[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4143-4144]
[FR Doc No: 2018-01703]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0025]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Broadway Bridge across the
Willamette River, mile 11.7, at Portland, OR. The deviation is
necessary to make adjustments to new equipment. This deviation allows
the bridge to operate the double bascule span one side at a time,
single leaf.

DATES: This deviation is effective without actual notice from January
30, 2018, to 11:59 p.m. on February 23, 2018. For the purposes of
enforcement, actual notice will be used from 1 a.m. on January 27,
2018, through January 30, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0025, is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: Multnomah County, the bridge owner,
requested the Broadway Bridge be authorized to open half the span in
single leaf mode to make adjustments to newly installed equipment. The
Broadway Bridge crosses the Willamette River at mile 11.7, and provides
90 feet of vertical clearance above Columbia

River Datum 0.0 while in the closed-to-navigation position, and
provides 125 feet of horizontal clearance with half the span open. This
bridge operates in accordance with 33 CFR 117.897. This deviation
allows the double bascule span of the Broadway Bridge across the
Willamette River, mile 11.7, to operate the bridge in single leaf mode
to marine traffic. The deviation period will be from 1 a.m. on January
27, 2018 to 11:59 p.m. on February 23, 2018. The bridge shall operate
in accordance to 33 CFR 117.897 at all other times.
    Waterway usage on this part of the Willamette River includes
vessels ranging from commercial tug and barge to small pleasure craft.
One particular shipping company regularly requests a full bridge span
opening in order to transit the river. In anticipation of this
deviation, the shipping company has agreed to give a 7 day notice and a
24 hour notice to the bridge owner for a request of a full bridge span
opening. If this procedure is followed, the bridge owner has agreed to
comply with these requests.
    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at anytime. The bridge will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridge so that vessels can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: January 16, 2018.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2018-01703 Filed 1-29-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Notices]
[Page 19557]
[DOCID:fr29ap09-72]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0161; FRL-8410-9]

Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has granted an experimental use permit (EUP) to the
following pesticide applicant. An EUP permits use of a pesticide for
experimental or research purposes only in accordance with the
limitations in the permit.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the information in this action,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0161. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. EUP

    EPA has issued the following EUP:
    82608-EUP-1. Issuance. AgroGreen, Biological Division, Minrav
Infrastructures (1993) Ltd., 3 Habossem Str, P.O. Box 153, Ashdod,
77101, Israel, represented by SciReg, Inc., 12733 Director's Loop,
Woodbridge, VA 22192, USA. This EUP allows the use of 85.84 pounds (39.
02 kilograms) of the end-use product BAFI SDN (100%), containing the
active ingredient Bacillus firmus isolate I-1582 for treating seeds to
be planted on 7,478.25 acres of corn, cotton, and soybean to evaluate
the control of nematodes. The program is authorized only in the States
of Illinois, Indiana, Iowa, Michigan, Mississippi, Missouri, and North
Carolina for seed treatments and in Alabama, Arkansas, Colorado,
Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,
Michigan, Minnesota, Mississippi, Missouri, Nebraska, North Carolina,
North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee,
Texas, and Wisconsin for planting treated seeds. Untreated seeds are to
be planted as controls on approximately 1,496 acres concurrently with
the planting of treated seeds in the specified states. The EUP is
effective from April 8, 2009 to April 8, 2011.

    Authority: 7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: April 17, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E9-9568 Filed 4-28-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Proposed Rules]
[Pages 5153-5154]
[FR Doc No: 2013-01310]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1195; Airspace Docket No. 12-AWP-7]

Proposed Amendment of Class E Airspace; Reno, NV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Reno/Tahoe
International Airport, Reno, NV. Decommissioning of the Compass Locator
at the Instrument Landing System Middle Marker (LMM) and the Middle
Marker (MM) has made this action necessary for the safety and
management of Instrument Flight Rules (IFR) operations at the airport.
This action also would adjust the geographic coordinates of the
airport.

DATES: Comments must be received on or before March 11, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2012-
1195; Airspace Docket No. 12-AWP-7, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2012-1195 and Airspace Docket No. 12-AWP-7) and be submitted in
triplicate

to the Docket Management System (see ADDRESSES section for address and
phone number). You may also submit comments through the Internet at
http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2012-1195 and Airspace Docket No. 12-AWP-7''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by amending Class E airspace designated as
an extension to Class C airspace area for Reno/Tahoe International
Airport, Reno, NV. Airspace reconfiguration is necessary due to the
decommissioning of the LMM and the MM navigation aids. The Airport
Reference Point (ARP) would be used to describe the airspace instead of
the LMM and the MM navigational aids. There would be no change in the
current configuration of the controlled airspace area. Also, the
geographic coordinates of the airport would be updated to coincide with
the FAA's aeronautical database. Controlled airspace is necessary for
the safety and management of IFR operations at the airport.
    Class E airspace designations are published in paragraph 6003, of
FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Reno/Tahoe International
Airport, Reno, NV.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 710 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 6003 Class E airspace designated as an extension to class
C surface areas.

