[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Page 82031]
[FR Doc No: 2011-33353]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Commercial Space Transportation Advisory Committee; Public
Teleconference

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Commercial Space Transportation Advisory Committee
Risk Management Working Group Teleconference.

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SUMMARY: Pursuant to Section 10(a)(2) of the Federal Advisory Committee
Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of a
teleconference of the Commercial Space Transportation Advisory
Committee (COMSTAC) Risk Management Working Group. The teleconference
will take place on Tuesday, January 24, 2012, starting at 1:30 p.m.
Eastern Standard Time. Individuals who plan to participate should
contact Susan Lender, Designated Federal Officer (DFO), (the Contact
Person listed below) by phone or email for the teleconference call in
number. The National Aeronautics and Space Administration (NASA) and
the FAA Office of Commercial Space Transportation (AST) have agreed to
prepare a study on the availability of commercial insurance sufficient
to meet the needs of NASA's Commercial Crew Program commercial
providers for missions transporting NASA astronauts to and from the
International Space Station. NASA's Commercial Crew Program requested
this study (via a signed memorandum of understanding with the FAA AST)
be conducted by AST because of its knowledge and resources in the
commercial space industry.
    The purpose of the teleconference is to:
    1. Brief the COMSTAC Risk Management Working Group on the study,
    2. Request assistance from the working group in preparing a
response to NASA, and
    3. Respond to any questions from the working group on the nature of
this task.
    Interested members of the public may submit relevant written
statements for the COMSTAC members to consider under the advisory
process. Statements may concern the issues mentioned above or
additional issues that may be relevant for the U.S. commercial space
transportation industry. Interested parties wishing to submit written
statements should contact Susan Lender, DFO, (the Contact Person listed
below) in writing (mail or email) by January 17, 2012, so that the
information can be made available to COMSTAC members for their review
and consideration before the January 24, 2012, teleconference. Written
statements should be supplied in the following formats: one hard copy
with original signature or one electronic copy via email.
    This notice will be posted on the FAA Web site at http://www.faa.gov/go/ast.
    Individuals who plan to participate and need special assistance
should inform the Contact Person listed below in advance of the
meeting.

FOR FURTHER INFORMATION CONTACT: Susan Lender (AST-5), Office of
Commercial Space Transportation (AST), 800 Independence Avenue SW.,
Room 331, Washington, DC 20591, telephone<PHONE_NUMBER>; Email
<EMAIL_ADDRESS>Complete information regarding COMSTAC is
available on the FAA Web site at: http://www.faa.gov/about/office_org/headquarters_offices/ast/advisory_committee/.

    Issued in Washington, DC.
 George C. Nield,
Associate Administrator for Commercial Space Transportation.
[FR Doc. 2011-33353 Filed 12-28-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6648-6650]
[FR Doc No: 2011-2570]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63811; File No. SR-OCC-2011-02]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change To Accommodate the Clearance
of Relative Performance Options

February 1, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on January 19, 2011, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared primarily by OCC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change would accommodate the clearance of options
on certain indexes measuring the relative performance of one reference

security or reference index relative to a second reference security or
reference index.

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by OCC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of this rule change is to accommodate the clearance of
options on certain indexes measuring the relative performance of one
reference security or reference index relative to a second reference
security or reference index (``Relative Performance Options''). A
reference security may be an exchange-traded fund (``ETF''). The
revised rules have been broadly drafted to cover Alpha Options
(described below) and any similar product that may be listed on any
participant exchange in the future.
    NASDAQ OMX PHLX LLC (``Phlx'') is proposing to list options
(``Alpha Options'') \4\ on NASDAQ OMX Alpha Indexes (``Alpha
Indexes''), a family of indexes developed by NASDAQ OMX Group, Inc.
(``Nasdaq''). Alpha Indexes are calculated based on two ETFs or other
reference securities underlying options that are also traded on Phlx.
For example, an Alpha Index may measure the relative total return of
two non-ETF securities, two ETFs, or one ETF and one non-ETF security
(the first component of each pair is referred to as the ``Target
Component,'' and the second component is referred to as the ``Benchmark
Component''). The Alpha Index is calculated by measuring the total
return performance of the Target Component relative to the total return
performance of the Benchmark Component based upon prices of
transactions on the primary listing exchange of each underlying
component. Each Alpha Index will initially be set at 100.00. Alpha
Options will be cash-settled, European-style options. In the event of a
corporate event that eliminates one of the underlying components of an
Alpha Index, Nasdaq will cease calculation of the Alpha Index for that
pair of underlying components, and all outstanding option positions
will be immediately settled at the last disseminated price of that
Alpha Index.
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    \4\ See SR-Phlx-2010-176, Release No. 34-63575, December 17,
2010.
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    Relative Performance Options are highly similar to other index
options cleared by OCC except for the identity and nature of the
underlying index. Therefore, OCC believes that the provisions of its
By-Laws and Rules governing index options, as they are currently in
effect, are generally sufficient to support the clearance and
settlement of Relative Performance Options. However, minor
modifications are needed to support Alpha Options and other types of
Relative Performance Options that may be introduced in the future. For
example, OCC's current Rules do not account for the possibility of an
index having a negative value as could occur for certain Relative
Performance Indexes. If this should ever occur, the index value would
be deemed to be equal to zero or, because certain systems may not
accept a zero index value, a near-zero positive amount. Therefore, OCC
proposes to modify its By-Laws to provide for such potential adjustment
of the index value by either the listing exchange or OCC.
    In addition, OCC's current By-Laws do not account for the
possibility that an expiration date may be accelerated when a reference
security (i.e., an individual reference security and not a reference
index) that is one of the components of an underlying relative
performance index ceases to be published as a result of a cash-out
merger or similar corporate event. If the value of an underlying
Relative Performance Index ceases to be published as a result of such
an event, the value of the overlying options would become fixed. OCC
therefore proposes to modify its By-Laws to provide that OCC will
either accelerate or not accelerate the expiration in consultation with
the relevant exchange on which the index underlying a Relative
Performance Option is listed.
    OCC believes the proposed rule change is consistent with the
requirements of Section 17A of the Act \5\ because it is designed to
promote the prompt and accurate clearance and settlement of
transactions in, including the expiry of, Relative Performance Options,
and to foster cooperation and coordination with persons engaged in the
clearance and settlement of such transactions, to remove impediments to
and perfect the mechanism of a national system for the prompt and
accurate clearance and settlement of such transactions, and, in
general, to protect investors and the public interest. The proposed
rule change accomplishes this purpose by applying substantially the
same rules and procedures to these transactions as OCC applies to
transactions in other index options. The proposed rule change is not
inconsistent with the existing rules of OCC, including any rules
proposed to be amended.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. OCC will notify the Commission of any written
comments received by OCC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

