[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38634-38636]
[FR Doc No: 2019-16880]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3369]

Evaluating the Clinical Pharmacology of Oligonucleotide
Therapeutics; Establishment of a Public Docket; Request for Information
and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for
information and comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments on evaluating the
clinical pharmacology of oligonucleotide therapeutics. There are many
unique clinical pharmacology considerations concerning the development
of oligonucleotide therapeutics; however, for the purposes of this
request, the Agency is specifically interested in

comments regarding the characterization of the effects of hepatic and
renal impairment, drug-drug interactions, and immunogenicity on the
pharmacokinetics of oligonucleotide therapeutics as well as the effects
of oligonucleotide therapeutics on cardiac electrophysiology. Public
comments will help the Agency develop recommendations for the design
and conduct of studies important to the safe and effective use of
oligonucleotide therapeutics and facilitate the regulatory assessment
of such studies.

DATES: Although you can comment at any time, to ensure that the Agency
considers your comment in our development of recommendations, submit
either electronic or written information and comments by October 7,
2019.

ADDRESSES: You may submit comments at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3369 for ``Evaluating the Clinical Pharmacology of
Oligonucleotide Therapeutics; Request for Comments.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Hobart Rogers, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-2213<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Oligonucleotide therapeutics typically are synthetically modified
single- or double-stranded ribonucleic acid (RNA) or deoxyribonucleic
acid (DNA) that exert pharmacologic effects through a variety of
mechanisms (e.g., altered splicing, RNA interference, immunomodulation,
microRNA modulation). Compared to small molecule or biological
products, oligonucleotide therapeutics have unique characteristics
regarding their chemistry, pharmacology, sites of action,
pharmacokinetic disposition, and pharmacodynamics. As a result, there
may be special considerations for the design and conduct of clinical
pharmacology studies to assess oligonucleotide therapeutics, such as
those designed to evaluate the effects of organ impairment or drug
interactions. Currently, none of FDA's currently published guidance
documents on clinical pharmacology assessments contain specific
recommendations for oligonucleotide therapeutics.

II. Request for Information and Comments

    Interested persons are invited to provide detailed information and
comments on certain aspects of evaluating the clinical pharmacology of
oligonucleotide therapeutics. This request focuses on oligonucleotide
therapeutics designed to hybridize to a cognate RNA to elicit a
pharmacologic effect. For all questions, organize any discussion by the
type of oligonucleotide therapeutics (e.g., by chemistry or
modification type). Please provide the rationale for your suggestions
and include supporting data if available. FDA is particularly
interested in responses to the following overarching questions:
    (1) Evaluating Drug-Drug Interactions (DDIs)
    (a) Under what circumstances should clinical DDI assessment be
warranted or not warranted for oligonucleotide therapeutics?
    (b) In circumstances where DDI assessments are warranted:
    (i) What types of DDI assessments are suitable and why (e.g., in
vitro studies, dedicated clinical studies, cocktail studies, population
pharmacokinetic analyses)? Please discuss the advantages, challenges,
and limitations with each type of assessment.
    (ii) What are the study design considerations (e.g., in vitro test

systems, population, analytes) for the types of assessments discussed
in item (1)(b)(i) above? Please describe the rationale for any design
considerations proposed.
    (2) Evaluating the Pharmacokinetics in Organ Impairment
    (a) Under what circumstances are organ impairment assessments for
oligonucleotide therapeutics warranted or not warranted for:
    (i) Renal function
    (ii) hepatic function
    (b) In circumstances where organ impairment assessments are
warranted:
    (i) What types of assessments are suitable for renal and/or hepatic
impairment and why (e.g., dedicated clinical studies, population
pharmacokinetic analyses)? Please discuss the advantages, challenges,
and limitations with each type of assessment.
    (ii) What are the study design considerations (e.g., study
population) for the types of assessments discussed in item (2)(b)(i)
above for renal and/or hepatic impairment? Please describe the
rationale for any design considerations proposed.
    (3) Evaluating Immunogenicity
    (a) Under what circumstances are immunogenicity assessments of
oligonucleotide therapeutics warranted or not warranted?
    (b) In circumstances where immunogenicity assessments are
warranted:
    What types of assessments are suitable and why (e.g., antibodies
against other components of the formulation, antibodies against a newly
created ``splice-altered'' protein, neutralizing titers, cytokine
measurements)? Please discuss the advantages, challenges, and
limitations with each type of assessment.
    (4) Evaluating QT Prolongation
    (a) Under what circumstances are cardiac electrophysiology
assessments warranted or not warranted in the evaluation of
oligonucleotide therapeutics?
    (b) In circumstances where cardiac electrophysiology assessments
are warranted:
    What types of assessments are suitable and why (e.g., hERG
inhibition assay, thorough QT assessment) in nonclinical or clinical
studies? Please discuss the advantages, challenges, and limitations
with each type of assessment.
    (5) With regard to the four questions above, when a sponsor seeks
to rely on previously generated data and information that it owns or to
which it has a right of reference, what scientific findings may be
applied across the sponsor's oligonucleotide therapeutics with shared
characteristics (e.g., similar backbone modifications)?
    FDA will consider all information and comments submitted.

