[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Rules and Regulations]
[Page 28994]
[FR Doc No: 2017-12939]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 33

[Docket No. FAA-2014-0376; Notice No. 33-014-01-SC]

Special Conditions: SNECMA, Silvercrest-2 SC-2D; Rated 10-Minute
One Engine Inoperative Takeoff Thrust at High Ambient Temperature;
Withdrawal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions, withdrawal.

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SUMMARY: The FAA is withdrawing previously published special conditions
for the Silvercrest-2 SC-2D engine model. We are requesting the
withdrawal because the ``Rated 10-Minute One Engine Inoperative Takeoff
Thrust at High Ambient Temperature (Rated 10-Minute OEI TOTHAT) is not
needed.

DATES: As of June 27, 2017, the special conditions published on October
31, 2014 at 79 FR 64666, are withdrawn.

FOR FURTHER INFORMATION CONTACT: Tara Fitzgerald, ANE-112, Engine and
Propeller Directorate, Aircraft Certification Service, 1200 District
Avenue, Burlington, Massachusetts, 01803-5213; telephone (781) 238-
7130; facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On April 19, 2011, SNECMA, now known as Safran Aircraft Engines
(SAE) applied for a new type certificate for the Silvercrest-2 SC-2D
engine model. At that time, the Silvercrest-2 SC-2D engine model was to
have a novel or unusual design feature when compared to the state of
technology described in the airworthiness standards for aircraft
engines. The design feature included an additional takeoff rating for
the Silvercrest-2 SC-2D engine model, named ``Rated 10-Minute One
Engine Inoperative Takeoff Thrust at High Ambient Temperature'' (Rated
10-Minute OEI TOTHAT). It was intended to maintain the takeoff thrust
in certain high ambient temperature conditions for a maximum of 10
minutes with one engine inoperative (OEI).

Reason for Withdrawal

    The FAA is withdrawing Notice No. 33-014-01-SC because of concerns
raised over the sufficiency of the ``Rated 10-Minute OEI TOTHAT''
special condition to meet the Automatic Takeoff Thrust Control System
(ATTCS) design requirement specified in Title 14, Code of Federal
Regulations (14 CFR) part 25, section I25.5(b)(2).
    The proposed takeoff rating was for use during OEI events that
occur during takeoff in high ambient temperature conditions, up to 5
degrees Celsius hotter than the rated takeoff corner point. The
assumptions for this rating are no longer valid and the ``Rated 10-
Minute OEI TOTHAT'' is not needed.

Conclusion

    This withdrawal does not preclude the FAA from issuing another
notice on the subject matter in the future or committing the agency to
any future course of action.

    Issued in Burlington, Massachusetts, on June 13, 2017.
Carlos A. Pestana,
Acting Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2017-12939 Filed 6-26-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Rules and Regulations]
[Page 23321-23322]
[DOCID:fr30ap08-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29157; Airspace Docket 07-ASO-23]

Establishment and Removal of Class E Airspace; Centre, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Centre-Piedmont
Cherokee County Airport, (PYP), Centre, AL and removes Class E airspace
at Centre Municipal Airport, Centre, AL, (C22). The operating status of
the airport will include Instrument Flight Rule (IFR) operations.

DATES: Effective Date: 0901 UTC, June 5, 2008. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On January 29, 2008, the FAA proposed to amend Title 14 Code of
Federal Regulations (14 CFR) part 71 by establishing Class E airspace
at Centre, AL, (73 FR 5135). This action will provide adequate Class E
airspace for IFR operations at the new airport, Centre-Piedmont
Cherokee County Airport (PYP), supporting the Area Navigation (RNAV)
Global Positioning System (GPS) Standard Instrument Approach Procedures
(SIAPs) developed for Runways (RWY) 07-25. Airspace supporting Centre
Municipal Airport (C22) is no longer required and through this action
will be removed. Class E airspace designations for airspace areas
extending upward from 700 feet or more above the surface of the earth
are published in Paragraph 6005 of FAA Order 7400.9R, signed August 15,
2007, and effective September 15, 2007,

which is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    Interested parties were invited to participate in this proposed
rulemaking by submitting written comments on the proposal to the FAA.
No comments objecting to the proposal were received.

The Rule

    The amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace at Centre, AL, to provide
controlled airspace required to support the new Area Navigation (RNAV)
Global Positioning System (GPS) Rwy 07-25 at Centre-Piedmont Cherokee
County Airport (PYP) and remove the Class E airspace at Centre
Municipal Airport (C22), Centre, AL.
    FAA has determined that this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace at Centre, AL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, and effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

ASO AL E5 Centre, AL [REMOVE]

Centre Municipal Airport, AL
* * * * *

ASO AL E5 Centre, AL [NEW]

Centre-Piedmont Cherokee County Airport, AL
    (Lat. 34[deg]05'24'' N., long. 85[deg]36'36'' W.)

