[Federal Register: January 9, 2009 (Volume 74, Number 6)]
[Notices]
[Page 904-906]
[DOCID:fr09ja09-41]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements on
Content and Format of Labeling for Human Prescription Drug and
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by
February 9, 2009.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:

202-395-6974, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0572. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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

Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products (OMB Control Number 0910-0572)--Extension

    FDA's final rule entitled ``Requirements on Content and Format of
Labeling for Human Prescription Drug and Biological Products'' (the
final rule), which published on January 24, 2006 (71 FR 3922), and was
effective on June 30, 2006, amended FDA's regulations governing the
format and content of labeling for human prescription drug and
biological products to require that the labeling of new and recently
approved products contain highlights of prescribing information, a
table of contents for prescribing information, reordering of certain
sections, minor content changes, and minimum graphical requirements.
These revisions were intended to make it easier for health care
practitioners to access, read, and use information in prescription drug
labeling, to enhance the safe and effective use of prescription drug
products, and reduce the number of adverse reactions resulting from
medication errors due to misunderstood or incorrectly applied drug
information.

A. Summary of Prescription Drug Labeling Content and Format
Requirements That Contain Collections of Information

    Section 201.56 (21 CFR 201.56) requires that prescription drug
labeling contain certain information in the format specified in either
Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80), depending
on when the drug was approved for marketing.
    Section 201.56(a) sets forth general labeling requirements
applicable to all prescription drugs. Section 201.56(b) specifies the
categories of new and more recently approved prescription drugs subject
to the revised content and format requirements in Sec. Sec.  201.56(d)
and 201.57. Section 201.56(c) sets forth the schedule for implementing
these revised content and format requirements. Section 201.56(e)
specifies the sections and subsections, required and optional, for the
labeling of older prescription drugs not subject to the revised format
and content requirements.
    Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include
``Highlights of Prescribing Information.'' Highlights provides a
concise extract of the most important information required under Sec.
201.57(c) (the Full Prescribing Information (FPI)), as well as certain
additional information important to prescribers. Section 201.57(b)
requires a table of contents to prescribing information, entitled
``Full Prescribing Information: Contents,'' consisting of a list of
each heading and subheading along with its identifying number to
facilitate health care practitioners' use of labeling information.
Section 201.57(c) specifies the contents of the FPI. Section 201.57(d)
mandates the minimum specifications for the format of prescription drug
labeling and establishes minimum requirements for key graphic elements
such as bold type, bullet points, type size, and spacing.
    Older drugs not subject to the revised labeling content and format
requirements in Sec.  201.57 remain subject to labeling requirements at
Sec.  201.80 (in the final rule, former Sec.  201.57 was redesignated
as Sec.  201.80). Section 201.80(f)(2) requires that within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.

B. Estimates of Reporting Burden

    The PRA information collection analysis in the final rule (71 FR
3922 at 3964 to 3967) (currently approved under OMB Control Number
0910-0572) estimated the reporting burden for a multi-year period. We
are requesting that OMB extend approval for the information in this
collection, as described below, which continue to be submitted to FDA
during this multi-year period.

Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57) (Table 1)

    New drug product applicants must: (1) Design and create
prescription drug labeling containing Highlights, Contents, and FPI,
(2) test the designed labeling (e.g., to ensure that the designed
labeling fits into carton-enclosed products), and (3) submit it to FDA
for approval. Based on the projected data estimated in the final rule,
FDA estimates that it takes applicants approximately 3,349 hours to
design, test, and submit prescription drug labeling to FDA as part of
an NDA or BLA under the revised regulations. Approximately 85
applicants submit approximately 107 new applications (NDAs and BLAs) to
FDA per year, totaling 358,343 hours.