III. Electronic Access

    Persons with access to the internet may obtain relevant clinical
pharmacology guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: August 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16880 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42717-42718]
[FR Doc No: 2022-15256]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER22-2347-000.
    Applicants: American Electric Power Service Corporation, Ohio Power
Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii: AEP
submits one amended Facilities Agreement re: ILDSA, SA No. 1336 to be
effective 9/12/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5079.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2348-000.
    Applicants: Tucson Electric Power Company.
    Description: Compliance filing: Order No. 881 Compliance Filing to
be effective 7/12/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5089.Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2349-000.
    Applicants: UNS Electric, Inc.
    Description: Compliance filing: Order No. 881 Compliance Filing to
be effective 7/12/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5093.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2350-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing: Compliance Filing of Tariff
Revisions re: Order No. 881 Transmission Line Ratings to be effective
12/31/9998.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5098.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2351-000.
    Applicants: Avista Corporation.
    Description: Compliance filing: Avista Corp Order No. 881
Compliance Filing to be effective 7/13/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5103.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2352-000.
    Applicants: Duke Energy Florida, LLC, Duke Energy Progress, LLC,
Duke Energy Carolinas, LLC.
    Description: Compliance filing: Duke Energy Florida, LLC submits
tariff filing per 35: Compliance Filing for Order No. 881 to be
effective 7/12/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5107.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2353-000.
    Applicants: Florida Power & Light Company.
    Description: Compliance filing: FPL Order No. 881 Compliance Filing
to be effective 9/11/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5111.Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2354-000.
    Applicants: GridLiance High Plains LLC.
    Description: Compliance filing: GHP Order 881 Compliance Filing to
be effective 9/11/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5119.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2355-000.
    Applicants: GridLiance Heartland LLC.
    Description: Compliance filing: GLH Order 881 Compliance Filing to
be effective 9/11/2022.

    Filed Date: 7/12/22.
    Accession Number: 20220712-5124.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2356-000.
    Applicants: Public Service Company of Colorado.
    Description: Compliance filing: 2022-07-12 Att S--Trans Line
Ratings--Order No. 881 to be effective 7/12/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5132.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2357-000.
    Applicants: ISO New England Inc., Eversource Energy Service Company
(as agent), Cross-Sound Cable Company, LLC, New England Power Pool
Participants Committee, The United Illuminating Company.
    Description: Compliance filing: ISO New England Inc. submits tariff
filing per 35: Amendments to ISO-NE Tariff in Compliance with Order No.
881 to be effective 9/10/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5139.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2358-000.
    Applicants: Versant Power.
    Description: Compliance filing: Order No. 881 Compliance Filing for
Versant Power, Maine Public District to be effective 7/12/2022.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5160.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2359-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Order Nos. 881 and 881-A Compliance
Filing to be effective 12/31/9998.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5161.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2360-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Compliance filing: Compliance Filing to Order No. 881
to be effective 12/31/9998.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5163.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2361-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Compliance filing: Order No. 881 Compliance Filing to
be effective 7/12/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5167.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2362-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2022-07-12 Compliance
Filing--FERC Order No. 881 to be effective 12/31/9998.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5170.
    Comment Date: 5 p.m. ET 8/2/22.

    Docket Numbers: ER22-2363-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2022-07-12_Compliance Filing on
Order 881 Managing Transmission Line Ratings to be effective 7/11/2025.
    Filed Date: 7/12/22.
    Accession Number: 20220712-5175.
    Comment Date: 5 p.m. ET 8/2/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: July 12, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-15256 Filed 7-15-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Page 8052]
[FR Doc No: 2010-3460]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. ER10-426-001]

Stetson Wind II, LLC; Notice of Filing

February 12, 2010.
    Take notice that, on February 5, 2010, Stetson Wind II, LLC filed
to amend, its filing in the above captioned docket with information
required under the Commission's regulations. Such filing served to
reset the filing date in this proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 19, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-3460 Filed 2-22-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 13 (Friday, January 22, 2021)]
[Notices]
[Pages 6643-6644]
[FR Doc No: 2021-01365]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9054-9]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed January 11, 2021 10 a.m. EST Through January 14, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210006, Final Supplement, NRCS, MO, East Locust Creek
Watershed Revised Plan, Review Period Ends: 02/22/2021, Contact: Chris
Hamilton<PHONE_NUMBER>.
EIS No. 20210007, Draft, USFS, DC, 36 CFR 228, Subpart A, Locatable
Minerals, Comment Period Ends: 03/22/2021, Contact: Michael Fracasso
303-241-3330.
EIS No. 20210008, Final, BLM, CA, Crimson Solar Project Final
Environmental Impact Statement and Proposed Land Use Amendment to the
California Desert Conservation Area Plan, Review Period Ends: 02/22/
2021, Contact: Miriam Liberatore<PHONE_NUMBER>.
EIS No. 20210009, Final, FTA, PA, King of Prussia Rail Extension
Project, Contact: Tim Lidiak<PHONE_NUMBER>.

    Under 23 U.S.C. 139(n)(2), FTA has issued a single FEIS and ROD.
Therefore, the 30-day wait/review period under NEPA does not apply to
this action.

EIS No. 20210010, Draft, FRA, MD, Draft Environmental Impact Statement
and Draft Section 4(f) Evaluation Baltimore-Washington Superconducting
MAGLEV Project, Comment Period Ends: 04/22/2021, Contact: Brandon
Bratcher<PHONE_NUMBER>.

Amended Notice

EIS No. 20200215, Draft, USFS, OR, Stella Restoration Project, Comment
Period Ends: 01/12/2021, Contact: Elizabeth Bly<PHONE_NUMBER>.

