[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Page 40400]
[FR Doc No: 2019-17396]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2058-098]

Avista Corporation; Notice of Availability of Environmental
Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC's)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed Avista Corporation's application for an amendment to the
license for the Clark Fork Hydroelectric Project (FERC Project No.
2058), and have prepared an Environmental Assessment (EA) for the
proposed amendment. The licensee proposes to construct and operate a
permanent upstream fish passage facility at the project's Cabinet Gorge
development. The project is located on the Clark Fork River in Bonner
County, Idaho and Sanders County, Montana and occupies federal land
within the Idaho Panhandle, Lolo, and Kootenai National Forests
administered by the U.S. Forest Service.
    The EA contains Commission staff's analysis of the potential
environmental effects of the proposed amendment to the license, and
concludes that the proposed amendment, with appropriate environmental
protective measures, would not constitute a major federal action that
would significantly affect the quality of the human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's website at
www.ferc.gov using the eLibrary link. Enter the docket number excluding
the last three digits in the docket number field to access the
document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
202-502-8659.
    You may also register online at www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support. For further information, contact Marybeth Gay at (202)
502-6125.

    Dated: August 8, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-17396 Filed 8-13-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 8997-8998]
[FR Doc No: 2018-04280]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3401]

Scientific Evaluation of the Evidence on the Beneficial
Physiological Effects of Isolated or Synthetic Non-Digestible
Carbohydrates Submitted as a Citizen Petition; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Scientific
Evaluation of the Evidence on the Beneficial Physiological Effects of
Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a
Citizen Petition (21 CFR 10.30).'' The guidance describes our views on
the scientific evidence needed and the approach to evaluating the
scientific evidence on the physiological effects to human health of
isolated or synthetic non-digestible carbohydrates that are added to
foods.

DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2018.

ADDRESSES: You may submit 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-2016-D-3401 for ``Scientific Evaluation of the Evidence on the
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR
10.30).'' 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 the guidance to the
Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Scientific Evaluation of the Evidence on the Beneficial
Physiological Effects of Isolated or Synthetic Non-Digestible
Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' We are
issuing this guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The guidance represents the current
thinking of FDA on this topic. 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.
    In the Federal Register of May 27, 2016 (81 FR 33742), we published
a final rule amending our Nutrition and Supplement Facts label
regulations. The final rule provides a definition of dietary fiber as
non-digestible soluble and insoluble carbohydrates (with three or more
monomeric units), and lignin that are intrinsic and intact in plants;
isolated or synthetic non-digestible carbohydrates (with three or more
monomeric units) determined by FDA to have physiological effects that
are beneficial to human health (Sec.  101.9(c)(6)(i)) (21 CFR
101.9(c)(6)(i)). One mechanism by which a manufacturer could request an
amendment to the list of isolated or synthetic non-digestible
carbohydrates that meet the dietary fiber definition is by using the
citizen petition process in 21 CFR 10.30. If an isolated or synthetic
non-digestible carbohydrate meets the dietary fiber definition, then it
would be added to the list of dietary fibers in Sec.  101.9(c)(6)(i).
    In the Federal Register of November 23, 2016, (81 FR 84516), we
announced the availability of a draft guidance for industry entitled
``Scientific Evaluation of the Evidence on the Beneficial Physiological
Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted
as a Citizen Petition (21 CFR 10.30)'' and gave interested parties an
opportunity to submit comments by January 23, 2017, for us to consider
before beginning work on the final version of the guidance. In the
Federal Register of January 13, 2017 (82 FR 4225), we extended the
comment period to February 13, 2017. We received several comments on
the draft guidance and have modified the final guidance where
appropriate. Changes to the guidance include: (1) The inclusion of
studies on diseased populations under certain circumstances as part of
our evaluation of the totality of the scientific evidence; (2)
additional detail and clarity on the physiological endpoints that we
consider when reviewing the scientific evidence; and (3) additional
detail regarding factors we consider when evaluating the strength of
the scientific evidence.\1\ In addition, we made editorial changes to
improve clarity. The guidance announced in this notice finalizes the
draft guidance dated November 2016.
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    \1\ This guidance addresses the scientific evaluation of
synthetic non-digestible carbohydrates and isolated non-digestible
carbohydrate ingredients that are produced as a result of the
processing of foods and other sources, to the extent that the
ingredients in and of themselves have a specific chemical structure
(carbohydrate composition and non-digestible bond linkages). These
isolated non-digestible carbohydrates may or may not vary in size.
Examples of isolated non-digestible carbohydrates include cellulose,
guar gum, and pectin.
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II. Paperwork Reduction Act of 1995

