc No: 2016-22435]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9110; Directorate Identifier 2015-NM-196-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211,
A321-213, and A321-231 airplanes. This proposed AD was prompted by a
report of certain tie rod assemblies installed on the hinged fairing
assembly of the main landing gear (MLG) with no cadmium plating on the
rod end threads. This proposed AD would require a detailed inspection
of certain tie rod assemblies installed on the hinged fairing assembly
of the MLG for the presence of cadmium plating, and replacement of tie
rod assemblies without cadmium plating. We are proposing this AD to
detect and correct the absence of cadmium plating on the rod end
threads of the tie rod assemblies. The absence of cadmium plating could
lead to galvanic corrosion of the tie rod end threads, resulting in rod
end failure, loss of a MLG door, and consequent damage to the airplane.

DATES: We must receive comments on this proposed AD by November 3,
2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9110; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9110;
Directorate Identifier 2015-NM-196-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0234, dated December 8, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-
231 airplanes. The MCAI states:

    A production quality issue was identified concerning tie rod
assemblies, having Part Number (P/N) starting with D52840212000 or
D52840212002, which are installed on the main landing gear (MLG)
hinged fairing assembly. This quality issue affects the cadmium
plating surface treatment which was inadvertently omitted from the
rod end threads of the assembly. The absence of cadmium plating
reduces the corrosion protection scheme.
    This condition, if not detected and corrected, could lead to
galvanic corrosion of

the tie rod end threads, possibly resulting in rod end failure, loss
of a MLG door, and consequent injury to persons on ground.
    To address this unsafe condition, Airbus identified the affected
[manufacturer serial number] MSN and issued [service bulletin] SB
A320-52-1167 to provide inspection instructions.
    For the reason described above, this [EASA] AD requires a one-
time inspection of the affected MLG hinged fairing tie rod
assemblies [for the presence of cadmium plating], and, depending on
findings, replacement of the affected tie rod assembly.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9110.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A320-52-1167, dated August 6,
2015. The service information describes procedures for a detailed
inspection for the presence of cadmium plating on tie rod assemblies
having certain part numbers, and procedures for replacement of tie rod
assemblies with no cadmium plating on the rod end threads. 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.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 20 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                  Action                                           Labor cost                             Parts cost        product         operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection...............................  2 work-hours x $85 per hour = $170........................              $0             $170           $3,400
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of airplanes that might need
these replacements:

                                                                   On-Condition Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                 Action                                              Labor cost                                      Parts cost              product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement.............................  13 work-hours x $85 per hour = $1,105...........................  Not available..............          $1,105
--------------------------------------------------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

Airbus: Docket No. FAA-2016-9110; Directorate Identifier 2015-NM-
196-AD.

(a) Comments Due Date

    We must receive comments by November 3, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A319-115, A319-132, A320-214,
A320-232, A321-211, A321-213, and A321-231 airplanes, certificated
in any category, as identified in Airbus Service Bulletin A320-52-
1167, dated August 6, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by a report of certain tie rod assemblies
installed on the hinged fairing assembly of the main landing gear
(MLG) with no cadmium plating on the rod end threads. We are issuing
this AD to detect and correct the absence of cadmium plating on the
rod end threads of the tie rod assemblies. The absence of cadmium
plating could lead to galvanic corrosion of the tie rod end threads,
resulting in rod end failure, loss of a MLG door, and consequent
damage to the airplane.

(f) Compliance

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

(g) Inspection and Corrective Action

    Within 80 months after the airplane's first flight, do a
detailed inspection of each tie rod assembly having a part number
(P/N) D52840212000 or D52840212002 at the MLG hinged fairing for the
presence of cadmium plating (gold colored threads), in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A320-52-1167, dated August 6, 2015. If during the inspection any tie
rod assembly is found that does not have cadmium plating, before
further flight, replace the tie rod assembly with a serviceable part
having the same part number and cadmium plating, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-52-
1167, dated August 6, 2015.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0234, dated December 8,
2015, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-9110.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 12, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-22435 Filed 9-16-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38590-38591]
[FR Doc No: 2011-16493]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 63

[EPA-HQ-OAR-2009-0234; EPA-HQ-OAR-2011-0044, FRL-9427-4]
RIN 2060-AP52

Proposed National Emission Standards for Hazardous Air Pollutants
From Coal- and Oil-Fired Electric Utility Steam Generating Units and
Standards of Performance for Fossil-Fuel-Fired Electric Utility,
Industrial-Commercial-Institutional, and Small Industrial-Commercial-
Institutional Steam Generating Units; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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SUMMARY: The EPA is announcing that the period for providing public
comments on the May 3, 2011, Proposed National Emission Standards for
Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility
Steam Generating Units and Standards of Performance for Fossil-Fuel-
Fired Electric Utility, Industrial-Commercial-Institutional, and Small
Industrial-Commercial-Institutional Steam Generating Units is being
extended for 30 days.