Burden Associated with Labeling Supplements for Applications Approved
Within 5 Years Prior to the Effective Date of the Rule (Sec.  201.57)
(Table 2)

    The final rule required that prescription drug applications
approved during the 5 years before, or pending on, the effective date
conform to format and content requirements at Sec.  201.57. For these
products, applicants must redesign and negotiate the labeling,
including Highlights and Contents, test the redesigned labeling, and
prepare and submit that labeling to FDA for approval. Based on the
projected data estimated in the final rule, labeling supplements for a
total of approximately 344 innovator products are expected to be
submitted to FDA over a 5-year period (beginning in year 3 and ending
in year 7 after the effective date of the final rule). Approximately
172 applicants submit these labeling supplements, and the time required
for redesigning, testing, and submitting the labeling to FDA is
approximately 196 hours per application, totaling 67,424 hours.

Burden Associated with Revised Labeling Efficacy Supplements Submitted
on or After the Effective Date of the Rule (Sec. Sec.  201.56(d) and
201.57) (Table 2)

    Efficacy supplemental applications for older drugs submitted to FDA
on or after the effective date of the final rule are subject to the
content and format requirements of Sec. Sec.  201.56(d) and 201.57. To
meet these requirements, applicants must revise the existing labeling
for these products. Each year an increasing number of innovator drug
labeling will have been revised, and over time, very few efficacy
supplements independently will generate labeling revisions. Based on
the projected data estimated in the final rule, the number of affected
efficacy supplements over 10 years, beginning with year 3, is 186, with
a decreasing number each year over the period. Approximately 172
applicants will

trigger approximately 186 efficacy supplements, each one requiring
approximately 196 hours to revise the labeling in the application,
totaling 36,456 hours. (As stated in the final rule, in addition to
this burden, a minimal annual reporting burden (fewer than 7) will
continue indefinitely).

Burden Associated with Revised Labeling for Efficacy Supplements for
Generic Drug Products (Sec.  201.57) (Table 2)

    Based on the projected data estimated in the final rule, beginning
in year 3 and continuing throughout the 10-year period analyzed,
approximately 42 generic applicants per year must submit labeling
supplements. Approximately 336 already approved generic drug
applications must submit labeling supplements over the 10-year period
after the effective date of the rule. The time required to revise and
submit this labeling to FDA is approximately 27 hours per application,
totaling 9,072 hours. (As stated in the final rule, in addition to this
burden, a minimal annual reporting burden associated with a very small
number of generic applications referencing older drugs may continue
indefinitely).

C. Capital Costs

    As discussed in the final rule, a small number of carton-enclosed
products may require new packaging to accommodate longer inserts. As
many as 5 percent of the existing products affected by the final rule
(i.e., products with new efficacy supplements, products approved in the
5 years prior to the effective date of the rule, and affected
abbreviated new drug applications) may require equipment changes at an
estimated cost of $200,000 each product.
    In the Federal Register of September 29, 2008 (73 FR 56592), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received relating to the
paperwork.
    FDA estimates the burden of this collection of information as
follows:

                    Table 1.--Estimated Annual Reporting Burden For New Drug Applications\1\
----------------------------------------------------------------------------------------------------------------
 Category (21 CFR                         No. of Responses per                         Hours per
     Section)        No. of Respondents         Respondent       Total  Responses       Response     Total Hours
----------------------------------------------------------------------------------------------------------------
Annual Burden for                     85                  1.26                 107            3,349      358,343
 Labeling
 Requirements in
 Sec.  Sec.
 201.56 and 201.57
----------------------------------------------------------------------------------------------------------------
Total               ....................  ....................  ..................  ...............      358,343
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2.--Estimated Annual Reporting Burdens For Labeling Revisions To Already-Approved Drug Products\1\
----------------------------------------------------------------------------------------------------------------
 Category (21 CFR                         No. of Responses per                         Hours per
     Section)        No. of Respondents         Respondent       Total  Responses       Response     Total Hours
----------------------------------------------------------------------------------------------------------------
Burden associated                    172                     2                 344              196       67,424
 with revised
 labeling for
 applications
 approved within 5
 years prior to
 June 30, 2006
 (Sec.   201.57)
----------------------------------------------------------------------------------------------------------------
Burden associated                    172                  1.08                 186              196       36,456
 with revised
 labeling for
 efficacy
 supplements
 submitted on or
 after June 30,
 2006 (Sec.  Sec.
  201.56(d) and
 201.57)
----------------------------------------------------------------------------------------------------------------
Burden associated                     42                     8                 336               27        9,072
 with revised
 labeling for
 efficacy
 supplements for
 generic drug
 products (Sec.
 201.57)
----------------------------------------------------------------------------------------------------------------
Total               ....................  ....................  ..................  ...............      112,952
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-175 Filed 1-8-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Page 55762]
[FR Doc No: 2015-23341]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0848]