    Revision to FR Notice Published 10/30/2020; Correction to Comment
Period Due Date from December 14, 2020 to January 12, 2021.

EIS No. 20200238, Draft, USFS, OR, VOID--Stella Restoration Project,

Comment Period Ends: 01/12/2021, Contact: Elizabeth Bly<PHONE_NUMBER>.

    Revision to FR Notice Published 11/27/2020; Retracted due to
erroneous filing.

    Dated: January 15, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-01365 Filed 1-21-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Rules and Regulations]
[Page 23631]
[FR Doc No: 2016-09347]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0309]

Drawbridge Operation Regulation; Arthur Kill, Staten Island, New
York

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Arthur Kill (AK) Railroad Bridge
across Arthur Kill, mile 11.6, between Staten Island, New York and
Elizabeth, New Jersey. This deviation allows the bridge to remain in
the closed position to facilitate bridge inspection.

DATES: This deviation is effective from 7:28 a.m. on July 16, 2016, to
5:41 p.m. July 24, 2016.

ADDRESSES: The docket for this deviation [USCG-2016-0309] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Joe Arca, Project Officer, First
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The AK Railroad Bridge, across Arthur Kill,
mile 11.6, between Staten Island, New York and Elizabeth, New Jersey
has a vertical clearance in the closed position of 31 feet at Mean High
Water and 35 feet at Mean Low Water. The existing drawbridge operation
regulations are listed at 33 CFR 117.702.
    The waterway supports both commercial and recreational navigation
of various vessel sizes. The operator of the bridge, Consolidated Rail
Corporation (Conrail), requested a temporary deviation to facilitate
scheduled bridge inspection of the movable span of the bridge. The
bridge must remain in the closed position to perform this inspection.
    Under this temporary deviation, the AK Railroad Bridge may remain
in the closed position as follows:

On July 16, 2016 from 7:28 a.m. to 11:31 a.m. and from 1:31 p.m. to
5:48 p.m.
On July 17, 2016 from 8:16 a.m. to 12:17 p.m. and 2:17 p.m. to 6:29
p.m.
On July 23, 2016 from 6:32 a.m. to 10:29 a.m. and from 12:29 p.m. to
4:47 p.m.
On July 24, 2016 from 7:16 a.m. to 11:22 a.m. and from 1:22 p.m. to
5:41 p.m.

    Vessels able to pass through the bridge in the closed positions may
do so at anytime. There are no alternate routes for vessel traffic. The
bridge can be opened in an emergency. The Coast Guard will also inform
the users of the waterway through our Local and Broadcast Notices to
Mariners of the change in operating schedule for the bridge so that
vessels can arrange their transits to minimize any impact caused by the
temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: April 19, 2016.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-09347 Filed 4-21-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32656-32657]
[DOCID:fr08jy09-115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 60203; File No. SR-NASDAQ-2009-053]

Securities Exchange Act of 1934; In the Matter of The NASDAQ
Stock Market LLC

June 30, 2009.

Order of Summary Abrogation

    Notice is hereby given that the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(3)(C) of the Securities
Exchange Act of 1934 (``Act''),\1\ is summarily abrogating a certain
proposed rule change of The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

    On June 24, 2009, NASDAQ filed SR-NASDAQ-2009-053. The proposed
rule change establishes a four-month pilot program that would reduce
transaction fees for members that trade equities on NASDAQ provided
that they also make markets in options on the NASDAQ OMX PHLX, Inc.
(``Phlx'') options exchange. The proposed rule change was immediately
effective upon filing with the Commission pursuant to Section
19(b)(3)(A) of the Act.\2\
---------------------------------------------------------------------------

    \2\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(3)(C) of the Act,\3\ at any time within
60 days of the date of filing a proposed rule change pursuant to
Section 19(b)(1) of the Act,\4\ the Commission may summarily abrogate
the change in the rules of the self-regulatory organization and require
that the proposed rule change be re-filed in accordance with the
provisions of Section 19(b)(1) of the Act \5\ and reviewed in
accordance with Section 19(b)(2) of the Act,\6\ if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(C).
    \4\ 15 U.S.C. 78s(b)(1).
    \5\ Id.
    \6\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    NASDAQ proposes to offer a reduced transaction fee for securities
listed on NASDAQ and the New York Stock Exchange LLC (``NYSE'') only to
member firms that: (1) Make markets in 400 or more options classes as a
Specialist, Streaming Quote Trader, or Remote Streaming Quote Trader on
Phlx; and (2) add average daily volume of 35 million shares of
liquidity on NASDAQ. Member firms meeting these criteria would pay a
reduced transaction fee of $0.0027 per share executed on NASDAQ for
securities listed on NASDAQ or NYSE. The Commission is concerned about
whether the proposal is consistent with the statutory requirements
applicable to a national securities exchange under the Act, including,
among other provisions, Section 6(b)(4) of the Act,\7\ which requires
that the rules of a national securities exchange provide for the
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other parties

using its facilities; Section 6(b)(5) of the Act,\8\ which requires,
among other things, that the rules of a national securities exchange
not be designed to permit unfair discrimination between customers,
issuers, brokers, or dealers; and Section 6(b)(8) of the Act,\9\ which
requires that the rules of a national securities exchange do not impose
any burden on competition not necessary or appropriate in furtherance
of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(4).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Accordingly, the Commission believes that the procedures provided
by Section 19(b)(2) of the Act \10\ will provide a more appropriate
mechanism for determining whether the proposed rule change is
consistent with the Act. Therefore, the Commission finds that it is
appropriate in the public interest, for the protection of investors,
and otherwise in furtherance of the purposes of the Act, to abrogate
the proposed rule change.
---------------------------------------------------------------------------

    \10\ Id.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(3)(C) of the
Act,\11\ that File No. SR-NASDAQ-2009-053, be and hereby is, summarily
abrogated. If NASDAQ chooses to re-file the proposed rule change, it
must do so pursuant to Sections 19(b)(1) \12\ and 19(b)(2) of the
Act.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(C).
    \12\ 15 U.S.C. 78s(b)(1).
    \13\ 15 U.S.C. 78s(b)(2).