    That airspace extending upward from 700 feet above the surface
within a 13-mile radius of Centre-Piedmont Cherokee County Airport.
* * * * *

    Issued in College Park, Georgia, on April 8, 2008.
Kathy Swann,
Acting Manager, System Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E8-9039 Filed 4-29-08; 8:45 am]

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[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24723-24724]
[FR Doc No: 2012-9944]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0370]

AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New
Drug Application for IRESSA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by
AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O.
Box 8355, Wilmington, DE 19803-8355. AstraZeneca has voluntarily
requested that approval of this application be withdrawn, thereby
waiving its opportunity for a hearing.

DATES: Effective April 25, 2012.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA approved IRESSA (gefitinib) Tablets on
May 2, 2003, under the Agency's accelerated approval regulations, 21
CFR part 314, subpart H. IRESSA is indicated as monotherapy after
failure of both platinum-based and docetaxel chemotherapies for the
continued treatment of patients with locally advanced or metastatic
non-small cell lung cancer who are benefiting or have benefited from
IRESSA. On August 26, 2010, FDA requested that AstraZeneca voluntarily
withdraw IRESSA (gefitinib) Tablets from the market, because the
postmarketing studies required as a condition of approval under subpart
H failed to verify and confirm clinical benefit. In a letter dated
February 1, 2011, AstraZeneca requested that FDA withdraw approval of
NDA 21-399 for IRESSA (gefitinib) Tablets, which AstraZeneca
characterized as a business decision, effective September 30, 2011. In
that letter, AstraZeneca waived any opportunity for a hearing otherwise
provided under Sec. Sec.  314.150 and 314.530. The letter also stated
that approximately 250 patients then receiving IRESSA treatment through
the Iressa Access Program would continue treatment under an expanded
access program, but no new patients would be added to the protocol. In
FDA's letter of February 4, 2011, responding to AstraZeneca's

February 1, 2011, letter, the Agency acknowledged AstraZeneca's
agreement to permit FDA to withdraw approval of IRESSA under Sec.
314.150(d) and waive its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and
under authority delegated by the Commissioner to the Director, Center
for Drug Evaluation and Research, approval of NDA 21-399, and all
amendments and supplements thereto, is withdrawn (see DATES).
Distribution of this product in interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: April 5, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-9944 Filed 4-24-12; 8:45 am]
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[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 870-871]
[FR Doc No: 2019-00479]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84974; File No. BX-2018-025]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change To Make Permanent the Exchange's Retail Price Improvement
Program

December 26, 2018.
    On July 9, 2018, Nasdaq BX, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to make permanent
the Exchange's Retail Price Improvement Program. The proposed rule
change was published for comment in the Federal Register on July 26,
2018.\3\ On August 31, 2018, the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\4\ On October 23, 2018, the
Commission instituted proceedings under Section 19(b)(2)(B) of

the Act \5\ to determine whether to approve or disapprove the proposed
rule change.\6\ The Commission has received no comments on the
proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83681 (July 20,
2018), 83 FR 35516.
    \4\ See Securities Exchange Act Release No. 84013, 83 FR 45479
(September 7, 2018). The Commission designated October 24, 2018, as
the date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \5\ 15 U.S.C. 78(s)(b)(2)(B).
    \6\ See Securities Exchange Act Release No. 84472, 83 FR 54411
(October 29, 2018).
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    Section 19(b)(2) of the Act \7\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may, however, extend the period for issuing an order
approving or disapproving the proposed rule change by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for notice and comment in the Federal Register on
July 26, 2018.\8\ January 22, 2019 is 180 days from that date, and
March 23, 2019 is 240 days from that date. The Commission finds it
appropriate to designate a longer period within which to issue an order
approving or disapproving the proposed rule change so that it has
sufficient time to consider the proposed rule change.\9\
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    \7\ 15 U.S.C. 78s(b)(2).
    \8\ See supra note 3.
    \9\ The Commission notes that on December 11, 2018, the Exchange
filed a proposed rule change to extend the pilot period to June 30,
2019. See Securities Exchange Act Release No. 84847, 83 FR 66326
(December 26, 2018) (SR-BX-2018-063).
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    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\10\ designates March 23, 2019, as the date by which the Commission
shall approve or disapprove the proposed rule change (File No. SR-BX-
2018-025).
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    \10\ 15 U.S.C. 78s(b)(2).

    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)(31).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00479 Filed 1-30-19; 8:45 am]
 BILLING CODE 8011-01-P


The Role of Pyrethroids in Disease Vector Control.

Janet Hemingway, Director of the Liverpool School of Tropical Medicine
and CEO of the Bill and Melinda Gates funded Innovative Vector Control
Consortium.

Public health pesticides are often the poor relations of agrochemicals.
In contrast to the agrochemical insecticides, no new insecticides have
been registered for effective mainstream vector control activities for
the last 25 years. The number of insecticides has actually been reduced
over this period with the phasing out of the cyclodienes, and drastic
reductions in the numbers of organophosphates and carbamates being
produced and marketed for large scale vector control. The situation is
sufficiently grave that DDT has been retained purely for use in indoor
residual spraying in malaria control because options for insecticide
choice are so limited.