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 Commissions Internet comment form (http://www.sec.gov/rules/sro.shtml) or
    Send an e-mail to<EMAIL_ADDRESS>Please include File Number
SR-OCC-2011-02 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-OCC-2011-02. This file
number should be included on the subject line if e-mail 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 Section, 100 F Street,
NE., Washington, DC 20549-1090, on official business days between the
hours of 10 a.m. and 3 p.m. Copies of such filings will also be
available for inspection and copying at the principal office of OCC and
on OCC's Web site at http://www.optionsclearing.com/components/docs/legal/rules_and_bylaws/sr_occ_11_02.pdf.
    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-OCC-2011-02
and should be submitted on or before February 22, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-2570 Filed 2-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Notices]
[Page 78159]
[FR Doc No: 2020-26603]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-1130; Notice of Availability Docket No. 20-ANE-6]

Notice of Availability of Categorical Exclusion and Record of
Decision (CATEX/ROD) for Boston Harbor Seaplane Operations, MA

AGENCY: Federal Aviation Administration, (FAA), DOT.

ACTION: Notice of availability.

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SUMMARY: The FAA, Eastern Service Center is issuing this notice to
advise the public of the availability of the Categorical Exclusion/
Record of Decision (CATEX/ROD) for the Boston Harbor Seaplane
Operations. The FAA reviewed the action and determined it to be
categorically excluded from further environmental review.

FOR FURTHER INFORMATION CONTACT: Mr. Andrew Pieroni, Federal Aviation
Administration, Operations Support Group, Eastern Service Center, 1701
Columbia Avenue, College Park, Georgia 30337,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Aviation Administration (FAA)
proposes to implement a Letter of Agreement (LOA) between Boston
Airport Traffic Control Tower (BOS ATCT), Boston Consolidated Terminal
Radar Approach Control (A90) and Tailwind Air Service for seaplane
operations in the Boston, Massachusetts Inner Harbor. This proposed LOA
would ensure standardized, safe and de-conflicted seaplane operations
in the Boston, Massachusetts Inner Harbor from BOS ATCT operations and
allows for efficient airspace operations in the General Edward Lawrence
Logan International Airport (BOS) Class B airspace. The proposed VFR
handling of seaplane arrivals and departures will enhance safety and
minimize delays for aircraft at BOS. The FAA reviewed the action and
determined it to be categorically excluded from further environmental
review according to FAA Order 1050.1F, Environmental Impacts: Policies
and Procedures. The applicable categorical exclusion is Sec.  5-
6.S(i.).

    Issued in College Park, Georgia, on November 24, 2020.
Andrew Pieroni,
Environmental Protection Specialist, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
[FR Doc. 2020-26603 Filed 12-2-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 114 (Thursday, June 13, 2013)]
[Notices]
[Pages 35630-35631]
[FR Doc No: 2013-14058]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR13-16-000]

Crosstex Processing Services, LLC; Notice of Petition for
Temporary Waiver of Filing and Reporting Requirements

    Take notice that on March 28, 2013, pursuant to Rule 204 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.204 (2012),
Crosstex Processing Services, LLC filed a petition requesting that the
Commission grant a temporary waiver of the tariff filing and reporting
requirements of sections 6 and 20 of the Interstate Commerce Act and
parts 341 and 357 of the Commission's regulations, with respect to
certain segments of the Cajun-Sibon pipeline system, as more
particularly described in the petition.

    Any person desiring to intervene or to protest in this proceedings
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Anyone filing a motion to intervene or protest must
serve a copy of that document on the Applicant. In reference to filings
initiating a new proceeding, interventions or protests submitted on or
before the comment deadline need not be served on persons other than
the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on June 19, 2013.

    Dated: June 7, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-14058 Filed 6-12-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Proposed Rules]
[Pages 76330-76333]
[FR Doc No: 2011-31425]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1342; Directorate Identifier 2011-CE-038-AD]
RIN 2120-AA64

Airworthiness Directives; DG Flugzeugbau GmbH Sailplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for DG

Flugzeugbau GmbH Models DG-500 Elan Orion sailplanes and DG-500M and
DG-500MB powered sailplanes. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as incorrect re-installation of the rear cockpit securing
rope for the headrest of the rear seat during maintenance, which could
cause the rear seat to interfere with the control stick of the
sailplane. We are issuing this proposed AD to require actions to
correct the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by January 23,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact DG
Flugzeugbau GmbH, Otto-Lilienthal-Weg 2, 76646 Bruchsal, Federal
Republic of Germany; telephone: +49 (0) 7251 3020140; fax: +49 (0) 7251
3020149; Internet: http://www.dg-flugzeugbau.de/tech-mitteilungen-e.html; email<EMAIL_ADDRESS>You may review copies of the
referenced service information at the FAA, Small Airplane Directorate,
901 Locust, Kansas City, Missouri 64106. 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; 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 (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-1342;
Directorate Identifier 2011-CE-038-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://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No.: 2011-0191, dated September 30, 2011 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Several occurrences have been reported of incorrect re-
installation of rear cockpit securing rope for the headrest of the
rear seat during maintenance. In one of these occurrences, the
aeroplane suffered an accident. The technical investigations
following this accident have revealed that the rear cockpit headrest
securing rope was too long, which caused the rear seat to interfere
with the control stick of the aeroplane.
    This condition if not detected and corrected, could lead to loss
of control of the aeroplane.
    To address this unsafe condition, DG Flugzeugbau have developed
a modification to be accomplished in accordance with the Working
Instruction No. 1 for Technical Note (TN) 348/20 in issue 3, dated
13 September 2011, for the English language version and in issue 2,
dated 22 October 2008, for the German language version (English
version revised at issue 3 to correct a translation discrepancy),
which aims to prevent wrong re-installation of the headrest securing
rope. TN 500/05 embodies this Working Instruction.
    For the reasons described above, this AD requires a one-time
inspection of the length of the rear cockpit headrest securing rope
and, in case of discrepancy, readjustment of the length. In
addition, this AD requires the installation of a modified headrest
securing rope with snap hook.

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

Relevant Service Information

    DG Flugzeugbau GmbH has issued Technical Note No. 500/05, dated
September 19, 2011, and Working Instruction No. 1 for TN348/20, Issue
3, dated September 13, 2011. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the Proposed AD

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

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 14 products of U.S.
registry. We also estimate that it would take about 2.5 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $1,088 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S.

operators to be $18,207 or $1,300.50 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 0.5 work-hour, for a cost of $42.50 per product. We have no
way of determining the number of products that may need these actions.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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

    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 AD:

DG Flugzeugbau GmbH: Docket No. FAA-2011-1342; Directorate
Identifier 2011-CE-038-AD.

