[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Page 12971]
[FR Doc No: 2011-5309]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0441]

Anastasios Pappas: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Anastasios Pappas, MD, for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on findings that Dr. Pappas was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. Dr. Pappas was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Dr. Pappas failed to respond. Dr. Pappas'
failure to respond constitutes a waiver of his right to a hearing
concerning this action.

DATES: This order is effective March 9, 2011.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of drug products under the
FD&C Act and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
    On April 4, 2006, Dr. Pappas pleaded guilty to a misdemeanor
offense of introducing and causing the introduction into interstate
commerce of a misbranded drug in violation of 21 U.S.C. 352(o), 331(a)
and 333(a)(1). On August 14, 2006, the U.S. district court for the
district of South Dakota, Southern Division, entered judgment against
Dr. Pappas for misdemeanor misbranding.
    FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: Dr. Pappas was a licensed dermatologist in
the state of South Dakota and a partner with Dakota Dermatology in
Sioux Falls, SD. Between August and November 2004, in the District of
South Dakota and elsewhere, Dr. Pappas placed three orders for a total
of six vials of botulinum toxin type A (TRI-toxin) from Toxin Research
International (TRI). Between September and November 2004, Dr. Pappas
administered TRI-toxin to patients. TRI was not duly registered with
FDA and, therefore, the TRI-toxin is deemed misbranded under 21 U.S.C.
352(o).
    As a result of his convictions, on November 16, 2010, FDA sent Dr.
Pappas a notice by certified mail proposing to debar him for 5 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Dr.
Pappas was convicted of a misdemeanor under Federal law for conduct
relating to the regulation of drug products under the FD&C Act, and the
conduct that served as a basis for the conviction undermines the
process for the regulation of drugs. The proposal also offered Dr.
Pappas an opportunity to request a hearing, providing him 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. Dr. Pappas failed to respond within the timeframe prescribed by
regulation and therefore has waived his opportunity for a hearing and
waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act,
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Anastasios Pappas has been convicted of a misdemeanor under
Federal law for conduct relating to the regulation of a drug product
under the FD&C Act and that the type of conduct that served as a basis
for the conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Dr. Pappas is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Dr. Pappas, in any capacity during Dr.
Pappas' debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Pappas
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment, he
will be subject to civil money penalties (section 307(a)(7) of the FD&C
Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Dr. Pappas during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Pappas for termination of debarment under
section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) should be
identified with Docket No. FDA-2010-N-0441 and sent to the Division of
Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-5309 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Notices]
[Page 70579-70580]
[DOCID:fr12de07-31]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. EL08-13-000]

Dynegy Moss Landing, LLC, Dynegy Morro Bay, LLC, El Segundo Power
LLC, and Reliant Energy, Inc., Complainants v. California Independent
System Operator Corporation, Respondents; Notice of Complaint

December 4, 2007.
    Take notice that on November 30, 2007, Dynegy Moss Landing, LLC,
Dynegy Morro Bay, LLC, El Segundo Power LLC, and Reliant Energy, Inc.
(Complainants), filed a formal complaint against the California
Independent System Operator Corporation (Respondent) pursuant to
sections 206 and 306 of the Federal Power Act, alleging that
Respondent's application of the must-offer compensation provisions
under its tariff commencing January 1, 2008, is unjust and unreasonable
and unduly discriminatory. The Complainants have requested fast track
processing.
    Complainants certify that copies of the complaint were served on
the contacts for Respondent as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 20, 2007.

 Kimberly D. Bose,
Secretary.
 [FR Doc. E7-24027 Filed 12-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62926-62928]
[FR Doc No: 2013-24658]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70665; File No. SR-BYX-2013-035]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of BATS Y-Exchange, Inc.