Drawbridge Operation Regulations; Mantua Creek, Paulsboro, NJ and
Raccoon Creek, Bridgeport, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedules that govern the S.R. 44 Bridge over Mantua Creek,
mile 1.7, at Paulsboro, NJ and Route 130 Bridge over Raccoon Creek,
mile 1.8, at Bridgeport, NJ. This deviation allows the bridges to
remain in the closed-to-navigation position to facilitate the 2015
Papal Visit to Philadelphia, PA.

DATES: This deviation is effective from 7 a.m. on September 26, 2015,
to 11 p.m. on September 28, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0848], 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. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6222, email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The New Jersey Department of Transportation,
who owns and operates the S.R. 44 Bridge and Route 130 Bridge, has
requested a temporary deviation from the current operating regulations
set out in 33 CFR 117.729 and 117.741, respectively, to facilitate
movement of vehicles during the 2015 Papal Visit to Philadelphia, PA.
    Under the normal operating schedule for the S.R. 44 Bridge over
Mantua Creek, mile 1.7, at Paulsboro, NJ and Route 130 Bridge over
Raccoon Creek, mile 1.8, at Bridgeport, NJ; the bridges shall open on
signal from May 1 through October 31, from 7 a.m. to 11 p.m.; and all
other times, if at least four hours notice is given. The vertical
clearances in the closed-to-navigation position of the S.R. 44 Bridge
and Route 130 Bridge are 25 feet and 4 feet, respectively, above mean
high water.
    Under this temporary deviation, the bridges will be closed to
navigation from 7 a.m. to 11 p.m. each day starting September 26
through September 28, 2015, except for scheduled daily openings at 7
a.m. and 7 p.m. The bridges will operate per the normal operating
schedules between 11 p.m. and 7 a.m. Mantua Creek and Raccoon Creek are
used by a variety of vessels including small commercial fishing vessels
and recreational vessels. The Coast Guard has carefully coordinated the
restrictions with commercial and recreational waterway users.
    Vessels able to pass through the bridges in the closed position may
do so at anytime. The bridges will be able to open for emergencies and
there is no alternate route for vessels unable to pass through the
bridges in the closed position. The Coast Guard will also inform the
users of the waterways through our Local and Broadcast Notice to
Mariners of the change in operating schedules for these bridges so that
vessels can arrange their transits to minimize any impacts caused by
this temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
their regular operating schedules 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: September 10, 2015.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2015-23341 Filed 9-16-15; 8:45 am]
BILLING CODE 9110-04-P


Date:	September 22, 2016

To:	Brenda Shine, EPA/OAQPS/SPPD

From:	Jeff Coburn

Subject:	Meeting Record for August 31, 2016 meeting between
Representatives of American Petroleum Institute (API) and
Representatives of the U.S. Environmental Protection Agency (EPA)

On August 31, 2016, representatives of the EPA and their contractor (RTI
International) participated in a meeting with representatives of API.
The names and affiliations of the participants are included in
Attachment 1. The purpose of the meeting was to discuss the existing
source oil and gas information collection request (ICR). The following
topics were discussed.

Timing. API representatives requested an update on the timing of the
ICR. EPA representatives noted that public commenters provided good
rationale for extending the response deadlines but that no timing
decisions had been made.

Part 2 Sampling Approach. API representatives reiterated their public
comment recommendations to use the gas to oil ratio groupings and to
develop a separate “stripper well” (wells producing less than 15
barrel day of oil equivalence) category. They also recommended that the
EPA reduce the number of facilities sampled in the stripper well, dry
gas well, and coal bed methane (CBM) well categories because these well
types did not have much equipment at the well site and would be,
therefore, less variable.