(a) Comments Due Date

    We must receive comments by January 23, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to DG Flugzeugbau GmbH Models DG-500 Elan Orion
sailplanes and DG-500M and DG-500MB powered sailplanes, all serial
numbers, that are:
    (i) Equipped with a headrest on the rear seat; and
    (ii) certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 25: Equipment/
Furnishing.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as incorrect re-
installation of the rear cockpit securing rope for the headrest of
the rear seat during maintenance. We are issuing this AD to correct
the length of the rear cockpit headrest securing rope, which if too
long, could cause the rear seat to interfere with the control stick
of the sailplane and could result in loss of control of the
sailplane.

(f) Actions and Compliance

    Unless already done, do the following actions:
    (1) Within the next 30 days after the effective date of this AD,
inspect the rear cockpit headrest securing rope to determine the
length. Do the inspection as specified in Instruction No. 2 of DG
Flugzeugbau GmbH Technical Note No. 500/05, dated September 19,
2011.
    (i) If the length of the rear cockpit headrest securing rope is
more than 450 millimeters (mm) or less than 400 mm, before further
flight, adjust the length of the rear cockpit headrest securing rope
to a length between 400 mm and 450 mm as shown in Sketch 2 of DG
Flugzeugbau GmbH Working Instruction No. 1 for TN348/20, Issue 3,
dated September 13, 2011. After doing the adjustment, do the action
required in paragraph (f)(2) of this AD.
    (ii) If the length of the rear cockpit headrest securing rope is
between 400 mm and 450 mm, do the action required in paragraph
(f)(2) of this AD.
    (2) Within 3 months after the effective date of this AD, replace
the rear cockpit headrest securing rope with a rear cockpit headrest
securing rope with a snap hook. Do the replacement following DG
Flugzeugbau GmbH Working Instruction No. 1 for TN348/20, Issue 3,
dated September 13, 2011, as specified in Instruction No. 3 of DG
Flugzeugbau GmbH Technical Note No. 500/05, dated September 19,
2011.
    (3) Replacement of the rear cockpit headrest securing rope with
a rear cockpit headrest securing rope with a snap hook done before
the effective date of this AD following DG Flugzeugbau GmbH Working
Instruction No. 1 for TN348/20, Issue 2, is considered acceptable
for compliance with paragraph (f)(2) of this AD.

(g) FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: No differences.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to Attn: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
sailplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(i) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2011-0191, dated September 30, 2011; DG Flugzeugbau GmbH Technical
Note No. 500/05, dated September 19, 2011; and DG Flugzeugbau GmbH
Working Instruction No. 1 for TN348/20, Issue 3, dated September 13,
2011, for related information. For service information related to
this AD, contact DG Flugzeugbau GmbH, Otto-Lilienthal-Weg 2, 76646
Bruchsal, Federal Republic of Germany; telephone: +49 (0) 7251
3020140; fax: +49 (0) 7251 3020149; Internet: http://www.dg-flugzeugbau.de/tech-mitteilungen-e.html; email<EMAIL_ADDRESS>You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on December 1, 2011.
John Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2011-31425 Filed 12-6-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]
[Page 52392-52393]
[DOCID:fr25au10-126]

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

DEPARTMENT OF TRANSPORTATION

Pipeline And Hazardous Materials Safety Administration

Office Of Hazardous Materials Safety; Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before September 24, 2010.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue, SE., Washington, DC, or at http://
regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on August 19, 2010.
Donald Burger,
Chief Special Permits and Approvals Branch.

                                               New Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                   Regulation(s)       Nature of special permits
    Application No.       Docket No.          Applicant               affected                  thereof
----------------------------------------------------------------------------------------------------------------
15088-N...............  ..............  Burlington Containers  49 CFR 173.226         To authorize the
                                         Brooklyn, NY.          173.227.               transportation in
                                                                                commerce of certain
                                                                                materials toxic by
                                                                                inhalation, Hazard Zone A
                                                                                and B, in
                                                                                alternative packaging
                                                                                by motor vehicle
                                                                                (mode 1).
15092-N...............  ..............  Tatonduk Outfitters    49 CFR 173.302(f)(3)   To authorize the
                                         Limited dbaEverts      and (f)(4) and        transportation in
                                         Air Alaska             173.304(f)(3) and     commerce of cylinders
                                         Fairbanks, AK.         (f)(4).               containing oxidizing
                                                                                gases without a rigid
                                                                                outer packaging
                                                                                capable of passing the
                                                                                Flame Penetration and
                                                                                Resistance Test and
                                                                                the Thermal Resistance
                                                                                Test when no other
                                                                                practical means of
                                                                                transportation exist
                                                                                (modes 4, 5).
15094-N...............  ..............  Tucker Aviation Inc.   49 CFR 173.302(f)(3)   To authorize the
                                         Dillingham, AK.        and (f)(4) and        transportation in
                                                                173.304(f)(3) and     commerce of cylinders
                                                                (f)(4).               containing oxidizing
                                                                                gases without a rigid
                                                                                outer packaging
                                                                                capable of passing the
                                                                                Flame Penetration and
                                                                                Resistance Test and
                                                                                the Thermal Resistance
                                                                                Test when no other
                                                                                practical means of
                                                                                transportation exist
                                                                                (modes 4, 5).

15095-N...............  ..............  Wright Air Service,    49 CFR 173.302(f)(3)   To authorize the
                                         Inc. Fairbanks, AK.    and (f)(4) and        transportation in
                                                                173.304(f)(3) and     commerce of cylinders
                                                                (f)(4).               containing oxidizing
                                                                                gases without a rigid
                                                                                outer packaging
                                                                                capable of passing the
                                                                                Flame Penetration and
                                                                                Resistance Test and
                                                                                the Thermal Resistance
                                                                                Test when no other
                                                                                practical means of
                                                                                transportation exist
                                                                                (modes 4, 5).
15096-N...............  ..............  NK CO., LTD Saha-Gu,   49 CFR 180.209(a),     To authorize the
                                         Busan.                 180.205(c)(f)(g) and  transportation in
                                                                (i) and               commerce of certain
                                                                173.302a(b)(2), (3),  DOT 3A, AAA, 3AX,
                                                                (4) and (5).          3AAX and 3T cylinders
                                                                                that have been
                                                                                retested every ten (10)
                                                                                years instead of every
                                                                                five (5)
                                                                                years by acoustic emission
                                                                                and ultrasonic examination
                                                                                (AE/IJE) in place of the
                                                                                internal visual inspection
                                                                                and the hydrostatic retest
                                                                                required by Sec.   180.205
                                                                                (modes 1, 2, 3, 4, 5).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-21017 Filed 8-24-10; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11163-11164]
[FR Doc No: 2019-05650]

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

DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2015-0271]

Agency Request for Renewal of a Previously Approved Information
Collection: Prioritization and Allocation Authority Exercised by the
Secretary of Transportation Under the Defense Production Act

AGENCY: Office of the Secretary of Transportation, DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to renew an information collection. The collection
involves information required in an application to request Special
Priorities Assistance. The information to be collected is necessary to
facilitate the supply of civil transportation resources to promote the
national defense. We are required to publish this notice in the Federal
Register by the Paperwork Reduction Act of 1995, Public Law 104-13.

