[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Notices]
[Pages 22269-22270]
[FR Doc No: 2013-08723]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0369]

International Conference on Harmonisation; Draft Guidance on M7
Assessment and Control of DNA Reactive (Mutagenic) Impurities in
Pharmaceuticals To Limit Potential Carcinogenic Risk; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``M7 Assessment and Control
of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit
Potential Carcinogenic Risk.'' The draft guidance was prepared under
the auspices of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH). The draft guidance emphasizes considerations of both safety
and quality risk management in establishing levels of mutagenic
impurities that are expected to pose negligible carcinogenic risk. It
outlines recommendations for assessment and control of mutagenic
impurities that reside or are reasonably expected to reside in a final
drug substance or product, taking into consideration the intended
conditions of human use. The draft guidance is intended to provide
guidance for new drug substances and new drug products during their
clinical development and subsequent applications for marketing.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 14, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance:

David Jacobson-Kram, Office of New Drugs, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5299, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

    Regarding the ICH:

Michelle Limoli, International Programs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 3342, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In February 2013, the ICH Steering Committee agreed that a draft
guidance entitled ``M7 Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to Limit Potential
Carcinogenic Risk'' should be made available for public comment. The
draft guidance is the product of the M7 Expert Working Group of the
ICH. Comments about this draft will be considered by FDA and the M7
Expert Working Group.
    The draft guidance provides guidance on the regulation of genotoxic
impurities in new drug substances and drug products.
    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 Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It

is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at

http://www.regulations.gov,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08723 Filed 4-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Pages 24808-24810]
[FR Doc No: 2016-09823]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-853-000.
    Applicants: Centra Pipelines Minnesota Inc.
    Description: Sec.  4(d) Rate Filing: Updated Shipper Index April
2016 to be effective 6/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5125.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-854-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate BP 2016-04-18 to be
effective 4/16/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5170.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-855-000.
    Applicants: National Grid LNG, LLC.
    Description: Compliance filing Section 34 to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5202.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-856-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Compliance filing Docket Nos. RP06-569-008 and RP07-
376-005 (consolidated) Compliance Filing to be effective 7/20/2010.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5225.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-857-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Compliance filing Order on Compliance with Order to be
effective 4/18/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5247.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-858-000.
    Applicants: WestGas InterState, Inc.
    Description: Compliance filing NAESB Compliance Filing to be
effective 4/16/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5271.
    Comments Due: 5 p.m. ET 5/2/16.

    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 Sec.  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.

Filings in Existing Proceedings

    Docket Numbers: RP16-422-001.
    Applicants: Monroe Gas Storage Company, LLC.
    Description: Compliance filing Monroe Gas Storage April 2016 Filing
for Docket No. RP16-422-000 to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5230.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-423-001.
    Applicants: Perryville Gas Storage LLC.
    Description: Compliance filing Perryville Gas Storage April 2016
Filing Docket No. RP16-423-000 to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5223.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-424-001.
    Applicants: Cadeville Gas Storage LLC.
    Description: Compliance filing Cadeville Gas Storage April 2016
Filing Docket No. RP16-424-000 to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5227.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-452-001.
    Applicants: Sierrita Gas Pipeline LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5173.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-457-001.
    Applicants: Young Gas Storage Company, Ltd.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5113.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-458-001.
    Applicants: Mojave Pipeline Company, L.L.C.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5165.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-460-001.
    Applicants: Dominion Carolina Gas Transmission, LLC.
    Description: Compliance filing NAESB Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5002.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-473-001.
    Applicants: High Island Offshore System, L.L.C.
    Description: Compliance filing Order 587 Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5139.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-480-001.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Compliance filing Stingray Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5089
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-483-001.
    Applicants: Panther Interstate Pipeline Energy, LLC.
    Description: Compliance filing Panther Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5086.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-492-001.
    Applicants: USG Pipeline Company, LLC.
    Description: Compliance filing Order No. 587-W Second Compliance
Filing to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5129.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-498-001.
    Applicants: MarkWest New Mexico, L.L.C.
    Description: Compliance filing MarkWest New Mexico Compliance
Filing to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5087.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-502-001.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Compliance filing MarkWest Pioneer Compliance Filing
to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5088.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-506-001.
    Applicants: KPC Pipeline, LLC.