    The 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
collections of information in Sec.  101.9 have been approved under OMB
control number 0910-0813.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04280 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P


Table 7a. Annual Burden and Cost for the Federal Government to Implement ( First Y Proposed NESHAP for Existing Ethylene Production Facilities A B C Burden item Technical Technical Manag hours per Occurrences hours per year hours p occurrence per year ( C = A x B) ( C x @ $ 34.00 @ $ 5 Review initial notification reports 8 11 88 Review notifications of compliance status 10 11 110 Review semiannual summary reports 15 22 330 Review notifications of performance tests 8 1 8 Attend initial performance tests 240 1 240 Review test results 20 1 20 Total hours 796 Total costs


[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Rules and Regulations]
[Pages 39384-39386]
[FR Doc No: 2015-16804]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0612]
RIN 1625-AA00

Safety Zone; Lake Metroparks Stand-Up Paddleboard Race; Lake
Erie, Fairport Harbor, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Erie, Fairport Harbor, OH. This safety zone is intended to
restrict vessels from a portion of Lake Erie during the Lake Metroparks
Stand-Up Paddleboard Race. This temporary safety zone is necessary to
protect mariners and race participants from the navigational hazards
associated with a paddleboard race.

DATES: This rule will be effective from 7:45 a.m. until 12:15 p.m. on
July 11, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0612]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Stephanie Pitts, Chief of Waterways Management, U.S.
Coast Guard Marine Safety Unit Cleveland; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Ms. Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER> or 1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
final details for this event were not known to the Coast Guard until
there was insufficient time remaining before the event to publish an
NPRM. Thus, delaying the effective date of this rule to wait for a
comment period to run would be impracticable and contrary to the public
interest because it would inhibit the Coast Guard's ability to protect
race participants and spectators from the hazards associated with a
paddleboard race.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

B. Basis and Purpose

    The legal basis and authorities for this rule are found in 33
U.S.C. 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;
and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to establish and define
regulatory safety zones.
    Between 7:45 a.m. and 12:15 p.m. on July 11, 2015, a paddleboard
race will be held along the shoreline of Lake Erie, Fairport Harbor,
OH, directly north of Fairport Harbor Lakefront Park. It is anticipated
that numerous spectator vessels will be in the immediate vicinity of
the race. The Captain of the Port Buffalo has determined that such an
event proximate to a gathering of watercraft pose a significant risk to
public safety and property. Such hazards include hazardous navigation
situations with less maneuverable watercraft and people falling into
the water.