October 11, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 1, 2013, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii)

of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposed rule change effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the fee schedule applicable to
Members \5\ and non-members of the Exchange pursuant to BYX Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
---------------------------------------------------------------------------

    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to the
use of the Exchange effective October 1, 2013, in order to modify
pricing related to executions that occur on BATS Exchange, Inc.
(``BZX'') through the Exchange's Destination Specific Order routing
strategy.\6\ BZX is implementing certain pricing changes effective
October 1, 2013, including modification of the fee of $0.0029 per share
when removing liquidity to a fee of $0.0030 per share when removing
liquidity. To maintain a direct pass through of the applicable
economics of Destination Specific Order executions at BZX, the Exchange
proposes to charge $0.0030 per share for a Destination Specific Order
executed on BZX, rather than the $0.0029 per share that it currently
charges for such orders. The Exchange is not proposing any other
changes to its routing fees at this time.
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    \6\ As defined in BYX Rule 11.9(c)(12).
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2. Statutory Basis
    The [sic] Exchange believes that the proposed rule change is
consistent with the requirements of the Act and the rules and
regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6 of the
Act.\7\ Specifically, the Exchange believes that the proposed rule
change is consistent with Section 6(b)(4) of the Act,\8\ in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and other persons using any facility or
system which the Exchange operates or controls. The Exchange notes that
it operates in a highly competitive market in which market participants
can readily direct order flow to competing venues if they deem fee
structures at a particular venue to be unreasonable and/or excessive.
The Exchange believes that the proposed changes to the Exchange's
routing fee for Destination Specific Orders executed on BZX are
equitably allocated, fair and reasonable, and non-discriminatory in
that they are equally applicable to all Members and are designed to
mirror the fee applicable to the execution if such routed orders were
executed directly by the Member at BZX.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Because the market
for order execution is extremely competitive, Members may readily opt
to disfavor the Exchange's routing services if they believe that
alternatives offer them better value. For orders routed through the
Exchange and executed at BZX through the Destination Specific Order
strategy, the proposed fee change is designed to equal the fee that a
Member would have received if such routed orders would have been
executed directly by a Member at BZX.

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

    No written comments were solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and paragraph (f) of Rule 19b-4
thereunder.\10\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BYX-2013-035 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BYX-2013-035. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the

provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BYX-2013-035 and should be
submitted on or before November 12, 2013

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24658 Filed 10-21-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Proposed Rules]
[Pages 43738-43740]
[FR Doc No: 2012-18256]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0772; Directorate Identifier 2007-SW-053-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

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
Eurocopter France (Eurocopter) Model EC130 B4 helicopters with a cabin
vibration damper installed. This proposed AD is prompted by a crack and
failure of a cabin vibration damper

blade. The proposed actions are intended to modify the cabin vibration
damper assembly to prevent contact with the flight controls in the
event of a cabin vibration blade failure, jamming of a flight control,
and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by September 24,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments 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 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

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 this proposed AD, the economic
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 service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 Forum Drive Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.eurocopter.com. You may review copies of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aerospace Engineer, FAA,
Regulations and Policy Group, 2601 Meacham Blvd., Fort Worth, Texas
76137; telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2006-0278, dated September 7, 2006 (AD 2006-0278), to correct an
unsafe condition for Eurocopter Model EC130 B4 helicopters. EASA
advises of a cracked cabin vibration damper blade, which could lead to
jamming of a flight control.

FAA's Determination

    This helicopter model is manufactured in France and is type
certificated for operation in the United States under the provisions of
14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the
applicable bilateral agreement, EASA has kept the FAA informed of the
situation described above. The FAA has examined the findings of EASA,
reviewed all available information, and determined that AD action is
necessary for helicopters of this type design that are certificated for
operation in the United States.
    We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition is likely to exist
or develop on other helicopters of the same type design.

Related Service Information

    Eurocopter has issued Alert Service Bulletin (ASB) No. 53A008,
Revision 0, dated July 19, 2006 (ASB 53A008), which supersedes ASB No.
05A002, Revision 0, dated July 18, 2006, and specifies installing a
cabin vibration damper containment device. EASA classified ASB 53A008
as mandatory and issued AD 2006-0278 to ensure the continued
airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require, depending on the modification
status of the helicopter, complying with certain portions of ASB
53A008.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires two daily visual inspections for cracks in the
blade of each cabin vibration damper and replacement of a blade if
there is a crack; this proposed AD does not. The EASA AD requires
compliance by a calendar date. This proposed AD requires compliance
within 100 hours time-in-service.

