[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26422-26423]
[FR Doc No: 2014-10583]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER10-1982-008; ER10-1253-007; ER10-1246-007; ER10-
1252-007.
    Applicants: Consolidated Edison Company of New York, Inc., Orange
and Rockland Utilities, Inc., Consolidated Edison Energy, Inc.,
Consolidated Edison Solutions, Inc.
    Description: Supplement to December 18, 2013 Triennial Market Power
Analysis in Northeast region of the Con Edison Companies.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5590.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER12-1436-006; ER14-152-001; ER14-153-001; ER14-
154-001; ER13-1793-003; ER10-3300-006; ER13-2386-001; ER10-3099-007;
ER12-1260-005; ER10-2329-003.
    Applicants: Eagle Point Power Generation LLC, Elgin Energy Center,
LLC, Gibson City Energy Center, LLC, Grand Tower Energy Center, LLC,
Hazle Spindle, LLC, La Paloma Generating Company, LLC, Lakeswind Power
Partners, LLC, RC Cape May Holdings, LLC, Stephentown Spindle, LLC,
Vineland Energy LLC.
    Description: Supplement to February 27, 2014 Notice of Change in
Status of the Rockland Sellers.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5209.
    Comments Due: 5 p.m. E.T. 5/22/14.

    Docket Numbers: ER14-727-001.
    Applicants: ISO New England Inc.
    Description: Demand Response Baseline Changes Compliance Filing to
be effective N/A.
    Filed Date: 5/1/14.
    Accession Number: 20140501-5128.
    Comments Due: 5 p.m. E.T. 5/22/14.

    Docket Numbers: ER14-1817-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-04-30--ER14-000 RSG Exemptions during emergencies
to be effective 5/1/2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5469.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1818-000.
    Applicants: Edison Mission Marketing & Trading, LLC.
    Description: Notice of Succession and Revisions to Market-Based
Rate Tariff to be effective 5/1/2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5471.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1819-000.
    Applicants: Southwestern Public Service Company.
    Description: 4-30-14--RS114-117 Consent Agrmts to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5478.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1820-000.
    Applicants: NRG Power Marketing LLC.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5484.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1821-000.
    Applicants: GenOn Energy Management, LLC.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5485.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1822-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Unexecuted service agreement between NYISO and TCR to
be effective 5/1/2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5488.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1823-000.
    Applicants: Energy Plus Holdings LLC.

    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5491.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1824-000.
    Applicants: CP Power Sales Twenty, L.L.C.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5495.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1825-000.
    Applicants: Hardwood Energy, LLC.
    Description: Cancellation of MBR Tariff to be effective 5/1/2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5497.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1826-000.
    Applicants: California Power Exchange Corporation.
    Description: Rate Filing for Rate Period 25 to be effective 7/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5530.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1827-000.
    Applicants: RRI Energy Services, LLC.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5536.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1828-000.
    Applicants: CP Power Sales Nineteen, L.L.C.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5539.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1829-000.
    Applicants: CP Power Sales Seventeen, L.L.C.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5540.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1830-000.
    Applicants: Green Mountain Energy Company.
    Description: Revised Market-Based Rate Tariff to be effective 5/1/
2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5541.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1831-000.
    Applicants: Virginia Electric and Power Company, PJM
Interconnection, L.L.C.
    Description: Dominion submits revisions to PJM OATT Att H-16A re
ADIT to be effective 5/1/2014.
    Filed Date: 4/30/14.
    Accession Number: 20140430-5545.
    Comments Due: 5 p.m. E.T. 5/21/14.

    Docket Numbers: ER14-1832-000.
    Applicants: Duke Energy Florida, Inc.
    Description: Duke Energy Florida, Inc. submits tariff filing per
35.13(a)(2)(iii): DEF IA Annual Cost Factor Update to be effective 5/1/
2014.
    Filed Date: 5/1/14.
    Accession Number: 20140501-5074.
    Comments Due: 5 p.m. E.T. 5/22/14.