DATES: Written comments should be submitted by May 24, 2019.

ADDRESSES: You may submit comments [identified by Docket No. DOT-OST-
2015-0271] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Anita Womack,<PHONE_NUMBER>, Office of
Intelligence, Security and Emergency Response, Office of the Secretary
of Transportation, U.S. Department of Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2105-0567.
    Title: Prioritization and Allocation Authority Exercised by the
Secretary of Transportation Under the Defense Production Act.
    Form Numbers: OST F 1254.
    Type of Review: Renewal of a previously approved information
collection.

Background

    The Defense Production Act Reauthorization of 2009 (Pub. L. 111-67,
September 30, 2009) requires each Federal agency with delegated
authority under section101 of the Defense Production Act of 1950, as
amended (50 U.S.C. App. Sec.  2061 et seq.) to issue final rules
establishing standards and procedures by which the priorities and
allocations authority is used to promote the national defense. The
Secretary of Transportation has the delegated authority for all forms
of civil transportation. DOT's final rule, Transportation Priorities
and Allocation System (TPAS), published October 2012, requires this
information collection. Form OST F 1254, Request for Special Priorities
Assistance, would be filled out by private sector applicants, such as
transportation companies or organizations. The private sector applicant
must submit company information, the services or items for which the
assistance is requested, and specific information about those services
or items.
    Respondents: Private sector applicants, such as transportation
companies or organizations.
    Number of Respondents: We estimate 6 respondents.
    Total Annual Burden: We estimate an average burden of 30 minutes
per respondent for an estimated total annual burden of 3 hours.
    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 the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department 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.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on March 20, 2019.
Donna O'Berry,
Deputy Director, Office of Intelligence, Security and Emergency
Response.
[FR Doc. 2019-05650 Filed 3-22-19; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33427]
[DOCID:fr13jy09-48]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13451-000]

McGinnis, Inc.; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

July 2, 2009.
    On April 29, 2009, McGinnis, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Greenup Hydrokinetic Project,
located on the Ohio River, in Greenup County, Kentucky, and Scioto
County, Ohio. The sole purpose of a preliminary permit, if issued, is
to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed project would consist of: (1) A 100 to 300-foot-long
by 20 to 52-foot-wide barge spudded down to the riverbed; (2) 10 6-8-
foot-long by 6-8-foot-diameter turbine-generators mounted in line along
the side of the barge; (3) one armored, high-voltage cable transmitting
the generated power to the existing transmission line located adjacent
to the proposed project area; and (4) appurtenant facilities. The
proposed project would generate about 1,533 megawatt-hours.
    Applicant Contact: Bruce D. McGinnis, Sr., McGinnis, Inc., P.O. Box
534, 502 Second St. Ext., South Point, OH 45680, phone:<PHONE_NUMBER>.
    FERC Contact: Sergiu Serban,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13451) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16440 Filed 7-10-09; 8:45 am]

BILLING CODE 6717-01-P


<EMAIL_ADDRESS> 12/19/2007 11:29 AM	To

	Margaret Sheppard/DC/USEPA/US@EPA

	cc

<EMAIL_ADDRESS><EMAIL_ADDRESS> 	bcc

	Subject

	Re: Request for clarification about Victaulic Vortex System

	Margaret:

Please find attached a submittal letter and the excel spread sheet as we

discussed in our Monday phone meeting.

If I can do anything additional please let me know as soon as possible.

Hope you have a safe and happy holiday

Regards

Bill Reilly

Director, Fire Safety Research


[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Page 44873]
[FR Doc No: 2018-19135]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9983-28-OAR]

Request for Nominations for the 2019 Clean Air Excellence Awards
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for nominations for Clean Air Excellence Awards.

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

SUMMARY: This notice announces the competition for the 2019 Clean Air
Excellence Awards Program. EPA established the Clean Air Excellence
Awards Program in February 2000 to recognize outstanding and innovative
efforts that support progress in achieving clean air.

DATES: All submissions of entries for the Clean Air Excellence Awards
Program must be postmarked by November 2, 2018.

FOR FURTHER INFORMATION CONTACT: Additional information on this awards
program, including the entry form, can be found on EPA's Clean Air Act
Advisory Committee (CAAAC) website: http://epa.gov/air/cleanairawards/index.html. Any member of the public who wants further information may
contact Ms. Catrice Jefferson, Office of Air and Radiation, U.S. EPA by
telephone at<PHONE_NUMBER> or by email at [email protected].

SUPPLEMENTARY INFORMATION: Awards Project Notice, Pursuant to 42 U.S.C.
7403(a)(1) and (2) and sections 103(a)(1) and (2) of the Clean Air Act
(CAA), notice is hereby given that the EPA's Office of Air and
Radiation (OAR) announces the opening of competition for the 2019 Clean
Air Excellence Awards Program (CAEAP). The intent of the program is to
recognize and honor outstanding, innovative efforts that help to make
progress in achieving cleaner air. The CAEAP is open to both public and
private entities. Entries are limited to efforts related to air quality
in the United States. There are five general award categories: (1)
Clean Air Technology; (2) Community Action; (3) Education/Outreach; (4)
State/Tribal/Local Air Quality Policy Innovations; and (5)
Transportation Efficiency Innovations. There are also two special
awards categories: (1) Thomas W. Zosel Outstanding Individual
Achievement Award; and (2) Gregg Cooke Visionary Program Award. Awards
are given periodically and are for recognition only.
    Entry Requirements: All applicants are asked to submit their entry
on a CAEAP entry form, contained in the CAEAP Entry Package, which may
be obtained from the CAAAC website at http://epa.gov/air/cleanairawards/entry.html. Applicants can also contact Ms. Catrice
Jefferson, Office of Air and Radiation, U.S. EPA by telephone at (202)
564-1668 or by email at [email protected]. The entry form is a
simple, four-part form asking for general information on the applicant;
a narrative description of the project; three (3) independent
references for the proposed entry; and your knowledge of EPA awards
programs and resources. Applicants should also submit additional
support documentation as necessary. Specific directions and information
on filing an entry form are included in the Entry Package.
    Judging and Award Criteria: EPA staff will use a screening process,
with input from outside subject experts, as needed. Members of the
CAAAC will provide advice to EPA on the entries. The EPA Assistant
Administrator for Air and Radiation will make the final award
decisions. Entries will be judged using both general criteria and
criteria specific to each individual category. These criteria are
listed in the 2019 Entry Package.