    Description: Compliance filing KPC Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5081.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-507-001.
    Applicants: NGO Transmission, Inc.
    Description: Compliance filing NGO Transmission Compliance Filing
to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5077.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-508-001.
    Applicants: Ryckman Creek Resources, LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5080.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-510-001.
    Applicants: B-R Pipeline Company.
    Description: Compliance filing Order No. 587-W Second Compliance
Filing to be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5130.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-512-001.
    Applicants: WBI Energy Transmission, Inc.
    Description: Compliance filing Compliance Filing with Order Issued
March 29 on Order Nos. 587-W & 809 to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5138.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-518-001.
    Applicants: DBM Pipeline, LLC.
    Description: Compliance filing DBM Pipeline Compliance Filing to be
effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5079.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-522-001.
    Applicants: Black Hills Shoshone Pipeline, LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5083.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-528-001.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Compliance filing Order 809 & NAESB 3.0 April
Compliance Filing to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5177
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-529-001.
    Applicants: Crossroads Pipeline Company.
    Description: Compliance filing GEH--Order No. 809 & NAESB 3.0 April
Compliance Filing to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5178.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-531-001.
    Applicants: Boardwalk Storage Company, LLC.
    Description: Compliance filing Compliance Filing in Docket No.
RP16-531-000 to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5180.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-532-001.
    Applicants: Hardy Storage Company, LLC.
    Description: Compliance filing Order 809 & NAESB 3.0 April
Compliance Filing to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5179.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-545-002.
    Applicants: Rendezvous Pipeline Company, LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5071.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-548-001.
    Applicants: Trans-Union Interstate Pipeline, L.P.
    Description: Compliance filing Compliance Filing for March 29th
Order to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5157.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-549-001.
    Applicants: PGPipeline LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5070.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-551-001.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Compliance filing Maritimes RP16-551 Compliance Filing
to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5124.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-552-001.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Compliance filing GEH--Order No 809 & NAESB 3.0 April
Compliance Filing to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5183.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-553-001.
    Applicants: Central Kentucky Transmission Company.
    Description: Compliance filing GEH Order 809 & NAESB 3.0 April
Compliance Filing to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5181.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-554-001.
    Applicants: Arlington Storage Company, LLC.
    Description: Compliance filing Arlington Storage Company, LLC.--
Order No. 587-W Directed Changes to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5091.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-555-001.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Compliance filing Tres Palacios Gas Storage LLC.--
Order No. 587-W Directed Changes to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5099.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-558-001.
    Applicants: Stagecoach Pipeline & Storage Company LL.
    Description: Compliance filing Stagecoach Pipeline & Storage
Company LLC.--Order No. 587-W Directed Changes to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5098.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-566-001.
    Applicants: Total Peaking Services, L. L. C.
    Description: Compliance filing TPS Order No. 809 Compliance Filing
Order Changes to be effective 4/1/16.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5204.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-570-001.
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Compliance filing NAESB 3.0 Compliance Filing to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5273.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-577-001.
    Applicants: Northwest Pipeline LLC.
    Description: Compliance filing NAESB 3.0 Compliance Filing (2) to
be effective 4/1/2016.

    Filed Date: 4/18/16.
    Accession Number: 20160418-5272.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-584-001.
    Applicants: WestGas InterState, Inc.
    Description: Compliance filing 20160418_NAESB Compliance Filing to
be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5233.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-597-002.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Compliance filing Order No. 587-W Compliance Filing to
be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5172.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-598-002.
    Applicants: Rockies Express Pipeline LLC.
    Description: Compliance filing Order No. 587-W Compliance Filing to
be effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5171.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-599-002.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing Order No. 587 W Compliance to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5174.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: RP16-800-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Tariff Amendment: Amendment to Filing (RP16-800) to be
effective 4/1/2016.
    Filed Date: 4/18/16.
    Accession Number: 20160418-5115.
    Comments Due: 5 p.m. ET 5/2/16.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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: April 19, 2016.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2016-09823 Filed 4-26-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Pages 8226-8229]
[FR Doc No: 2014-02934]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71486; File No. SR-FINRA-2014-004]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change and
Amendment No. 1 Thereto Relating to Amendments to FINRA Rule 5110
(Corporate Financing Rule--Underwriting Terms and Arrangements)