Definition of Facility. API representatives stated that the proposed
definition of facility is too broad that the EPA should limit production
facilities to the well site (disturbed area around the well pad and
associated equipment in that area) and the “centralized production”
tank battery. API representatives presented a diagram of a production
area in California where approximately 10,000 heavy oil stripper wells
produced liquids to two centralized production areas. If a
“facility” was defined as all of the interconnected wells supplying
a centralized tank battery, this facility would have to report for
thousands of wells, creating undue burden for the respondent and highly
skewing the data set towards heavy oil stripper wells. While API
representatives noted that this was an extreme example, other facilities
exist where hundreds of wells produce to the same centralized tank
battery. API representatives stated that the recent source determination
rule is only applicable to new sources, so the “connected and
adjacent” provisions in the source determination rule are not really
applicable to existing facilities. API representatives noted that, in
the California site example, most of the wells were either permitted
separately or were “well head only” sites that did not require
permits. API representatives suggested that the definition of a facility
for production facilities be a well site and its associated production
area.

Economic Questions. EPA representatives noted that there were several
comments that suggested that the EPA collect economic data on the
operations of the well to inform the “remaining useful life” of the
well site. API representatives indicated that these types of questions
were reasonable but would likely be considered confidential business
information. They also noted that the question regarding the presence of
a flare could be wrongly interpreted to suggest controlling emissions
might be cost effective. First, with the current expansive definition of
facility, the flare may be miles away from a given source. Second, some
equipment, such as older tanks, might not be retrofit-able to a control
device and would have to be replaced if the emissions from the tank were
required to be controlled.

Liquids Unloading. API representatives suggested that the EPA drop or
limit questions regarding liquids unloading. According the API
representatives, liquids unloading is a technical issue related to well
production and not an emissions control issue. API representatives
stated that liquids unloading using artificial lift systems should not
be included in the ICR because they are not an emissions source and are
automated such that operators may not know specifically when liquids
unloading was being performed. The also noted that the type of liquids
unloading systems were highly dependent on well depth, well drilling
type (vertical versus directional), reservoir pressure and other issues.
API representatives noted that the EPA in the New Source Performance
Standards subpart OOOOa and State agencies have elected not to regulate
liquids unloading due to the technical issues, and they offered to
provide the EPA with a webinar that they had used previously for
describing the complexities of liquids unloading. API representatives
confirmed that liquids unloading could be an issue for dry gas and CBM
wells. The EPA representative expressed interest in learning more about
liquids unloading and recommended that API provide the suggested liquids
unloading webinar.

Attachment 1

Participants in August 31, 2016 EPA/API Meeting

API Representatives

Shankar Ananthakrishna, Chevron

Adam Bering, Encana

Rachel Buckbee, BP

Grover Campbell, Devon

Lisa Campbell, ERM

Jim Cooper, Chesapeake

Denise Grubert, ERM

Greg Johnston, Chesapeake

Tom Monahan, XTO

Dennis Newman, Oxy

Laura Perry, ConocoPhillips

Lynn Reed, ONEOK

Vanessa Ryan, Chevron

Matt Todd, API

John Wagner, APIAndy Woerner, ERM

Dana Wood, BP

Angela Zivkovich, Anadarko

U.S. EPA Representatives

David Cozzie

Amy Hambrick

Jodi Howard

Penny Lassiter

Karen Marsh

Bruce Moore

Brenda Shine

Lisa Thompson

Peter Tsirigotis

Matthew Witosky

Jonathan Witt

RTI International (EPA Contractor)

Jeff Coburn

 PAGE

 PAGE   2

  PAGE   \* MERGEFORMAT  3


[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Proposed Rules]
[Pages 1774-1776]
[FR Doc No: 2014-00169]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0164; Directorate Identifier 2013-NE-10-AD]
RIN 2120-AA64

Airworthiness Directives; Austro Engine GmbH Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede airworthiness directive (AD) 2013-14-
08 that applies to all Austro Engine GmbH model E4 engines. AD 2013-14-
08 requires removing from service certain part number (P/N) waste gate
controllers. Since we issued AD 2013-14-08 we received several reports
of power loss events due to fracture of the waste gate controller
lever. This proposed AD would require removing certain P/N waste gate
controllers from service. We are proposing this AD to prevent failure
of the waste gate controller lever, which could lead to damage to one
or more engines, loss of thrust control, and damage to the airplane.

