[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34759-34762]
[FR Doc No: 2021-13968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0515]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Experience Reporting and
Recordkeeping for Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on postmarketing reporting and
recordkeeping of adverse experiences for drug and biological products.

DATES: Submit either electronic or written comments on the collection
of information by August 30, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 30, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2021-N-0515 for ``Postmarketing Adverse Experience Reporting and
Recordkeeping for Drug and Biological Products.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Postmarketing Adverse Experience Reporting and Recordkeeping for Drug
and Biologics Products

OMB Control Number 0910-0230--Extension

    This information collection supports statutory provisions set forth
in the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the
monitoring of FDA-regulated products. Specifically, FDA must be
promptly informed of adverse experiences associated with the use of
marketed drugs, including human drugs and biological products.
Regulations in Sec. Sec.  310.305 and 314.80 (21 CFR 310.305 and
314.80) implement reporting and recordkeeping requirements that enable
FDA to take action to protect the public health from adverse drug
experiences. All applicants who have received marketing approval for
drug products are required to report serious, unexpected adverse drug
experiences (15-day ``Alert reports''), as well as followup reports
(Sec.  314.80(c)(1)) to FDA. This includes reports of all foreign or
domestic adverse experiences as well as those based on information from
applicable scientific literature and certain reports from postmarketing
studies. Section 314.80(c)(1)(iii) pertains to such reports submitted
by nonapplicants.
    Under Sec.  314.80(c)(2), applicants must provide periodic reports
of adverse drug experiences. For the reporting interval, a periodic
report includes reports of serious, expected adverse drug experiences,
all nonserious adverse drug experiences, and an index of these reports;
a narrative summary and analysis of adverse drug experiences; an
analysis of the 15-day Alert reports submitted during the reporting
interval; and a history of actions taken because of adverse drug
experiences. Under Sec.  314.80(j), applicants must keep for 10 years
records of all adverse drug experience reports known to the applicant.
    For marketed prescription drug products without approved new drug
applications (NDAs) or abbreviated new drug applications (ANDAs),
manufacturers, packers, and distributors are required to report to FDA
serious, unexpected adverse drug experiences as well as followup
reports (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the
submission of followup reports to reports forwarded to the
manufacturers, packers, and distributors by FDA. Under Sec.
310.305(g), each manufacturer, packer, and distributor shall maintain
for 10 years records of all adverse drug experiences required to be
reported.
    Section 760 of the FD&C Act (21 U.S.C. 379aa) also provides for
mandatory safety reporting for over-the-counter (OTC) human drug
products not subject to applications approved under section 505 of the
FD&C Act (21 U.S.C. 355) (NDAs or ANDAs). These requirements apply to
all OTC drug products marketed without an approved application,
including those marketed under the OTC Drug Monograph Review process
(whether or not subject to a final monograph), those marketed outside
the monograph system, and including those that have been discontinued
from marketing but for which a report of an adverse event was received.
Under 21 CFR 329.100, respondents must submit reports according to
section 760 of the FD&C Act in an electronic format.
    To assist respondents with implementation of section 760 of the
FD&C Act, FDA developed the guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products