February 5, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 24, 2014, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. On February
4, 2014, FINRA filed Amendment No. 1 to the proposed rule change.\3\
The Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, FINRA: (1) modified Exhibit 5 to correct
a marking error; and (2) modified Form 19b-4 on page 4 and Exhibit 1
on page 17 to replace the language ``exchange-traded funds formed as
grantor or statutory trusts'' with the language ``collective
investment vehicles that are not registered as investment
companies.'' This Notice reflects the changes made by Amendment No.
1.
---------------------------------------------------------------------------

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

    FINRA is proposing to amend FINRA Rule 5110 (Corporate Financing
Rule--Underwriting Terms and Arrangements) to expand the circumstances
in which termination fees and rights of first refusal are permissible;
exempt from the filing requirements certain collective investment
vehicles that are not registered as investment companies; and make
clarifying, non-substantive changes regarding documents filed through
FINRA's electronic filing system.\4\
---------------------------------------------------------------------------

    \4\ The effective date of the electronic filing requirements
under Rule 5110 was July 12, 2002. See Notice to Members 02-26.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    FINRA Rule 5110 (Corporate Financing Rule--Underwriting Terms and
Arrangements) (the ``Rule''), among other things, regulates
underwriting compensation, requires the filing of specified information
in connection with public offerings in which members will participate,
and prohibits unfair arrangements in connection with public offerings
of securities. FINRA proposes to amend the Rule's provisions regarding
unfair arrangements to: (1) Expand the circumstances under which
members and issuers may negotiate termination fees and rights of first
refusal (``ROFR''), with specified conditions; (2) exempt from the
filing requirements exchange-traded funds formed as grantor or
statutory trusts; and (3) codify the electronic filing requirement.
Termination Fees and Rights of First Refusal
    Rule 5110(f) (Unreasonable Terms and Arrangements) sets forth terms
and arrangements that, when proposed in connection with a public
offering of securities, are considered unfair and unreasonable. Rule
5110(f)(2)(D) addresses fees in connection with a public offering of
securities that is not completed according to the terms of agreement
between the issuer and underwriter (``terminated offering'').
Specifically, paragraph (D) generally provides that it is unfair and
unreasonable for a member to arrange for the payment of any
compensation by an issuer in connection with a terminated offering
(``termination fee'' or ``tail fee''). Paragraph (D) further clarifies
that this prohibition does not include compensation negotiated and paid
in connection with a separate transaction that occurs in lieu of the
proposed offering, or reimbursement of out-of-pocket accountable
expenses actually incurred by the member.\5\
---------------------------------------------------------------------------

    \5\ Rule 5110(f)(2)(C) prohibits payment of commissions or
reimbursement of expenses to an underwriter prior to the
commencement of the sale of the securities being offered, except for
a reasonable advance against out-of-pocket accountable expenses
actually anticipated to be incurred by the underwriter. To the
extent such expenses are not actually incurred, any advance received
must be reimbursed to the issuer.
    Paragraph (D) currently provides that the reimbursement of out-
of-pocket accountable expenses actually incurred by the member will
not be presumed to be unfair or unreasonable under normal
circumstances. The proposed amendment modifies paragraph (D) to
specify that out-of-pocket accountable expenses must be bona fide.
---------------------------------------------------------------------------

