[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63896-63898]
[FR Doc No: 2018-26854]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4750]

Interpretation of the ``Deemed To Be a License'' Provision of the
Biologics Price Competition and Innovation Act of 2009; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Interpretation of the `Deemed To Be a License' Provision of the
Biologics Price Competition and Innovation Act of 2009.'' This guidance
describes FDA's interpretation of the statutory provision under which
an application for a biological product approved under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be
deemed to be a license for the biological product under the Public
Health Service Act (PHS Act) on March 23, 2020. Specifically, this
guidance describes FDA's interpretation of the ``deemed to be a
license'' provision of the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act) for biological products that are approved under
the FD&C Act as of March 23, 2020. This guidance also provides
recommendations to sponsors of proposed protein products intended for
submission in an application that may not receive final approval under
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of the transition
provision of the BPCI Act.

DATES: The announcement of the guidance is published in the Federal
Register on December 12, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2015-D-4750 for ``Interpretation of the `Deemed To Be a License'
Provision of the Biologics Price Competition and Innovation Act of
2009; Guidance for Industry; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the

``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-
796-3475; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Interpretation of the `Deemed To Be a License' Provision of
the Biologics Price Competition and Innovation Act of 2009.''
    This guidance describes FDA's interpretation of the provision of
the BPCI Act under which an application for a biological product
approved under section 505 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a
license for the biological product under section 351 of the PHS Act (42
U.S.C. 262) on March 23, 2020. Specifically, this guidance describes
FDA's interpretation of the ``deemed to be a license'' provision in
section 7002(e) of the BPCI Act for biological products that are
approved under section 505 of the FD&C Act as of March 23, 2020 (the
transition date). This guidance also provides recommendations to
sponsors of proposed protein products intended for submission in an
application that may not receive final approval under section 505 of
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation of section 7002(e)
of the BPCI Act.
    Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
clarified the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide),'' and describing
procedures for submission of a marketing application for a ``biological
product.'' FDA previously stated its interpretation of the statutory
terms ``protein'' and ``chemically synthesized polypeptide'' in the
amended definition of ``biological product'' (see FDA's draft guidance
for industry entitled ``New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 2),'' available on FDA's website
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Elsewhere in this issue of the Federal
Register, FDA also has issued a proposed rule to amend its regulation
that defines ``biological product'' to incorporate changes made by the
BPCI Act, and to provide its interpretation of the statutory terms
``protein'' and ``chemically synthesized polypeptide.'' When final,
this regulation will codify FDA's interpretation of these terms.
    The BPCI Act requires that a marketing application for a
``biological product'' (that previously could have been submitted under
section 505 of the FD&C Act) must be submitted under section 351 of the
PHS Act; this requirement is subject to certain exceptions during a 10-
year transition period ending on March 23, 2020 (see section
7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an
approved application for a biological product under section 505 of the
FD&C Act shall be deemed to be a license for the biological product
under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI
Act). Among other things, while section 7002(e)(4) of the BPCI Act
explicitly provides that an approved application under section 505 of
the FD&C Act shall be deemed to be a license on March 23, 2020, the
statute does not provide a means for deeming an approved new drug
application (NDA) to be an approved biologics license application (BLA)
prior to, or after, the transition date. Therefore, FDA interprets
section 7002(e) of the BPCI Act to plainly mean that, on March 23,
2020, only approved NDAs will be deemed to be BLAs. After March 23,
2020, the Agency will not approve any application submitted under
section 505 of the FD&C Act for a biological product subject to the
transition provision that is pending or tentatively approved. Such an
application may, for example, be withdrawn and submitted under section
351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance,
FDA provides recommendations to minimize the impact on development
programs for any proposed biological products intended for submission
under section 505 of the FD&C Act that may not be able to receive final
approval by March 23, 2020.
    In the Federal Register of March 14, 2016 (81 FR 13373), FDA
announced the availability of the draft of this guidance. FDA received
several comments on the draft guidance, and those comments were
considered as the guidance was finalized. This final guidance explains
that FDA interprets section 7002(e) of the BPCI Act and section 351 of
the PHS Act to mean that an approved NDA for a biological product that
will be deemed to be ``licensed'' under section 351(a) of the PHS Act
on March 23, 2020, can be a reference product for a proposed biosimilar
product or a proposed interchangeable product (see section 351(i)(4) of
the PHS Act). However, a biological product that was first approved in
an NDA under section 505 of the FD&C Act and deemed ``licensed'' under
section 351(a) of the PHS Act on March 23, 2020, will not have been
``first licensed under subsection (a)'' for purposes of section
351(k)(7) of the PHS Act. Thus, such a biological product will not be
eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS
Act. Moreover, FDA interprets the limitations on eligibility for
reference product exclusivity in section 351(k)(7)(C) of the PHS Act to
apply to any reference product. The guidance also clarifies the
Agency's approach to supplements submitted to an approved NDA for a
biological product before March 23, 2020, that are pending on the
transition date.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Interpretation of the `Deemed To Be a
License' Provision of the Biologics Price Competition and Innovation
Act of 2009.'' 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collection of information in 21 CFR part 312 has been approved under
OMB control number 0910-0014; the collection of information in 21 CFR
part 314 has been approved under OMB control number 0910-0001; the
collection of information in 21 CFR part 601 has been approved under
OMB control number 0910-0338; and the collection of information for
applications submitted under section 351(k) of the PHS Act has been
approved under OMB control number 0910-0719; the collection of
information in FDA's guidance for industry entitled ``Formal Meetings
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants'' has been approved under OMB control number 0910-0802; and
the collection of information in FDA's guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products'' has been approved under OMB control number 0910-0429.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26854 Filed 12-11-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6450-6451]
[FR Doc No: 2019-03393]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-440, OMB Control No. 3235-0496]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Appendix F to Rule 15c3-1

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in appendix F to Rule 15c3-1
(``Appendix F'' or ``Rule 15c3-1f'') (17 CFR 240.15c3-1f) under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.). The Commission
plans to submit this existing collection of information to the Office
of Management and Budget (``OMB'') for extension and approval.
    Under appendix F, a class of broker-dealers known as over-the
counter (``OTC'') derivatives dealers may apply to the Commission for
authorization to compute net capital charges for market and credit risk
in accordance with appendix F in lieu of computing securities haircuts
under paragraph (c)(2)(vi) of Exchange Act Rule 15c3-1.
    At present, three OTC derivatives dealers have been approved to use
appendix F. Two OTC derivatives dealers have applied to use appendix F,
and the staff expects that one additional OTC derivatives dealer will
apply to use appendix F during the next three years. The Commission
estimates that the three approved OTC derivatives dealers and two OTC
derivatives dealers with pending applications (if approved) will spend
an average of approximately 1,000 hours each per year reporting
information concerning their VAR models and internal risk management

systems, for an annual burden of 5,000 hours. The Commission estimates
that, on average, a firm initially will take approximately 1,000 hours
to prepare an application to use appendix F. For the one firm expected
to apply, this would result in an annual burden of 333 hours per year
amortized over three years. For the two years after it registers, the
new registrant would spend an average of approximately 1,000 hours each
year reporting information concerning its VAR model and internal risk
management system, for an annual burden of 667 hours per year amortized
over 3 years.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an
email to<EMAIL_ADDRESS>
    Dated: February 22, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03393 Filed 2-26-19; 8:45 am]
 BILLING CODE 8011-01-P


in response to the order. In addition, because the mere filing of the
objection (or indeed, the filing of a judicial challenge) would not
necessarily extend the deadline for submission of the studies, in order
for this process to be completed in a timely fashion, EPA expects order
recipients to present their objections with sufficient specificity and
detail to allow the Agency to adequately and fairly evaluate the
issue(s) presented. EPA intends to review the issues presented and
provide a written response within a reasonable amount of time. The
Agency understands that it will need to respond within sufficient time
for the order recipient to either comply with the order or determine
whether to pursue its concerns through judicial review.