    Dated: August 28, 2018.
Catrice Jefferson,
Office of Air and Radiation.
[FR Doc. 2018-19135 Filed 8-31-18; 8:45 am]
 BILLING CODE 6560-50-P


Codex maximum residue limits (MRLs) are not established for residues of difenoconazole in/on members of the pea and bean, dried shelled, except soybean, subgroup 6C and harmonization with the established Canadian MRLs in/on a variety dried pea seeds and dried bean seeds (all at 0.03 ppm) is not possible because the Canadian MRL would not be adequate to cover residues expected from the proposed foliar uses in the U.S.  There are no established Codex, Canadian or Mexican MRLs for residues of difenoconazole in/on members of the bushberry subgroup 13-07B, pea hay and pea vines so harmonization is not possible.  For milk, the residue definition (sum of parent and its metabolite, CGA-205375) and recommended milk tolerance increase (0.02 ppm) will be harmonized with the established Codex MRL in milk but not the established Canadian MRL (0.01 ppm) which is limit to residues of parent only.  An International Residue Limit Status Sheet is attached in Appendix I.

Table 13. 	Tolerance Summary for Difenoconazole.
Commodity
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Correct Commodity Definition;
Comments
Bushberry, subgroup 13-07B
                                      3.0
                                      4.0
Bushberry subgroup 13-07B
Pea and bean, dried shelled (except soybean), subgroup 6C
                                      0.2
                                     0.20
Pea and bean, dried shelled, except soybean, subgroup 6C
Peas, hay
                                      40
                                      40
Pea, field, hay
Peas, vines
                                      10
                                      10
Pea, field, vines
Chickpea
                                     0.08
                                    delete
With the establishment of a tolerance in/on pea and bean, dried shelled, except soybean, subgroup 6C (0.20 ppm), this tolerance is not appropriate and should be deleted.
Milk
                                      --
                                     0.02
The new dried pea hay and vine feedstuffs significantly increased the maximum reasonably balance diet (MRBD) for dairy cattle (from 2.8 ppm to 7.2 ppm).  Based on the MRBDs for livestock and the available feeding study data, HED concludes that the currently established tolerance for residues of difenoconazole and its metabolite CGA-205375, expressed as difenoconazole equivalents, in milk should be increased from 0.01 ppm to 0.02 ppm to support the proposed new uses on dried peas.  Other currently established livestock commodity tolerances remain adequate.
References

DP#s:	172067 and 178394
Subject:	PP#2E4051.  CGA-169374 (Difenoconazole, Dividend(R)) in Imported Wheat, Barley, and Rye Grain.  First Food Use.  CBTS#s 9029, 9895.
From:	R. Lascola
To:	J. Stone/C. Giles-Parker
Dated:	10/26/92
MRIDs:	42090001-42090004, 42090032-42090059, and 42303901

DP#:	327788
Subject:	Triazole-Based Metabolites:  Guidance On Residue Chemistry Data Submissions.
From:	M. Doherty
To:	C. Giles-Parker
Date:	4/25/06
MRIDs:	None

DP#:	340379
Subject:	PP#6F7115; Difenoconazole.  Petition for Establishment of Tolerances on Fruiting Vegetables, Pome Fruit, Sugar Beets, Tuberous and Corm Vegetables, and Imported Papaya.  Summary of Analytical Chemistry and Residue Data.
From:	W. Wassell/M. Sahafeyan
To:	D. Rosenblatt/S. Brothers
Dated:	8/9/07
MRIDs:	46950215-46950237

DP#:	None (ACB memo)
Subject:	Review of Proposed Tolerance Enforcement Method for Difenoconazole.  ACB Project # B07-26.
From:	C. Stafford
To:	D. Vogel
Dated:	10/29/07
MRIDs:	None

DP#	356135
Subject:	Difenoconazole.   Submission of Residue Analytical Methods Data in Response to DP#265858.  Submission of Storage Stability Data in Response to DP#307059.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	J. Bazuin/T. Kish
Dated:	9/17/09
MRIDs:	47413501 and 47413502

DP#s	361054 and 362648
Subject:	Difenoconazole.  Application for Amended Section 3 Registration to Add Uses on Bulb Vegetables, Brassica Leafy Vegetables, Cucurbit Vegetables, Citrus Fruits, Grapes, Pistachios, and Tree Nuts.  Submission of Residue Analytical Methods Data in Response to DP#340379.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	9/17/09
MRIDs:	47586101-47586107 and 47648604-47648605

DP#	374898
Subject:	Difenoconazole.  The Need for Additional Independent Laboratory Validation (ILV) Information for the Livestock Enforcement Method REM 147.07.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	3/3/10
MRIDs:	None

DP#	375159
Subject:	Difenoconazole.  Dissociation Constant in Water Data to Satisfy OPPTS 830.7370 Guideline Requirements.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	5/26/10
MRIDs:	47957001

DP#	375194
Subject:	Difenoconazole.  Submission of Storage Stability Data in Livestock Commodities in Response to DP# 340379.  Submission of a Report of a New Cattle Feeding Study.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	6/17/10
MRIDs:	47957201-47957203

DP#	378829
Subject:	Difenoconazole.  Application for Amended Section 3 Registration to Add Uses on Carrots, Chickpeas, Soybeans, Stone Fruits (Group 12), Strawberries, and Turnip Greens.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	2/23/11
MRIDs:	47929801-47929805

DP#:		391350
Subject:	Difenoconazole:  Report of the Residues of Concern Knowledgebase Sub-committee (ROCKS).
From:		W. Irwin, ROCKS Member
Through:	C. Olinger and E. Scollon, ROCKS Co-Chairs
To:		HED Difenoconazole Risk Assessment Team
Dated:		9/19/11
MRIDs:	NA

DP#	382946
Subject:	Difenoconazole.  Submission of Confined Rotational Crop Data in Response to Data Deficiencies Identified as a Condition of Registration Under Previous Petitions.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	R. Kearns/T. Kish
Dated:	12/7/11
MRID:	48203402

DP#	363016
Subject:	Storage Stability of 1,2,4-Triazole, Triazolylalanine and Triazolylacetic Acid in Various Crop Matrices and Processed Commodities (up to four years under frozen storage).
From:	D. Drew
To:	T. Gibson
Dated:	1/12/12
MRID:	47606601

DP#	389912
Subject:	Difenoconazole.  Petition for Postharvest Use on Tuberous and Corm Vegetables Subgroup 1C and Foliar Uses on Fruiting Vegetables Group 8-10, Citrus Fruits Group 10-10, Pome Fruits Group 11-10, and Low growing Berry Subgroup 13-07G, Except Cranberry.  Summary of Analytical Chemistry and Residue Data.
From:	B. Cropp-Kohlligian
To:	S. Jackson/B. Madden
Dated:	5/30/12
MRID:	48437101

Attachments:
Appendix I - International Residue Limit Status Sheet
Appendix II - Tolerance Assessment Calculations

Template Version September 2005

Appendix I.  International Residue Limit Status Sheet.