Pyrethroids are absolutely essential for disease vector control and any
restriction in their availability could have catastrophic consequences
for control of many of these deadly diseases. Malaria still kills up to
2 million children under the age of 5 every year. The bulk of these
deaths are in sub-Saharan Africa. Additional loss of income through
illness in adults has a major economic impact on many rural communities.
We have two interventions that have a proven impact on reducing disease
transmission – insecticide impregnated bednets and indoor residual
house spraying. Type I and type II pyrethroids are the major
insecticides used in both applications. A sub-set of pyrethroids are the
only insecticides recommended for use on impregnated nets. Their rapid
mode of action, safety for use in close human contact, contact irritancy
and long residual action in Long Lasting Insecticide net formulations
are essential characteristics for insecticides on nets. This combination
is found in no other insecticide class currently available for public
health use.

Indoor residual spraying (IRS) has more options but pyrethroids still
account for more than 70% of this growing market. The only other options
are DDT, organophosphates or a single carbamate. Pyrethroids in the
absence of operational levels of insecticide resistance are the
insecticide class of choice for IRS. The ability to use the second and
third generation pyrethroids at very low dosages make them almost as
cost effective as DDT and new formulations of pyrethroids with a 6 month
or better residual life should eventually allow us to remove that last
vestiges of reliance on DDT for IRS. Resistance to pyrethroids, because
of the different modes of action and metabolic susceptibilities of
different pyrethroids means that it is also possible to maintain the use
of these insecticides by careful insecticide selection when resistance
first arises. Any reduction in the numbers of type I and type II
pyrethroids in this market would be highly detrimental.

In addition to the use of nets and indoor spraying a number of new
pyrethroid formulations on different emanators are currently being
trialled in Mexico and other disease endemic countries. These utilise
the new pyrethroids which more readily vaporise to provide protection to
the residents of houses in which the emanators are placed. Early results
suggest that these should be an effective alternative to nets
particularly against earlier biting malaria vectors (such as Anopheles
culicifacies) and against the vectors of dengue (Aedes aegypti). Again
the characteristics of these insecticides mean that only the pyrethroids
are suitable for use in this format.

While malaria control activities are the major consumers of pyrethroids
it is clear that their large scale use for malaria also has significant
benefits in controlling other vector borne disease in many parts of the
world where these diseases co-exist. The benefits include control of
dengue, leishmaniasis and filariaisis. The global burden of these vector
borne diseases is summarised in table 1. Our ability to control these
diseases is crucially dependent on the availability of a range of
different pyrethroids with characteristics that can be matched to the
application and use setting. We would ask that the EPA consider the
major ramifications in terms of loss of human life and increase in
suffering that any reduction in availability of pyrethroids would cause
in the 100+ countries in which these diseases are endemic before any
global recommendations are made based on theoretical risk analysis in
non-disease endemic countries such as the USA.

Table 1: The current burden of vector borne diseases that are all
transmitted peridomestically (Source: WHO/TDR)

1 World-Wide Disability Adjusted Life Years

Disease	Vector	Disease Burden

DALYS1 (thousands)	Deaths

(thousands)

Malaria	Anopheles mosquitoes	42,280	1,724

Dengue	Aedes mosquitoes	     653	     21

Lymphatic filariasis	Anopheles and Culex mosquitoes	 5,644	      0

Leishmaniasis	Sandflies	 2,357	    59

Chagas disease	Triatomid bugs	    649	   13


[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Notices]
[Pages 4393-4394]
[FR Doc No: 2012-1839]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification
of Repair Stations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on November 22, 2011, vol. 76, no. 225, page 72240.
Information is collected from applicants who wish to obtain repair
station certification. Applicants must submit FAA form 8310-3 to the
appropriate FAA flight standards district office for review.

DATES: Written comments should be submitted by February 27, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0682.
    Title: Certification of Repair Stations.
    Form Numbers: FAA Form 8310-3.
    Type of Review: Renewal of an information collection.
    Background: Part 145 of Title 14, Code of Federal Regulations (14
CFR) prescribes the requirements for the issuance of repair station
certificates and associated ratings to maintenance and alteration
organizations. The information requested is required from applicants
who wish repair station certification. Applicants must submit the
required data to the appropriate FAA district office for review and
acceptance/approval. If the information is satisfactory, an onsite
inspection is conducted. When all the FAR Part 145 requirements have
been met an air agency certificate and repair station operations
specifications with appropriate ratings and limitations are issued.
    Respondents: Approximately 4,625 maintenance and alteration
organizations.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 8 hours.
    Estimated Total Annual Burden: 37,000 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)

ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on January 19, 2012.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2012-1839 Filed 1-26-12; 8:45 am]
BILLING CODE 4910-13-P