    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
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: May 1, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-10583 Filed 5-7-14; 8:45 am]
BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Air and Radiation/ Office of Atmospheric Programs 2. OMB control number b.   None a_ 2060 __  _ 0258_ __ __ __ __ __

3. Type of information collection ( check one) a.   New collection b.   Revision of a currently approved collection c. X Extension of a currently approved collection d.   Reinstatement, without change, of a previously approved collection for which approval has expired e.   Reinstatement, with change, of a previously approved collection for which approval has expired f.   Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b.   Emergency  Approval requested by: / / c.   Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities?   Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b.   Other Specify: / /___

7. Title Acid Rain Program Under Title IV of the CAA Amendments of 1990 ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR# 1633.14, EPA Form Numbers 7610 and 7620 9. Keywords Acid Rain, Sulfur Dioxide, Nitrogen oxides, emissions trading 10. Abstract The information to be collected under this ICR is necessary to implement the Acid Rain Program. The program calls for major reductions of the pollutants that cause acid rain, while establishing a successful cap and trade program to achieve environmental results. Respondents include electric utilities, industrial sources, and other persons.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. X Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. X Voluntary b. X Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents ____ 1,700________ b. Total annual responses ________ 17,855________ 1. Percentage of these responses collected electronically 87 % c. Total hours requested _______ 1,971,276___ __ d. Current OMB inventory ________ 1,600,807______ e. Difference _______________ 370,469______ f. Explanation of difference 1. Program Change __________( 8,575) _______ 2. Adjustment __________ 379,044_________ 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs ___$ 71,307________ b. Total annual costs ( O& M) ______________$ 70,951________ c. Total annualized cost requested __________$ 142,258________ d. Current OMB inventory _________________$ 171,969_______ e. Difference __________________($ 29,711)_______ f. Explanation of difference 1. Program change ____________________$ 0 _______ 2. Adjustment _____________________($ 29,711) ______

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. X_ Application for benefits e. __ Program planning or management b. X_ Program evaluation f. __ Research c. __ General purpose statistics g. _ P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b.   Third party disclosure c. X Reporting 1. X On occasion 2.   Weekly 3.   Monthly 4. X Quarterly 5.   Semi annually 6. X Annually 7.   Biennially 8.   Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

  Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Kenon Smith____________________________ Phone: _( 202) 564 9164___________________________

OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53820-53822]
[FR Doc No: 2020-19094]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1564]

Principles for Selecting, Developing, Modifying, and Adapting
Patient-Reported Outcome Instruments for Use in Medical Device
Evaluation; Draft Guidance for Industry, Food and Drug Administration
Staff, and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Principles for
Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome
Instruments for Use in Medical Device Evaluation.'' The FDA encourages
the collection, analysis, and integration of patient perspectives in
the development, evaluation, and surveillance of medical devices,
including digital health technologies. Patient-reported outcome (PRO)
instruments facilitate the systematic collection of patient
perspectives as scientific evidence to support the regulatory and
healthcare decision-making process. This draft guidance describes
principles that should be considered when using PRO

instruments in the evaluation of medical devices and provides
recommendations about the importance of ensuring the measures are
``fit-for-purpose.'' This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by October 30, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2020-D-1564 for ``Principles for Selecting, Developing, Modifying,
and Adapting Patient-Reported Outcome Instruments for Use in Medical
Device Evaluation.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Principles for Selecting, Developing, Modifying, and Adapting
Patient-Reported Outcome Instruments for Use in Medical Device
Evaluation'' to the Office of Policy, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6884 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    A PRO instrument can be used in a clinical investigation to measure
the effects of a medical intervention or changes in the health status
of a patient. PRO instruments allow for collection of certain data as
evidence of safety and effectiveness which is complementary to other
clinical outcomes and/or biomarkers. Information from well-defined and
reliable PRO instruments can provide valuable evidence for benefit-risk
assessments and can be used in medical device labeling to communicate
the effect of a treatment on patient symptoms, functioning, or quality
of life when the labeling is consistent with the PRO instrument's
documented measurement capability. PRO instruments may be used to
inform a patient's eligibility for inclusion within a study, to capture
safety or effectiveness outcomes, and may be aligned as primary or
secondary endpoints or used as a stand-alone outcome assessment or
component of a composite endpoint. FDA determines the validity evidence
needed to support use of a PRO instrument for a particular regulatory
purpose informed by the way it is used in the clinical investigation.
FDA uses the term ``fit-for-purpose'' to describe this flexible
approach. In addition to providing evidence to assess the safety and
effectiveness of medical devices, PRO instruments can measure the
impact of medical devices on patient well-being and other concepts that
may influence payers, healthcare providers, and patients when making
decisions about potential treatments or management options.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).