Marketed Without an Approved Application,'' available at https://www.fda.gov/media/77193/download. The guidance document discusses what
should be included in a serious adverse drug event report submitted
under section 760(b)(1) of the FD&C Act, including how to submit these
reports and followup reports under section 760(c)(2) of the FD&C Act.
    Section 760(e) of the FD&C Act also requires that responsible
persons maintain records of nonprescription drug adverse event reports,
whether the event is serious or not, for a period of 6 years. FDA's
guidance recommends that respondents maintain records of efforts to
obtain the minimum data elements for a report of a serious adverse drug
event and any followup reports.
    The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed drug provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the adverse drug experience
reporting system contributes directly to increased public health
protection because the information enables FDA to make important
changes to the product's labeling (such as adding a new warning), to
make decisions about risk evaluation and mitigation strategies or the
need for postmarketing studies or clinical trials and, when necessary,
to initiate removal of a product from the market.
    In addition, this information collection includes an International
Council for Harmonisation (ICH) guidance for industry entitled
``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2)
Format (Periodic Benefit-Risk Evaluation Report),'' available at
https://www.fda.gov/media/85520/download. The guidance describes the
conditions under which applicants may use the ICH3 E2C(R2) Periodic
Benefit-Risk Evaluation Report format for certain types of adverse
event reporting. FDA regulations in Sec. Sec.  314.80(c)(2) and
600.80(c)(2) (21 CFR 600.80(c)(2)) require applicants to submit
postmarketing periodic safety reports for each approved application.
The reports must be submitted quarterly for the first 3 years following
the U.S. approval date and annually thereafter and must contain the
information described in Sec. Sec.  314.80(c)(2)(ii) and
600.80(c)(2)(ii) (the information collection associated with 21 CFR
part 600--Biological Products, is approved under OMB control number
0910-0308). The Agency guidance assists respondents with satisfying the
regulatory requirements in an alternative format, noting that the
process differs depending on whether an applicable periodic safety
update report (PSUR) waiver is in place. The information collection
burden for waivers of a PSUR are currently approved in OMB control
number 0910-0771; however, it is being consolidated with this
information collection for administrative efficiency.
    Similarly, the information collection accounts for burden that may
be applicable to the guidance document, ``Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During a
Pandemic,'' available at https://www.fda.gov/media/72498/download. In
response to the Coronavirus Disease 2019 public health emergency, we
revised the Agency guidance document, ``, to provide recommendations
for recordkeeping applicable to any pandemic, not just influenza,
including recommendations for planning, notification, and documentation
for continuity of operations for firms that report postmarketing
adverse events during any pandemic.
    Respondents to this collection of information are (1)
manufacturers, packers, distributors, and applicants of FDA-regulated
drug and biologic products; (2) manufacturers, packers, and
distributors of marketed prescription drug products without an FDA-
approved application; and (3) manufacturers, packers, and distributors
of marketed nonprescription drug products, including OTC drug products
marketed without an approved application, OTC drug products marketed
under the OTC Drug Monograph Review process (whether subject to a final
monograph or not), and drug products marketed outside the monograph
system.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
    21 CFR section or type of        Number of     responses per   Total annual   Average burden    Total hours
     respondent and activity        respondents     respondent       responses     per response
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310.305(c)(5)...................               3               1               3               1               3
314.80(c)(1)(iii)...............               5               1               5               1               5
314.80(c)(2)....................             820           17.32          14,202              60         852,120
Reports of serious adverse drug              285             690         196,650               6       1,179,900
 events (Sec.   329.100)........
Applicants that have a PSUR                   55             3.4             187               1             187
 waiver for an approved
 application....................
Applicants that do not have a                 29             2.3              67               2             134
 PSUR waiver for an approved
 application....................
Notifying FDA when normal                    350               1             350               8           2,800
 reporting is not feasible......
                                 -------------------------------------------------------------------------------
    Total 2.....................  ..............  ..............         211,464  ..............       2,035,149
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1 The reporting burden for Sec.  Sec.   310.305(c)(1), (2), and (3), and 314.80(c)(1)(i) and (ii) is covered
  under OMB control number 0910-0645.
2 The capital costs or operating and maintenance costs associated with this collection of information are
  approximately $25,000 annually.

                                Table 2--Estimated Annual Recordkeeping Burden 1
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                                                     Number of                    Average burden
   21 CFR section or FD&C Act        Number of      records per    Total annual         per         Total hours
      section and activity         recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305.........................              25               1              25              16             400
314.80(j).......................             325           2,025         658,240              16      10,531,840
Recordkeeping of nonprescription<PHONE_NUMBER>         265,700               8       2,125,600
 drug adverse event reports
 (Section 760(e)(1) of the FD&C
 Act)...........................
Adding Adverse Event report                  100               1             100              50           5,000
 planning to Continuity of
 Operations Plans...............
Maintaining documentation of                 350               1             350               8           2,800
 pandemic conditions and
 resultant high absenteeism.....
Maintaining records to identify              350               1             350               8           2,800
 what reports have been stored
 and when the reporting process
 was restored...................
                                 -------------------------------------------------------------------------------
    Total 2.....................  ..............  ..............         924,765  ..............      12,668,440
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1 There are no capital costs or operating costs associated with this collection of information.
2 There are maintenance costs of approximately $22,000 annually.

    The information collection reflects adjustments resulting in an
overall decrease in burden hours and an increase in annual responses.
We believe these adjustments reflect expected fluctuations in burden
and invite comment on our assumptions.

    Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13968 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Proposed Rules]
[Pages 10446-10449]
[FR Doc No: 2010-4808]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0050]
RIN 1625-AA87

Security Zone; Potomac River, Washington Channel, Washington, DC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary security
zone in certain waters of Washington Channel on the Potomac River. The
security zone is necessary to provide for the security and safety of
life and property of event participants, spectators and mariners during
the U.S. Coast Guard Commandant's Change of Command ceremony from 6
a.m. through 5 p.m. on May 25, 2010. Entry into this zone is prohibited
unless authorized by the Captain of the Port, Baltimore, Maryland, or
his designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before April 7, 2010.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-0050 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Mr. Ronald Houck, Sector Baltimore Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V.

Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2010-0050), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2010-0050'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2010-0050'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Background and Purpose

    The Coast Guard will conduct a Change of Command ceremony at Fort
McNair in Washington, DC. To address security concerns during the
event, the Captain of the Port, Baltimore, Maryland proposes to
establish a security zone upon certain waters of the Washington
Channel. This proposed security zone will help the Coast Guard to
prevent vessels or persons from engaging in waterborne terrorist
actions during the U.S. Coast Guard Commandant's Change of Command
ceremony. Due to the catastrophic impact a terrorist attack during the
ceremony would have against the large number of dignitaries, and the
surrounding area and communities, a security zone is prudent for this
type of event.

Discussion of Proposed Rule

    On Tuesday, May 25, 2010, the U.S. Coast Guard Commandant's Change
of Command ceremony will be held at Fort Lesley J. McNair, in
Washington, DC. The event will consist of several high-ranking
dignitaries and a background comprised of U.S. Coast Guard vessels
anchored adjacent to Fort McNair on the confined waters of the
Washington Channel on the Potomac River. Due to the need to safeguard
event participants and prevent vessels or persons from approaching Fort
McNair and thereby bypassing the security measures established on shore
during the event, vessel traffic will be restricted on certain waters
of the Washington Channel.
    The Captain of the Port Baltimore, Maryland, is proposing to
establish a security zone from 6 a.m. through 5 p.m. on May 25, 2010.
U.S. Coast Guard patrol vessels will be provided to prevent the
movement of persons and vessels in an area approximately 200 yards wide
and 450 yards long within Washington Channel. The proposed regulated
area is adjacent to Fort McNair and includes all waters of the
Washington Channel, from shoreline to shoreline, bounded on the north
along latitude 38[deg]52'03'' N and bounded on the south along latitude
38[deg]51'50'' N.
    Vessels underway at the time this security zone is implemented
would be required to immediately proceed out of the zone. Entry into
this zone is prohibited unless authorized by the Captain of the Port or
his designated representative. The Captain of the Port will issue
Broadcast Notices to Mariners to publicize the security zone and notify
the public of changes in the status of the zone. Such notices will
continue until the ceremony is complete.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. Although this security
zone restricts vessel traffic through the affected area, the effect of
this regulation will not be significant due to the limited size and
duration that the regulated area will be in effect. In addition,
notifications will be made to the maritime community via marine
information broadcasts so mariners may adjust their plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule may affect the following
entities, some of which might be small entities: the owners or
operators of vessels intending to operate or transit through or within
the security zone during the enforcement period. The security zone will
not have a significant economic impact on a substantial number of small
entities for the following reasons. The security zone is of limited
size and duration. Although the security zone will apply to the entire
width of the channel, maritime advisories will be widely available to
the maritime community before the effective period.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Mr. Ronald L. Houck, Coast Guard
Sector Baltimore, Waterways Management Division, at telephone number
410-576-2674. The Coast Guard will not retaliate against small entities
that question or complain about this proposed rule or any policy or
action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This proposed rule would not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This proposed
rule involves establishing a temporary security zone. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.
    We seek any comments or information that may lead to the discovery
of a

significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add Sec.  165.T05-0050 to read as follows:

Sec.  165.T05-0050  Security Zone; Potomac River, Washington Channel,
Washington, DC.