J. How Would EPA Handle Responses from Recipients of Test Orders?

    Just as there are many different, acceptable responses that
recipients may provide to a test order, so too are there many actions
that EPA may take. In some cases, a recipient's response would affect
only the recipient. This would be the case for a response from a test
order recipient:
     Who claims that it is not subject to the order (see Unit
IV.F.1.d.); or
     Who voluntarily cancels its registration (see Unit
IV.F.1.e.); or
     Who reformulates its registered products (see Unit
IV.F.1.f.); or

     Who claims that it qualifies for the formulator's
exemption (see Unit IV.F.1.g.); or
     Who claims that it does not or no longer manufacture(s) or
import(s) the chemical (see Unit IV.F.1.h.).
    Each of these responses would only affect the specific recipient's
obligation under the order. If EPA agreed with the response, the
recipient would not be required to generate the EDSP data (not subject
to the order or qualified for the formulator's exemption) or EPA would
cancel the recipient's registration as requested. EPA actions on these
kinds of responses would not affect other order recipients; they would
still be required to respond to the order by generating the data or
making one of the other acceptable responses.
    In some cases, however, another recipient's response may have
consequences for other recipients. This would be the case for a
response from a test order recipient:
     Who intends to generate the data (see Unit IV.F.1.a.); or
     Who cites or submits existing data (see Unit IV.F.1.b.);
or
     Who enter (or offer to enter) a joint agreement to
generate the data (see Unit IV.F.1.c.); or
     Who commits to not sell their chemical for use in the
pesticide market (see Unit IV.F.1.i.).
    The following discussion summarizes how EPA expects to handle
responses to test orders that may have consequences for other
recipients.
    1. Publication order recipients, responses, and order status. As
noted earlier, EPA intends to publish the list of all order recipients
in the Federal Register and post the list on the Agency's website. The
Agency intends to also post the status of the testing orders, including
recipients' responses, on the Agency website so that both order
recipients and the public can check on the status of responses to the
orders. This information is intended to enable recipients of test
orders to identify and join other order recipients to develop the data
in response to the order, which in turn would help achieve EPA's goals
of minimizing duplicative testing and promoting fair and equitable
sharing of test costs. For example, if more than one recipient has
agreed to perform the required studies (see Unit IV.F.1.a.), it will be
reflected on the list and having this information will help them
explore the possibility of generating the data jointly. In addition, a
recipient who has agreed to generate required EDSP data can see all
other recipients who have informed the Agency that they would be
willing to share the cost of performing the required studies (see Unit
IV.F.1.b.). This information will aid in their sorting of offers to
share the cost of generating the required data from any recipient whom
EPA indicates has promised to make an offer to share test costs, but
has not yet contacted the recipient.
    2. Publication of EPA decisions regarding reliance on existing data
or requests for an exemption under section 408(p)(4), and decisions
challenging the issuance of the test orders. The EPA website would also
contain information on decisions about whether a test recipient may
rely on existing data (see Unit IV.F.1.c.). If so, the Agency intends
to regard the existing data as meeting the requirement for all test
order recipients. Similarly, if EPA determines that a recipient has
demonstrated that the Agency should exempt the chemical from testing
under section 408(p)(4) (see Unit IV.F.1.h.), that decision would apply
equally to all test order recipients. Finally, a recipient's challenge
to the legal basis for a test order (see Unit IV.F.1.i.) might be
resolved in a way that affects the validity of the order for other
recipients. Publishing these decisions may also be considered by others
with similar questions.
    3. Generation of data, tracking compensability of submitted data,
and enforcing compensation obligations. When EDSP data on an active
ingredient are submitted, EPA intends to handle the submission in the
same manner used under FIFRA. The name of the data submitter would be
added to the Data Submitters List and all future applicants for
registration of a pesticide containing the active ingredient would be
required to cite and offer to pay compensation in order to rely on the
data for the 15-year period following submission of such data.
    In the case of EDSP data on pesticide inert ingredients, as
explained in Unit IV.C.2.c., EPA intends to establish a list (i.e., the
PIIDSSL) to identify any person who has submitted compensable data on a
pesticide inert ingredient in response to a test order issued under
FFDCA section 408(p). Assuming at least one recipient of a test order
submits the required EDSP data, EPA would add the name of the submitter
to the PIIDSSL under the name of the ingredient as an ``original data
submitter.'' The PIIDSSL would also include any other test order
recipient who has made an offer to share the cost of testing as an
``approved source,'' i.e., a source from whom an applicant or
registrant may obtain the pesticide inert and not have to offer to pay
compensation to the original data submitter. Since it is important to
have as complete a list of approved sources as possible, EPA encourages
original data submitters to identify additional companies as approved
sources, for example, because they have a contract to buy from the data
submitter. Then, pursuant to FIFRA section 3(c)(1)(F), when an
applicant's product contains a pesticide inert ingredient on the
PIIDSSL, the applicant would identify the source of the pesticide inert
ingredient. If the applicant's source does not appear on the PIIDSSL,
the applicant would either switch to a source on the PIIDSSL, offer to
pay compensation to the original data submitter(s) on the PIIDSSL, or
generate their own data.
    EPA intends to also take a number of measures to ensure that
pesticide registrants are not obtaining the pesticide inert ingredient
from an ``unapproved'' source. Shortly after the receipt of test order
responses, EPA intends to make public the commitments made by
recipients of test orders-the names of the companies that have agreed
to generate (or share in the cost of generating) test data (``data
generators'') and the names of the companies that have committed to
discontinue selling into the pesticide market. If at least one order
recipient has agreed to generate the required data, EPA intends to
inform registrants that in the future they will need to obtain the
pesticide inert ingredient only from a data submitter or approved
source, offer to pay compensation to the data submitter for the right
to rely on existing data, or generate new data.
    The Agency thinks these procedures will result in a system that
effectively provides data use protections to generators of EDSP data on
pesticide active and inert ingredients. Through this system all
manufacturers and importers of pesticide inert ingredients will
understand whether or not they are allowed to sell into the pesticide
market. If a manufacturer or importer takes the necessary steps that
allow it to sell into the pesticide market, such a company would be
listed on the PIIDSSL. Those manufacturers and importers whose products
reached the pesticide market through other suppliers could add the
names of the suppliers to the PIIDSSL. Similarly, through this system,
applicants for new products and registrants of existing products will
understand from which sources they may purchase a pesticide inert
ingredient without having to offer to pay compensation, or without
running the risk of needing to generate their own data.
    The Agency recognizes that these safeguards do not automatically
ensure compliance with the data use