The draft guidance, when finalized, will represent the current thinking
of FDA on ``Principles for Selecting, Developing, Modifying, and
Adapting Patient-Reported Outcome Instruments for Use in Medical Device
Evaluation.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to
download an electronic copy of ``Principles for Selecting, Developing,
Modifying, and Adapting Patient-Reported Outcome Instruments for Use in
Medical Device Evaluation'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 18042 to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
------------------------------------------------------------------------

    Dated: August 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19094 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Rules and Regulations]
[Pages 23110-23112]
[FR Doc No: 2013-08907]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0932; Directorate Identifier 2012-NM-014-AD;
Amendment 39-17426; AD 2013-08-09]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-200, -200LR, -300, -300ER, and 777F series
airplanes. This AD was prompted by a report that during a test of the
oxygen system, an operator found that the passenger oxygen masks did
not properly flow oxygen, and that a loud noise occurred in the
overhead area, which was caused by the flex line separating from the
hard line due to a missing clamshell coupler. This AD requires, for
certain airplanes, performing a detailed inspection of certain areas of
the airplane oxygen system to ensure clamshell couplers are installed
and fully latched, and corrective actions if necessary. For all
airplanes, this AD requires performing and meeting the requirements of
the low pressure leak test. We are issuing this AD to prevent the
oxygen system flex line from separating from the hard line, which could
cause an oxygen leak and a drop in the oxygen system pressure,
resulting in improper flow of oxygen through the passenger masks and
injury to passengers if emergency oxygen is needed.

DATES: This AD is effective May 23, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 23, 2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. 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 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: Susan Monroe, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a Notice of Proposed Rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on September 11, 2012 (77
FR 55768). That NPRM proposed to require, for certain airplanes,
performing a detailed inspection of certain areas of the airplane
oxygen system to ensure clamshell couplers are installed and fully
latched, and corrective actions if necessary. For all airplanes, that
NPRM proposed to require performing and meeting the requirements of the
low pressure leak test.

Comments

    We gave the public the opportunity to participate in developing
this AD. The Boeing Company and Kristopher Charles Kleiner supported
this final rule. The following presents the comment received on the
NPRM (77 FR 55768, September 11, 2012) and the FAA's response to the
comment.

Request Clarification of Note 1 to Paragraph (i) of NPRM (77 FR 55768,
September 11, 2012)

    Air New Zealand requested clarification of Note 1 to paragraph (i)
of the NPRM (77 FR 55768, September 11, 2012). Air New Zealand asked if
the FAA intended to state a specific revision for the installation of
the clamshell coupler in Subject 35-00-00, Oxygen, of Chapter 35,
Oxygen, of Part II, Practices and Procedures, of the Boeing 777
Aircraft Maintenance Manual, Revision 65, dated May 5, 2012, knowing
that it will be revised within the time frame of this NPRM. Air New
Zealand also asked if an alternative method of compliance (AMOC) will
be required if an operator intends to use a later revision of the
maintenance manual.
    We agree to provide clarification of Note 1 to paragraph (i) of the
NPRM (77 FR 55768, September 11, 2012). Note 1 to paragraph (i) of the
NPRM is provided as guidance and is not an AD requirement; therefore,
approval of an AMOC will not be required for using later revisions of
the maintenance manual. Since we issued the NPRM, the aircraft
maintenance manual has been revised. We have updated Note 1 to
paragraph (i) of this AD with the latest revision. We have changed this
AD accordingly.

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--and minor editorial changes.
We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 55768, September 11, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 55768, September 11, 2012).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 6 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                              Parts     Cost per   Cost on U.S.
                   Action                              Labor cost              cost     product      operators
----------------------------------------------------------------------------------------------------------------
Detailed inspection and leak test..........  26 work-hours x $85 per hour          $0     $2,210         $13,260
                                              = $2,210.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

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, Incorporation by
reference, 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 adding the following new airworthiness
directive (AD):

2013-08-09 The Boeing Company: Amendment 39-17426; Docket No. FAA-
2012-0932; Directorate Identifier 2012-NM-014-AD.

(a) Effective Date

    This AD is effective May 23, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and 777F series airplanes; certificated in any
category; as identified in Boeing Special Attention Service Bulletin
777-35-0024, dated September 1, 2011.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 35, Oxygen.

(e) Unsafe Condition

    This AD was prompted by a report that during a test of the
oxygen system, an operator found that the passenger oxygen masks did
not properly flow oxygen and that a loud noise occurred in the
overhead area, which was caused by the flex line separating from the
hard line due to a missing clamshell coupler. We are issuing this AD
to prevent the oxygen system flex line from separating from the hard
line, which could cause an oxygen leak and a drop in the oxygen
system pressure, resulting in improper flow of oxygen through the
passenger masks and injury to passengers if emergency oxygen is
needed.