DATES: Comments. The public comment period for the proposed rule
published May 3, 2011 (76 FR 24976) is being extended for 30 days to
August 4, 2011, in order to provide the public additional time to
submit comments and supporting information.

ADDRESSES: Comments. Written comments on the proposed rule may be
submitted to EPA electronically, by mail, by facsimile, or through hand
delivery/courier. Please refer to the proposal for the addresses and
detailed instructions.
    Docket. Publicly available documents relevant to this action are
available for public inspection either electronically in http://www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, 1301 Constitution Avenue, NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. A reasonable fee may be charged for copying.
    Worldwide Web. The EPA Web sites for this rulemaking are are at:
http://www.epa.gov/airquality/powerplanttoxics/actions.html or http://www.epa.gov/ttn/atw/utility/utilitypg.html.

FOR FURTHER INFORMATION CONTACT: For the national emission standards
for hazardous air pollutants (NESHAP) action: Mr. William Maxwell,
Energy Strategies Group, Sector Policies and Programs Division, (D243-
01), Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
Telephone number:<PHONE_NUMBER>; Fax number<PHONE_NUMBER>; E-mail
address<EMAIL_ADDRESS>For the new source performance standard
(NSPS) action: Mr. Christian Fellner, Energy Strategies Group, Sector
Policies and Programs Division, (D243-01), Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Research
Triangle Park, North Carolina 27711; Telephone number:<PHONE_NUMBER>;
Fax number<PHONE_NUMBER>; E-mail address<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Comment Period

    Due to requests we have received from both the public and members
of Congress to extend the public comment period for the May 3, 2011,
Proposed Mercury and Air Toxics Standards Rule, the EPA is extending
the public comment period for an additional 30 days. Therefore, the
public comment period will end on August 4, 2011, rather than July 5,
2011.

How can I get copies of this document and other related information?

    The EPA has established the official public dockets No. EPA-HQ-OAR-
2011-0044 (NSPS action) or No. EPA-HQ-OAR-2009-0234 (NESHAP action).
The EPA has also developed websites for these proposed rulemakings at
the addresses given above.

    Dated: June 24, 2011.
Gina McCarthy,
Assistant Administrator for Air and Radiation.
[FR Doc. 2011-16493 Filed 6-30-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Page 29260]
[FR Doc No: 2021-11413]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10022-06-OMS]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, District of Columbia

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Environmental Protection Agency's
(EPA) approval of the District of Columbia's request to revise/modify
certain of its EPA-authorized programs to allow electronic reporting.

DATES: EPA approves the authorized program revisions/modifications as
of June 1, 2021.

FOR FURTHER INFORMATION CONTACT: Shirley M. Miller, CROMERR Program
Manager, U.S. Environmental Protection Agency, Office of Information
Management, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington,
DC 20460,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of Title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On February 17, 2021, the District of Columbia Department of Energy
and Environment (DOEE) submitted an application titled DC UST Portal
for revisions/modifications to its EPA-approved programs under title 40
CFR to allow new electronic reporting. EPA reviewed DOEE's request to
revise/modify its EPA-authorized programs and, based on this review,
EPA determined that the applications met the standards for approval of
authorized program revisions/modifications set out in 40 CFR part 3,
subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's
decision to approve the District of Colombia's request to revise/modify
its following EPA-authorized programs under 40 CFR parts 281, to allow
electronic reporting under 40 CFR part 280 is being published in the
Federal Register:

Part 281: Technical Standards and Corrective Action Requirements for
Owners and Operators of Underground Storage Tanks (UST) Reporting under
CFR 280

    DOEE was notified of EPA's determination to approve its application
with respect to the authorized programs listed above.