protections. But the Agency expects that manufacturers and importers
who commit not to sell their chemical into the pesticide market will
adhere to this promise and will work with their customers to ensure
they also observe this market constraint.
    EPA also intends to take steps to try to prevent companies from
inadvertently subverting the commitment made by order recipients. For
example, the Agency's Federal Register document that announces the
issuance of the FFDCA section 408(p) order(s), would also inform those
companies who sell a chemical that is used as a pesticide inert
ingredient (other than test order recipients) that they may receive and
become subject to an FFDCA section 408(p) order if they obtain the
pesticide inert ingredient (either directly or indirectly) from a
source who has not committed to generate the EDSP data but then sell
the pesticide inert ingredient into the pesticide market. EPA intends
to inform manufacturers who agree to generate the data that EPA intends
to rely on them to bring to EPA's attention information indicating that
a pesticide registrant appears to be obtaining the pesticide inert
ingredient from an ``unapproved'' source. As indicated previously, EPA
intends to issue ``catch-up'' orders to any manufacturer or importer of
a pesticide inert ingredient who enters the market place after EPA has
issued a test order for that ingredient.
    4. All test order recipients for a pesticide inert ingredient ``opt
out'' of the pesticide market. If no test order recipient has agreed to
generate the required data, the Agency intends to issue a Federal
Register notice informing registrants that the pesticide inert
ingredient will no longer be available for use in formulating pesticide
products unless someone commits to generate the required data. EPA
intends to ask for a commitment to generate the required data within 6
months of publication. After that date, EPA would take steps to remove
the pesticide inert ingredient from its list of cleared pesticide
inerts and to revoke any tolerances or tolerance exemptions for the
pesticide inert ingredient. EPA would also remind registrants that
under existing regulations, they must apply to amend their
registrations before they may sell a pesticide product that has a
composition that differs from the approved Confidential Statement of
Formula for the product. On a case-by-case basis, EPA may issue a DCI
notice and/or a section 408(p) test order for the required data to
registrants whose products contain the pesticide inert ingredient.

K. Adverse Effects Reporting Requirements

    Under FIFRA section 6(a)(2), pesticide product registrants are
required to submit adverse effects information about their products to
the EPA. Among other things, the implementing regulations in 40 CFR
part 159, subpart D provide registrants with detailed instructions on
whether, when, and how to report information in the possession of the
registrant or its agents.
    In addition, under TSCA section 8(c), companies can be required to
record, retain and in some cases report ``allegations of significant
adverse reactions'' to any substance/mixture that they produce, import,
process, or distribute. EPA's TSCA section 8(c) rule requires
producers, importers, and certain processors of chemical substances and
mixtures to keep records concerning significant adverse reaction
allegations and report those records to EPA upon notice in the Federal
Register or upon notice by letter. The TSCA section 8(c) rule also
provides a mechanism to identify previously unknown chemical hazards in
that it may reveal patterns of adverse effects which otherwise may not
be otherwise noticed or detected. Further information is available
under 40 CFR part 717.
    Under TSCA section 8(e), U.S. chemical manufacturers, importers,
processors, and distributors are required to notify EPA within 30
calendar days of new, unpublished information on their chemicals that
may lead to a conclusion of substantial risk to human health or to the
environment. The term ``substantial risk'' information refers to that
information which offers reasonable support for a conclusion that the
subject chemical or mixture poses a substantial risk of injury to
health or the environment and need not, and typically does not,
establish conclusively that a substantial risk exists. For additional
information about TSCA section 8(e), please go to http://www.epa.gov/
oppt/chemtest/pubs/sect8e.htm.
    EPA does not require duplicate submission of EDSP results under
FIFRA section 6(a)(2) or TSCA section 8(c) or (e). Any information
submitted under FIFRA section 6(a)(2) or TSCA section 8(c) or 8(e)
procedures does not need to be submitted again to satisfy the FFDCA
section 408(p) test order. The test order recipient would instead
submit the necessary information to cite to the previously submitted
information as described earlier in this document.

V. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), EPA submitted this document to
the Office of Management and Budget (OMB) for review. Any changes made
in response to OMB recommendations have been documented in the docket
for this action as required by section 6(a)(3)(E) of the Executive
Order.

B. Paperwork Reduction Act (PRA)

    The information collection requirements associated with issuing
orders for Tier 1 screening under the EDSP have been submitted for
review and approval by OMB under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq. An 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. As a new ICR, the Agency
does not yet have an OMB control number for this information collection
activity. Once assigned, EPA will announce the OMB control number for
this information collection in the Federal Register, and will add it to
any related collection instruments or forms used, and include it in the
orders issued.
    A copy of the final ICR package submitted to OMB for review and
approval under the PRA (identified under EPA ICR No. 2249.01) has been
placed in the docket for this policy. A draft of the ICR package was
issued for public comment pursuant to the PRA and 5 CFR 1320.8(d) on
December 13, 2007 (72 FR 70839) (FRL-8155-8). The ICR has been revised
to address comments received, and the following is a brief summary of
the final ICR package that was submitted to OMB for approval under the
PRA and which describes the information collection activities discussed
in the final policy and procedures document, along with EPA's estimated
burden in more detail.
    Under the PRA, ``burden'' is defined at 5 CFR 1320.3(b). For the
purposes of this ICR, the information collection activities include
reviewing the order, providing the initial response, participating in a
consortia, generating the data, preparing and submitting a progress
report, submitting the data, requesting an extension, and maintaining
records. As described in more detail in the ICR, the total estimated
per chemical/per respondent paperwork burden is 3,008 hours, with an
estimated cost of $212,369. Annualized over 3 years, the per

respondent burden is 1,003 hours, and the cost is $70,790. The total
annualized estimated paperwork burden for this ICR is 108,364 hours,
with an estimated total annual cost of $7,478,116 million. Although
individual respondent burden varies based on their individual
activities, this estimate assumes that the respondent actively
participates in all potential activities, including developing
consortia, generating all of the potential data, submitting a progress
report, requesting an extension, and submitting the data.
    Pursuant to 5 CFR 1320.12, the submission of the ICR to OMB, along
with a solicitation of comments on that ICR, is addressed in a separate
document published elsewhere in today's Federal Register. Please follow
the instructions in that document to view the ICR and submit comments
on the revised ICR.

VI. References

    The following is a list of the documents that are specifically
referenced in this document and placed in the docket that was
established under Docket ID number EPA-HQ-OPPT-2007-1080. For
information on accessing the docket, refer to the ADDRESSES unit at the
beginning of this document.
    1. EPA. Endocrine Disruptor Screening and Testing Advisory
Committee (EDSTAC) Final Report. August 1998. http://www.epa.gov/
scipoly/oscpendo/pubs/edspoverview/finalrpt.htm.
    2. Organization for Economic Cooperation and Development (OECD).
Final Report of the OECD Workshop on Harmonization of Validation and
Acceptance Criteria for Alternative Toxicological Test Methods. August
1996.
    3. EPA. Response to Comments on the Endocrine Disruptor Screening
Program: Draft Policies and Procedures for Initial Screening and
Testing. March 2009.
    4. EPA. EPA's Approach for Considering Other Scientifically
Relevant Information (OSRI) under the Endocrine Disruptor Screening
Program. March 17, 2009.

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors,
Pesticides and pests, Reporting and recordkeeping.

    Dated: April 3, 2009.
James Jones,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.