(f) Compliance

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

(g) Inspection

    Within 36 months after the effective date of this AD, do the
applicable actions in paragraph (g)(1) or (g)(2) of this AD.
    (1) For Groups 1-6, 8, and 9 airplanes, as identified in Boeing
Special Attention Service Bulletin 777-35-0024, dated September 1,
2011: Do a detailed inspection of certain areas of the airplane
oxygen system to ensure clamshell couplers are installed and fully
latched, and perform and meet the requirements of the low pressure
leak test, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 777-35-0024, dated
September 1, 2011.
    (2) For Group 7 airplanes, as identified in Boeing Special
Attention Service Bulletin 777-35-0024, dated September 1, 2011:
Perform and meet requirements of the low pressure leak test, in
accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-35-0024, dated September 1, 2011.

(h) Corrective Action if Clamshell Coupler Is Not Fully Latched

    If, during any inspection required by paragraph (g) of this AD,
any clamshell coupler is not fully latched: Before further flight,
latch the clamshell coupler, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 777-35-
0024, dated September 1, 2011.

(i) Corrective Action if Clamshell Coupler Is Not Installed

    If, during any inspection required by paragraph (g) of this AD,
any clamshell coupler is not installed: Before further flight,
install a clamshell coupler.

    Note 1 to paragraph (i) of this AD:  Guidance on installation of
the clamshell coupler may be found in Subject 35-00-00, Oxygen, of
Chapter 35, Oxygen, of Part II, Practices and Procedures, of the
Boeing 777 Aircraft Maintenance Manual, Revision 67, dated January
5, 2013.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Certification Office (ACO), FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the ACO, send it to the attention of the
person identified in the Related Information section of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector,

or lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.

(k) Related Information

    For more information about this AD, contact Susan Monroe,
Aerospace Engineer, Cabin Safety and Environmental Systems Branch,
ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 777-35-0024, dated
September 1, 2011.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.
    (4) You may review copies of the referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, Washington. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 5, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-08907 Filed 4-17-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Proposed Rules]
[Pages 58191-58193]
[FR Doc No: 2018-24995]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0980; Product Identifier 2017-SW-123-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK
117 C-2 helicopters. This proposed AD would require establishing or
reducing the life limit of various parts. This proposed AD is prompted
by recalculations. The actions of this proposed AD are intended to
address an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by January 18,
2019.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0980; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

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

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2017-0174, dated September 12,
2017 (EASA AD 2017-0174), to correct an unsafe condition for Airbus
Helicopters Model MBB-BK 117 C-2 helicopters. EASA advises that
recalculation by Airbus Helicopters has resulted in new or reduced life
limits for certain parts. EASA AD 2017-0174 states the life limits are
mandatory for continued airworthiness and failing to replace life-
limited parts as specified could result in an unsafe condition. To
address this condition, EASA AD 2017-0174 requires replacing the
affected parts before exceeding their new or reduced life limit.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information

    We reviewed Airbus Helicopters Alert Service Bulletin ASB MBB-BK117
C-2-04A-008, Revision 0, dated April 27, 2017, for Model MBB-BK 117 C-2
and C-2e helicopters. This service information specifies entering into
the helicopter records the reduced and new airworthiness life limits
for certain part-numbered main rotor head, swash plate, rotor flight
controls, cyclic controls, and upper controls parts.

Proposed AD Requirements

    This proposed AD would require establishing and reducing the life
limit of the following parts: Main rotor head--nut, upper and lower
quadruple nut, bolts, and inner sleeve; swash plate control ring
assembly; rotor flight control collective bellcrank-K; cyclic

control rod tube; and upper control forked lever.