                        Difenoconazole (128847; 7/1/14)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.475:
Plant: difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole

Livestock:  sum of difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, and its metabolite, CGA-205375, 1-[2-chloro-4-(4-chloro-phenoxy)phenyl]-2-[1,2,4]triazol-1-yl-ethanol, calculated as the stoichiometric equivalent of difenoconazole

Difenoconazole, 1-[2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole.

Plants: difenoconazole

Animal commodities: sum of difenoconazole and 1-[2-chloro-4-(4-chloro-phenoxy)-
phenyl]-2-(1,2,4-triazol)-1-yl-ethano), expressed as difenoconazole.
The residue is fat-soluble.
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico[2]
Codex[3]
Bushberry, subgroup 13-07B
4.0

Pea and bean, dried shelled, except soybean, subgroup 6C
0.20
0.03 Dry (adzuki beans, beans, blackeyed peas,
 broad beans, catjang seeds, chickpeas, cowpea seeds, field peas, guar seeds, kidney beans, lablab beans, lentils, lima beans, moth beans, mung beans, navy beans, pigeon peas, pink beans, pinto beans, rice beans, southern peas, tepary beans, urd beans, grain lupin

Pea, field, hay
40

Pea, field, vines
10

Milk
0.02
0.01

0.02
Completed:  M. Negussie; 07/07/14
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Appendix II.  Tolerance Assessment Calculations.

The Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures were used for calculating the recommended tolerances.  As specified in the OECD document, the average residue from each field trial was used.  The rounding procedures specified in the OECD guidelines were also used.

Pea and bean, dried shelled, except soybean, subgroup 6C

The dataset used to establish the tolerance for residues of difenoconazole in/on peas and beans, dried shelled, except soybean, subgroup 6C consisted of dried bean seed and dried pea seed field trial data representing four foliar applications of an EC formulation of difenoconazole at 0.115 lb ai/A/application with a 14-day RTI and a 14-day PHI.  Previously submitted chickpea seed field trial data (MRID 47929805; PP#9F7676; DP# 378829, 2/23/11, B. Cropp-Kohlligian) reflecting the same formulation and use rate were also used.

The dataset used to establish the tolerances for residues of difenoconazole in/on pea hay and pea vines consisted of pea field trial data for hay and vines representing two foliar applications of an EC formulation of difenoconazole at 0.115 lb ai/A/application with a 14-day RTI and a 0-day PHI.

The residue values which were used to calculate the tolerance are provided below in Table II-1.  Using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures, the recommended tolerances are 0.05 ppm in/on dried bean seed, 0.20 ppm in/on dried pea seed, 40 ppm in/on pea hay and 10 ppm in/on pea vines.  (Figure II-1)  Since the maximum field trial values, highest average field trial values and recommended tolerances for dried bean seed and dried pea seed are within 5x, a crop group tolerance can be set for pea and bean, dried shelled, except soybean, subgroup 6C and is recommended at 0.20 ppm based on the dried pea seed data.  The recommended tolerances are the same as the petitioned-for tolerances.

Table II-1.	Residue data used to calculate tolerance for difenoconazole in/on dried bean, seed; dried pea, seed; pea, hay; and pea, vines.
Regulator:
EPA
Chemical:
Difenoconazole
Crops:
Dried bean, seed; Dried pea, seed; Pea hay; Pea vines
PHI:
14-days for seed and 0-days for pea hay/vines
App. Rate:
4 x 0.115 lb ai/A/application for seed and 2 x 0.115 lb ai/A/application for pea hay/vines; 14-day RTI.
Submitter:
Syngenta
MRID Citation:
MRID 49227601
MRID 47929805; PP#9F7676; DP# 378829, 2/23/11, B. Cropp-Kohlligian

Figure II-1.	Tolerance spreadsheet summary of difenoconazole magnitude of the residue data for legume 			commodities.
Compound
                                Difenoconazole
Crop
                               Dried Bean, seed
                                Dried Pea, seed
                                   Pea, Hay
                                  Pea, Vines
Region/Country
                                      USA
                                      USA
                                      USA
                                      USA
GAP
                                 0.46 lb ai/A
<EMAIL_ADDRESS>lb ai/A
                                  14-day RTI
                                  14-day PHI
                                 0.46 lb ai/A
<EMAIL_ADDRESS>lb ai/A
                                  14-day RTI
                                  14-day PHI
                                 0.23 lb ai/A
<EMAIL_ADDRESS>lb ai/A
                                  14-day RTI
                                   0-day PHI
                                 0.23 lb ai/A
<EMAIL_ADDRESS>lb ai/A
                                  14-day RTI
                                  0-day PHI
Total number of data (n)
                                      11
                                       5
                                       5
                                       5

Percentage of censored data
                                      45%
                                      20%
                                      0%
                                      0%
Number of non-censored data
                                       6
                                       4
                                       5
                                       5

Lowest residue
                                     0.010
                                     0.010
                                     4.430
                                     1.490
Highest residue
                                     0.031
                                     0.089
                                    17.100
                                     4.850
Median residue
                                     0.010
                                     0.028
                                     9.930
                                     3.690

Mean
                                     0.014
                                     0.034
                                    10.672
                                     3.468
Standard deviation (SD)
                                     0.008
                                     0.032
                                     4.631
                                     1.304

Correction factor for censoring (CF)
                                     0.697
                                     0.867
                                     1.000
                                     1.000

Highest residue
                                     0.031
                                     0.089
                                    17.100
                                     4.850
Mean + 4 SD
                                     0.046
                                     0.162
                                    29.197
                                     8.683
CF x 3 mean
                                     0.030
                                     0.089
                                    32.016
                                    10.404
Unrounded MRL
                                     0.046
                                     0.162
                                    32.016
                                    10.404

                                  Rounded MRL
                                     0.05
                                      0.2
                                      40
                                      10

High uncertainty of MRL estimate due to small dataset.
High uncertainty of MRL estimate due to small dataset.
High uncertainty of MRL estimate due to small dataset.