    Dated: May 25, 2021.
Jennifer Campbell,
Director, Office of Information Management.
[FR Doc. 2021-11413 Filed 5-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Rules and Regulations]
[Page 23159]
[FR Doc No: 2012-9353]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Parts 229 and 238

[Docket Nos. FRA-2009-0094 and FR-2009-0095, Notice No. 4]
RIN 2130-AC16

Locomotive Safety Standards; Correction

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Final rule; correction.

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SUMMARY: FRA is notifying the public that the correct docket number for
the Locomotive Safety Standards final rule is FRA-2009-0094. The final
rule issued on April 9, 2012, incorrectly identified docket number FR-
2009-0095 as the public docket for this rulemaking proceeding. FRA is
requesting that all petitions for reconsideration and all comments on
any petitions for reconsideration related to this proceeding be
submitted to FRA-2009-0094.

DATES: The deadline for petitions for reconsideration of the final rule
published April 9, 2012, at 77 FR 21312, remains June 8, 2012. The
deadline for comments on such petitions remains July 23, 2012.

ADDRESSES: Petitions for reconsideration or comments on such petitions:
Any petitions and any comments to petitions related to Docket No. FRA-
2009-0094, may be submitted by any of the following methods: Web Site:
Federal eRulemaking Portal, http://www.regulations.gov. Follow the
online instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: Room W12-140 on the Ground level of the
West Building, 1200 New Jersey Avenue SE., W12-140, Washington, DC
between 9 a.m. and 5 p.m. Monday through Friday, except Federal
holidays.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name and
docket number or Regulatory Identification Number (RIN) for this
rulemaking. Note that all comments received will be posted without
change to http://www.regulation.gov including any personal information.
FRA wishes to inform all potential petitioners that anyone is able to
search the electronic form of all comments received into any agency
docket by the name of the individual submitting the petition (or
signing the petition, if submitted on behalf of an association,
business, labor union, etc.). You may review DOT's complete Privacy Act
Statement in the Federal Register published on April 11, 2000 (Volume
65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
Room W12-140 on the Ground level of the West Building, 1200 New Jersey
Avenue SE., Washington, DC between 9 a.m. and 5 p.m. Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Michael Masci, Trial Attorney, Office
of Chief Counsel, FRA, 1200 New Jersey Avenue SE., Washington, DC
(telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: On April 9, 2012, FRA published a final rule
related to locomotive safety standards. See 77 FR 21312. The final rule
established a public docket to receive petitions for reconsideration in
response to FRA's final rule related to locomotive safety standards and
comments on such petitions. That final rule mistakenly lists FR-2009-
0095 (``incorrect docket'') as the docket number for the final rule.
The correct docket number for this proceeding is FRA-2009-94 (``correct
docket''). FRA requests that petitions for reconsideration related to
the final rule and comments on such petitions be submitted to the
correct docket.
    Petitions for reconsideration and comments on such petitions
submitted to the incorrect docket will be fully considered as part of
the locomotive safety standards rulemaking. Because the incorrect
docket is listed in the April 9, 2012, Federal Register document
issuing the final rule, petitions for reconsideration and comments on
such petitions submitted to the incorrect docket will remain valid. FRA
will transfer all comments and information that are received in the
incorrect docket to the correct docket. As such, interested parties
that wish to read petitions for reconsideration related to the final
rule and comments on such petitions should access docket FRA-2009-0094
to locate them.

    Issued in Washington, DC, on April 12, 2012.
Ron Hynes,
Acting Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2012-9353 Filed 4-17-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Pages 9256-9257]
[FR Doc No: 2012-3606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0123]

Design and Methodology for Postmarket Surveillance Studies Under
Section 522 of the Federal Food, Drug, and Cosmetic Act; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Design and Methodology for Postmarket Surveillance
Studies under Section 522 of the Federal Food, Drug and Cosmetic Act''.
The purpose of the public workshop is to provide a forum for discussion
among FDA, industry, governmental agencies, academia, clinicians and
various stakeholders with experience in epidemiology, statistics, and
biomedical research to advance the design and methodologies for medical
device surveillance studies in the ``postmarket'' setting, i.e., after
FDA premarket approval or clearance of the device and marketing of the
device has begun.

DATES: The meeting will be held on March 7, 2012, from 8 a.m. to 5:30
p.m.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm 1503 (the Great Room), Silver Spring,
MD 20993. For parking and security information, please visit the
following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public workshop will also be available to be viewed online via webcast.