C. Discussion of the Final Rule

    With the aforementioned hazards in mind, the Captain of the Port
Buffalo has determined that this temporary safety zone is necessary to
ensure the safety of participants and safety vessels during the Lake
Metroparks Stand-Up Paddleboard Race. The safety zone will encompass
all waters of Lake Erie, Fairport Harbor, OH directly north of Fairport
Harbor Lakefront Park from 41[deg] 45.5' N. and 081[deg] 16.5' W. to
41[deg] 45.8' N. and 081[deg] 16.5' W. to 41[deg] 45.9' N. and 081[deg]
15.6' W. to 41[deg] 45.6' N. and 081[deg] 15.6' W. (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
relatively small and enforced for a relatively short time. Also, the
safety zone is designed to minimize its impact on navigable waters.
Furthermore, the safety zone has been designed to allow vessels to
transit around it. Thus, restrictions on vessel movement within that
particular area are expected to be minimal. Under certain conditions,
moreover, vessels may still transit through the safety zone when
permitted by the Captain of the Port.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this rule on small entities. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not
have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to transit or anchor in a portion of Lake Erie on the morning of July
11, 2015.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: this
safety zone would be effective, and thus subject to enforcement, for
only four hours and 15 minutes early in the morning. Traffic may be
allowed to pass through the zone with the permission of the Captain of
the Port. The Captain of the Port can be reached via VHF channel 16.
Before the enforcement of the zone, we would issue local Broadcast
Notice to Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the ``For Further
Information Contact'' section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

    This 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.

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone and,
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T09-0612 to read as follows:

Sec.  165.T09-0612  Safety Zone; Lake Metroparks Stand-Up Paddleboard
Race, Fairport Harbor, OH.

    (a) Location. The safety zone will encompass all waters of Lake
Erie, Fairport Harbor, OH directly north of Fairport Harbor Lakefront
Park from 41[deg] 45.5' N. and 081[deg] 16.5' W. to 41[deg] 45.8' N.
and 081[deg] 16.5' W. to 41[deg] 45.9' N. and 081[deg] 15.6' W. to
41[deg] 45.6' N. and 081[deg] 15.6' W. (NAD 83).
    (b) Enforcement period. This regulation will be enforced on July
11, 2015 from 7:45 a.m. until 12:15 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the Captain of the Port Buffalo
or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: June 25, 2015.
B.W. Roche,
Captain, U. S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2015-16804 Filed 7-8-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14708-14710]
[FR Doc No: 2019-07146]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85532; File No. SR-NYSEArca-2019-21]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Current Pilot Program Related to Rule 7.10-E, Clearly Erroneous
Executions

April 5, 2019.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on April 3, 2019, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the current pilot program related
to Rule 7.10-E, Clearly Erroneous Executions, to the close of business
on October 18, 2019. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries,

set forth in sections A, B, and C below, of the most significant parts
of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to extend the current
pilot program related to Rule 7.10-E, Clearly Erroneous Executions, to
the close of business on October 18, 2019. This change is being
proposed in connection with proposed amendments to the Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan'') that would allow the Plan to continue to operate on a
permanent basis.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (File No. 4-631)
(``Eighteenth Amendment'').
---------------------------------------------------------------------------

    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Rule 7.10-E that, among other things: (i) Provided for
uniform treatment of clearly erroneous[thinsp]execution reviews in
multi-stock events involving twenty or more securities; and (ii)
reduced the ability of the Exchange to deviate from the objective
standards set forth in the rule.\5\ In 2013, the Exchange adopted a
provision designed to address the operation of the Plan.\6\ Finally, in
2014, the Exchange adopted two additional provisions providing that:
(i) A series of transactions in a particular security on one or more
trading days may be viewed as one event if all such transactions were
effected based on the same fundamentally incorrect or grossly
misinterpreted issuance information resulting in a severe valuation
error for all such transactions; and (ii) in the event of any
disruption or malfunction in the operation of the electronic
communications and trading facilities of an Exchange, another SRO, or
responsible single plan processor in connection with the transmittal or
receipt of a trading halt, an Officer, acting on his or her own motion,
shall nullify any transaction that occurs after a trading halt has been
declared by the primary listing market for a security and before such
trading halt has officially ended according to the primary listing
market.\7\ These changes are currently scheduled to operate for a pilot
period that coincides with the pilot period for the Limit Up-Limit Down
Plan,\8\ including any extensions to the pilot period for the Plan.\9\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 62886 (Sept. 10,
2010), 75 FR 56613 (Sept. 16, 2010) (SR-NYSEArca-2010-58).
    \6\ See Securities Exchange Act Release No. 68809 (Feb. 1,
2013), 78 FR 9081 (Feb. 7, 2013) (SR-NYSEArca-2013-12).
    \7\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-NYSEArca-2014-48).
    \8\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \9\ See Securities Exchange Act Release No. 71807 (March 26,
2014), 79 FR 18087 (March 31, 2014) (SR-NYSEArca-2014-32).
---------------------------------------------------------------------------