Residues (mg/kg)
Residues (mg/kg)
Residues (mg/kg)
Residues (mg/kg)

                                     0.030

                                     0.015

                                     9.930

                                     4.310

                                     0.013

                                     0.089

                                     4.430

                                     3.690

                                     0.010

                                     0.029

                                    12.500

                                     3.000

                                     0.010
                                       *
                                     0.010
                                       *
                                     9.400

                                     1.490

                                     0.012

                                     0.028

                                    17.100

                                     4.850

                                     0.010
                                       *

                                     0.010
                                       *

                                     0.011

                                     0.031

                                     0.01
                                       *

                                     0.01
                                       *

Bushberry subgroup 13-07B

The dataset used to establish the tolerance for residues of difenoconazole in/on bushberry subgroup 13-07B consisted of blueberry field trial data representing four foliar applications of an EC formulation of difenoconazole at 0.115 lb ai/A/application and a 7-day RTI and a 1-day PHI.
An analysis of the field trials found that two of the eleven trials submitted (NAFTA Growing Region 1; Trials T162 and T163 conducted in PE, Canada) were not independent field trials being less than 20 miles apart and reflecting the same variety and application timing resulting in substantially similar residue levels.  Hence, only the trial with the higher residue of difenoconazole (T162) was used to calculate the tolerance for residues of difenoconazole in/on bushberry subgroup 13-07B.

The residue values which were used to calculate the tolerance are provided below in Table II-2.  Using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures, the recommended tolerance is 4.0 ppm in/on bushberry subgroup 13-07B (Figure II-2).  The recommended tolerance is not the same as the petitioned-for tolerance (3.0 ppm) due to the independent field trial determination.

Table II-2.	Residue data used to calculate tolerance for difenoconazole in/on bushberry subgroup 13-07B.
Regulator:
EPA
Chemical:
Difenoconazole
Crop:
Blueberry
PHI:
1-day
App. Rate:
4 x 0.115 lb ai/A/application; 7-day RTI.
Submitter:
Syngenta
MRID Citation:
MRID 49227602

Figure II-2.	Tolerance spreadsheet summary of difenoconazole magnitude of the residue data for 					bushberries.
                                   Compound
                                Difenoconazole
                                     Crop
                                   Blueberry
                                Region/Country
                                   USA/PMRA
                                      GAP
                                 0.46 lb ai/A
<EMAIL_ADDRESS>lb ai/A
                                   7-day RTI
                                   1-day PHI

                           Total number of data (n)
                                      10

                          Percentage of censored data
                                      0%
                          Number of non-censored data
                                      10

                                Lowest residue
                                     0.330
                                Highest residue
                                     1.900
                                Median residue
                                     0.920

                                     Mean
                                     1.009
                            Standard Deviation (SD)
                                     0.534

                     Correction factor for censoring (CF)
                                     1.000

                                Highest residue
                                     1.900
                                  Mean + 4 SD
                                     3.144
                                  CF x 3 Mean
                                     3.027
                                 Unrounded MRL
                                     3.144

                                  Rounded MRL
                                       4

Residues (mg/kg)

                                   1.200[1]

                                     1.400

                                     1.900

                                     0.840

                                     1.000

                                     0.650

                                     0.400

                                     0.670

                                     0.330

                                     1.700

1  Average Residue from Trial T162.  An analysis of the field trials found that two of the eleven trials submitted (NAFTA Growing Region 1; Trials T162 and T163 conducted in PE, Canada) were not independent field trials being less than 20 miles apart and reflecting the same variety and application timing resulting in substantially similar residue levels.  Hence, only the trial with the higher residue of difenoconazole (T162) was used to calculate the tolerance for residues of difenoconazole in/on bushberry subgroup 13-07B.


[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25875-25876]
[FR Doc No: 2014-10262]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0530]

Center for Devices and Radiological Health Guidance Development
and Prioritization; Public Workshop; Requests for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Center for Devices and Radiological Health
Guidance Development and Prioritization Public Workshop.'' The topics
to be discussed include the FDA's Center for Devices and Radiological
Health's (CDRH) guidance development process, guidance development best
practices for FDA, CDRH, and CDRH stakeholders, and CDRH guidance
priorities and priority development.
    Date and Time: The public workshop will be held on June 5, 2014,
from 9 a.m. to 3 p.m.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503A), Silver Spring, MD 20993-0002. Entrance for public
workshop participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Cathy Norcio, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5448, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 5 p.m., EDT, May 29, 2014. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>no later than May 22, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Susan Monahan to register (see Registration
contact for special accommodations). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 5 p.m., EDT, May 29, 2014. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information no later than June 2, 2014. If you have never
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain feedback on
CDRH's guidance development and guidance prioritization processes. In
order to permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public workshop topics. The deadline for submitting
comments related to this public workshop is July 7, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Please identify comments with the docket number found in
brackets in the heading of this document. Received comments may be
viewed in person in the Division of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and will be posted to the docket at
http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

SUPPLEMENTARY INFORMATION:

I. Background

    Guidance documents are documents issued by FDA and prepared for FDA
staff and/or FDA stakeholders. They describe the Agency's
interpretation of, or policy on, a regulatory issue (see Sec.
10.115(b) (21 CFR 10.115(b))). Unlike statutes and regulations,
guidances themselves do not create legally binding requirements (see
Sec.  10.115(d)). Nevertheless, guidance documents are important
because they assist both staff and industry in understanding FDA's
current thinking on certain topics. FDA's Good Guidance Practices
regulation (Sec.  10.115) governs the development and issuance of
guidance, and it gives interested parties a number