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-15998 Filed 7-7-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 8, 2009 (Volume 74, Number 108)]
[Rules and Regulations]
[Page 27078-27079]
[DOCID:fr08jn09-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0115; Airspace Docket No. 09-AGL-3]

Amendment of Class E Airspace; Mount Sterling, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at Mount Sterling, IL.
Additional controlled airspace is necessary to accommodate Area
Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at
Mount Sterling Municipal Airport, Mount Sterling, IL. The FAA is taking
this action to enhance the safety and management of Instrument Flight
Rule (IFR) operations at Mount Sterling Municipal Airport.

DATES: Effective Date: 0901 UTC, August 27, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone (817)
321-7716.

SUPPLEMENTARY INFORMATION:

History

    On March 9, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Mount
Sterling, IL, adding additional controlled airspace at Mount Sterling
Municipal Airport, Mount Sterling, IL. (74 FR 9974, Docket No. FAA-
2009-0115). Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received. Class E airspace designations are
published in paragraph 6005 of FAA Order 7400.9S signed October 3,
2008, and effective October 31, 2008, which is incorporated by
reference in 14 CFR Part 71.1. The Class E airspace designations listed
in this document will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace at Mount Sterling, IL, adding
additional controlled airspace at Mount Sterling Municipal Airport,
Mount Sterling, IL, for the safety and management of IFR operations.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it adds additional controlled airspace at Mount Sterling Municipal
Airport, Mount Sterling, IL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

AGL IL E5 Mount Sterling, IL [Amended]

Mount Sterling Municipal Airport, IL
    (Lat. 39[deg]59'07'' N., long. 90[deg]48'15'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Mount Sterling Municipal Airport.
* * * * *

    Issued in Fort Worth, Texas, on May 14, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-13185 Filed 6-5-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Rules and Regulations]
[Page 39688]
[FR Doc No: 2015-16985]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-1036]

Safety Zones; Recurring Marine Events in Captain of the Port Long
Island Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce two safety zones for fireworks
displays in the Sector Long Island Sound area of responsibility on the
dates and times listed in the table below. This action is necessary to
provide for the safety of life on navigable waterways during the
events. During the enforcement periods, no person or vessel may enter
the safety zones without permission of the Captain of the Port (COTP)
Sector Long Island Sound or designated representative.

DATES: The regulations in 33 CFR 165.151 will be enforced during the
dates and times as listed in the SUPPLEMENTARY INFORMATION section of
this document.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email Petty Officer Ian Fallon, Waterways
Management Division, U.S. Coast Guard Sector Long Island Sound;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.151 on the specified dates and times as
indicated in the following Table.

                        Table 1 To Sec.   165.151
------------------------------------------------------------------------

------------------------------------------------------------------------
7.8 Westport Police Athletic League       Date: July 3, 2015.
 Fireworks.                               Rain Date: July 6,
                                          2015.
                                          Time: 8:30 p.m. to
                                          10:00 p.m.
                                          Location: Waters off
                                          Compo Beach, Westport, CT in
                                          approximate position,
                                          41[deg]06'15'' N,
                                          073[deg]20'57'' W (NAD 83).
7.29 Mashantucket Pequot Fireworks.....   Date: July 11, 2015.
                                          Rain Date: July 12,
                                          2015.
                                          Time: 8:30 p.m. to
                                          10:30 p.m.
                                          Location: Waters of
                                          the Thames River New London,
                                          CT in approximate positions
                                         Barge 1, 41[deg]21'03.03'' N,
                                          072[deg]5'24.5'' W
                                         Barge 2, 41[deg]20'51.75'' N,
                                          072[deg]5'18.90'' W (NAD 83).
------------------------------------------------------------------------

    Under the provisions of 33 CFR 165.151, the fireworks displays
listed above are established as safety zones. During the enforcement
periods, persons and vessels are prohibited from entering into,
transiting through, mooring, or anchoring within the safety zones
unless they receive permission from the COTP or designated
representative.
    This notice of enforcement is issued under authority of 33 CFR part
165 and 5 U.S.C. 552 (a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of this enforcement period via the Local Notice to
Mariners or marine information broadcasts. If the COTP determines that
the safety zones need not be enforced for the full duration stated in
this notice of enforcement, a Broadcast Notice to Mariners may be used
to grant general permission to enter the regulated area.