Costs of Compliance

    We estimate that this proposed AD would affect 128 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD. Labor costs are estimated at $85 per
work-hour.
    Replacing a nut would take about 5 work-hours and parts would cost
about $3,352 for an estimated replacement cost of $3,777.
    Replacing a quadruple nut upper would take about 5 work-hours and
parts would cost about $3,283 for an estimated replacement cost of
$3,708.
    Replacing a quadruple nut lower would take about 5 work-hours and
parts would cost about $3,405 for an estimated replacement cost of
$3,830.
    Replacing a bolt would take about 2 work-hours and parts would cost
about $370 for an estimated replacement cost of $540.
    Replacing an inner sleeve would take about 2 work-hours and parts
would cost about $20,073 for an estimated replacement cost of $20,243.
    Replacing a control ring assembly would take about 5 work-hours and
parts would cost about $11,141 for an estimated replacement cost of
$11,566.
    Replacing a bellcrank-K (collective) would take about 4 work-hours
and parts would cost about $3,400 for an estimated replacement cost of
$3,740.
    Replacing a control rod tube would take about 4 work-hours and
parts would cost about $1,084 for an estimated replacement cost of
$1,424.
    Replacing a forked lever would take about 3 work-hours and parts
would cost about $6,049 for an estimated replacement cost of $6,304.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 adding the following new airworthiness
directive (AD):

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2018-0980;
Product Identifier 2017-SW-123-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 C-2 helicopters with a part listed in Table 1 to
paragraph (e) of this AD installed, certificated in any category.

    Note 1 to paragraph (a) of this AD: Helicopters with an MBB-
BK117 C-2e designation are Model MBB-BK117 C-2 helicopters.

(b) Unsafe Condition

    This AD defines the unsafe condition as a part remaining in
service beyond its fatigue life. This condition could result in
failure of a part and loss of control of the helicopter.

(c) Comments Due Date

    We must receive comments by January 18, 2019.

(d) Compliance

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

(e) Required Actions

    Before further flight, remove from service any part that has
reached or exceeded its new or reduced life limit as listed in Table
1 to paragraph (e) of this AD. Thereafter, remove from service each
part on or before reaching its new or reduced life limit as listed
in Table 1 to paragraph (e) of this AD. For purposes of this AD, a
``landing'' is counted any time the helicopter lifts off into the
air and then lands again regardless of the duration of the landing
and regardless of whether the engine is shut down.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TP19NO18.001

BILLING CODE 4910-13-C

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin ASB MBB-BK117 C-2-
04A-008, Revision 0, dated April 27, 2017, which is not incorporated
by reference, contains additional information about the subject of
this AD. For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2017-0174, dated September 12, 2017. You
may view the EASA AD on the internet at http://www.regulations.gov
in the AD Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6220, Main Rotor
Head; 6230 Main Rotor Mast/Swashplate; and 6710, Main Rotor Control.

    Issued in Fort Worth, Texas, on November 6, 2018.
James A. Grigg,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2018-24995 Filed 11-16-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 6 (Tuesday, January 10, 2012)]
[Notices]
[Pages 1542-1543]
[FR Doc No: 2012-179]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66092; File No. SR-NASDAQ-2011-175]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Fees for Members Using the NASDAQ Market Center