    The Commission recently published the proposed Eighteenth Amendment
to the Plan to allow the Plan to operate on a permanent, rather than
pilot, basis. The Exchange proposes to amend Rule 7.10-E to untie the
pilot program's effectiveness from that of the Plan and to extend the
pilot's effectiveness to the close of business on October 18, 2019--
i.e., six months after the expiration of the current pilot period for
the Plan. If the pilot period is not either extended, replaced or
approved as permanent, the prior versions of paragraphs (c), (e)(2),
(f), and (g) shall be in effect, and the provisions of paragraphs (i)
through (k) shall be null and void.\10\ In such an event, the remaining
sections of Rule 7.10-E would continue to apply to all transactions
executed on the Exchange. The Exchange understands that the other
national securities exchanges and Financial Industry Regulatory
Authority (``FINRA'') will also file similar proposals to extend their
respective clearly erroneous execution pilot programs, the substance of
which are identical to Rule 7.10-E.
---------------------------------------------------------------------------

    \10\ See supra notes 6-8. The prior versions of paragraphs (c),
(e)(2), (f), and (g) generally provided greater discretion to the
Exchange with respect to breaking erroneous trades.
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to Rule 7.10-
E. The Exchange believes the benefits to market participants from the
more objective clearly erroneous executions rule should continue on a
limited six month pilot basis after Commission approves the Plan to
operate on a permanent basis. Assuming the Plan is approved by the
Commission to operate on a permanent, rather than pilot, basis the
Exchange intends to assess whether additional changes should also be
made to the operation of the clearly erroneous execution rules.
Extending the effectiveness of Rule 7.10-E for an additional six months
should provide the Exchange and other national securities exchanges
additional time to consider further amendments to the clearly erroneous
execution rules in light of the proposed Eighteenth Amendment to the
Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\11\ in general, and
Section 6(b)(5) of the Act,\12\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange believes that the
proposed rule change promotes just and equitable principles of trade in
that it promotes transparency and uniformity across markets concerning
review of transactions as clearly erroneous. The Exchange believes that
extending the clearly erroneous execution pilot under Rule 7.10-E for
an additional six months would help assure that the determination of
whether a clearly erroneous trade has occurred will be based on clear
and objective criteria, and that the resolution of the incident will
occur promptly through a transparent process. The proposed rule change
would also help assure consistent results in handling erroneous trades
across the U.S. equities markets, thus furthering fair and orderly
markets, the protection of investors and the public interest. Based on
the foregoing, the Exchange believes the amended clearly erroneous
executions rule should continue to be in effect on a pilot basis while
the Exchange and the other national securities exchanges consider and
develop a permanent proposal for clearly erroneous execution reviews.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of harmonized clearly erroneous
execution rules across the U.S. equities markets while the Exchange and
other national securities exchanges consider further amendments to
these rules in light of the proposed Eighteenth Amendment to the Plan.
The Exchange understands that the other national securities exchanges
and FINRA will also file similar proposals to extend their respective
clearly erroneous execution pilot programs. Thus, the proposed rule
change will help to ensure consistency across market centers without
implicating any competitive issues.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \16\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current clearly erroneous execution pilot program to
continue uninterrupted, without any changes, while the Exchange and the
other national securities exchanges consider and develop a permanent
proposal for clearly erroneous execution reviews. For this reason, the
Commission hereby waives the 30-day operative delay requirement and
designates the proposed rule change as operative upon filing.\17\
---------------------------------------------------------------------------