    Dated: June 24, 2015.
H.L. Morrison,
Commander, U.S. Coast Guard, Acting Captain of the Port Sector Long
Island Sound.
[FR Doc. 2015-16985 Filed 7-9-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8620-8622]
[FR Doc No: 2011-3347]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0594; Directorate Identifier 98-ANE-43-AD;
Amendment 39-16604; AD 2011-04-04]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney JT8D-209, -217, -217A,
-217C, and -219 Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for Pratt & Whitney (PW) JT8D-209, -217, -217A, -217C, and -219
turbofan engines. That AD currently requires revisions to the engine
manufacturer's time limits section (TLS) to include enhanced inspection
of selected critical life-limited parts at each piece-part opportunity.
This new AD modifies the TLS of the manufacturer's engine manual and an
air carrier's approved continuous airworthiness maintenance program to
incorporate additional inspection requirements. This AD was prompted by
PW developing, and the FAA approving, improved inspection procedures
for the critical life-limited parts. The mandatory inspections are
needed to identify those critical rotating parts with conditions, which
if allowed to continue in service, could result in uncontained
failures. We are issuing this AD to prevent critical life-limited
rotating engine part failure, which could result in an uncontained
engine failure and damage to the airplane.

DATES: This AD is effective March 22, 2011.

ADDRESSES:

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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ian Dargin, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>, fax:
781-238-7199; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2005-18-02, Amendment 39-14242 (70 FR 71610,
November 29, 2005). That AD applies to the specified products. The NPRM
published in the Federal Register on August 18, 2010 (75 FR 50945).
That NPRM proposed to modify the TLS of the manufacturer's engine
manual and an air carrier's approved continuous airworthiness
maintenance program to incorporate additional inspection requirements.
PW has developed and the FAA has approved improved inspection
procedures for the critical life-limited parts. The mandatory
inspections are needed to identify those critical rotating parts with
conditions which, if allowed to continue in service, could result in
uncontained failures.

Comment

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
and the FAA's response to the comment.

Request

    One commenter, American Airlines, requested that we change the

compliance time from within 30 days after the effective date of the AD,
to within 180 days after the effective date of the AD. This change
would give PW the time to revise fan hub inspection Alert Service
Bulletin No. A6272, dated September 24, 1996, to obtain an Alternative
Method of Compliance to fan hub inspection AD 97-17-04R1, and to allow
automatic eddy current inspection per engine manual Section 72-33-31,
Inspection No.-05.
    We agree. Availability of the tooling will take about 6 months, and
the risk will be negligible since a manual inspection is now in place.
We revised this AD as requested.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously. We also determined that this
change will not increase the economic burden on any operator nor
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 1,143 JT8D-209, -217, -217A, -
217C, and -219 turbofan engines installed on airplanes of U.S.
registry. We also estimate that it will take about 10 work-hours per
engine to perform the actions, and that the average labor rate is $85
per work-hour. Since this is an added inspection requirement, included
as part of the normal maintenance cycle, no additional part costs are
involved. Based on these figures, we estimate the total cost of the AD
to U.S. operators to be $971,550.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under 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, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-14242 (70 FR
71610, November 29, 2005), and adding the following new AD:

2011-04-04 Pratt & Whitney: Amendment 39-16604. Docket No. FAA-2010-
0594; Directorate Identifier 98-ANE-43-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective March 22,
2011.

Affected ADs

    (b) This AD supersedes AD 2005-18-02, Amendment 39-14242.

Applicability

    (c) This AD applies to Pratt & Whitney (PW) JT8D-209, -217, -
217A, -217C, and -219 turbofan engines. These engines are installed
on, but not limited to Boeing 727 and McDonnell Douglas MD-80 series
airplanes.

Unsafe Condition

    (d) This AD results from the need to require enhanced inspection
of selected critical life-limited parts of JT8D-209, -217, -217A, -
217C, and -219 turbofan engines. We are issuing this AD to prevent
critical life-limited rotating engine part failure, which could
result in an uncontained engine failure and damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified unless the
actions have already been done.
    (f) Within the next 180 days after the effective date of this
AD, (1) revise the Time Limits section (TLS) of the manufacturer's
engine manual, part number 773128, as appropriate for PW JT8D-209, -
217, -217A, -217C, and -219 turbofan engines, and (2) for air
carriers, revise the approved mandatory inspections section of the
continuous airworthiness maintenance program, by adding the
following:

``Critical Life Limited Part Inspection

    A. Inspection Requirements:
    (1) This section contains the definitions for individual engine
piece-parts and the inspection procedures, which are necessary, when
these parts are removed from the engine.
    (2) It is necessary to do the inspection procedures of the
piece-parts in Paragraph B when:
    (a) The part is removed from the engine and disassembled to the
level specified in paragraph B and
    (b) The part has accumulated more than 100 cycles since the last
piece-part inspection, provided that the part is not damaged or
related to the cause of its removal from the engine.
    (3) The inspections specified in this section do not replace or
make unnecessary other recommended inspections for these parts or
other parts.
    B. Parts Requiring Inspection.

    Note:  Piece-part is defined as any of the listed parts with all
the blades removed.