    (a) Location. The following area is a security zone: all waters of
the Washington Channel, from shoreline to shoreline, bounded on the
north along latitude 38[deg]52'03'' N and bounded on the south along
latitude 38[deg]51'50'' N (North American Datum 1983).
    (b) Definitions. As used in this section:
    Captain of the Port Baltimore means the Commander, U.S. Coast Guard
Sector Baltimore, Maryland.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Baltimore to assist in enforcing the security zone described in
paragraph (a) of this section.
    (c) Regulations. (1) The general security zone regulations found in
33 CFR 165.33 apply to the security zone created by this temporary
section, Sec.  165.T05-0050.
    (2) Entry into or remaining in this zone is prohibited unless
authorized by the Coast Guard Captain of the Port Baltimore. Vessels
already at berth, mooring, or anchor at the time the security zone is
implemented do not have to depart the security zone. All vessels
underway within this security zone at the time it is implemented are to
depart the zone.
    (3) Persons desiring to transit the area of the security zone must
first request authorization from the Captain of the Port Baltimore or
his designated representative. To seek permission to transit the area,
the Captain of the Port Baltimore and his designated representatives
can be contacted at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing
this section can be contacted on Marine Band Radio, VHF-FM channel 16
(156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel, or other
Federal, State, or local agency vessel, by siren, radio, flashing
lights, or other means, the operator of a vessel shall proceed as
directed. If permission is granted, all persons and vessels must comply
with the instructions of the Captain of the Port Baltimore or his
designated representative and proceed at the minimum speed necessary to
maintain a safe course while within the zone.
    (4) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (d) Enforcement period. This section will be enforced from 6 a.m.
through 5 p.m. on May 25, 2010.

    Dated: February 24, 2010.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore Maryland.
[FR Doc. 2010-4808 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60393-60394]
[FR Doc No: 2017-27368]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-476-000]

Gulf South Pipeline Company, LP ; Notice of Schedule for
Environmental Review of the Westlake Expansion Project

    On July 20, 2017, Gulf South Pipeline Company, LP (Gulf South)
filed an application in Docket No. CP17-476-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate facilities in
Calcasieu Parish, Louisiana. The proposed project is known as the
Westlake Expansion Project (Project) and would provide about 200
million cubic feet of natural gas per day to the proposed 980 megawatt
natural gas-fired combined cycle electric generating plant near
Westlake, Louisiana.
    On July 31, 2017, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--February 27, 2018
90-day Federal Authorization Decision Deadline--May 29, 2018

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Gulf South proposes to construct and operate the following
facilities as part of the Project in Calcasieu Parish, Louisiana:
     One new 10,000 horsepower compressor station (Westlake
Compressor Station) and appurtenant facilities;
     approximately 1,600 feet of 16-inch-diamater natural gas
pipeline lateral; and
     two new metering and regulating stations (Entergy Lake
Charles and Varibus Meter and Regulator Stations).

Background

    On August 30, 2017, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Westlake Expansion
Project and Request for Comments on Environmental Issues (NOI). The NOI
was sent to affected landowners; federal, state, and local government
agencies; elected officials; Native American tribes; environmental
groups; and local libraries. In response to the NOI, the Commission
received comments from the U.S. Environmental Protection Agency (EPA),
the Louisiana Department of Wildlife and Fisheries (LDWF), Choctaw
Nation of Oklahoma, three Louisiana state senators/representatives, the
Southwest Louisiana Economic Development Alliance (SWLA), and the
Calcasieu Parish Police Jury. The primary issues raised by the EPA and
the LDWF are impacts on wetlands and wetland mitigation, waters of the
United States, and construction and operational air quality impacts.
The Choctaw Nation of

Oklahoma requested to be a consulting party, be involved in the
development of the Area of Potential Effect, and requested Project
shapefiles, which Gulf South provided. The Louisiana state senators/
representatives, SWLA, and the Calcasieu Parish Police Jury commented
that they support the Project due to its potential economic benefits.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select ``General
Search'' from the eLibrary menu, enter the selected date range and
Docket Number excluding the last three digits (i.e., CP17-476), and
follow the instructions. For assistance with access to eLibrary, the
helpline can be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
[email protected]. The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: December 14, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-27368 Filed 12-19-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54156-54157]
[FR Doc No: 2018-23389]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84464; File No. SR-ICEEU-2018-017]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Amendments to the Clearing Rules and the CDS Procedures