    Currently, paragraph (f)(2)(E) of Rule 5110 provides that, in the
event that an issuer terminates an offering with an underwriter and
subsequently consummates a similar transaction, a termination fee may
be permissible under certain circumstances. Historically, FINRA has
only considered permitting termination fee arrangements under this
provision where the subsequent transaction is an exchange offer or
similar offering where members provide substantial structuring or
advisory services (beyond that traditionally provided in connection
with a distribution of a public offering).\6\ In such cases, FINRA
believes that a

termination fee may be appropriate given the extent of the services
provided by the member to the issuer.
---------------------------------------------------------------------------

    \6\ See Notice to Members 97-82 (November 1997). Further, the
Rule provides that a tail fee may not have a duration of more than
two years from the date the member's services are terminated;
however, the Rule provides that a member may demonstrate on the
basis of information satisfactory to FINRA that an arrangement of
more than two years is not unfair or unreasonable under the
circumstances.
---------------------------------------------------------------------------

    FINRA has reevaluated its rules around termination fees and
believes it is appropriate to update the Rule to provide members with a
greater degree of flexibility and expand the circumstances under which
participating members and issuers may negotiate termination fee
arrangements. Specifically, FINRA is proposing to amend Rule 5110(f)(2)
(Prohibited Arrangements) to generally permit termination fees where:
(1) the agreement between the participating member and the issuer
specifies that the issuer has a right of ``termination for cause''
(i.e., where a member fails materially to perform the underwriting
services contemplated in the written agreement); \7\ (2) the agreement
specifies that an issuer's exercise of its right of ``termination for
cause'' eliminates any obligations with respect to the payment of any
termination fee; \8\ (3) the amount of any specified termination fee is
reasonable in relation to the services contemplated in the written
agreement; and (4) the agreement specifies that the issuer is not
responsible for paying the termination fee unless an offering or other
type of transaction is consummated by the issuer (without involvement
of the member) within two years of the date the engagement is
terminated with the member by the issuer. FINRA believes the proposal
provides members with a greater degree of flexibility in negotiating
the terms of their agreements for terminated offerings, while also
providing protection for issuers if a member fails materially to
perform the underwriting services contemplated in the written
agreement.
---------------------------------------------------------------------------

    \7\ The specific meaning of ``termination for cause'' would be
dictated by the agreement. For purposes of this proposal, a
``termination for cause'' would include a member's material failure
to perform the underwriting services contemplated in the written
agreement, but is not required to include events that are outside
the participating member's control.
    \8\ Members would continue to be permitted to receive
reimbursement of out-of-pocket, bona fide, accountable expenses
actually incurred by the participating member in connection with a
terminated offering.
---------------------------------------------------------------------------

    Current Rule 5110(f)(2)(F) and (G) address ``ROFRs'', which provide
a member with the right to underwrite or participate in future public
offerings, private placements or other financings of the issuer. Rule
5110(f)(2)(F) deems as unfair and unreasonable any ROFR provided to a
member that: (1) Has a duration of more than three years from the date
of effectiveness or commencement of sales of the public offering, or
(2) provides more than one opportunity to waive or terminate the ROFR
in consideration of any payment or fee.\9\ Rule 5110(f)(2)(G) prohibits
any payment or fee to waive or terminate a ROFR regarding future public
offerings, private placements or other financings that exceed specified
values or that is not paid in cash.
---------------------------------------------------------------------------

    \9\ Historically, FINRA has interpreted the Rule to permit ROFRs
only in the case of successful offerings.
---------------------------------------------------------------------------

    FINRA also has reevaluated its rules around ROFRs and proposes
amendments to permit ROFRs in the case of both successful as well as
terminated offerings. FINRA proposes that ROFRs would be permissible
where: (1) The agreement between the participating member and issuer
specifies that the issuer has a right of termination for cause (i.e.,
where a member fails materially to perform the underwriting services
contemplated in the written agreement); (2) an issuer's exercise of its
right of ``termination for cause'' eliminates any obligations with
respect to the provision of any ROFR; and (3) any fees arising from
services provided under a ROFR are customary for those types of
services. As is currently the case, the Rule would continue to provide
that the duration of any ROFR may not be for more than three years from
the date of commencement of sales of the public offering (in the case
of a successful offering). In the case of a terminated offering, the
duration may not be for more than three years from the date the
engagement is terminated by the issuer. In both cases, the agreement
may not provide for more than one opportunity to waive or terminate the
ROFR in consideration of any payment or fee.\10\
---------------------------------------------------------------------------