January 4, 2012.
    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 December 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by NASDAQ. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ proposes to modify pricing for NASDAQ members using the
NASDAQ Market Center. NASDAQ will implement the proposed change
immediately. The text of the proposed rule change is available at
http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, NASDAQ 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. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    On December 27, 2011, NASDAQ experienced a technical issue with
some order entry ports using the Financial Information Exchange
(``FIX'') protocol. The issue, which was caused by a software release
that had an unintended effect on FIX order entry ports, resulted in
numerous ``cancel reject'' messages being sent to market participants
that sent cancel requests to NASDAQ. Upon the issue being discovered,
the FIX ports of approximately fifty members were disconnected for
approximately ninety minutes to allow the software release to be
removed and the prior version to be made operational.
    Because NASDAQ's fee and rebate schedule in Rule 7018 provides that
members may achieve better pricing if they achieve certain specified
volumes of activity during a given month, the FIX port issue may have
impacted the ability of affected members to reach the required volumes.
For example, a member with shares of liquidity provided in all
securities through one of its Nasdaq Market Center market participant
identifiers (``MPIDs'') that represent more than 0.90% of the total
consolidated volume reported to all consolidated transaction reporting
plans by all exchanges and trade reporting facilities (``Consolidated
Volume'') during a month receives a rebate of $0.00295 per share
executed with respect to liquidity that it provides during the month
through displayed quotes/orders. By contrast, members providing lower
volumes of liquidity receive lower rebates with respect to displayed
quotes/order ranging from $0.0020 to $0.0029 per share executed. If a
member had provided liquidity that represented slightly in excess of
0.90% of Consolidated Volume on each day of December 2011 other than
December 27, but was prevented from reaching comparable levels on that
date due to the FIX port issue, it is possible that the rebate it would
ultimately earn for the entire month would be lower than would
otherwise have been the case. Similarly, under Rule 7014, a member may
be entitled to receive an enhanced rebate under NASDAQ's Investor
Support Program or Pre-Market Investor Program, based on its
achievement of certain volume criteria specified in the rule. The
ability of a member to achieve these criteria may have also been
affected by the FIX port issue.
    Accordingly, in order to ensure that fees and rebates are not
adversely impacted by the FIX port issue, NASDAQ proposes to exclude
December 27 from calculations made under Rules 7014 and 7018 if doing
so would allow a member to achieve more favorable pricing than would be
the case if the day were included. Thus, members that are unaffected by
the FIX port issue would not have the day arbitrarily excluded from
their calculations. NASDAQ will perform all calculations needed to
implement the change. If a member believes that it incurred other costs
as a result of the FIX port issue, claims for such costs would be
governed by NASDAQ Rule 4626, which establishes procedures for claims
against NASDAQ for costs associated with NASDAQ system issues.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\3\ in general, and with Section
6(b)(4) of the Act,\4\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls. NASDAQ believes that the proposed
change is reasonable because it will allow members to receive December
2011 pricing that is based on either the exclusion, or the inclusion,
of December 27, whichever is more favorable to the member. The proposed
change is equitable, because it will ensure that the fees and rebates
applicable to members that were subject to the FIX port issue are not
adversely affected by the issue.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f.
    \4\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. The change will
help to ensure that members that were affected by the FIX port issue
are not required to pay higher fees, or receive lower rebates, during
December 2011 than would otherwise be the case. Accordingly, NASDAQ
believes that the proposed changes will protect members from incurring
unanticipated charges.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\5\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(a)(ii). [sic]
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-175 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-NASDAQ-2011-175. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal offices
of the Exchange. All comments received will be posted without change;
the Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2011-175, and should be submitted on or before January 31, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-179 Filed 1-9-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Rules and Regulations]
[Page 3827]
[FR Doc No: 2021-00271]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 80

 [EPA-HQ-OAR-2020-0240; FRL-10017-21-OAR]

Final Anti-Backsliding Determination for Renewable Fuels and Air
Quality

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has determined that
no additional measures are necessary pursuant to Clean Air Act (CAA)
section 211(v) to mitigate the adverse air quality impacts of the
renewable fuel volumes required under CAA section 211(o).

DATES: January 15, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2020-0240. All documents in the docket are
listed at the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rich Cook, Office of Transportation
and Air Quality, Assessment and Standards Division, Environmental
Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CAA section 211(v) requires EPA to take two actions. First, EPA
must complete ``a study to determine whether the renewable fuel volumes
required under [CAA section 211(o)] will adversely impact air quality
as a result in changes of vehicle and engine emissions of air
pollutants.'' The study, commonly known as the ``anti-backsliding
study,'' must include consideration of different blend levels, types of
renewable fuels, and available vehicle technologies, as well as
appropriate national, regional, and local air quality control measures.
EPA has completed the required study, which is available in the docket
for this action and at https://www.epa.gov/renewable-fuel-standard-program/anti-backsliding-determination-and-study.
    Second, considering the results of the study, EPA must proceed down
one of two paths: Either ``promulgate fuel regulations to implement
appropriate measures to mitigate, to the greatest extent achievable. .
.any adverse impacts on air quality, as a result of the renewable
volumes required by [Section 211]'' or ``make a determination that no
such measures are necessary.''
    EPA announced its proposed determination on June 8, 2020 (85 FR
35048) and invited public comment. The proposed determination is
available in the docket for this action and at https://www.epa.gov/renewable-fuel-standard-program/anti-backsliding-determination-and-study.

II. Final Determination

    After considering public comment, we determine, as proposed, that
no additional appropriate fuel control measures are necessary to
mitigate adverse air quality impacts of required renewable fuel
volumes. More information on this determination can be found in the
supporting document, which is available in the docket for this action
and at https://www.epa.gov/renewable-fuel-standard-program/anti-backsliding-determination-and-study.