October 22, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, as amended (``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on October 15, 2018, ICE Clear Europe Limited (``ICE
Clear Europe'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes described in Items I, II and
III below, which Items have been prepared primarily by ICE Clear
Europe. Ice Clear Europe filed the proposed rule change pursuant to
Section 19(b)(3)(A) \3\ of the Act and subparagraph (f)(4) \4\ of Rule
19b-4 thereunder. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited proposes to modify certain provisions of
its CDS Procedures (the ``CDS Procedures'') and its Clearing Rules (the
``Rules'') \5\ to account for a change in the DC Secretary for the
Credit Derivatives Determinations Committees.
---------------------------------------------------------------------------

    \5\ Capitalized terms used but not defined herein have the
meanings specified in the Rules and CDS Procedures.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe proposes to modify certain provisions of its CDS
Procedures and its Rules to account for an expected change in the DC
Secretary for the Credit Derivatives Determinations Committees. The DC
Secretary performs certain administrative functions in respect of the
Credit Derivatives Determinations Committees that make certain
determinations relevant to cleared CDS Contracts under the Rules and
CDS Procedures. The International Swaps and Derivatives Association
(``ISDA''), which currently serves as the DC Secretary, has announced
that it intends to cease performing that role and that it has appointed
a new DC Secretary. Once the transition is complete, certain references
in the Rules and CDS Procedures to ISDA will no longer be accurate.
    The amendments will add a new term in the CDS Procedures for ``DC
Secretary,'' which will mean ISDA or such other secretary of the Credit
Derivatives Determinations Committees as may be appointed from time to
time under the Credit Derivatives Determinations Committees Rules to
carry out the functions required thereunder. Certain references to
actions by ISDA will be modified to refer to actions by either ISDA or
the DC Secretary. Specifically, the definition of ``RMP Deadline
Time'', which is a deadline for certain obligations upon a Relevant
Restructuring Event, is being modified such that ``the date of
publication by ISDA of the Final List'' will become ``the date of
publication by ISDA or DC Secretary of the Final List''. Section 6.5(d)
relating to Deliverable Obligations disputes will be amended such that
relevant time periods will refer to the date on which ISDA or DC
Secretary publicly announces the resolution of the Credit Derivatives
Determinations Committee.
    Further pursuant to the proposed amendments, the definition of
``Determining Body'' in the Rules is being amended to clarify that
neither the Credit Derivatives Determination Committee nor a secretary
of the Credit Derivatives Determination Committee (or any such other
body or Person) is a Representative or committee of the Clearing House.
(b) Statutory Basis
    ICE Clear Europe believes that the changes described herein are
consistent with the requirements of Section 17A of the Act \6\ and the
regulations thereunder applicable to it. Section 17A(b)(3)(F) of the
Act \7\ in particular requires, among other things, that the rules of
the clearing agency be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts and transactions, to
assure the safeguarding of securities and funds in the custody or
control of the clearing agency or for which it is responsible and the
protection of investors, and, in general, protect investors and the
public interest. The proposed amendments are designed to address
industry changes resulting in the appointment of a new DC Secretary for
the Credit Derivatives Determinations Committees. Amending the CDS
Procedures and Rules to be consistent with these industry changes
ensures that they will continue to be effective for announcements or
other actions by the DC Secretary. The amendments do not affect the
substantive terms of cleared CDS Contracts. As a result, in ICE Clear
Europe's view, the amendments are consistent with the prompt and
accurate clearance and settlement of transactions and the protection of
investors and the public interest (and will not affect the safeguarding
of securities or funds in the custody or control of the clearing agency
or for which it is responsible).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed rule changes would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purpose of the Act. The proposed
changes to the CDS Procedures and the Rules are intended to accommodate
an industry-wide change in the administration of the Credit Derivatives
Determination Committees, and will not change the substantive terms of
cleared CDS Contracts. The change will apply uniformly across all CDS
Clearing Members and market participants. ICE Clear Europe does not
believe the amendments will adversely affect competition among CDS
Clearing Members, the cost of clearing, or the ability of market
participants to clear CDS contracts generally. Therefore, ICE Clear
Europe does not believe the proposed rule changes impose any burden on
competition that is inappropriate in furtherance of the purposes of the
Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received with respect to the proposed
rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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 protected]. Please include
File Number SR-ICEEU-2018-017 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2018-017. 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 website (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 website viewing and printing in
the Commission's Public Reference Section, 100 F Street NE, Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/notices/Notices.shtml?regulatoryFilings. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
ICEEU-2018-017 and should be submitted on or before November 16, 2018.
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    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-23389 Filed 10-25-18; 8:45 am]
 BILLING CODE 8011-01-P