[FR Doc. E9-8706 Filed 4-14-09; 8:45 am]

BILLING CODE 6560-50-S


Based on the foregoing, the Commission estimates the following
aggregate total PRA burdens and costs, by category of entity, resulting
from Rule 908, as adopted and as proposed to be amended herein.
    The Commission has estimated that the total paperwork burden
associated with submitting a request for a substituted compliance
determination with respect to regulatory reporting and public
dissemination will be approximately 1,120 hours, plus $1,120,000 for 14
requests.\415\ The Commission further estimated that the aggregated
burden for the first year will be 800 hours, plus $800,000 for the
services of outside professionals.\416\ The Commission estimated that
it would receive 2 requests for substituted compliance determinations
pursuant to Rule 908(c)(2)(ii) in each subsequent year. Assuming the
same approximate time and costs, the Commission stated that the
aggregate burden for each year following the first year will be up to
160 hours of company time and $160,000 for the services of outside
professionals.\417\
---------------------------------------------------------------------------

    \415\ The Commission staff estimates that the paperwork burden
associated with making a substituted compliance request pursuant to
Rule 908(c)(2)(ii) will be approximately 80 of in-house counsel
time, plus $80,000 for the services of outside professionals (based
on 200 hours of outside counsel time x $400). See id. at 31110
    \416\ The Commission staff estimates that the paperwork burden
associated with making a substituted compliance request pursuant to
Rule 908(c)(2)(ii) will be up to approximately 800 hours (80 hours
of in-house counsel time x 10 respondents), plus $800,000 for the
services of outside professionals (based on 200 hours of outside
counsel time x $400 x 10 respondents). See Cross-Border Proposing
Release, 78 FR 31110.
    \417\ The Commission staff estimates that the paperwork burden
associated with making a substituted compliance request pursuant to
Rule 908(c)(2)(ii) would be up to approximately 160 hours (80 hours
of in-house counsel time x 2 respondents) + plus $160,000 for the
services of outside professionals (based on 200 hours of outside
counsel time x $400 x 2 respondents). See Cross-Border Proposing
Release, 78 FR 31110.
---------------------------------------------------------------------------

G. Request for Comments

    Pursuant to 44 U.S.C. 3505(c)(2)(B), the Commission solicits
comment to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of our functions, including
whether the information shall have practical utility;
    2. Evaluate the accuracy of our estimate of the burden of the
proposed collection of information;
    3. Determine whether there are ways to enhance the quality,
utility, and clarity of the information to be collected; and
    4. Evaluate whether there are ways to minimize the burden of
collection of information on those who are to respond, including
through the use of automated collection techniques or other forms of
information technology.
    Persons submitting comments on the collection of information
requirements should direct them to the Office of Management and Budget,
Attention: Desk Officer for the Securities and Exchange Commission,
Office of Information and Regulatory Affairs, Washington, DC 20503, and
should also send a copy of their comments to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090, with reference to File Number S7-03-15.
Requests for materials submitted to OMB by the Commission with regard
to this collection of information should be in writing, with reference
to File Number S7-03-15 and be submitted to the Securities and Exchange
Commission, Office of FOIA/PA Operations, 100 F Street NE., Washington,
DC 20549-2736. As OMB is required to make a decision concerning the
collections of information between 30 and 60 days after publication, a
comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication.

X. Consideration of Impact on the Economy

    For purposes of the Small Business Regulatory Enforcement Fairness
Act of 1996 (``SBREFA) \418\ the Commission must advise the OMB whether
the proposed regulation constitutes a ``major'' rule. Under SBREFA, a
rule is considered ``major'' where, if adopted, it results or is likely
to result in: (1) An annual effect on the economy of $100 million or
more; (2) a major increase in costs or prices for consumers or
individual industries; or (3) significant adverse effect on
competition, investment or innovation.
---------------------------------------------------------------------------

    \418\ Public Law 104-121, Title II, 110 Stat. 857 (1996)
(codified in various sections of 5 U.S.C. and 15 U.S.C. and as a
note to 5 U.S.C. 601).
---------------------------------------------------------------------------

    The Commission requests comment on the potential impact of the
proposed rules and amendments on the economy on an annual basis.
Commenters are requested to provide empirical data and other factual
support for their views to the extent possible.

XI. Regulatory Flexibility Act Certification

    Section 3(a) of the Regulatory Flexibility Act of 1980 (``RFA'')
\419\ requires the Commission to undertake an initial regulatory
flexibility analysis of the proposed rules on ``small entities.''
Section 605(b) of the RFA \420\ provides that this requirement shall
not apply to any proposed rule or proposed rule amendment which, if
adopted, would not have a significant economic impact on a substantial
number of small entities. Pursuant to 5 U.S.C. 605(b), the Commission
hereby certifies that the proposed rules and rule amendments to
Regulation SBSR would not, if adopted, have a significant economic
impact on a substantial number of small entities. In developing these
proposed amendments to Regulation SBSR, the Commission has considered
their potential impact on small entities. For purposes of Commission
rulemaking in connection with the RFA, a small entity includes: (1)
When used with reference to an ``issuer'' or a ``person,'' other than
an investment company, an ``issuer'' or ``person'' that, on the last
day of its most recent fiscal year, had total assets of $5 million or
less; \421\ or (2) a broker-dealer with total capital (net worth plus
subordinated liabilities) of less than $500,000 on the date in the
prior fiscal year as of which its audited financial statements were
prepared pursuant to Rule 17a-5(d) under the Exchange Act,\422\ or, if
not required to file such statements, a broker-dealer with total
capital (net worth plus subordinated liabilities) of less than $500,000
on the last day of the preceding fiscal year (or in the time that it
has been in business, if shorter); and is not affiliated with any
person (other than a natural person) that is not a small business or
small organization.\423\
---------------------------------------------------------------------------

    \419\ 5 U.S.C. 603(a).
    \420\ 5 U.S.C. 605(b).
    \421\ See 17 CFR 240.0-10(a).
    \422\ 17 CFR 240.17a-5(d).
    \423\ See 17 CFR 240.0-10(c).
---------------------------------------------------------------------------

    The Commission believes, based on input from security-based swap
market participants and its own information, that the majority of
security-based swap transactions have at least one counterparty that is
either a security-based swap dealer or major security-based swap
participant, and that these entities--whether registered broker-dealers
or not--would exceed the thresholds defining ``small entities'' set out
above. Accordingly, neither of these types of entities would likely
qualify as small entities for purposes of the RFA. Moreover, even in
cases where one of the counterparties to a security-based swap is not
covered by these definitions, the Commission believes that any such
entities would not be ``small entities'' as defined in Commission Rule
0-10. Feedback from industry participants and the Commission's own
information about the security-based swap market indicate that only
persons or entities with assets significantly in excess of $5 million
participate in the security-based swap market.\424\ Given the magnitude
of this figure, and the fact that it so far exceeds $5 million, the
Commission continues to believe that the vast majority of, if not all,
security-based swap transactions are between large entities for
purposes of the RFA.
---------------------------------------------------------------------------

    \424\ For example, as revealed in a current survey conducted by
Office of the Comptroller of the Currency, 99.9% of CDS positions by
U.S. commercial banks are held by those with assets over $80
billion. See Office of the Comptroller of the Currency, ``Quarterly
Report on Bank Trading and Derivatives Activities First Quarter
2014'' (2014).
---------------------------------------------------------------------------

    In addition, the Commission believes that persons that are likely
to register as SDRs would not be small entities. Based on input from
security-based swap market participants and its own information, the
Commission continues to believe that most if not all registered SDRs
would be part of large business entities, and that all registered SDRs
would have assets exceeding $5 million and total capital exceeding
$500,000. Therefore, the Commission continues to believe that no
registered SDRs would be small entities.
    The proposed rules and rule amendments would apply to all platforms
on which security-based swaps are executed and registered clearing
agencies that clear security-based swaps. Based on the Commission's
existing information about the security-based swap market and the
entities likely to be platforms and registered clearing agencies, the
Commission preliminarily believes that these entities would not be
small entities. The Commission preliminarily believes that most, if not
all, of the platforms and registered clearing agencies would be large
business entities or subsidiaries of large business entities, and that
all platforms would have assets in excess of $5 million and annual
receipts in excess of $7,000,000. Therefore, the Commission
preliminarily believes that no platforms or registered clearing
agencies would be small entities.
    The Commission encourages written comments regarding this
certification. The Commission solicits comment as to whether the
proposed rules and amendments to Regulation SBSR could have an effect
on small entities that has not been considered. The Commission requests
that commenters describe the nature of any impact on small entities and
provide empirical data to support the extent of such impact.