of opportunities to provide input into the guidance development
process. Interested parties may provide input by:
    (1) Submitting Comments on Guidance Topics Listed in CDRH's
Proposed Guidance Development lists: FDA announces annually in the
Federal Register the Web site location where the Agency posts lists of
prioritized medical device guidance documents that CDRH intends to
publish in the fiscal year. This information for fiscal year 2014 may
be found in the Federal Register at 78 FR 66746 (November 6, 2013) and
on the Internet at http://www.gpo.gov/fdsys/pkg/FR-2013-11-06/pdf/2013-26547.pdf and at http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/mdufaiii/ucm321367.htm. In
addition, FDA establishes a docket where CDRH invites interested
persons to submit comments on any or all of the guidance documents
identified in the annual Proposed Guidance Development lists. Comments
may include draft language on the proposed topics, suggestions for new
or different guidance documents, and/or the relative priority of
guidance documents.
    (2) Submitting Proposed Draft Guidance to FDA for Consideration:
Submitting proposed draft guidance, rather than a guidance topic,
enables FDA to review and consider a fully developed approach to an
issue of interest to a stakeholder. FDA may then adopt that approach,
in full or in part, in a draft guidance that would be issued for public
comment. This process holds the potential to shorten the total time for
guidance development and facilitate consensus on novel, complex, or
controversial issues. FDA solicits proposed draft guidances at a
variety of different venues, such as trade association meetings and on
the FDA Web site. Interested parties may submit proposed draft
guidances on unsolicited topics, as well. While some stakeholders have
developed proposed draft guidances for FDA's consideration, few have
used this approach.
    (3) Commenting on Draft Level 1 Guidance: Generally, FDA solicits
public input on Level 1 guidances prior to implementation. The Agency
posts draft Level 1 guidances on its Web site, and it publicizes the
draft guidance by issuing a notice of availability (NOA) in the Federal
Register. Generally, the Agency requests that public comments on the
guidance be provided within 60 days of publication of the draft
guidance. Once the comment period has closed, the Agency reviews the
comments and considers them as it finalizes the policy at issue and
publishes the final guidance. The Agency posts the final Level 1
guidance on its Web site and publicizes the final guidance by
publishing an NOA in the Federal Register. In some instances, FDA may
hold public meetings or workshops prior to issuing a draft Level 1
guidance or after issuing the draft but prior to finalizing the
guidance to solicit additional comments or perspectives on the policy
at issue.
    (4) Commenting on Level 2 Guidance and Level 1 Immediately in
Effect Guidance: Generally, FDA does not solicit public input on Level
2 guidance or on Level 1 Immediately in Effect guidance prior to
implementing the guidance. Level 2 guidance documents are guidance
documents that set forth existing practices or minor changes in
interpretation or policy (Sec.  10.115(c)(2)) Level 1 Immediately in
Effect guidances are issued when prior public participation is not
feasible or appropriate (Sec.  10.115(g)(2)). However, FDA posts both
types of guidance on its Web site, and interested parties may comment
on them at any time after they have been issued. FDA will review the
comments and revise the guidances, as appropriate. These streamlined
options permit FDA to issue guidance more expeditiously than standard
Level 1 guidance, while still providing stakeholders with an
opportunity to comment. The additional administrative steps required
for standard Level 1 guidance (i.e., issuing draft guidance, providing
a comment period, and issuing final guidance) generally make the
issuance of standard Level 1 guidance a longer process.
    (5) Suggesting that FDA Revise or Withdraw an Existing Guidance
Document: The Agency accepts and considers suggestions for revising or
withdrawing existing guidance documents at any time. FDA is committed
to updating its Web site in a timely manner to reflect the Agency's
review of previously issued guidance documents, including the deletion
of guidance documents that no longer represent the Agency's
interpretation of, or policy on, a regulatory issue. CDRH encourages
stakeholders to provide information concerning why a guidance should be
revised or withdrawn, and, if applicable, provide comments about how a
guidance should be revised.
    This public workshop and the opening of a docket requesting
comments and suggestions provide stakeholders with an additional
opportunity to actively engage with CDRH regarding the level of public
participation and other best practices in guidance development as well
as how CDRH should develop its guidance priorities. To facilitate
transparency, the workshop will also include information about the
development and practical implementation of CDRH's internal guidance
development process. CDRH encourages collaborative efforts with the
public in the development of guidance documents and believes this
workshop will help advance these efforts. CDRH is committed to
exploring ways to facilitate stakeholder participation in guidance
development within the confines of applicable statutes and regulations,
considering the need to provide all interested parties access to the
process, issuing documents in a timely manner, and balancing internal
resources effectively to accomplish its public health mission.

II. Topics for Discussion at the Public Workshop

    The topics to be discussed include CDRH's guidance development
process, guidance development best practices for FDA, CDRH, and CDRH
stakeholders, and CDRH guidance priorities and priority development.

    Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10262 Filed 5-5-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Page 31058]
[FR Doc No: 2019-13845]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-141-000.
    Applicants: SR Meridian III, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of SR Meridian III, LLC.
    Filed Date: 6/21/19.
    Accession Number: 20190621-5189.
    Comments Due: 5 p.m. ET 7/12/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2126-005.
    Applicants: Idaho Power Company.
    Description: Updated Market Power Analysis for the Northwest Region
of Idaho Power Company.
    Filed Date: 6/21/19.
    Accession Number: 20190621-5180.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER11-2105-003.
    Applicants: Oklahoma Gas and Electric Company.
    Description: Notice of Non-Material Change in Status of Oklahoma
Gas and Electric Company.
    Filed Date: 6/21/19.
    Accession Number: 20190621-5184.
    Comments Due: 5 p.m. ET 7/12/19.

    Docket Numbers: ER15-1682-008.
    Applicants: TransCanyon DCR, LLC.
    Description: Compliance filing: Amended Formula Rate Templace
Second Compliance Filing for ADIT to be effective 6/27/2018.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5106.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER17-802-005.
    Applicants: Exelon Generation Company, LLC.
    Description: Compliance filing: Informational Filing Regarding
Three Mile Island Unit Retirement to be effective N/A.
    Filed Date: 6/21/19.
    Accession Number: 20190621-5081.
    Comments Due: 5 p.m. ET 7/12/19.

    Docket Numbers: ER19-1826-001.
    Applicants: Bolt Energy, LLC.
    Description: Tariff Amendment: MBR Tariff to be effective 6/12/
2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5117.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2234-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1276R20 KCPL NITSA NOA to be
effective 9/1/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5015.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2235-000.
    Applicants: Tuscola Bay Wind, LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Baseline to be effective 8/23/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5044.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2236-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2415R12 Kansas Municipal
Energy Agency NITSA NOA to be effective 9/1/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5054.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2237-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: PSCo-TSGT-Utility Svcs
Agrmt-379-Exhibit D-0.1.0 to be effective 6/25/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5056.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2238-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: Revised Rate Schedule No.
188 (MT)--Colstrip 1 & 2 Transmission Agreement to be effective 9/1/
2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5074.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2239-000.
    Applicants: AES Shady Point, LLC.
    Description: Tariff Cancellation: AES Shady Point Notice of Tariff
Cancellation to be effective 6/25/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5116.
    Comments Due: 5 p.m. ET 7/15/19.

    Docket Numbers: ER19-2240-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to the OATT and OA
re FTR Hourly Cost Calculation Update to be effective 9/1/2019.
    Filed Date: 6/24/19.
    Accession Number: 20190624-5152.
    Comments Due: 5 p.m. ET 7/15/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 24, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13845 Filed 6-27-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 29, 2010 (Volume 75, Number 59)]
[Notices]
[Page 15447]
[DOCID:fr29mr10-75]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1877-DR; Docket ID FEMA-2010-0002]

Iowa; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1877-DR), dated February 25, 2010, and
related determinations.

DATES: Effective Date: March 19, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
February 25, 2010.

    Buena Vista, Dickinson, O'Brien, Palo Alto, Plymouth, and
Pocahontas Counties for Public Assistance.
    Buena Vista, Dickinson, O'Brien, Palo Alto, and Plymouth
Counties for emergency protective measures (Category B), including
snow assistance, under the Public Assistance program for any
continuous 48-hour period during or proximate to the incident
period.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-6945 Filed 3-26-10; 8:45 am]
BILLING CODE 9111-23-P