    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2019-21 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-NYSEArca-2019-21. 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 Room, 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. 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-NYSEArca-2019-21 and should be submitted
on or before May 2, 2019.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-07146 Filed 4-10-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Notices]
[Pages 2668-2671]
[FR Doc No: 2023-00774]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96634; File No. SR-ICEEU-2022-027]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change Relating to the Capital Replenishment
Plan

January 11, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 29, 2022, ICE Clear Europe Limited (``ICE Clear Europe'' or
the ``Clearing House'') 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. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') proposes to adopt a new Capital Replenishment Plan to document
certain tools, procedures and arrangements to replenish its financial
resources in the event of Clearing Member default and in the event of
losses not caused by Clearing Member default.\3\
---------------------------------------------------------------------------

    \3\ Capitalized terms used but not defined herein have the
meanings specified in the Capital Replenishment Plan or, if not
defined therein, the ICE Clear Europe Clearing Rules.
---------------------------------------------------------------------------

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 is proposing to adopt a new Capital Replenishment
Plan (the ``Plan'') to document certain tools, procedures and
arrangements that the Clearing House may use to replenish its capital,
when necessary. The Plan \4\ would address replenishment of both ICE
Clear Europe's own resources contribution to its guaranty funds and
capital required under applicable law, including the capital
requirement under EMIR as incorporated into UK law following the Brexit
transition (the ``EMIR capital requirement'').\5\ The Plan would
recognize that a need to replenish capital may arise because of a
Clearing Member default, the occurrence of sudden extraordinary one-off
losses, net losses resulting from custody or investment risks, or from
recurring losses which may arise from general business risks.\6\
---------------------------------------------------------------------------

    \4\ The Plan would consolidate and replace a pre-existing
capital requirement framework and related practices.
    \5\ Commission Delegated Regulation (EU) No. 152/2013 of 19
December 2012 supplementing Regulation (EU) No. 648/2012 of the
European Parliament and of the Council with regard to regulatory
technical standards on capital requirements for central
counterparties, as on-shored into UK law following the end of the
Brexit transition period.
    \6\ The Plan would also serve as a recovery tool and would be
part of ICE Clear Europe's overall Recovery Plan.
---------------------------------------------------------------------------

    The Plan would set out the overall purposes of the Plan and the
Clearing House's overall approach to capital management and maintaining
capital resources. The Plan is intended, among other purposes, to set
out for senior management, the audit committee and the Board actions
they may consider to replenish capital and to identify stakeholders and
their respective responsibilities with respect to ICE Clear Europe's
continued compliance with relevant laws and regulations