XII. Statutory Basis and Text of Proposed Rules

    Pursuant to the Exchange Act, 15 U.S.C. 78a et seq., and
particularly Sections 3C(e), 11A(b), 13(m)(1), 13A(a), 23(a)(1), 30(c),
and 36(a), 15 U.S.C. 78c-3(e), 78k-1(b), 78m(m)(1), 78m-1(a),
78w(a)(1), 78dd(c), and 78mm(a) thereof, the Commission is proposing to
amend Rules 900, 901, 905, 906, 907, and 908 of Regulation SBSR under
the Exchange Act, 17 CFR 242.900, 242.901, 242.905, 242.906, 242.907,
and 242.908.

List of Subjects in 17 CFR Part 242

    Brokers, Reporting and recordkeeping requirements, Securities.

Text of Amendments

    In accordance with the foregoing, and as amended elsewhere in this
issue of the Federal Register, the Commission proposes to further amend
17 CFR part 242 as follows:

PART 242--REGULATIONS M, SHO, ATS, AC, NMS, AND SBSR AND CUSTOMER
MARGIN REQUIREMENTS FOR SECURITY FUTURES

0
1. The authority citation for part 242 continues to read as follows:

    Authority: 15 U.S.C. 77g, 77q(a), 77s(a), 78b, 78c, 78g(c)(2),
78i(a), 78j, 78k-l(c), 78l, 78m, 78n, 78o(b), 78o(c), 78o(g),
78q(a), 78q(b), 78q(h), 78w(a), 78dd-1, 78mm, 80a-23, 80a-29, and
80a-37, unless otherwise noted.

0
2. In Sec.  242.900, revise paragraph (u) and add paragraph (tt) to
read as follows:

Regulation SBSR--Regulatory Reporting and Public Dissemination of
Security-Based Swap Information

Sec.  242.900  Definitions.

* * * * *
    (u) Participant, with respect to a registered security-based swap
data repository, means:
    (1) A counterparty, that meets the criteria of Sec.  242.908(b), of
a security-based swap that is reported to that registered security-
based swap data repository to satisfy an obligation under Sec.
242.901(a);
    (2) A platform that reports a security-based swap to that
registered security-based swap data repository to satisfy an obligation
under Sec.  242.901(a); or
    (3) A registered clearing agency that is required to report to that
registered

security-based swap data repository whether or not it has accepted a
security-based swap for clearing pursuant to Sec.  242.901(e)(1)(ii).
* * * * *
    (tt) Widely accessible, as used in paragraph (cc) of this section,
means widely available to users of the information on a non-fee basis.
0
3. In Sec.  242.901 add paragraphs (a)(1), (a)(2)(i), (a)(3), and
(e)(1)(ii) and revise paragraphs (e)(2) and (h) to read as follows:

Sec.  242.901  Reporting obligations.

    (a) * * *
    (1) Platform-executed security-based swaps that will be submitted
to clearing. If a security-based swap is executed on a platform and
will be submitted to clearing, the platform on which the transaction
was executed shall report to a registered security-based swap data
repository the information required by Sec. Sec.  242.901(c),
901(d)(1), 901(d)(9), and 901(d)(10).
    (2) * * *
    (i) Clearing transactions. For a clearing transaction, the
reporting side is the registered clearing agency that is a counterparty
to the transaction.
* * * * *
    (3) Notification to registered clearing agency. A person who, under
Sec.  242.901(a)(1) or Sec.  242.901(a)(2)(ii), has a duty to report a
security-based swap that has been submitted to clearing at a registered
clearing agency shall promptly provide that registered clearing agency
with the transaction ID of the submitted security-based swap and the
identity of the registered security-based swap data repository to which
the transaction will be reported or has been reported.
* * * * *
    (e) * * *
    (1) * * *
    (ii) Acceptance for clearing. A registered clearing agency shall
report whether or not it has accepted a security-based swap for
clearing.
    (2) All reports of life cycle events and adjustments due to life
cycle events shall, within the timeframe specified in paragraph (j) of
this section, be reported to the entity to which the original security-
based swap transaction will be reported or has been reported and shall
include the transaction ID of the original transaction.
* * * * *
    (h) Format of reported information. A person having a duty to
report shall electronically transmit the information required under
this section in a format required by the registered security-based swap
data repository to which it reports.
* * * * *
0
4. In Sec.  242.905, revise paragraph (a) to read as follows:

Sec.  242.905  Correction of errors in security-based swap information.

    (a) Duty to correct. Any counterparty or other person having a duty
to report a security-based swap that discovers an error in information
previously reported pursuant to Sec. Sec.  242.900 through 242.909
shall correct such error in accordance with the following procedures:
    (1) If a person that was not the reporting side for a security-
based swap transaction discovers an error in the information reported
with respect to such security-based swap, that person shall promptly
notify the person having the duty to report the security-based swap of
the error; and
    (2) If the person having the duty to report a security-based swap
transaction discovers an error in the information reported with respect
to a security-based swap, or receives notification from a counterparty
of an error, such person shall promptly submit to the entity to which
the security-based swap was originally reported an amended report
pertaining to the original transaction report. If the person having the
duty to report reported the initial transaction to a registered
security-based swap data repository, such person shall submit an
amended report to the registered security-based swap data repository in
a manner consistent with the policies and procedures contemplated by
Sec.  242.907(a)(3).
* * * * *
0
5. In Sec.  242.906, revise paragraphs (b) and (c) to read as follows:

Sec.  242.906  Other duties of participants.

* * * * *
    (b) Duty to provide ultimate parent and affiliate information. Each
participant of a registered security-based swap data repository that is
not a platform or a registered clearing agency shall provide to the
registered security-based swap data repository information sufficient
to identify its ultimate parent(s) and any affiliate(s) of the
participant that also are participants of the registered security-based
swap data repository, using ultimate parent IDs and counterparty IDs.
Any such participant shall promptly notify the registered security-
based swap data repository of any changes to that information.
    (c) Policies and procedures of security-based swap dealers, major
security-based swap participants, registered clearing agencies, and
platforms. Each participant of a registered security-based swap data
repository that is a security-based swap dealer, major security-based
swap participant, registered clearing agency, or platform shall
establish, maintain, and enforce written policies and procedures that
are reasonably designed to ensure that it complies with any obligations
to report information to a registered security-based swap data
repository in a manner consistent with Sec. Sec.  242.900 through
242.909. Each such participant shall review and update its policies and
procedures at least annually.
0
6. In Sec.  242.907, revise paragraph (a)(6) to read as follows:

Sec.  242.907  Policies and procedures of registered security-based
swap data repositories.