    \10\ FINRA is proposing to redesignate Rule 5110(f)(2)(G) as
Rule 5110(f)(2)(F), which prohibits any payment or fee to waive or
terminate a ROFR regarding future public offerings, private
placements or other financings that exceed specified values or that
is not paid in cash.
---------------------------------------------------------------------------

Filing Requirements for Certain Exchange-Traded Funds

    Rule 5110(b)(8) (Exempt Offerings) generally provides an exemption
for investment companies from the filing requirements of the Rule.\11\
Due to this exemption, exchange-traded funds (``ETFs'') that are
structured as investment companies generally are exempt. However, this
exemption does not include certain other ETFs that are not investment
companies. FINRA believes it is appropriate to add an exemption for
these ETFs even if they do not fall under the definition of an
``investment company'' for the same reason that investment company ETFs
are exempted from the Rule. Specifically, the creation structure of
ETFs, whereby the component securities are deposited in return for
shares of the fund, is not a distribution model that Rule 5110 was
designed to address. Thus, FINRA is proposing to exempt offerings of
securities issued by a pooled investment vehicle, whether formed as a
trust, partnership, corporation, limited liability company or other
collective investment vehicle, that is not registered as an investment
company under the Investment Company Act and has a class of equity
securities listed for trading on a national securities exchange;
provided that such equity securities may be created or redeemed on any
business day at their net asset value per share.
---------------------------------------------------------------------------

    \11\ Rule 5110(b)(8)(C) exempts from the Rule's filing
requirements securities of ``open-end'' investment companies as
defined in Section 5(a)(1) of the Investment Company Act of 1940
(``Investment Company Act'') and securities of any ``closed-end''
investment company as defined in Section 5(a)(2) of the Investment
Company Act that: (1) makes periodic repurchase offers pursuant to
Rule 23c-3(b) under of the Investment Company Act; and (2) offers
its shares on a continuous basis pursuant to Rule 415(a)(1)(xi) of
SEC Regulation C.
---------------------------------------------------------------------------

Electronic Filing
    Rule 5110(b) (Filing Requirements) generally provides that no
member or person associated with a member shall participate in any
manner in a public offering of securities subject to Rules 2310, 5110
or 5121 unless the specified documents and information relating to the
offering have been filed with and reviewed by FINRA. FINRA proposes to
amend the Rule to make clarifying, non-substantive changes regarding
documents filed through FINRA's electronic filing system.\12\
---------------------------------------------------------------------------

    \12\ The effective date of the electronic filing requirements
under Rule 5110 was July 12, 2002. See Notice to Members 02-26.
---------------------------------------------------------------------------

Industry Consultation
    FINRA engaged in an extensive consultative process regarding the
proposed rule change, including through the issuance of a Regulatory
Notice soliciting comment on the termination fee and ROFR provisions,
the exemption for ETFs, and the codification of the electronic filings
requirement. Commenters generally supported the proposal as set forth
in the Notice, requesting certain clarifications and modifications. A
summary of the comments received in response to the Regulatory Notice
is discussed in Item 5 below.\13\
---------------------------------------------------------------------------

    \13\ The Commission notes that Item 5 is part of the rule filing
itself; it not part of this Notice.
---------------------------------------------------------------------------

    FINRA will announce the implementation date of the proposed rule
change in a Regulatory Notice to be published no later than 60 days

following Commission approval. The effective date of the proposed rule
change will be no later than 120 days following Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act \14\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    The proposed rule change provides more flexibility to issuers and
participating members in the negotiation of termination fee and ROFR
terms and arrangements, while also promoting just and equitable
principles of trade by providing important protections for issuers who
terminate agreements with members for cause. Issuers can benefit from
the advice underwriters provide prior to raising capital, and may be
able to utilize more of an underwriter's resources if they can wait to
pay until they have the additional capital they plan to receive in a
public offering. This may be especially true for foreign issuers that
may need substantial advice and restructuring before accessing the U.S.
capital markets. Accordingly, issuers may want to enter into
termination fee or ROFR agreements if they provide an incentive to
underwriters to devote additional resources when the risk of not
receiving remuneration for those services is mitigated.
    In addition, the proposed rule change provides an exemption for
certain other collective investment vehicles that are not registered as
investment companies, as exists for open-end and certain closed-end
investment companies. The proposed rule change also formalizes that
members must use FINRA's electronic filing system to file required
information and documents relating to offerings in which they
participate.