Costs of Compliance

    We estimate that this proposed AD would affect 122 helicopters of
U.S. registry. We estimate that operators may incur the following costs
in order to comply with this AD.
     $340 for 4 work hours to install a vibration damper casing
assembly at an average labor rate of $85 per work hour,
     $1,500 for required parts per helicopter, and
     $224,480 total cost for the fleet.

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, 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 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.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

Eurocopter France: Docket No. FAA-2012-0772; Directorate Identifier
2007-SW-053-AD.

(a) Applicability

    This AD applies to Model EC130 B4 helicopters with a cabin
vibration damper installed, except those modified in accordance with
Modification 073565, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a cracked cabin
vibration damper blade. This condition could result in failure of
the blade, jamming of the flight controls, and subsequent loss of
control of the helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    Within the next 100 hours time-in-service:
    (1) For helicopters that have not been modified in accordance
with Modification 073521 or Modification 073525, install a vibration
damper casing assembly on both sides of the helicopter by following
paragraphs 2.B.2.a, and 2.B.5 of the Accomplishment Instructions of
Eurocopter Alert Service Bulletin (SB) No. 53A008, dated July 19,
2006 (ASB 53A008).
    (2) For helicopters that have been modified in accordance with
Modification 073521 either at the time of manufacture or pursuant to
Eurocopter SB No. 53-006, Revision 1, dated September 30, 2004; or
Modification 073525 either at the time of manufacture or pursuant to
Eurocopter SB No. 53-007, Revision 1, dated February 19, 2007,
install a vibration damper casing assembly on both sides of the
helicopter by following paragraphs 2.B.3.a, 2.B.3.b, and 2.B.5 of
the Accomplishment Instructions of ASB 53A008.

(e) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Rotorcraft Standards Staff, FAA, may approve
AMOCs for this AD. Send your proposal to Gary Roach, Aerospace
Engineer, FAA, 2601 Meacham Blvd., Fort Worth, Texas 76137;
telephone:<PHONE_NUMBER>, fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(f) Additional Information

    (1) Eurocopter Service Bulletin (SB) No. 53-006, Revision 1,
dated September 30, 2004; SB No. 53-007, Revision 1, dated February
19, 2007; and Alert SB No. 05A002, Revision 0, dated July 18, 2006,
which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this proposed AD, contact American Eurocopter
Corporation, 2701 Forum Drive, Grand Prairie, TX 75053-4005,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.eurocopter.com. You may review the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2006-0278, dated September 7, 2006.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 1810 Helicopter
Vibration Analysis.

    Issued in Fort Worth, Texas, on July 18, 2012.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-18256 Filed 7-25-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33717-33718]
[FR Doc No: 2021-13597]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0525]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Marketing; Administrative Procedures, Policies, and Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) 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: Submit written comments (including recommendations) on the
collection of information by July 26, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0435. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Prescription Drug Marketing; Administrative Procedures, Policies, and
Requirements--21 CFR Part 203