    (a) * * *
    (6) For periodically obtaining from each participant other than a
platform or a registered clearing agency information that identifies
the participant's ultimate parent(s) and any participant(s) with which
the participant is affiliated, using ultimate parent IDs and
counterparty IDs.
* * * * *
0
7. In Sec.  242.908, revise paragraphs (b)(1) and (2) and add
paragraphs (b)(3) and (4) to read as follows:

Sec.  242.908  Cross-border matters.

* * * * *
    (b) * * *
    (1) A U.S. person;
    (2) A registered security-based swap dealer or registered major
security-based swap participant;
    (3) A platform; or
    (4) A registered clearing agency.
* * * * *

    By the Commission.
    Dated: February 11, 2015.
Brent J. Fields,
Secretary.

    Note: The following appendix will not appear in the Code of
Federal Regulations:

Appendix

Reopening of Comment Periods for Certain Rulemaking Releases and Policy
Statement Applicable to Security-Based Swaps Proposed Pursuant to the
Securities Exchange Act of 1934 and the Dodd-Frank Wall Street Reform
and Consumer Protection Action

[Release No. 34-69491; File No. S7-34-10]

http://www.sec.gov/comments/s7-34-10/s73410.shtml

     Email message from Christopher Young, Director, U.S.
Public Policy, ISDA, to Thomas Eady, SEC, dated March 27, 2014
(``ISDA III'').

     Email message from Marisol Collazo, Chief Executive
Officer, DTCC Data Repository US LLC, to Thomas Eady and Michael J.
Gaw, SEC, dated March 24, 2014 (with attached letters submitted to
the CFTC regarding CME Rule 1001) (``DTCC VIII'').
     Letter from Kim Taylor, President, Clearing, CME Group,
and Kara L. Dutta, General Counsel, ICE Trade Vault (``ICE''), LLC,
to Elizabeth M. Murphy, Secretary, Commission, dated November 19,
2013 (``CME/ICE Letter'').
     Letter from Kara L. Dutta, General Counsel, ICE Trade
Vault, LLC, to Elizabeth M. Murphy, Secretary, Commission, dated
September 23, 2013 (``ICE Letter'').
     Letter from Larry E. Thompson, General Counsel,
Depository Trust & Clearing Corporation (``DTCC''), to Elizabeth M.
Murphy, Secretary, SEC, dated August 21, 2013 (``DTCC VI'').
     Letter from Jeff Gooch, Head of Processing, Markit,
Chair and CEO, MarkitSERV, to Elizabeth M. Murphy, Secretary,
Commission, dated August 21, 2013 (``MarkitSERV IV'').
     Letter from Kathleen Cronin, Senior Managing Director,
General Counsel, CME Group Inc., to Elizabeth M. Murphy, Secretary,
Commission, dated August 21, 2013 (``CME II'').

Comments on Proposed Rule: Regulation SBSR--Reporting and Dissemination
of Security-Based Swap Information

[Release No. 34-63346; File No. S7-34-10]

http://www.sec.gov/comments/s7-34-10/s73410.shtml

     Letter from Larry E. Thompson, General Counsel, the
Depository Trust & Clearing Corporation (``DTCC''), to the Honorable
Mary L. Schapiro, Chairman, Commission, and the Honorable Gary
Gensler, Chairman, CFTC, dated June 3, 2011 (``DTCC IV'').
     Letter from John R. Gidman, Association of
Institutional Investors, to David A. Stawick, Secretary, CFTC, and
Elizabeth M. Murphy, Secretary, Commission, dated June 2, 2011
(``Institutional Investors Letter''). [Note: This comment letter is
in fact dated ``June 2, 2010,'' but the Commission deems the true
date to be June 2, 2011. The comment letter references proposed
Regulation SBSR, which the Commission issued in November 2010, and
thus the comment could not have been submitted in June 2010.]
     Letter from Richard M. Whiting, Executive Director and
General Counsel, FSR, to David A. Stawick, Secretary, CFTC, and
Elizabeth M. Murphy, Secretary, Commission, dated May 12, 2011
(``Roundtable Letter'').
     MFA Recommended Timeline for Adoption and
Implementation of Final Rules Pursuant to Title VII of the Dodd-
Frank Act (``MFA Recommended Timeline''), attached to letter from
Richard H. Baker, President and Chief Executive Officer, MFA, to the
Honorable Mary L. Schapiro, Chairman, Commission, dated March 24,
2011.
     Letter from Edward J. Rosen, Cleary Gottlieb Steen &
Hamilton LLP, on behalf of Bank of America Merrill Lynch, BNP
Paribas, Citi, Credit Agricole Corporate and Investment Bank, Credit
Suisse Securities (USA), Deutsche Bank AG, Morgan Stanley, Nomura
Securities International, Inc., PNC Bank, Soci[eacute]t[eacute]
General, UBS Securities LLC, and Wells Fargo & Company, to Elizabeth
M. Murphy, Secretary, Commission, and David A. Stawick, Secretary,
CFTC, dated February 14, 2011 (``Cleary I'').
     Letter from Andrew Downes, Managing Director, UBS
Investment Bank, and James B. Fuqua, Managing Director, UBS
Securities LLC, to Elizabeth M. Murphy, Secretary, Commission, dated
February 7, 2011 (``UBS Letter'').
     Letter from Richard G. Ketchum, Chairman and Chief
Executive Officer, Financial Industry Regulatory Authority
(``FINRA''), to Elizabeth M. Murphy, Secretary, Commission, dated
January 27, 2011 (``FINRA Letter'').
     Letter from Dennis M. Kelleher, President and Chief
Executive Officer, Stephen W. Hall, Securities Specialist, and
Wallace C. Turbeville, Derivatives Specialist, Better Markets, Inc.
(``Better Markets''), to Elizabeth M. Murphy, Secretary, Commission,
dated January 24, 2011 (``Better Markets II'').
     Letter from Kevin Gould, President, Markit North
America, Inc., to Elizabeth M. Murphy, Secretary, Commission, dated
January 24, 2011 (``Markit I'').
     Letter from Jeff Gooch, Chief Executive Officer,
MarkitSERV LLC, to Elizabeth M. Murphy, Secretary, Commission, dated
January 24, 2011 (``MarkitSERV I'').
     Letter from Larry E. Thompson, General Counsel, DTCC,
dated January 18, 2011 (``DTCC II'').
     Letter from Karrie McMillan, General Counsel, ICI, to
Elizabeth M. Murphy, Secretary, Commission, dated January 18, 2011
(``ICI I'').
     Letter from Robert Pickel, Executive Vice Chairman,
ISDA, and Kenneth E. Bentsen, Jr., Executive Vice President, Public
Policy and Advocacy, SIFMA, to Elizabeth M. Murphy, Secretary,
Commission, dated January 18, 2011 (``ISDA/SIFMA I''), and
accompanying study, ``Block trade reporting for over-the-counter
derivatives markets'' (``ISDA/SIFMA Block Trade Study'').
     Letter from Stuart J. Kaswell, Executive Vice
President, Managing Director, and General Counsel, Managed Funds
Association, to Elizabeth M. Murphy, Secretary, Commission, dated
January 18, 2011 (``MFA I'').
     Letter from Lee H. Olesky, Chief Executive Officer, and
Douglas L. Friedman, General Counsel, Tradeweb Markets LLC, to
Elizabeth M. Murphy, Secretary, Commission, dated January 18, 2011
(``Tradeweb Letter'').
     Letter from Gus Sauter, Managing Director and Chief
Investment Officer, and John Hollyer, Principal and Head of Risk
Management and Strategy Analysis, Vanguard, to Elizabeth M. Murphy,
Secretary, Commission, dated January 18, 2011 (``Vanguard Letter'').
     Letter from Julian Harding, Chairman, WMBAA, to
Elizabeth M. Murphy, Secretary, Commission, dated January 18, 2011
(``WMBAA II'').
     Letter from R. Glenn Hubbard, Co-Chair, John L.
Thornton, Co-Chair, and Hal S. Scott, Director, Committee on Capital
Markets Regulation, David A. Stawick, Secretary, CFTC, and Elizabeth
M. Murphy, Secretary, Commission, dated January 18, 2011 (``CCMR
I'').
     Letter from Spencer Bachus, Ranking Member, Committee
on Financial Services, and Frank Lucas, Ranking Member, Committee on
Agriculture, U.S. House of Representatives, to The Honorable Timothy
Geithner, Secretary, Department of Treasury, the Honorable Gary
Gensler, Chairman, CFTC, the Honorable Mary Schapiro, Chairman,
Commission, and the Honorable Ben Bernanke, Chairman, Federal
Reserve, dated December 16, 2010 (``Bachus/Lucas Letter'').
     Letter from Chris Barnard, dated December 3, 2010
(``Barnard I'').