------------------------------------------------------------------------
           Description                  Section         Inspection No.
------------------------------------------------------------------------
Hub (Disk), 1st Stage
 Compressor:
    * Hub Detail--All P/Ns......            72-33-31       -03, -04, -05
    * Hub Assembly--All P/Ns....            72-33-31       -03, -04, -05
Disk, 13th Stage Compressor--All            72-36-47                 -02
 P/Ns...........................
HP Turbine, First Stage:
    Rotor Assembly--All P/Ns....            72-52-02                 -04

    Disk--All P/Ns..............            72-52-02                 -03
Disk, 2nd Stage Turbine--All P/             72-53-16                 -02
 Ns.............................
* Disk, 3rd Stage Turbine--All P/           72-53-17            -02, -03
 Ns.............................
* Disk, 4th Stage Turbine--All P/           72-53-18            -02, -03
 Ns.............................
------------------------------------------------------------------------

     (g) The parts that have an Engine Manual Inspection Task and or
Sub Task Number reference updated in the table of this AD, are
identified by an asterisk (*) that precedes the part nomenclature.
    (h) Except as provided in paragraph (i) of this AD, and
notwithstanding contrary provisions in section 43.16 of the Federal
Aviation Regulations (14 CFR 43.16), these mandatory inspections
shall be performed only in accordance with the TLS of the
manufacturer's engine manual.

Alternative Methods of Compliance (AMOC)

    (i) You must perform these mandatory inspections using the TLS
of the manufacturer's engine manual unless you receive approval to
use an AMOC under paragraph (j) of this AD. Section 43.16 of the
Federal Aviation Regulations (14 CFR 43.16) may not be used to
approve alternative methods of compliance or adjustments to the
times in which these inspections must be performed.
    (j) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Maintaining Records of the Mandatory Inspections

    (k) You have met the requirements of this AD when you revise the
TLS of the manufacturer's engine manual as specified in paragraph
(f) of this AD. For air carriers operating under part 121 of the
Federal Aviation Regulations (14 CFR part 121), you have met the
requirements of this AD when you modify your continuous
airworthiness maintenance plan to reflect those changes. You do not
need to record each piece-part inspection as compliance to this AD,
but you must maintain records of those inspections according to the
regulations governing your operation. For air carriers operating
under part 121, you may use either the system established to comply
with section 121.369 or an alternative accepted by your principal
maintenance inspector if that alternative:
    (1) Includes a method for preserving and retrieving the records
of the inspections resulting from this AD; and
    (2) Meets the requirements of section 121.369(c); and
    (3) Maintains the records either indefinitely or until the work
is repeated.
    (l) These record keeping requirements apply only to the records
used to document the mandatory inspections required as a result of
revising the TLS of the manufacturer's engine manual as specified in
paragraph (f) of this AD. These record keeping requirements do not
alter or amend the record keeping requirements for any other AD or
regulatory requirement.

Related Information

    (m) For more information about this AD, contact Ian Dargin,
Aerospace Engineer, Engine Certification Office, FAA, Engine and
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; e-mail<EMAIL_ADDRESS>phone:<PHONE_NUMBER>, fax: 781-
238-7199.

    Issued in Burlington, Massachusetts, on February 3, 2011.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2011-3347 Filed 2-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 16, 2007 (Volume 72, Number 158)]
[Proposed Rules]
[Page 45949-45952]
[DOCID:fr16au07-16]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28942; Directorate Identifier 2007-NM-093-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-100, -200, -200C, -
300, -400, and -500 Series Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500
series airplanes. This proposed AD would require repetitive detailed
and high-frequency eddy current inspections for cracking around the
heads of the fasteners on the forward fastener row of certain areas of
the station (STA) 259.5 circumferential butt splice, and repair if
necessary. This proposed AD would also require a preventive
modification, which would eliminate the need for the repetitive
inspections. This proposed AD results from a report that an operator
found multiple cracks in the fuselage skin of a Model 737-200 airplane,
at the forward fastener row of the STA 259.5 circumferential butt
splice between stringers 19 and 24. We are proposing this AD to prevent
cracking of the STA 259.5 circumferential butt splice, which could
result in loss of structural integrity of the fuselage skin and
possible loss of cabin pressure.

DATES: We must receive comments on this proposed AD by October 1, 2007.

ADDRESSES: Use one of the following addresses to submit comments on
this proposed AD.
     DOT Docket Web site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Government-wide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     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.
     Fax:<PHONE_NUMBER>.
     Hand Delivery: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle,
Washington 98124-2207, for the service information identified in this
proposed AD.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6447; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to submit any relevant written data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed in the ADDRESSES section. Include the docket number ``Docket No.
FAA-2007-28942; Directorate Identifier 2007-NM-093-AD'' at the
beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of the
proposed AD. We will consider all comments received by the closing date
and may amend the proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact with FAA
personnel concerning this proposed AD. Using the search function of
that Web site, anyone can find and read the comments in any of our
dockets, including the name of the individual who sent the comment (or
signed the comment on behalf of an association, business, labor union,
etc.). You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78), or you
may visit http://dms.dot.gov.

Examining the Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
, or in person at the Docket Operations office between 9

a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
Docket Operations office (telephone<PHONE_NUMBER>) is located on the
ground floor of the West Building at the DOT street address stated in
the ADDRESSES section. Comments will be available in the AD docket
shortly after the Docket Management System receives them.

Discussion

    We have received a report indicating that an operator found
multiple cracks in the fuselage skin of a Model 737-200 airplane that
had accumulated 69,350 total flight cycles. The cracking was found at
the forward fastener row of the station (STA) 259.5 circumferential
butt splice between stringers 19 and 24, and some cracks had joined
into one large crack. This condition, if not corrected, could result in
loss of structural integrity of the fuselage skin and possible loss of
cabin pressure.