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

    FINRA 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 discussed above, the
proposed rule change sets out consistent rules for all members entering
into agreements with issuers for the provision of services in
connection with a public offering of securities, and also enhances
competition among members that provide underwriting services to issuers
by broadening the types of compensation arrangements that firms can
negotiate with issuers. In addition, the amendments require that any
termination fee paid must be reasonable in relation to the underwriting
services contemplated and any ROFR fees paid must be customary in
relation to the services the member provides.
    Further, the proposed rule change provides additional protections
to issuers that choose to enter into a termination fee agreement or
provide a right of first refusal by requiring that the agreement
provide issuers with a right to terminate for cause. Thus, under the
proposal, issuers would have no obligation to pay a termination fee or
be bound to a member by a ROFR if that member has failed materially to
provide the underwriting services contemplated in the agreement.
    The proposed rule change also would promote competition by
eliminating disparate filing requirements for exchange-traded
collective investment vehicles not registered as investment companies
as compared to those that are structured as investment companies. FINRA
does not believe that the codification of the electronic filing
requirement or the other non-substantive and clarifying amendments
contained in the filing will impact competition. Therefore, FINRA 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.

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

    On June 6, 2012, FINRA published Regulatory Notice 12-27
(``Notice'' or ``Notice 12-27'') requesting comment on FINRA's proposal
to amend Rule 5110. A copy of the Notice is attached as Exhibit 2a.\15\
The comment period expired on July 23, 2012. FINRA received three
comments in response to the Notice.\16\ A list of the commenters in
response to the Notice is attached as Exhibit 2b, and copies of the
comment letters received in response to the Notice are attached as
Exhibit 2c. A summary of the comments and FINRA's response is provided
below.
---------------------------------------------------------------------------

    \15\ The Commission notes that Exhibits 2a, 2b, and 2c, are part
of the rule filing itself; they are not exhibits to this Notice.
    \16\ See Letter from Bradley J. Swenson, Chief Compliance
Officer, ALPS Distributors, Inc., to Joseph E. Price, Senior Vice
President, FINRA, dated July 23, 2012 (``ALPS letter''); letter from
Sean Davy, Managing Director, Corporate Credit Markets Division,
Securities Industry and Financial Markets Association, to Marcia E.
Asquith, Corporate Secretary, FINRA, dated July 23, 2012 (``SIFMA
letter''); and letter from Jeffrey W. Rubin, Chair, Federal
Regulation of Securities Committee, Business Law Section of the
American Bar Association, to Marcia E. Asquith, Corporate Secretary,
FINRA, dated July 30, 2012 (``ABA letter'').
---------------------------------------------------------------------------

    In Notice 12-27, FINRA proposed amendments substantially similar to
the instant proposal. FINRA proposed to expand the circumstances under
which termination fees and ROFRs would be permissible while providing
protections for issuers that terminate arrangements with members for
cause. The Notice also proposed to eliminate the filing requirements
for exchange-traded funds that are structured as grantor or statutory
trusts.
    Commenters generally supported the proposal as set forth in the
Notice and requested certain clarifications and modifications. With
respect to the ``termination for cause'' provision, two commenters
expressed concern that the provision would give an issuer broad
discretion regarding the circumstances in which it could avoid paying
an agreed upon termination fee to a member in the event of a terminated
offering.\17\ One commenter suggested limiting the circumstances under
which an issuer could exercise its right to terminate for cause to an
action or event that is ``within the direct control of the member'' and
results in a material failure on the part of the member to provide the
underwriting services.\18\ Commenters also suggested that the issuer's
termination for cause should take into account current market, economic
and political conditions.\19\ Another commenter suggested that the
issuer's termination for cause be limited to cases in which the issuer
requests the member to perform customary and reasonable services in
connection with the public offering and ``it is determined that the
member has materially failed to provide such services.'' \20\
---------------------------------------------------------------------------