covering regulatory capital. This Plan takes into account both the
minimum legal capital requirements, including under the EMIR capital
requirement, as well as a higher target capital requirement (which
includes a voluntary capital contribution as well as a notification
buffer). The replenishment tools and actions under the Plan have been
developed so as to prioritize replenishing the legal capital
requirement first. Replenishment of additional capital to the target
amount can be addressed once the legal requirement has been restored,
(or at the same time at the discretion of the Board, resources
permitting).
    The Plan outlines the general steps the Clearing House would expect
to take to replenish capital, including (1) first assessing and using
available accumulated financial resources, (2) then looking to use
reasonably calculated forecasts as to future profits, (3) if those
resources are insufficient to restore capital to the legal requirement,
by seeking resources from its parent company in the ICE group, and (4)
thereafter, with the approval of its parent and subject to the rights
of existing shareholders, by seeking additional capital from third
parties. ICE Clear Europe may also bypass the first two steps outlined
above and immediately request capital from its parent company.
    The Plan also states that overall accountability for the plan lies
with the Finance Director, President, and the Board. The Plan would be
subject to annual review, and capital replenishment would be included
in the annual default management test schedule. The Plan would identify
specific internal control and governance responsibilities for the
Finance Director, President, the Board and Board Risk Committee
relating to monitoring capital compliance and replenishment. The
Finance Director would be responsible for monitoring ICE Clear Europe's
compliance with the applicable regulatory capital requirements,
reporting capital adequacy internally and to regulators, escalating
matters relating to capital adequacy to the President where
appropriate, and contributing to the development of plans to increase
and/or replenish Eligible Capital as required for ICE Clear Europe to
continue to meet its regulatory capital requirements. The President
would be responsible for ensuring ICE Clear Europe meets its capital
adequacy obligations under relevant laws and regulations. The Board
Risk Committee would be responsible for reviewing and recommending to
the Board the principles underlying the capital planning process, as
well as the Plan, itself, and the Board itself would be responsible for
approving the principles and the Plan. The Board would also be
responsible for holding the President accountable for demonstrating
adherence to ICE Clear Europe's capital policies and for reviewing and
approving any capital transactions.
    The Plan would also address the determination of the target capital
amount in excess of the legal minimum capital requirement. ICE Clear
Europe seeks to maintain excess capital above the threshold at which
notification would be required to the Bank of England (which is
generally 10% above the required capital level). In addition, ICE Clear
Europe endeavors to maintain additional capital, on a voluntary basis,
approximately equal to an additional 10% of the required capital level
plus the 10% buffer referenced above.
    The Plan would also provide further detail as to the use of the
capital replenishment tools referenced above in different default loss
and non-default loss scenarios and related actions to be taken for each
tool, including as to the key individuals and departments involved and
approvals required, the estimated timing for various actions, relevant
documentation requirements, the procedure for determination of the
relevant amount of additional resources to be sought or applied from
the relevant sources, and the process for consultation with Clearing
Members and regulators, among other matters. Annexes to the Plan also
set out relevant templates for documentation.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed adoption of the Capital
Replenishment Plan is consistent with the requirements of section 17A
of the Act \7\ and the regulations thereunder applicable to it. In
particular, section 17A(b)(3)(F) of the Act \8\ requires, among other
things, that the rules of a 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, 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 the public interest. The Capital
Replenishment Plan is intended to document procedures for replenishing
capital, for both the own resources contribution to the guaranty funds
and the EMIR capital requirements for the Clearing House. As a part of
the broader Recovery Plan, the proposed Capital Replenishment Plan will
facilitate the continued operation of the Clearing House following a
significant loss from one or more Clearing Member defaults or a non-
default loss (including investment or custodial losses and losses from
general business risk) by replenishing needed financial resources. The
Plan would address replenishment to both the minimum legal capital
requirement and the higher target level intended to provide additional
resources as an operating buffer. The amendments thus are consistent
with the continued prompt and accurate clearance and settlement of
securities transactions and derivatives transactions and the
safeguarding of securities and funds in the custody or control of the
Clearing House or for which it is responsible, following a significant
default or non-default loss. The amendments thus also enhance the
protection of investors and the public interest in the continued sound
operation of the Clearing House, consistent with the requirements of
section 17A(b)(3)(F) of the Act.\9\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1.
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Capital Replenishment Plan is also consistent with relevant
provisions of Rule 17Ad-22. Rule 17Ad-22(e)(3)(ii) \10\ provides that
the ``covered clearing agency shall establish, implement, maintain and
enforce written policies and procedures reasonable designed to, as
applicable [. . .] maintain a sound risk management framework for
comprehensively managing legal, credit, liquidity, operational, general
business, investment, custody and other risks that arise in or are
borne by the covered clearing agency, which . . . includes plans for
the recovery or orderly wind-down of the covered clearing agency
necessitated by credit losses, liquidity shortfalls, losses from
general business risk, or any other losses.'' As discussed above, the
Plan serves as a part of the broader Recovery Plan and is intended to
document tools, arrangements and procedures for replenishing capital
when needed as a result of default losses or non-default losses,
including losses from general business risk. The Plan further sets out
the roles and functions of the Board, ICE Clear Europe management and
other internal personnel and committees in taking such steps to
replenish financial resources. In ICE Clear Europe's view, the
implementation of the Capital Replenishment Plan is therefore