OMB Control Number 0910-0435--Extension

    This information collection supports FDA regulations codified at
part 203 (21 CFR part 203) implementing the Prescription Drug Marketing
Act of 1987 (PDMA) and the Prescription Drug Amendments of 1992. The
Federal Food, Drug, and Cosmetic Act, as amended by the PDMA,
establishes requirements for the following:
     Reimportation of prescription drugs.
     The sale, purchase, or trade of or the offer to sell,
purchase, or trade, prescription drugs that were purchased by hospitals
or health care entities or donated to charitable organizations.
     The distribution of prescription drug samples by mail,
common carrier, or another means of distribution.
     Applications for reimportation to provide emergency
medical care.
     An appeal from an adverse decision by the district office.
     Drug sample storage and handling.
     Fulfillment houses, shipping and mailing services,
comarketing agreements, and third-party recordkeeping.
     Donation of drug samples to charitable institutions.
    The PDMA was enacted, in part, because insufficient safeguards
existed over the drug distribution system to prevent the introduction
and retail sale of substandard, ineffective, or counterfeit drugs. The
PDMA is intended to ensure that drug products purchased by consumers
are safe and effective, and to avoid an unacceptable risk that
counterfeit, adulterated, misbranded, subpotent, or expired drugs are
sold.
    The applicable regulations in part 203 include reporting and
recordkeeping requirements intended to help achieve the following
goals: (1) To ban the reimportation of prescription drugs produced in
the United States, except when reimported by the manufacturer or under
FDA authorization for emergency medical care; (2) to ban the sale,
purchase, or trade, or the offer to sell, purchase, or trade, of any
prescription drug sample; (3) to limit the distribution of drug samples
to practitioners licensed or authorized to prescribe such drugs or to
pharmacies of hospitals or other healthcare entities at the request of
a licensed or authorized practitioner; (4) to require licensed or
authorized practitioners to request prescription drug samples in
writing; (5) to mandate storage, handling, and recordkeeping
requirements for prescription drug samples; and (6) to prohibit, with
certain exceptions, the sale, purchase, or trade, or the offer to sell,
purchase, or trade, of prescription drugs that were purchased by
hospitals or other healthcare entities or that were donated or supplied
at a reduced price to a charitable organization.
    In the Federal Register of March 12, 2021 (86 FR 14128), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR section; activity        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
203.11; reimportation                        1               1               1  0.5 (30 minutes)           \2\ 1
 applications.
203.37(a); falsification of                140            21.4           3,000  0.25 (15                     750
 records.                                                                        minutes).
203.37(b); loss or theft of                140          178.57          25,000  0.25 (15                   6,250
 samples.                                                                        minutes).
203.37(c); conviction of                     1               1               1  1...............               1
 representatives.
203.37(d); contact person.....              20               1              20  0.25 (15                       5
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............          28,022  ................           7,007
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest whole number.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
                                 Number of       records per      Total annual    Average burden
  21 CFR section; activity     recordkeepers     recordkeeper       records            per          Total hours
                                                     \2\                          recordkeeping
----------------------------------------------------------------------------------------------------------------
                                          Subpart C: Sales restrictions
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b); returns..            2,200          71.9909          158,380  0.25 (15                 39,595
                                                                                minutes).
----------------------------------------------------------------------------------------------------------------
203.23(c); documentation of             2,200          71.9909          158,380  0.08 (~6                 12,670
 storage of returns.                                                              minutes).
----------------------------------------------------------------------------------------------------------------
                                               Subpart D: Samples
----------------------------------------------------------------------------------------------------------------
203.30-203.39; documentation              140              202           28,280  ~.07-.08 (~4-5            2,121
 regarding sample                                                                 minutes).
 distributions.
                             -----------------------------------------------------------------------------------
    Total...................  ...............  ...............          345,040  ...............          54,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest whole number.

    Based on a review of Agency data, we assume 2,200 respondents may
incur burden resulting from the information collection activity
associated with the requirements in Sec.  203.23(a) through (c). A
total of 140 pharmaceutical companies have submitted information to the
Agency on drug sample distribution under part 203. Those same
respondents also have recordkeeping requirements under part 203. Our
estimate of the burden of the average burden per recordkeeping reflects
a cumulative average to cover all applicable requirements. Since our
last request for OMB approval, we have adjusted our estimate of the
overall burden downward to reflect a decrease of 2,567,713 hours and
64,432,232 records annually. We attribute this adjustment to a more
accurate reflection of the number of respondents to the information
collection and clarification that burden attributable to requirements
of the Drug Quality and Security Act are not included in this
information collection.

    Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13597 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Proposed Rules]
[Pages 45385-45387]
[FR Doc No: 2014-18465]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0522; Directorate Identifier 2014-NM-087-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-
200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR,
and 747SP series airplanes. This proposed AD was prompted by reports of
cracks at the lower forward corner of the main entry door (MED) 1
cutout. This proposed AD would require repetitive inspections of the
MED door 1 for cracking, and repair if necessary. This proposed AD also
provides optional terminating modification; and would require post-
repair or post-modification inspections for cracking, and corrective
actions if necessary. We are proposing this AD to detect and correct
skin cracking, which can become large and could adversely affect the
structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by September 19,
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 proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.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>.