DATES: We must receive comments on this proposed AD by March 11, 2014.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Austro
Engine GmbH, Rudolf-Diesel-Strasse 11, A-2700 Weiner Neustadt, Austria;
phone: +43 2622 23000; fax: +43 2622 23000-2711; Internet:
www.austroengine.at. You may

view this service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call 781-
238-7125.

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-2013-
0164; 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 mandatory continuing airworthiness
information, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Frederick Zink, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
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-2013-0164;
Directorate Identifier 2013-NE-10-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 because of 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

    On July 10, 2013, we issued AD 2013-14-08, Amendment 39-17513 (78
FR 42677, July 17, 2013), (``AD 2013-14-08''), for all Austro Engine
GmbH model E4 engines. AD 2013-14-08 requires removing from service
certain P/N waste gate controllers. AD 2013-14-08 resulted from several
reports of power loss events due to fracture of the waste gate
controller lever. We issued AD 2013-14-08 to prevent failure of the
waste gate controller lever, which could lead to damage to one or more
engines, loss of thrust control, and damage to the airplane.

Actions Since AD 2013-14-08 Was Issued

    Since we issued AD 2013-14-08, we received notification of
additional waste gate controller P/Ns that require removal from
service. Also since we issued AD 2013-14-08, the European Aviation
Safety Agency (EASA) has issued AD 2013-0213, dated September 13, 2013,
which requires removal and replacement of affected waste gate
controllers. We also changed the unsafe condition statement in AD 2013-
14-08 to clarify the relationship between the unsafe condition and the
engine.

Relevant Service Information

    We reviewed Austro Engine Mandatory Service Bulletin (MSB) No. MSB-
E4-007/6, Revision 6, dated September 18, 2013. The service information
describes procedures for removal and installation of the waste gate
controllers.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain all of the requirements of AD 2013-
14-08. This proposed AD would expand the applicability by adding
additional P/Ns of affected waste gate controllers.

Costs of Compliance

    We estimate that this proposed AD would affect 128 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 0.5 hours per engine to comply with this proposed AD. The
average labor rate is $85 per hour. Required parts cost about $231 per
engine. Based on these figures, we estimate the total cost of this
proposed AD to U.S. operators to be $35,008.

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 have 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 that the 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 to the extent
that it justifies making a regulatory distinction, 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 removing airworthiness directive (AD)
2013-14-08, Amendment 39-17513 (78 FR 42677, July 17, 2013), and adding
the following new AD:

Austro Engine GmbH Engines: Docket No. FAA-2013-0164; Directorate
Identifier 2013-NE-10-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by March 11,
2014.

(b) Affected ADs

    This AD supersedes AD 2013-14-08, Amendment 39-17513 (78 FR
42677, July 17, 2013).

(c) Applicability

    This AD applies to all Austro Engine GmbH model E4 engines, with
a waste gate controller, part number (P/N) E4A-41-120-000, Revision
060, or lower revision; or a waste gate controller, P/N E4B-41-120-
000, Revision 010, or lower revision, installed.

(d) Unsafe Condition

    This AD was prompted by engine power loss events due to fracture
of the waste gate controller lever. We are issuing this AD to
prevent failure of the waste gate controller lever, which could lead
to damage to one or more engines, loss of thrust control, and damage
to the airplane.

(e) Compliance

    (1) Comply with this AD within the compliance times specified,
unless already done.
    (2) At the next maintenance action for any reason, or within 110
flight hours after the effective date of this AD, or within three
months after the effective date of this AD, whichever occurs first,
remove from service waste gate controller, P/N E4A-41-120-000,
Revision 060, or lower revision, and waste gate controller, P/N E4B-
41-120-000, Revision 010 or lower revision.