* * * * *

AWP NV E3 Reno, NV [Amended]

Reno/Tahoe International Airport, NV
    (Lat. 39[deg]29'57'' N., long. 119[deg]46'05'' W.)

    That airspace extending upward from the surface within 1.8 miles
each side of the Reno/Tahoe International Airport 360[deg] bearing
extending from the 5-mile radius of the airport to 12 miles north of
the airport, and within 1.8 miles each side of the Reno/Tahoe
International Airport 180[deg] bearing extending from the 5-mile
radius of the airport to 10.5 miles south of the airport.

    Issued in Seattle, Washington, on December 6, 2012.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-01310 Filed 1-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 16, 2007 (Volume 72, Number 199)]
[Notices]
[Page 58662]
[DOCID:fr16oc07-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

October 10, 2007.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP03-36-028.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits its Thirty-
Fourth Revised Sheet 9 et al. to its FERC Gas Tariff, First Revised
Volume 1, to become effective 11/4/07.
    Filed Date: 10/04/2007.
    Accession Number: 20071005-0075.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 16, 2007.

    Docket Numbers: RP03-323-013.
    Applicants: Williston Basin Interstate Pipeline Co.
    Description: Williston Basin Interstate Pipeline Company submits
negotiated Rate Schedule FT-1 Service Agreement.
    Filed Date: 10/02/2007.
    Accession Number: 20071003-0228.
    Comment Date: 5 p.m. Eastern Time on Monday, October 15, 2007.

    Docket Numbers: RP06-200-037.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits Thirtieth Revised
Sheet 22 et al. to FERC Gas Tariff, First Revised Volume 1 to be
effective 10/10/07.
    Filed Date: 10/09/2007.
    Accession Number: 20071010-0079.
    Comment Date: 5 p.m. Eastern Time on Monday, October 22, 2007.

    Docket Numbers: RP97-255-076.
    Applicants: TransColorado Gas Transmission Company.
    Description: TransColorado Gas Transmission Co submits Fifteenth
Revised Sheet 21 et al. to FERC Gas Tariff, First Revised Volume 1 to
be effective 9/9/07.
    Filed Date: 10/09/2007.
    Accession Number: 20071010-0080.
    Comment Date: 5 p.m. Eastern Time on Monday, October 22, 2007.

    Docket Numbers: RP08-14-001.
    Applicants: Texas Eastern Transmission LP.
    Description: Texas Eastern Transmission, LP re-submits the entire
Service Agreement including the corrected Exhibit A as well as the
accompanying redlines comparing the agreement to its 10/1/07 filing.
    Filed Date: 10/04/2007.
    Accession Number: 20071009-0091.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 16, 2007.

    Docket Numbers: RP08-19-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Guardian Pipeline LLC submits Original Sheet 7 et al.
to its FERC Gas Tariff, Original Volume 1, to become effective 11/1/07.
    Filed Date: 10/04/2007.
    Accession Number: 20071005-0076.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 16, 2007.

    Docket Numbers: RP08-20-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits Third Revised
Sheet 153 et al. to FERC Gas Tariff, Fifth Revised Volume 1.
    Filed Date: 10/05/2007.
    Accession Number: 20071009-0092.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 17, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Acting Deputy Secretary.
 [FR Doc. E7-20339 Filed 10-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Rules and Regulations]
[Pages 65808-65810]
[FR Doc No: 2012-26198]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0427; Directorate Identifier 2011-NM-202-AD;
Amendment 39-17233; AD 2012-21-17]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A320-214 and -232 airplanes. This AD was prompted by
reports that medium-head fasteners were installed in lieu of shear-head
fasteners on a certain upper panel, which manufacturer fatigue and
damage tolerance analyses demonstrated could have an effect on panel
fatigue life. This AD requires repetitive inspections for cracking of
certain fasteners, and repairs if necessary. We are issuing this AD to
detect and correct such cracking, which could result in the loss of
structural integrity of the airplane.