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-2014-
0522; 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
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Nathan Weigand, Aerospace Engineer,
Airframe Branch, ANM-120S, Seattle Aircraft Certification Office (ACO),
FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; 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 proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0522;
Directorate Identifier 2014-NM-087-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

    We have received reports of cracks at the lower forward corner of
the MED 1 cutout on two airplanes. A 1.0-inch crack in the skin and
bearstrap was found on an airplane with 17,605 total flight cycles. A
5.0-inch crack was found in the skin, skin doubler, and bearstrap on an
airplane with 21,759 total flight cycles. In addition, four cracks
between 0.18- and 1.85-inch were found on Boeing's fatigue test
airplane

between 40,000 and 52,250 total pressure cycles. The manufacturer's
analysis has determined that the cracking initiates in the skin and can
propagate into the bonded doubler and bearstrap. Skin cracks that are
not found and repaired can become large and could adversely affect the
structural integrity of the airplane.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 747-53A2863, dated March
11, 2014. For information on the procedures and compliance times, see
this service information at http://www.regulations.gov by searching for
Docket No. FAA-2014-0522.

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 these same type
designs.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the Service
Information.''
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' correct or address any condition found.
Corrective actions in an AD could include, for example, repairs.

Differences Between This Proposed AD and the Service Information

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 165 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                      Labor cost          Parts cost    Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection (per door)...........  11 work-hours x $85 per            $0  $935 per inspection  $154,275 per
                                   hour = $935 per                        cycle.               inspection cycle.
                                   inspection cycle.
Optional modification (per door)  Up to 66 work[dash]hours            0  Up to $5,610.......  Up to $925,650.
                                   x $85 per hour = $5,610.
Post-repair or -modification      11 work-hours x $85 per             0  $935 per inspection  $154,275 per
 inspection (per door).            hour = $935 per                        cycle.               inspection cycle.
                                   inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repair 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 this
repair:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                         Labor cost                Parts cost           Cost per product
----------------------------------------------------------------------------------------------------------------
Repair (per door)..................  66 work-hours x $85 per      $7,380 or $9,360......  $12,990 or $14,970.
                                      hour = $5,610.
----------------------------------------------------------------------------------------------------------------

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. Amend Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2014-0522; Directorate Identifier
2014-NM-087-AD.

(a) Comments Due Date

    We must receive comments by September 19, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, 747SR, and 747SP series airplanes, certificated
in any category, as identified in Boeing Alert Service Bulletin 747-
53A2863, dated March 11, 2014.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports of cracks at the lower forward
corner of the main entry door (MED) 1 cutout. We are issuing this AD
to detect and correct skin cracking, which can become large and
could adversely affect the structural integrity of the airplane.

(f) Compliance

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

(g) Repetitive Inspections and Corrective Actions

    Except as specified in paragraph (j)(1) of this AD, at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 747-53A2863, dated March 11, 2014: Do
a detailed inspection and a surface high frequency eddy current
inspection for cracking of the applicable main entry door 1; and do
all applicable corrective actions; in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2863, dated March 11, 2014. Do all applicable corrective actions
before further flight. Repeat the inspections of the applicable main
entry door 1 thereafter at the intervals specified in paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 747-53A2863,
dated March 11, 2014. Accomplishing the corrective actions required
by this paragraph terminates the repetitive inspection requirements
of this paragraph.

(h) Optional Terminating Action

    For airplanes on which no crack is found during the initial
inspections required by paragraph (g) of this AD: Installing the
preventive modification in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2863, dated
March 11, 2014, terminates the repetitive inspections required by
paragraph (g) of this AD.