(f) Installation Prohibition

    After the effective date of this AD, do not install any waste
gate controller, P/N E4A-41-120-000, Revision 060, or lower
revision, or waste gate controller, P/N E4B-41-120-000, Revision
010, or lower revision, onto any engine, nor approve for return to
service any engine that has either waste gate controller installed.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(h) Related Information

    (1) For more information about this AD, contact Frederick Zink,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2013-0213,
dated September 13, 2013, for more information. You may examine the
MCAI on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0164-0002.
    (3) Austro Engine Mandatory Service Bulletin No. MSB-E4-007/6,
Revision 6, dated September 18, 2013, which is not incorporated by
reference in this AD, can be obtained from Austro Engine GmbH, using
the contact information in paragraph (h)(4) of this AD.
    (4) For service information identified in this AD, contact
Austro Engine GmbH, Rudolf-Diesel-Strasse 11, A-2700 Weiner
Neustadt, Austria; phone: +43 2622 23000; fax: +43 2622 23000-2711;
Internet: www.austroengine.at.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on December 31, 2013.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-00169 Filed 1-9-14; 8:45 am]
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[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Notices]
[Page 51592-51593]
[DOCID:fr30au06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP05-119-002; CP05-121-002]

Cameron Interstate Pipeline, LLC; Notice of Amendment

August 22, 2006.
    Take notice that on August 4, 2006, with supplemental information
added on August 17, and August 21, 2006, Cameron Interstate Pipeline,
LLC (Cameron Interstate Pipeline), 101 Ash Street, San Diego, CA 92101,
filed in the above referenced docket(s), an abbreviated application to
amend its certificates of public convenience and necessity issued
pursuant to section 7(c) of the Natural Gas Act, and the Commission's
regulations, 18 CFR Parts 157 and 284. In Docket No. CP05-119-002
Cameron Interstate Pipeline is seeking to amend its certificate to
construct and operate its pipeline, and in Docket No. CP05-121-002 it
is seeking to amend its blanket certificate to transport natural gas.
    The application is on file with the Commission and open for public
inspection. This application is available for review at the Commission
in the Public Reference Room or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``eLibrary'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866)208-
3676, or for TTY, contact<PHONE_NUMBER>.
    Any questions regarding Cameron Interstate Pipeline's application
should be directed to: William D. Rapp, Senior Regulatory Counsel,
Sempra Energy, 101 Ash Street HQ 13, San Diego, CA 92101, phone (619)
699-5050, e-mail<EMAIL_ADDRESS>or Marty C. Swartz, Director of
Development, Sempra Pipelines & Storage, 101 Ash Street HQ 13, San
Diego, CA 92101, phone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
    Cameron Interstate requests authority to: (i) Increase the diameter
of the pipeline facilities previously authorized by the Commission from
36 inches to 42 inches, (ii) construct an additional 1.1 miles of 42
inch pipeline, (iii) construct the necessary facilities to establish
three additional pipeline interconnections, and (iv) revise its
transportation rates to reflect the increased costs of the additional
1.1 miles of pipeline and three new interconnections (about $ 9.8
million), and to allocate costs to interruptible transportation.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date listed below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of this filing and all subsequent filings made with
the Commission and must mail a copy of all filing to the applicant and
to every other party in the proceeding. Only parties to the proceeding
can ask for court review of Commission orders in the proceeding.
    However, other persons do not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party

to the proceeding. The Commission's rules require that persons filing
comments in opposition to this project provide copies of their protests
only to the party or parties directly involved in the protest.
    Persons who wish to comment only on the environmental review of
this project, or in support of or in opposition to this project, should
submit an original and two copies of their comments to the Secretary of
the Commission. Environmental commenters will be placed on the
Commission's environmental mailing list, will receive copies of the
environmental documents, and will be notified of meetings associated
with the Commission's environmental review process. Environmental
commenters will not be required to serve copies of filed documents on
all other parties. The Commission's rules require that persons filing
comments in opposition to the project provide copies of their protests
only to the applicant. However, the non-party commenters will not
receive copies of all documents filed by other parties or issued by the
Commission (except for the mailing of environmental documents issued by
the Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: September 13, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-14380 Filed 8-29-06; 8:45 am]

BILLING CODE 6717-01-P