FOR FURTHER INFORMATION CONTACT: Samantha Jacobs, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4201C, Silver Spring, MD 20993, 301-796-
6897, email<EMAIL_ADDRESS>or Mary Beth Ritchey, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4118, Silver Spring, MD 20993,
301-796-6638, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Registration: To register for the public
workshop, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm289465.htm (or go to
http://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops & Conferences calendar and select this public workshop from
the posted events list). Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone number. For persons interested in attending this workshop
and without Internet access, please call one of the people listed in
the FOR FURTHER INFORMATION CONTACT section in this document in order
to register. Registrants will receive confirmation once they have been
accepted. You will be notified if you are on a waitlist. There is no
fee to attend the public workshop, but attendees must register in
advance. Registration will be on a first-come, first-served basis.
Persons interesting in attending this workshop must register online by
February 29, 2012. Registration is mandatory as space is limited and
onsite registration will not be available. FDA may limit the number of
participants from each organization.
    If you need special accommodations due to a disability, please
contact Susan Monahan at<EMAIL_ADDRESS>no later than March
1, 2012.
    Security: Non-U.S. citizens are subject to additional security
screening, and they should register as soon as possible. Entrance for
the public meeting participants (non-FDA employees) is through Building
1 where routine security check procedures will be performed. For
parking and security information, please visit the Web site address in
the ADDRESSES section of this document.
    Streaming Webcast of the Public Workshop: This workshop will also
be webcast. Persons interested in viewing the webcast must register
online by 5 p.m. on February 29, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but view using one connection
per location. Webcast participants will be sent technical system
requirements after registration, and will be sent connection access
information after March 1, 2012. If you have never attended a Connect
Pro meeting 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: http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Background: Under section 522(a) of the Federal Food, Drug and
Cosmetic Act (FD&C Act), enacted by the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115, Sec.  212, 111
Stat. 2346), codified at 21 U.S.C. 360l(a), FDA may order a
manufacturer to conduct postmarket surveillance for any Class II or
Class III device (i) Intended to be implanted in the human body for
more than 1 year or to be used to sustain or support life outside a
device user facility, or (ii) whose failure would be reasonably likely
to have serious adverse health consequences. The Food and Drug
Administration Amendments of 2007 (FDAAA) (Pub. L. 110-85, Sec.  307,
121 Stat. 865) expanded the scope of section 522 to include devices
intended for pediatric use.

Agenda for the Public Workshop

1. Why are we holding this public workshop?

    The purpose of the proposed workshop is to facilitate discussion
among the FDA, industry, governmental agencies, academia, clinicians,
and key stakeholders with experience in epidemiology, statistics, and
biomedical research in the scientific community to advance the design
and methodologies for medical device surveillance studies in the
postmarket setting.

2. Who is the target audience for this public workshop? Who should
attend this public workshop?

    This workshop is open to all interested parties. The target
audience is professionals in the scientific community interested in
advancing the infrastructure and methodology for postmarket
surveillance studies.

3. What are the topics we intend to address at the public workshop?

    We intend to discuss a large number of issues at the workshop,
including, but not limited to the following:

     Regulations for postmarket surveillance studies,
     Challenges and opportunities for collaborative efforts,
     Innovative methodologies and scientific infrastructure to
promote innovation,
     Role of networks, registries and observational studies,

4. Where can I find out more about this public workshop?

    Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/cdrh/meetings.html.
    Comments: Regardless of attendance at the public workshop,
interested persons may submit electronic comments, or written comments
by April 6, 2012. Submit electronic comments to http://www.regulations.gov. Submit written comment to the Division of Dockets
Management (HFA-305), Food and Drug Administration 5630 Fishers Lane,
rm, 1061, Rockville, MD 20852. Comments are to be identified with the
docket number found in brackets in the heading of this document. In
addition, when responding to specific topics listed in paragraph 3 of
the ``Agenda for the Public Workshop'' section of this document, please
identify the topic you are addressing. Received comments may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Any written
request for a transcript is to be sent to the Division of Freedom of
Information. Written requests are to be sent to Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will
also be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public
workshop from the posted events list), approximately 45 days after the
public workshop.