Relevant Service Information

    We have reviewed Boeing Special Attention Service Bulletin 737-53-
1267, dated November 28, 2006. The service bulletin describes
procedures for doing repetitive detailed and high-frequency eddy
current (HFEC) surface inspections for cracking around the heads of the
fasteners on the forward fastener row of certain areas of the STA 259.5
circumferential butt splice, and applicable repair if necessary.
Certain areas of the circumferential butt splice are those described in
the Accomplishment Instructions of Service Bulletin 737-53-1267 as
areas that have not had a preventive modification installed in
accordance with Boeing Service Bulletin 737-53-1076, or have not had a
Boeing, FAA-approved repair accomplished.
    The service bulletin also describes procedures for doing a
preventive modification of certain areas of the STA 259.5
circumferential butt splice, including removing the existing fasteners,
doing an HFEC rotary probe inspection of the fastener holes, and, if no
crack is found, oversizing the holes and installing new protruding head
fasteners. The preventive modification eliminates the need for the
repetitive inspections.
    The service bulletin specifies compliance times that depend upon
the number of total flight cycles accumulated by the airplane.
Compliance times for doing the initial inspections begin at or before
the accumulation of 50,000 total flight cycles, with grace periods
ranging between 500 and 4,500 flight cycles after the release date of
the service bulletin. The service bulletin specifies that repetitive
inspections shall be done thereafter at intervals of 9,000 flight
cycles, until the preventive modification is done. The service bulletin
specifies that all repairs are to be done before further flight and
that the preventive modification is to be done before the accumulation
of 75,000 total flight cycles or within 6,000 flight cycles after the
release date of the service bulletin, whichever comes later.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously.

Costs of Compliance

    There are about 2,150 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD, at an average labor
rate of $80 per work hour. Required parts would be supplied by the
operator.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                         Number of U.S.-
                Action                  Work       Cost per airplane       registered           Fleet cost
                                        hours                               airplanes
----------------------------------------------------------------------------------------------------------------
Inspection...........................       5  $400, per inspection                 654  $261,600, per
                                                cycle.                                    inspection cycle.
Preventive modification..............      24  $1,920..................             654  $1,255,680.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

products identified in this rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-28942; Directorate Identifier 2007-NM-
093-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by October
1, 2007.

Affected ADs

    (b) Accomplishing repairs and modifications described in
paragraphs (f) and (g) of this AD is considered acceptable for
compliance with repair requirements of paragraphs (f) and (g) of AD
92-25-09, amendment 39-8424, for the areas of the station (STA)
259.5 circumferential butt splice only.

Applicability

    (c) This AD applies to Boeing Model 737-100, -200, -200C, -300,
-400, and -500 series airplanes, certificated in any category, as
identified in Boeing Special Attention Service Bulletin 737-53-1267,
dated November 28, 2006.

Unsafe Condition

    (d) This AD results from a report that an operator found
multiple cracks in the fuselage skin of a Model 737-200 airplane, at
the forward fastener row of the STA 259.5 circumferential butt
splice between stringers 19 and 24. We are issuing this AD to
prevent cracking of the STA 259.5 circumferential butt splice, which
could result in loss of structural integrity of the fuselage skin
and possible loss of cabin pressure.

Compliance

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

Inspections

    (f) At the applicable initial compliance time specified in
paragraph 1.E. ``Compliance'' of Boeing Special Attention Service
Bulletin 737-53-1267, dated November 28, 2006, except as provided by
paragraph (j) of this AD: Do detailed and high-frequency eddy
current inspections for cracking around the heads of the fasteners
on the forward fastener row of certain areas of the station (STA)
259.5 circumferential butt splice, by doing all of the actions
specified in Part 1 of the Accomplishment Instructions of the
service bulletin, except as provided by paragraph (i) of this AD.
Repeat the inspections thereafter at the intervals specified in
paragraph 1.E. of the service bulletin. Doing the preventive
modification specified in paragraph (h) of this AD terminates the
repetitive inspection requirements of this paragraph.

Repair

    (g) If any crack is found during any inspection required by this
AD, before further flight, repair in accordance with Part 1 of the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 737-53-1267, dated November 28, 2006.

Preventive Modification

    (h) At the compliance time specified in paragraph 1.E. of Boeing
Special Attention Service Bulletin 737-53-1267, dated November 28,
2006, except as provided by paragraph (j) of this AD: Do the
preventive modification in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 737-53-
1267, dated November 28, 2006. Doing the preventive modification
terminates the repetitive inspections required by paragraph (f) of
this AD.

Modification or Repair Done in Accordance with AD 92-25-09

    (i) Inspections described by paragraph (f) of this AD are not
required for areas of the STA 259.5 circumferential butt splice that
have been modified in accordance with the service information
specified in Table 1 of this AD. (Boeing Service Bulletin 737-53-
1076, Revision 4, dated September 26, 1991, is cited as an
appropriate source of service information for doing certain
requirements of AD 92-25-09.)