    Dated: January 5, 2021.
Andrew Wheeler,
Administrator.
[FR Doc. 2021-00271 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Rules and Regulations]
[Pages 57801-57803]
[FR Doc No: 2016-20389]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0735]
RIN 1625-AA00

Safety Zone; Nahant Bay, Marblehead, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Captain of the Port (COTP) Boston Zone within a
2,500-yard radius around a position approximately 6nm Northeast of
Nahant Bay, MA, for a Department of Defense (DOD) Training Exercise.
The safety zone is needed to protect Navy personnel, support vessels,
and the maritime public from the hazards associated with this training
exercise. Entering into, transiting through, mooring, or anchoring
within this safety zone during periods of enforcement is prohibited
unless authorized by the Coast Guard Sector Boston COTP or the COTP's
designated representative.

DATES: This rule is effective on August 24, 2016 from 7:00 p.m. through
10:00 p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0735 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email, Mark Cutter, Sector Boston Waterways Management
Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
CFR Code of Federal Regulations
DHS Department of Homeland Security
DOD Department of Defense
FR Federal Register
NPRM Notice of Proposed Rulemaking
NAD 83 North American Data of 1983
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a NPRM with respect to this rule
because publishing a NPRM would be impracticable. DOD Training Exercise
will take place on August 24, 2016. The DOD Exercise will consist of
High-altitude military parachuting freefall insertion approximately 6nm
Northeast of Nahant, MA, in position 42[deg] 27.000' N., 070[deg]
50.000' W. This exercise will present safety hazards and risks to Navy
personnel, support vessels, and the maritime public during the
exercise. It would be impracticable to delay promulgating this rule, as
it would not be possible to conduct notice and comment rulemaking
before the date of the exercise. For this reason, the Coast Guard finds
it impracticable to delay this regulation.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. Delaying the effective
date of this rule would be impracticable for the same reasons specified
above.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The

COTP has determined that the potential hazards associated with this DOD
Training Exercise create a serious safety concern for anyone transiting
within a 2,500-yard radius of position 42[deg] 27.000' N., 070[deg]
50.000' W. This rule is needed to protect Navy personnel, vessels, and
the normal marine traffic in the navigable waters within the safety
zone while this exercise is be being conducted.

IV. Discussion of Rule

    This rule establishes a safety zone from 7:00 p.m. until 10:00 p.m.
on August 24, 2016. The safety zone will cover all navigable waters
within a 2,500-yard radius of position 42[deg] 27.000' N., 070[deg]
50.000' W. The duration of the zone is intended to protect Navy
personnel, vessels, and normal marine traffic in these navigable waters
during the DOD training exercise. No vessel or person will be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. The implementation of this
temporary safety zone is necessary for the protection of all waterway
users. The size of the zone is the minimum necessary to provide
adequate protection for the waterway users, adjoining areas, and the
public. Vessel traffic will be able to safely transit around this
safety zone. Any hardships experienced by persons or vessels are
considered minimal compared to the interest in protecting the public.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone that will prohibit entry within 2,500 yards
of position 42[deg] 27.000' N., 070[deg] 50.000' W. during the DOD
training exercise. It is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination will be available in the docket
where indicated under ADDRESSES. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment Rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T01-0735 to read as follows:

Sec.  165.T01-0735  Safety Zone; DOD Training Exercise, Nahant Bay,
Marblehead, MA.

    (a) Location. The following area is a safety zone: All navigable
waters within 2,500-yards of 42[deg] 27.000' N., 070[deg] 50.000' W.
while the DOD Training Exercise is underway.
    (b) Regulations. While this security zone is being enforced, the
following regulations, along with those contained in Sec.  165.33,
apply:
    (1) Under the general safety zone regulations in subpart B of this
part, you may not enter the safety zone described in paragraph (a) of
this section unless authorized by the COTP or a COTP designated
representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM channel 16 or by phone at<PHONE_NUMBER>
(Sector Boston Command Center). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or a
COTP designated representative.
    (c) Enforcement period. This section will be enforced from 7:00
p.m. until 10:00 p.m. on August 24, 2016.
    (d) Definitions. As used in this section, designated representative
means is any Coast Guard commissioned, warrant, or petty officer or any
federal, state, or local law enforcement officer who has been
designated by the COTP to act on the COTP's behalf. The COTP's
representative may be on a Coast vessel, a Coast Guard Auxiliary
vessel, state or local law enforcement, or a location on shore.
    (e) Penalties. Those who violate this section are subject to the
penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: August 19, 2016.
C. C. Gelzer,
Captain, U.S. Coast Guard, Captain of the Port Boston.
[FR Doc. 2016-20389 Filed 8-22-16; 4:15 pm]
 BILLING CODE 9110-04-P