    Dated February 10, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-3606 Filed 2-15-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Notices]
[Page 38211]
[DOCID:fr31jy09-80]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Arthritis 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: Arthritis 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 September 16, 2009, from
8:30 a.m. to 3:15 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel telephone number is<PHONE_NUMBER>.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-6793, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. 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: The committee will discuss biologics license application
(BLA) 12-5338, clostridial collagenase, Auxilium Pharmaceuticals, Inc.,
for the proposed treatment of advanced Dupuytren's disease. Dupuytren's
disease is a condition in which the tendons of the hand that help move
the fingers of the hand become thickened and scarred.
    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
September 1, 2009. Oral presentations from the public will be scheduled
between approximately 12:45 p.m. to 1:45 p.m. Those desiring to make
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 August 24, 2009. 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 August 25, 2009.
    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 Nicole Vesely 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: July 23, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-18356 Filed 7-30-09; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date: 8/9/12

SUBJECT:	Metconazole.   Summary of Risk Issues Associated With Increase
In Tolerance For Corn Stover.

PC Code:  125619	DP Barcode:  D399532

Decision No.: 457152	Registration Nos.: 7969-246, 7969-263

Petition No.: 1F7937	Regulatory Action: Section 3 Registration

Risk Assessment Type: NA	Case No.: NA

TXR No.: NA	CAS No.: 125116-23-6

MRID No.: 48639901	40 CFR: 180.617

		              									Ver.Apr.08

FROM:	Jeffrey L Dawson, Acting Branch Chief

		Registration Action Branch III (RAB3)

		Health Effects Division (HED; 7509P)

THROUGH:	Steve Funk, Senior Chemist

		RAB3/HED (7509P)

TO:		Mary Waller/Tamue Gibson, RM#21		  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1

		Registration Division (7505P)

The petitioner, BASF Corporation, requested to increase the established
tolerance for sweet corn stover from 4.5 to 25 ppm as a result of the
additional data.  In order to support this BASF submitted additional
field trials for metconazole on corn stover.  These data were reviewed
and summarized in D399057.

The analysis completed in D399057 concluded that the additional five
field trials on field corn stover, submitted to represent sweet corn
stover, resolve the deficiency regarding geographic representation of
sweet corn stover field trials and based on the Organisation for
Economic Co-operation and Development (OECD) tolerance calculation
procedures, the appropriate tolerance for sweet corn stover is 30 ppm.
The petitioner proposed a tolerance of 25.0 ppm on corn, sweet, stover.
All corn stover (sweet, field, and pop) can be harvested at the same
minimum preharvest interval.  The petitioner must submit a revised
Section F to propose a tolerance of 30 ppm on corn, sweet, stover; corn,
field, stover; and corn, pop, stover.

The impact on dietary risk estimates was also examined.  Submission of
additional corn stover residue data caused an increase in the maximum
reasonably balanced dietary burden for dairy cattle; no increase
occurred for beef cattle, swine, or poultry.  The increase was driven by
one in twenty-five field trials with a highest average field trial
(HAFT) of 22.7 ppm in corn stover; the remaining field trial residues
were 0.14 to 3.23 ppm.  Based on the cattle feeding study and the
calculated dietary burden based on the maximum reasonably balanced diet,
no changes are required in the established livestock tolerances as a
result of submission of the additional corn stover field trials.  If
additional uses increase the livestock dietary burdens, additional
livestock feeding studies conducted at higher rates may be needed.
Since corn stover (a livestock feed item) is not included in the dietary
exposure assessment a revised dietary exposure assessment and a human
health risk assessment are not needed.

Actions of this type trigger a review of the toxicological databases for
impacted chemicals.  In this case, data needs for metconazole were
examined in a meeting of the Hazard and Science Policy Council (HASPOC)
in order to determine if additional data were required in order to
adequately characterize the toxicity of metconazole.   In particular,
the need for an acute neurotoxicity study and a subchronic inhalation
toxicity study were examined.  When data are missing, additional
uncertainty factors can be applied as described in current policies.
Based on a weight-of-evidence (WOE) approach and considering all the
available metconazole hazard and exposure information, the HASPOC
recommended that a subchronic inhalation toxicity study and an acute
neurotoxicity study are not required for metconazole at this time.  They
also indicated, however, these issues will be re-evaluated if the
metconazole use pattern changes.

 Metconazole.   Additional Residue Data on Corn Stover.  Summary of
Residue Data. (N. Dodd, D399057,7/19/12).

 Metconazole: Summary of Hazard and Science Policy Council (HASPOC)
Meeting of July 19, 2012:  Recommendations on the Requirement of a
Subchronic Inhalation Study and an Acute Neurotoxicity Study. (Rury, K,.
TXR0056405, 8/9/12)

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