                                          Table 1.--Service Information
----------------------------------------------------------------------------------------------------------------
        Boeing Service Bulletin                    Revision level                            Date
----------------------------------------------------------------------------------------------------------------
737-53-1076...........................  4..................................  September 26, 1991.
737-53-1076...........................  3..................................  September 20, 1990.
737-53-1076...........................  2..................................  February 8, 1990.
737-53-1076...........................  1..................................  November 23, 1988.
737-53-1076...........................  Original Issue.....................  October 30, 1986.
----------------------------------------------------------------------------------------------------------------

Compliance Times

    (j) Where the service bulletin specifies compliance times
relative to the release date of Boeing Special Attention Service
Bulletin 737-53-1267, dated November 28, 2006, this AD requires
compliance at compliance times relative to the effective date of
this AD.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing

Commercial Airplanes Delegation Option Authorization Organization
who has been authorized by the Manager, Seattle ACO, to make those
findings. For a repair method to be approved, the repair must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

    Issued in Renton, Washington, on July 30, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-16104 Filed 8-15-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2865-2866]
[FR Doc No: 2010-782]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0488]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Records and Reports
Concerning Experience With Approved New Animal Drugs; Adverse Event
Reports on Forms FDA 1932, 1932a, and 2301

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by
February 18, 2010.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0284.
Also include the FDA docket number found in brackets in the heading of
this document

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

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

Records and Reports Concerning Experience With Approved New Animal
Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301 (OMB
Control Number 0910-0284)--Extension

    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360b(l) and Sec.  514.80 (21 CFR 514.80) of FDA
regulations require applicants of approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects (see Sec.
514.80(b)).
    This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously
submitted to FDA may not be adequate, as animal drug effects can change
over time and less apparent effects may take years to manifest.
    Under Sec.  514.80(d), an applicant must report adverse drug
experiences and product/manufacturing defects on Form FDA 1932,
``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product
Defect Report.'' Periodic drug experience reports and special drug
experience reports must be accompanied by a completed Form FDA 2301,
``Transmittal of Periodic Reports and Promotional Material for New
Animal Drugs'' (see Sec.  514.80(d)). Form FDA 1932a, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report''
allows for voluntary reporting of adverse drug experiences or product/
manufacturing defects.
    The electronic versions of Forms FDA 1932 and 1932a have been
incorporated into the agency-wide information collection
(MedWatch\Plus\Portal and Rational Questionnaire) that was announced
for public comment in the Federal Register on October 23, 2008 (73 FR
63153). MedWatch\Plus\ Portal and Rational Questionnaire is part of a
new electronic system for collecting, submitting, and processing
adverse event reports and other safety information for all FDA-
regulated products. In the Federal Register of May 20, 2009 (74 FR
23721), FDA announced the submission for OMB review and clearance of
the electronic data collection using MedWatch\Plus\ Portal and Rational
Questionnaire.
    Burden hours for the electronic versions of these forms were
included as part of the MedWatch\Plus\ Portal and Rationale
Questionnaire information collection approved under OMB control number
0910-0645. It is estimated that, during the first 3 years that the
MedWatch\Plus\ Portal is in use, half of the reports will be submitted
in paper format and half will be submitted electronically. In order to
avoid double counting, an estimated 50 percent of total annual
responses for FDA Form 1932 (404) and FDA Form 1932a (81.5) are counted
here as part of OMB Control No. 0910-0284 for the paper versions of
Forms FDA 1932 and 1932a, and an estimated 50 percent of the total
annual responses (404) and (81.5) for Form FDA 1932 and FDA Form 1932a
respectively, are counted as part of OMB Control No. 0910-0645 for the
electronic reporting of these adverse reports using the MedWatch\Plus\
Portal.
    In the Federal Register of October 15, 2009 (74 FR 52967), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    In a separate 30-day notice, FDA requested public comment on data
elements associated with revisions to Forms FDA 1932 and 1932a (both
paper and electronic) under revised OMB Control No. 0910-0645 (November
20, 2009, 74 FR 60265). The agency plans to give companies time to
accommodate the revisions since the proposed revisions may require
changes to validated databases. The agency plans to provide a
transition period for respondents until September 30, 2010, during
which the current FDA Form 1932 (version dated 01/2007-- approved under
this OMB Control No. 0910-0284) will be accepted as well as the revised
FDA Form 1932 approved under revised OMB Control No. 0910-0645. After
the transition period, Form FDA 2301 will

continue to be counted as part of OMB Control No. 0910-0284.
    The reporting and recordkeeping burden estimates, including the
total number of annual responses, are based on the submission of
reports to the Division of Surveillance, Center for Veterinary
Medicine. The annual frequency of responses was calculated as the total
annual responses divided by the number of respondents.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      No. of      Annual Frequency      Total Annual      Hours per
      21 CFR Section or Section  of the Act        FDA Form No.    Respondents      per Response          Responses        Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3)          1932\2\          404                44.26             17,881             1             17,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary reporting FDA Form 1932a for the              1932a\2\           81.5               1                    81.5        1\3\                 81.5
 public
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(4)                                                2301           84                17.0               1,428            16             22,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(i)                                             2301           84                 0.31                 26             2                 52
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(ii)                                            2301           84                33.92              2,849             2              5,698
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(iii)                                           2301          646                 0.08                 51.68          2                103
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total hours                                                                                46,663.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden hours were determined as explained previously.
\3\ The hours per response for paper versions of Forms FDA 1932 and 1932a are assumed to be 1 hour. The hours per response for the electronic version of
  Form FDA 1932 is assumed to be 1 hour, while the electronic version of Form FDA 1932a is assumed to take .6 hours to complete the form and gather the
  required information as part of the MedWatch\Plus\ Portal information collection (see 74 FR 23721 at 23727).

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR        No. of         Annual Frequency
Section    Recordkeepers     per Recordkeeping    Total Annual  Records   Hours per  Record      Total Hours
----------------------------------------------------------------------------------------------------------------
514.80(                646                 7.20                    4,651                 14             65,116.8
 e)\2\
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Section 514.80(e) covers all recordkeeping hours for all adverse event reporting.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-782 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S