    \17\ See ABA and SIFMA letters.
    \18\ See ABA letter.
    \19\ See ABA and SIFMA letters.
    \20\ See SIFMA letter. SIFMA also suggested that the termination
for cause provision be operative as a function of the rule itself
and not be required to be included in the written agreement. FINRA
disagrees and believes it is important that the termination clause
be known to issuers and set forth in any written agreement regarding
the provision of underwriting services by a participating member in
connection with a public offering of securities.
---------------------------------------------------------------------------

    FINRA continues to believe that it is an important issuer
protection that members' arrangements include an issuer's right to
terminate an agreement for cause, but has modified the proposal to
provide that a ``termination for

cause'' shall include the participating member's material failure to
provide the underwriting services contemplated in the agreement, since
agreements may be drafted broadly to include services that are not
related to the member's role as an underwriter. FINRA also has
clarified in this filing that an issuer's termination of an agreement
due to events that are outside the member's control need not constitute
a ``termination for cause'' under the proposal.
    One commenter suggested amending the ``termination for cause''
provision to allow related persons and affiliates of the issuer and
member to be parties to the written agreement noting that, in certain
cases, the provisions and associated obligations may be reflected in an
agreement between these persons.\21\ Rule 5110 defines the terms
``issuer'' and ``participating member'' broadly to include certain
related persons and affiliates. FINRA has revised the proposal to
reflect the term ``participating member'' when referencing the parties
to a member's written agreement with an issuer.
---------------------------------------------------------------------------

    \21\ See SIFMA letter.
---------------------------------------------------------------------------

    Notice 12-27 proposed that the agreement between the issuer and
member provide that any termination fee must be reasonable and any fee
arising from services provided under a ROFR be customary. Commenters
argued that requiring the inclusion of the reasonable and customary
language in a written agreement between the issuer and member is
unnecessary and suggested that FINRA require these standards in the
rule, but not require that they be expressed in the written
agreement.\22\ FINRA agrees and has reflected those changes in the
instant filing. One commenter also suggested that FINRA clarify whether
an issuer's payment of termination fees would be considered
underwriting compensation in connection with a subsequent public
offering that has been consummated within two years of the termination
of services.\23\
---------------------------------------------------------------------------

    \22\ See ABA and SIFMA letters. SIFMA stated that these
standards should be ``operative as a function of the rule itself and
should not be required to be set forth in a written agreement . . .
.''
    \23\ See SIFMA letter. Under the Rule, items of value, such as
termination fees or fees paid for services rendered pursuant to a
ROFR are counted as compensation if they are received within 180
days prior to filing an offering or during the offering period. See
Rule 5110(c)(3)(A)(xiii).
---------------------------------------------------------------------------

    In Notice 12-27, FINRA proposed an exemption from the filing
requirements for ETFs formed as a grantor trust or statutory trust in
which the portfolio assets include commodities, currencies or other
assets that are not securities. Commenters supported this proposed
amendment and further suggested that FINRA modify the proposed rule
language to define the term ``ETF'' and broadly exempt from the Rule
all ETFs without regard to how they are structured and organized.\24\
FINRA has amended the language of the proposal to exempt offerings of
securities issued by a pooled investment vehicle, whether formed as a
trust, partnership, corporation, limited liability company or other
collective investment vehicle, that is not registered as an investment
company under the Investment Company Act and has a class of equity
securities listed for trading on a national securities exchange;
provided that such equity securities may be created or redeemed on any
business day at their net asset value per share. FINRA believes that
the current exemption for investment companies would capture virtually
all other ETFs.
---------------------------------------------------------------------------