DATES: This AD becomes effective December 5, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 5,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

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:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on May 8, 2012 (77 FR
26996). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A problem was reported during the installation of upper panels
on Frame 35 in Airbus A320 final assembly line. Investigations
revealed that medium head fasteners, Part Number (P/N) EN6114V3,
were installed in lieu of shear head fasteners, P/N ASNA2657V3 and
ASNA2043V3, which were previously used. Installation of these medium
head fasteners leads to a deeper countersink in the panel. Fatigue
and damage tolerance analyses were performed, the results of which
demonstrated that this installation could have a fatigue impact on
two rows of fasteners between stringers (STGR) 5 and 6, and
indicated the need for a specific inspection in this area.
    This condition, if not detected and corrected, could impair the
structural integrity of the affected aeroplanes.
    For the reasons described above, this [European Aviation Safety
Agency (EASA)] AD requires repetitive special detailed [high
frequency eddy current] inspections [for cracking] of the affected
fasteners and, depending on findings, the accomplishment of
associated corrective actions [repair].

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received.

Support for the NPRM (77 FR 26996, May 8, 2012)

    Mr. Jason Aldrich stated that it appears from the analysis gathered
that the repairs/modifications (proposed by the NPRM (77 FR 26996, May
8, 2012)) could significantly reduce potential damage to the airplane,
which would directly result in improved safety for persons.

Request To Clarify Repair Approval

    Airbus requested that we revise paragraph (h) of the NPRM (77 FR
26996, May 8, 2012) to clarify that any Repair Approval Sheet (RAS)
approved under authority of Airbus Design Organization Approval (DOA)
number EASA 21J.031 is acceptable as a repair method for the EASA or
its delegated agent.
    We disagree to change the AD because a change is not necessary.
Paragraph (h) of the AD allows repairs approved by EASA or its
delegated agent. We understand that Airbus has discretion to provide
repair to their operators that meets the certification basis of the
airplane and mitigates the unsafe condition addressed in the AD. We
have not changed the AD in this regard.

Request for Terminating Action

    Airbus requested that we allow a repair performed according to the
proposed requirements in paragraph (h) of the NPRM (77 FR 26996, May 8,
2012) as terminating action, as stated in paragraph (3) of EASA
Airworthiness Directive 2011-0176, dated September 13, 2011.
    We disagree to allow repairs as terminating action in this AD. The
action identified by EASA in its AD is not necessarily terminating
action. Under the provision of paragraph (i) of this AD, we will
consider requests for approval of an alternative method of compliance
(AMOC) if sufficient data are submitted to substantiate that a proposed
repair meets an acceptable level of safety as terminating action for
the repetitive inspections. We have not changed the AD in this regard.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 26996, May 8, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 26996, May 8, 2012).

Costs of Compliance

    We estimate that this AD will affect 44 products of U.S. registry.
We also estimate that it will take about 3 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $11,220, or $255 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD. We
have no way of determining the number of products that may need these
actions.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 26996, May 8, 2012),
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.

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 AD:

2012-21-17 Airbus: Amendment 39-17233. Docket No. FAA-2012-0427;
Directorate Identifier 2011-NM-202-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective December 5,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A320-214 and -232 airplanes;
certificated in any category; manufacturer serial numbers 3456,
3503, 3516, 3529, 3591, 3597, 3611, 3631, 3696, 3698, 3714, 3719,
3775, 3777, 3780, 3782, 3786, 3797, 3805, 3812, 3870, 3907, 3909,
3913, 3922, 3929, 3946, 3953, 3975, 3979, 3991, 4010, 4012, 4014,
4027, 4034, 4043, 4046, 4064, 4065, 4084, 4093, 4094, and 4097.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports that medium-head fasteners were
installed in lieu of shear-head fasteners on a certain upper

panel, which manufacturer fatigue and damage tolerance analyses
demonstrated could have an effect on panel fatigue life. We are
issuing this AD to detect and correct such cracking, which could
result in the loss of structural integrity of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Repetitive Inspection

    Before the accumulation of 35,900 total flight cycles or 88,100
total flight hours, whichever occurs first: Do a high frequency eddy
current inspection for cracking of the two rows of six fasteners at
frame 35 between stringers 5 and 6 on the left and right sides, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-53-1244, excluding Appendix 1, dated March 17, 2011.
Repeat the inspection thereafter at intervals not to exceed 28,100
flight cycles or 56,300 flight hours, whichever occurs first.

(h) Corrective Action

    If any crack is detected during any inspection required by
paragraph (g) of this AD: Before further flight, repair the crack
using a method approved by either the Manager, International Branch,
ANM-116, Transport Airplane Directorate, FAA; or the European
Aviation Safety Agency (EASA) or its delegated agent.