consistent with the requirements of Rule 17Ad-22(e)(3)(ii).\11\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.17Ad-22(e)(3)(ii).
    \11\ 17 CFR 240.17Ad-22(e)(3)(ii).
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(2) \12\ provides that the ``covered clearing agency
shall establish, implement, maintain and enforce written policies and
procedures reasonable designed to, as applicable [. . .] provide for
governance arrangements'' that ``are clear and transparent'' \13\ and
``specify clear and direct lines of responsibility''.\14\ The Plan
identifies responsibilities of key ICE Clear Europe personnel, the
Board and other stakeholders with respect to ongoing compliance with
capital requirements and for capital replenishment when necessary. The
Plan also provides for annual review by ICE Clear Europe's President,
Finance Director, and Board to ensure that it remains up-to-date and is
reviewed in accordance with the Clearing House's internal governance
processes. In ICE Clear Europe's view, the documents are therefore
consistent with the requirements of Rule 17Ad-22(e)(2).\15\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17Ad-22(e)(2).
    \13\ 17 CFR 240.17Ad-22(e)(2)(i).
    \14\ 17 CFR 240.17Ad-22(e)(2)(v).
    \15\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

    In addition, the Plan is consistent with the requirements of Rule
17Ad-22(e)(15),\16\ which states that a clearing agency shall
``identify, monitor, and manage, the covered clearing agency's general
business risk and hold sufficient liquid net assets funded by equity to
cover potential general business losses . . .'' by ``[m]aintaining a
viable plan, approved by the board of directors and updated at least
annually, for raising additional equity should its equity fall close to
or below the amount required under paragraph (e)(15)(ii) of this
section.'' \17\ As stated above, the Plan has been approved by the ICE
Clear Europe Board of Directors, would be reviewed and updated
annually, and would outline the tools available to restore additional
capital if needed. Specifically, the Plan serves as a part of the
broader Recovery Plan and is intended to document tools, arrangements
and procedures for replenishing capital when needed, including as a
result of losses from general business risk. The capital restoration
levels detailed in the Plan are based on the Clearing House's legal
capital requirements and its own target capital level. These are
designed to exceed the amount required under Rule 17Ad-
22(e)(15)(ii).\18\ As a result, it is ICE Clear Europe's view that the
Plan is consistent with Rule 17Ad-22(e)(15).\19\
---------------------------------------------------------------------------

    \16\ 17 CFR 240.17Ad-22(e)(15).
    \17\ 17 CFR 240.17Ad-22(e)(15)(iii).
    \18\ 17 CFR 240.17Ad-22(e)(15)(ii).
    \19\ 17 CFR 240.17Ad-22(e)(15).
---------------------------------------------------------------------------

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

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
Capital Replenishment Plan is intended to facilitate replenishment of
capital when necessary as a result of a clearing member default, the
occurrence of sudden extraordinary one-off losses, any net losses
incurred resulting from custody or investment risks, or from recurring
losses which may arise from general business risks. The Plan will not
affect the rights or obligations of Clearing Members, and is designed
to facilitate continued operation of the Clearing House following a
loss. ICE Clear Europe does not believe that the proposal would
adversely affect the ability of Clearing Members or other market
participants generally to access clearing services. Further, ICE Clear
Europe believes that the Plan would not otherwise affect competition
among Clearing Members, adversely affect the market for clearing
services, or limit market participants' choices for obtaining clearing
services. Accordingly, ICE Clear Europe does not believe that the
amendments would impose any impact or burden on competition that is not
appropriate in furtherance of the purpose of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change

    Written comments relating to the proposed amendment has 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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2022-027 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-2022-027. 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 Room, 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/clear-europe/regulation.
    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-2022-027

and should be submitted on or before February 7, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-00774 Filed 1-13-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 64974-64975]
[FR Doc No: 2012-26106]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: EC13-16-000.
    Applicants: Chisholm View Wind Project, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, Request for Expedited Consideration and Confidential
Treatment of Chisholm View Wind Project, LLC.
    Filed Date: 10/15/12.
    Accession Number: 20121015-5221.
    Comments Due: 5 p.m. ET 11/5/12.