Re-Opening of Comment Periods for Certain Rulemaking Releases and
Policy Statement Applicable to Security-Based Swaps Proposed Pursuant
to the Securities Comments on Statement of General Policy on the
Sequencing of the Compliance Dates for Final Rules Applicable to
Security-Based Swaps Adopted Pursuant to the Securities Exchange Act of
1934 and the Dodd-Frank Wall Street Reform and Consumer Protection Act

[Release No. 34-67177; File No. S7-05-12]

     Letter from Kenneth E. Bentsen, Jr., Executive Vice
President, Public Policy and Advocacy, SIFMA, to Elizabeth M.
Murphy, Secretary, Commission, dated August 13, 2012 (``SIFMA II'').

Comments on Cross-Border Security-Based Swap Activities; Re-Proposal of
Regulation SBSR and Certain Rules and Forms Relating to the
Registration of Security-Based Swap Dealers and Major Security-Based
Swap Participants

(Release No. 34-69490; File No. S7-02-13)

http://www.sec.gov/comments/s7-02-13/s70213.shtml

     Letter from Karel Engelen, Senior Director, Head of
Data, Reporting & FpML, ISDA, to Elizabeth M. Murphy, Secretary,
Commission, dated November 14, 2014 (``ISDA IV'').

Real-Time Reporting: Title VII Provisions of the Dodd-Frank Wall Street
Reform and Consumer Protection Act

http://www.sec.gov/comments/df-title-vii/real-time-reporting/real-time-reporting.shtml

     Letter from Gerald Donini, Barclays Capital, Inc., to
David A Stawick, Secretary, CFTC, and Elizabeth M. Murphy,
Secretary, SEC, dated February 3, 2011 (``Barclays I'').
     Letter from James Hill, Managing Director, Morgan
Stanley, to David A Stawick, Secretary, CFTC, and Elizabeth M.
Murphy, Secretary, SEC, dated November 1, 2010 (``Morgan Stanley
Letter'').

Comments on Reporting of Security-Based Swap Transaction Data

[Release No. 34-63094; File No. S7-28-10]

http://www.sec.gov/comments/s7-28-10/s72810.shtml

     Letter from Larry E. Thompson, General Counsel, DTCC,
to Elizabeth M. Murphy,

Secretary, Commission, dated December 20, 2010 (``DTCC I'').
     Letter from Robert Pickel, Executive Vice Chairman,
ISDA, to Elizabeth Murphy, Secretary, Commission, dated December 10,
2010 (``ISDA I'').

Comments on Proposed Rule: Security-Based Swap Data Repository
Registration, Duties, and Core Principles

[Release No. 34-63347; File No. S7-35-10]

http://www.sec.gov/comments/s7-35-10/s73510.shtml

     Letter from Larry E. Thompson, General Counsel, DTCC,
to Elizabeth M. Murphy, Secretary, Commission, dated January 24,
2011 (``DTCC III'').

Comments on Joint Public Roundtable on International Issues Relating to
the Implementation of Title VII of the Dodd-Frank Wall Street Reform
and Consumer Protection Act

[Release No. 34-64939; File No. 4-636]

http://www.sec.gov/comments/4-636/4-636.shtml

     Letter from Jeff Gooch, Chief Executive Officer,
MarkitSERV, to David A. Stawick, Secretary, CFTC, and Elizabeth M.
Murphy, Secretary, Commission, dated September 19, 2011
(``MarkitSERV III'').

Roundtable Transcripts

     Joint CFTC-SEC Staff Roundtable on Implementation, May
2, 2011. Available at<EMAIL_ADDRESS>(``Implementation Roundtable, Day 1'').
     Joint CFTC-SEC Staff Roundtable on Implementation, May
3, 2011. Available at<EMAIL_ADDRESS>(``Implementation Roundtable, Day 2'').
[FR Doc. 2015-03125 Filed 3-18-15; 8:45 am]
 BILLING CODE P


[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Proposed Rules]
[Pages 11879-11881]
[FR Doc No: 2020-04043]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-1099; Product Identifier 2018-SW-026-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Airbus Helicopters Model EC 155B and EC155B1 helicopters. This
proposed AD would require modifying the wiring of the attitude and
heading reference system (AHRS) connector. This proposed AD is prompted
by a report of wiring of the AHRS contrary to approved design
specifications. The actions of this proposed AD are intended to address
an unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by April 28,
2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://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 https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
1099; 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, any
comments received, and other information. The street address for Docket
Operations is listed above. 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 https://www.airbus.com/helicopters/services/technical-support.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: George Schwab, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites 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.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2018-0069, dated March 26, 2018
(EASA AD 2018-0069), to correct an unsafe condition for Airbus
Helicopters Model EC 155 B and EC 155 B1 helicopters. EASA advises that
the AHRS1 and AHRS2 on Model EC 155-series helicopters use the same
flight/ground signal contrary to the approved design specification,
which requires the AHRS1 and AHRS2 to use independent signals to ensure
redundancy. EASA states that if AHRS1 and AHRS2 both receive an
incorrect ``ground'' status due to a single failure while in flight, it
will generate an error in the computation of the attitude and vertical
speed and, as a result, an incorrect display of these indications to
the flight crew. EASA advises that this condition, if not corrected,
could lead to erroneous attitude and vertical speed indications,
resulting in increased workload for the flight crew and reduced control
of the helicopter during flight in instrument meteorological conditions
(IMC).
    Accordingly, EASA AD 2018-0069 requires modifying the connection of
connector 11 ALPHA, and based on the helicopter configuration, also
modifying the wiring to connector 11 ALPHA.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other helicopters of
the same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB)
No. EC155-34A033, Revision 2, dated January 30, 2018. This service
information specifies re-allocating the electronic board output
connections by modifying the wiring of connector 11 ALPHA for
helicopters with modification (MOD) 0722B51 installed and modifying the
wiring to connector 11 ALPHA for those helicopters that also have a
combined voice and flight data recording system (MOD 0731B89)
installed.
    The FAA also reviewed Airbus Helicopters ASB No. EC155-34A037,
Revision 0, dated February 19, 2018. This service information specifies
installing MOD 0722B51 by modifying the wiring of connector 11 ALPHA to
separate the flight/ground information so the left-hand landing gear
flight information is also used by the automatic pilot system as well
as but separately from the right-hand landing gear flight information.
This service information also specifies re-allocating the electronic
board output connections by modifying the wiring of connector 11 ALPHA.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA also reviewed Airbus Helicopters ASB No. EC155-34A033,
Revision 0, dated July 19, 2017, and Airbus Helicopters ASB No. EC155-
34A033, Revision 1, dated October 9, 2017. Revisions 0 and 1 of this
service information contain the same procedures for modifying the
wiring as Revision 2. However, Revision 1 clarifies the applicable
helicopter configurations and updates the post-modification testing
procedures, and Revision 2 clarifies the post-modification test
procedures and updates a figure.