(i) Post-Repair or Post-Modification Repetitive Inspections and
Corrective Actions

    For airplanes on which the corrective actions required by
paragraph (g) of this AD have been done, or airplanes that have
installed the preventive modification specified in paragraph (h) of
this AD: At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-53A2863, dated
March 11, 2014, do a detailed inspection for cracking of the
applicable main entry door 1; and do all applicable corrective
actions; in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2863, dated March 11, 2014,
except as specified in paragraph (j)(2) of this AD. Do all
applicable corrective actions before further flight. Repeat the
inspection of the applicable main entry door 1 thereafter at the
intervals specified in paragraph 1.E., ``Compliance,'' of Boeing
Alert Service Bulletin 747-53A2863, dated March 11, 2014.

(j) Exceptions to Service Information

    (1) Where paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 747-53A2863, dated March 11, 2014, specifies a
compliance time ``after the Original issue date of this service
bulletin,'' this AD requires compliance within the specified
compliance time after the effective date of this AD.
    (2) If any cracking is found during any inspection required by
this AD, and Boeing Alert Service Bulletin 747-53A2863, dated March
11, 2014, specifies to contact Boeing for appropriate action: Before
further flight, repair the cracking using a method approved in
accordance with the procedures specified in paragraph (k) of this
AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (l)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane.

(l) Related Information

    (1) For more information about this AD, contact Nathan Weigand,
Aerospace Engineer, Airframe Branch, ANM-120S, Seattle Aircraft
Certification Office (ACO), FAA, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.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 July 25, 2014.
Ross Landes,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-18465 Filed 8-4-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 7007-7009]
[FR Doc No: 2015-02513]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-B-1467]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Mitigation reconsider the changes. The flood hazard
determination information may be changed during the 90-day period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each

community is available for inspection at both the online location and
the respective community map repository address listed in the table
below. Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 16, 2015.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map        Effective date of     Community
                                          No.               community          repository             revision             modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mississippi:
    Harrison....................  City of Gulfport     Mr. Marshall        Department of       http://                Mar. 30, 2015........       285253
                                   (14-04-8258P).       Pemberton,          Urban               www.msc.fema.gov/
                                                        Mississippi State   Development,        lomc.
                                                        Floodplain          Building Code
                                                        Administrator,      Services, 2200
                                                        P.O. Box 267,       15th Street,
                                                        Jackson, MS 39205.  Trailer B5,
                                                                            Gulfport, MS
                                                                            39501.
    Harrison....................  Unincorporated       Mr. Marshall        Harrison County     http://                Mar. 30, 2015........       285255
                                   areas of Harrison    Pemberton,          Code Office,        www.msc.fema.gov/
                                   County(14-04-8258P   Mississippi State   15309 Community     lomc.
                                   ).                   Floodplain          Road, Gulfport,
                                                        Administrator,      MS 39503.
                                                        P.O. Box 267,
                                                        Jackson, MS 39205.
Oklahoma:
    Cleveland...................  City of Moore (14-   Mr. Stephen O.      City Hall, 301      http://                Apr. 2, 2015.........       400044
                                   06-2112P).           Eddy, Manager,      North Broadway      www.msc.fema.gov/
                                                        City of Moore,      Street, Moore, OK   lomc.
                                                        301 North           73160.
                                                        Broadway Street,
                                                        Moore, OK 73160.
Pennsylvania:
    Montgomery..................  Borough of Ambler    The Honorable       Borough Hall, 122   http://                Apr. 3, 2015.........       420947
                                   (14-03-0829P).       Jeanne Sorg,        East Butler         www.msc.fema.gov/
                                                        Mayor, Borough of   Avenue, Ambler,     lomc.
                                                        Ambler, 122 East    PA 19002.
                                                        Butler Avenue,
                                                        Ambler, PA 19002.
Texas:
    Collin......................  City of Plano (14-   The Honorable       Department of       http://                Mar. 20, 2015........       480140
                                   06-0359P).           Harry               Engineering, 1520   www.msc.fema.gov/
                                                        LaRosiliere,        K Avenue, Plano,    lomc.
                                                        Mayor, City of      TX 75074.
                                                        Plano, 1520 K
                                                        Avenue, Plano, TX
                                                        75074.
    Dallas and Denton...........  City of Coppell (14- The Honorable       Engineering         http://                Mar. 19, 2015........       480170
                                   06-2759P).           Karen Hunt,         Department, 265     www.msc.fema.gov/
                                                        Mayor, City of      Parkway             lomc.
                                                        Coppell, P.O. Box   Boulevard,
                                                        9478, Coppell, TX   Coppell, TX 75019.
                                                        75019.
    Denton......................  Town of Northlake    The Honorable       Town Hall, 1400 FM  http://                Apr. 8, 2015.........       480782
                                   (14-06-3449P).       Peter Dewing,       407, Northlake,     www.msc.fema.gov/
                                                        Mayor, Town of      TX 76247.           lomc.
                                                        Northlake, 1400
                                                        FM 407,
                                                        Northlake, TX
                                                        76247.
    Denton......................  Unincorporated       The Honorable Mary  Denton County       http://                Apr. 9, 2015.........       480774
                                   areas of Denton      Horn, Denton        Government          www.msc.fema.gov/
                                   County (14-06-       County Judge, 110   Center, 1505 East   lomc.
                                   2427P).              West Hickory        McKinney Street,
                                                        Street, 2nd         Suite 175,
                                                        Floor, Denton, TX   Denton, TX 76209.
                                                        76201.