    \24\ See ABA and ALPS letters.
---------------------------------------------------------------------------

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2014-004 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-FINRA-2014-004. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal offices of FINRA.
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-FINRA-2014-
004, and should be submitted on or before March 4, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-02934 Filed 2-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Rules and Regulations]
[Pages 53270-53271]
[FR Doc No: 2016-19189]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0752]

Drawbridge Operation Regulation; Rockaway Inlet, Queens, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Marine Parkway Bridge across the
Rockaway Inlet, mile 3.0, at Queens, New York. This deviation is
necessary to allow the bridge owner to replace span guide rollers,
counterweight guide shoes and trunnion journal at the bridge.

DATES: This deviation is effective from 7 a.m. on October 17, 2016 to 5
p.m. on October 28, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0752] 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.

FURTHER INFORMATION CONTACT: If you have questions on this temporary
deviation, call or email Judy Leung-Yee, Project Officer, First Coast
Guard District, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Marine Parkway Bridge, mile 3.0, across
the Rockaway Inlet, has a vertical clearance in the closed position of
55 feet at mean high water and 59 feet at mean low water. The existing
bridge operating regulations are found at 33 CFR 117.795(a).
    The waterway is transited by commercial barge traffic of various
sizes.
    The bridge owner, MTA Bridges and Tunnels, requested a temporary
deviation from the normal operating schedule to replace span guide
rollers, counterweight guide shoes and trunnion journal at the bridge.
    Under this temporary deviation, the Marine Parkway Bridge shall
remain in the closed position from 7 a.m. on October 17, 2016 to 5 p.m.
October 28, 2016.
    Vessels able to pass under the bridge in the closed position may do
so at anytime. The bridge will not be able to open for emergencies and
there is no immediate alternate route for vessels to pass.
    The Coast Guard will inform the users of the waterways through our
Local Notice and Broadcast to Mariners of the change in operating
schedule for the bridge so that vessel operations can arrange their
transits to minimize any impact caused by the temporary deviation. The
Coast Guard notified various companies of the commercial oil and barge
vessels and they have no objections to 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: August 9, 2016.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-19189 Filed 8-11-16; 8:45 am]
 BILLING CODE 9110-04-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 USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0029 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G 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. G Other Specify: / /___

7. Title NSPS for Iron and Steel Plants: Basic Oxygen Process Furnaces ( 40 CFR Part 60, Subparts N and Na)

8. Agency form number( s) ( If applicable) EPA ICR Number 1069.07 9. Keywords Basic oxygen furnaces, basic oxygen process furnace shops ( BOPF) shops, steel plants, iron and steel plants, NSPS.

10. Abstract NSPS Subpart N is applicable to BOPFs in iron and steel plants commencing construction, modification or reconstruction after June 11, 1973. NSPS Subpart Na is applicable to any top blown BOPF, hot metal transfer station or skimming station for which construction, reconstruction, or modification commenced after January 20, 1983. Owners and operators of affected sources are subject to the monitoring, recordkeeping and reporting requirements of 40 CFR Part 60, Subpart A, the General Provisions, unless specified otherwise in the regulation. Monitoring requirements specific to BOPF shops provide information on the operation of the emissions control device and compliance with the mass and visible emission standards. Owners or operators are also required to maintain records for two years. Semiannual reports of measurements that average 10 percent below the average measurements obtained during the most recent performance tests are required. These notifications, reports, and records are essential in determining compliance; and are required, in general, of all sources subject to NSPS.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 4 b. Total annual responses 10 1. Percentage of these responses collected electronically 0 % c. Total hours requested 1,012 d. Current OMB inventory 1,795 e. Difference  783 f. Explanation of difference 1. Program Change 2. Adjustment  783 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 18 b. Total annual costs ( O& M) $ 8 c. Total annualized cost requested $ 26 d. Current OMB inventory $ 35 e. Difference $ 9 f. Explanation of difference 1. Program change 2. Adjustment $ 9 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. X Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

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

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Maria Malave Phone: ( 202) 564 7027 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, EPAand 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 forthEPAin 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 Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance 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