Proposed AD Requirements

    This proposed AD would require, before further flight in IMC or
within 660 hours time-in-service (TIS), whichever occurs first,
modifying the wiring at connector 11 ALPHA based on the helicopter
configuration and in accordance with specified portions of the
applicable ASB.

Differences Between This Proposed AD and the EASA AD

    The compliance time for the EASA AD is within 7 or 12 months
depending on helicopter configuration. The compliance time for this
proposed AD would be before further flight in IMC or within 660 hours
TIS, whichever occurs first.

Costs of Compliance

    The FAA estimates that this proposed AD affects 17 helicopters of
U.S. Registry. The FAA estimates that operators may incur the following
costs in order to comply with this proposed AD. Labor costs are
estimated at $85 per work-hour.
    Modifying the wiring would take about 4 work-hours and parts would
cost about $20 for an estimated cost of

$360 per helicopter and $6,120 for the U.S. fleet.

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.
    The FAA is 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

    The FAA 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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: Docket No. FAA-2019-1099; Product Identifier
2018-SW-026-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC 155B and EC155B1
helicopters, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as incorrect wiring of an
attitude and heading reference system (AHRS). This condition could
result in the display of misleading attitude and vertical speed
information, and subsequent loss of control of the helicopter in
instrument meteorological conditions (IMC).

(c) Comments Due Date

    The FAA must receive comments by April 28, 2020.

(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 in IMC or within 660 hours time-in-
service, whichever occurs first:
    (1) For helicopters with wiring change modification (MOD)
0722B51 installed, modify the wiring of connector 11 ALPHA as
depicted in Figure 1 of Airbus Helicopters Alert Service Bulletin
(ASB) No. EC155-34A033, Revision 2, dated January 30, 2018 (ASB
EC155-34A033). If a combined voice and flight data recording system
(MOD 0731B89) is installed, also modify the wiring to connector 11
ALPHA as depicted in Figure 2 of ASB EC155-34A033.
    (2) For helicopters without wiring change MOD 0722B51 installed,
modify the wiring of connector 11 ALPHA as depicted in Figure 1 and
Figure 2 of Airbus Helicopters ASB No. EC155-34A037, Revision 0,
dated February 19, 2018.

(f) Special Flight Permits

    A special flight permit may be issued for operation under visual
flight rules only.

(g) 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:
George Schwab, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
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.

(h) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin (ASB) No. EC155-
34A033, Revision 0, dated July 19, 2017, and Airbus Helicopters ASB
No. EC155-34A033, Revision 1, dated October 9, 2017, which are not
incorporated by reference, contain 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 https://www.airbus.com/helicopters/services/technical-support.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. 2018-0069, dated March 26, 2018. You may
view the EASA AD on the internet at https://www.regulations.gov in
the AD Docket.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 3420, Attitude and
Direction Data System.

    Issued in Fort Worth, Texas, on February 14, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-04043 Filed 2-27-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35373-35374]
[FR Doc No: 2012-14362]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1951-000]

Duke Energy Dicks Creek, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Duke Energy Dicks Creek, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 27, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC

Online service, please email<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 7, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-14362 Filed 6-12-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Rules and Regulations]
[Page 38660]
[FR Doc No: 2022-13872]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2022-0428]

Safety Zone; Marine Events Within the Eighth Coast Guard
District; Lower Mississippi River; New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a temporary safety zone for a
fireworks display located on the navigable waters of the Lower
Mississippi River between mile marker (MM) 94.3 and MM 95.3. This
action is needed to provide for the safety of life on these navigable
waterways during this event. During the enforcement periods, the
operator of any vessel in the regulated area must comply with
directions from the Captain of the Port New Orleans or designated
representative.

DATES: The regulations in 33 CFR 165.801, Table 5, line 3 will be
enforced from 8:30 p.m. though 9:30 p.m. on July 4, 2022.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Commander William
Stewart, Sector New Orleans, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a temporary
safety zone in 33 CFR 165.801, Table 5, line 3, for the Riverfront
Marketing Group Independence Day Celebration fireworks display event.
This regulation will be enforced from 8:30 p.m. through 9:30 p.m. on
July 4, 2022. This action is being taken to provide for the safety of
life on these navigable waterways during this event. Our regulation for
marine events within the Eighth Coast Guard District, 33 CFR 165.801,
specifies the location of the regulated area on the Lower Mississippi
River, between mile marker (MM) 94.3 and MM 95.3. During the
enforcement period, if you are the operator of a vessel in the
regulated area, you must comply with directions from the Captain of the
Port or a designated representative.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard plans to provide notification of this enforcement
period via a Marine Safety Information Bulletin and/or Broadcast Notice
to Mariners.

    Dated: June 23, 2022.
K.K. Denning,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2022-13872 Filed 6-28-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Page 51961]
[FR Doc No: 2011-21160]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4784-082]

Brown Bear Power, LLC, Topsham Hydroelectric Generating Facility
Trust No. 1, Topsham Hydro Partners Limited Partnership; Notice of
Application for Partial Transfer of License, and Soliciting Comments
and Motions To Intervene

    On August 3, 2011, Brown Bear Power, LLC, Topsham Hydroelectric
Generating Facility (Trust No. 1), and Topsham Hydro Partners Limited
Partnership (THP), co-licensees of the Pejepscot Project No. 4784,
filed an application for the partial transfer of license for the
Pejepscot Project, located on the Androscoggin River in Sagadahoc,
Cumberland, and Androscoggin Counties, Maine.
    Applicants seek Commission approval for a partial transfer of the
license for the Pejescot Project from Brown Bear, Trust No. 1, and THP,
jointly, to THP, solely. As proposed, following the transfer THP will
be the sole licensee of the Pejepscot Project.
    Applicants' Contacts: Nicole Poole, Topsham Hydroelectric
Generating Facilities Trust No. 1, 300 Delaware Avenue, 9th floor,
Wilmington, DE 19801,<PHONE_NUMBER>; Christine M. Miller, Brown Bear
Power LLC, 200 Clarendon Street 55th Floor, Boston MA 02116, (617) 531-
6338; Christine M. Miller, Topsham Hydro Partners Limited Partnership,
200 Clarendon Street 55th Floor, Boston MA 02116.
    FERC Contact: Krista Sakallaris<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 15 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a) (1)
and the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. More information about
this project can be viewed or printed on the eLibrary link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-4784) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

    Dated: August 12, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21160 Filed 8-18-11; 8:45 am]
BILLING CODE 6717-01-P