    Denton......................  Unincorporated       The Honorable Mary  Denton County       http://                Apr. 8, 2015.........       480774
                                   areas of Denton      Horn, Denton        Government          www.msc.fema.gov/
                                   County (14-06-       County Judge, 110   Center, 1505 East   lomc.
                                   3449P).              West Hickory        McKinney Street,
                                                        Street, 2nd         Suite 175,
                                                        Floor, Denton, TX   Denton, TX 76209.
                                                        76201.
    Ellis.......................  City of Midlothian   The Honorable Bill  City Hall, 104      http://                Mar. 5, 2015.........       480801
                                   (14-06-1375P).       Houston, Mayor,     West Avenue E,      www.msc.fema.gov/
                                                        City of             Midlothian, TX      lomc.
                                                        Midlothian, 104     76065.
                                                        West Avenue E,
                                                        Midlothian, TX
                                                        76065.
    Gonzales....................  City of Gonzales     The Honorable       820 St. Joseph      http://                Mar. 25, 2015........       480254
                                   (14-06-1672P).       Robert A. Logan,    Street, Gonzales,   www.msc.fema.gov/
                                                        Mayor, City of      TX 78629.           lomc.
                                                        Gonzales, 820 St.
                                                        Joseph Street,
                                                        Gonzales, TX
                                                        78629.
    Hays........................  Unincorporated       The Honorable Bert  Hays County         http://                Mar. 30, 2015........       480321
                                   areas of Hays        Cobb, MD, Hays      Development         www.msc.fema.gov/
                                   County (14-06-       County Judge, 111   Services            lomc.
                                   2877P).              East San Antonio    Department, 2171
                                                        Street, Suite       Yarrington Road,
                                                        300, San Marcos,    San Marcos, TX
                                                        TX 78666.           78667.
    Tarrant.....................  City of Bedford (14- The Honorable Jim   Public Works        http://                Mar. 19, 2015........       480585
                                   06-2009P).           Griffin, Mayor,     Department, 1813    www.msc.fema.gov/
                                                        City of Bedford,    Reliance Parkway,   lomc.
                                                        2000 Forest Ridge   Bedford, TX 76021.
                                                        Drive, Bedford,
                                                        TX 76021.
    Tarrant.....................  City of Fort Worth   The Honorable       Department of       http://                Mar. 6, 2015.........       480596
                                   (14-06-2425P).       Betsy Price,        Transportation      www.msc.fema.gov/
                                                        Mayor, City of      and Public Works,   lomc.
                                                        Fort Worth, 1000    1000 Throckmorton
                                                        Throckmorton        Street, Fort
                                                        Street, Fort        Worth, TX 76102.
                                                        Worth, TX 76102.
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[FR Doc. 2015-02513 Filed 2-6-15; 8:45 am]
BILLING CODE 9110-12-P