(i) 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) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    Refer to MCAI EASA Airworthiness Directive 2011-0176, dated
September 13, 2011; and Airbus Service Bulletin A320-53-1244,
excluding Appendix 1, dated March 17, 2011; for related information.

(k) 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) Airbus Service Bulletin A320-53-1244, excluding Appendix 1,
dated March 17, 2011.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS-EAW (Airworthiness Office), 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.
    (4) You may review copies of the 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>.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on October 16, 2012.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26198 Filed 10-30-12; 8:45 am]
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[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Pages 74852-74854]
[FR Doc No: 2012-30382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1197]

Draft Guidance for Industry on Certification of Designated
Medical Gases; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Certification
Process for Designated Medical Gases.'' This draft guidance describes
the new certification process created by the Food and Drug
Administration Safety and Innovation Act (FDASIA) for certain medical
gases and explains how FDA plans to implement that process.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 19, 2013. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance and attached Form 3864 by February 19, 2013.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Michael Folkendt, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8331.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Certification Process for Designated Medical Gases.'' This
guidance is intended to help persons or entities interested in
requesting a certification for a designated medical gas under the new
approval process for designated medical gases created by FDASIA (Pub.
L. 112-144, 126 Stat. 993).
    Title XI, subtitle B, of FDASIA added sections 575 and 576 to the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), which created a
certification process for designated medical gases. Specifically,
section 575 provides that oxygen, nitrogen, nitrous oxide, carbon
dioxide, helium, carbon monoxide, and medical air are designated
medical gases. Section 576 permits any person, beginning on January 5,
2013, to request a certification of a medical gas for certain
indications and describes when FDA will grant or deny these requests.
    This draft guidance explains how FDA plans to implement this new
certification process. Specifically, the draft guidance describes the
medical gases that are eligible for certification, who should submit a
certification request, what information should be submitted, and how
FDA will evaluate and act on the request. The draft guidance also
describes how the new certification requirement will be enforced and
describes FDA's intent to exercise enforcement discretion in certain
instances.
    FDA has also developed a form to help requestors submit their
certification requests. FDA recommends that requestors use this form.
The form

and an instructions page for use in completing the form are attached to
this draft guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the Agency's current thinking on the
certification process for designated medical gases. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if that approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Request for Certification Process for Designated Medical
Gas.
    Description of Respondents: Respondents to this collection of
information are manufacturers and/or marketers of certain medical gas
drug products.
    Burden Estimate: Under section 576 of the FD&C Act and the draft
guidance, the following information would be submitted to FDA by a
person requesting certification of a designated medical gas product:
The requestor's name, address, and other contact information; the name,
address, and other contact information of the manufacturing facilities
involved in the production of the gas; and certain affirmations that
the gas meets applicable compendial standards and that the product is
manufactured in accordance with current good manufacturing practice.
Requestors will make certification requests using FDA Form 3864 and
will include a cover letter explaining the nature of the submission (as
explained in the Instructions page to the form). In certain
circumstances FDA may ask followup questions if additional information
is needed from the requestor to determine whether a medical gas
qualifies for certification as a designated medical gas.
    Based on our knowledge of the medical gas marketplace, we estimate
that a total of approximately 50 requestors (``number of respondents''
in table 1) will submit certification requests for designated medical
gases in 2013. We expect that a small number (we estimate five) of
these requestors will need to resubmit their certification requests,
which we also expect to occur in 2013. Thus, for 2013, we estimate
approximately 55 ``total responses'' in table 1. In 2014 and beyond we
expect to receive only a small number of submissions. We estimate 5 per
year, and estimate 1 out of 10 such submissions will require
resubmission, for a total of 5.5 annualized responses (as reflected in
table 2). Those submissions would consist of new certification
requests, resubmissions, and postapproval submissions to provide FDA
with updated information (e.g., a change of ownership or closure of a
particular manufacturing facility). In every case the requestor should
submit a new Form 3864 together with a cover letter explaining the
nature of the submission. For all submissions, we estimate that
preparing and submitting the form and cover letter to FDA will take
approximately 2 hours per requestor (``average burden per response'' in
the tables in this document). This estimate includes the time that some
requestors may need to reply to followup questions by FDA.

                                                      Table 1--Estimated 2013 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                                                                        Number of      responses per   Total responses    per response     Total hours
                                                                       respondents       respondent                        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3864 and other requested information......................              50              1.1               55                2              110
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                       Table 2--Estimated Annual Reporting Burden in 2014 and Subsequent Years \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                                                                        Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3864 and other requested information......................               5              1.1              5.5                2               11
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket

number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed in the previous sentence to find the
most current version of the guidance.

    Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30382 Filed 12-17-12; 8:45 am]
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