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

    Docket Numbers: ER13-90-000.
    Applicants: Public Service Electric and Gas Company, PJM
Interconnection, L.L.C.
    Description: PJM TOs--Revisions to the PJM Tariff to Modify Cost
Allocation to be effective 2/1/2013.
    Filed Date: 10/11/12.
    Accession Number: 20121011-5112.
    Comments Due: 5 p.m. ET 11/9/12.

    Docket Numbers: ER13-132-000.
    Applicants: Southwestern Public Service Company.
    Description: 2012-10-16-SPS-Sherman 3-CA-657-0 0 0 to be effective
10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5026.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-133-000.
    Applicants: Sycamore Cogeneration Company, Southern California
Edison Company.
    Description: Application of Sycamore Cogeneration Company and
Southern California Edison Company for affiliate transaction.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5049.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-134-000.
    Applicants: GP Big Island, LLC.
    Description: GP Big Island, LLC submits tariff filing per 35.1:
Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5092.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-135-000.
    Applicants: Brunswick Cellulose LLC.
    Description: Brunswick Cellulose LLC submits tariff filing per
35.1: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5093.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-136-000.
    Applicants: Georgia-Pacific Brewton LLC.
    Description: Georgia-Pacific Brewton LLC submits tariff filing per
35.1: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5094.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-137-000.
    Applicants: Georgia-Pacific Cedar Springs LLC.
    Description: Georgia-Pacific Cedar Springs LLC submits tariff
filing per 35.1: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5095.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-138-000.
    Applicants: Georgia-Pacific Consumer Operations LLC.
    Description: Georgia-Pacific Consumer Operations LLC, Palatka
submits tariff filing per 35.1: Georgia-Pacific Entities to be
effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5096.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-139-000.
    Applicants: Lockhart Power Company.
    Description: Lockhart Power Company submits Notice of Cancellation
of its OATT.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5101.

    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-140-000.
    Applicants: Georgia-Pacific Consumer Operations LLC.
    Description: Georgia-Pacific Consumer Operations LLC, Port Hudson
submits tariff filing per 35.1: Georgia-Pacific Entities to be
effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5102.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-141-000.
    Applicants: Georgia-Pacific Consumer Products LP.
    Description: Georgia-Pacific Consumer Products LP, Naheola submits
tariff filing per 35.1: Georgia-Pacific Entities to be effective 10/17/
2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5103.
    Comments Due: 5 p.m. ET 11/6/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 16, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-26106 Filed 10-23-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Proposed Rules]
[Page 73983]
[DOCID:fr30no10-23]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Proposed Modification of the Salt Lake City, UT, Class B Airspace
Area; Public Meetings

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of meetings.

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

SUMMARY: This notice announces three fact-finding informal airspace
meetings to solicit information from airspace users and others
concerning a proposal to revise the Class B airspace area at Salt Lake
City, UT. The purpose of these meetings is to provide interested
parties an opportunity to present views, recommendations, and comments
on the proposal. All comments received during these meetings will be
considered prior to any revision or issuance of a notice of proposed
rulemaking.

DATES: The informal airspace meetings will be held on Wednesday,
January 26, 2011, from 6 p.m.-9 p.m.; Tuesday, February 1, 2011, from 6
p.m.-9 p.m.; and Thursday, February 3, 2011, from 6 p.m.-9 p.m.
Comments must be received on or before March 15, 2011.

ADDRESSES: (1) The meeting on Wednesday, January 26, 2011, will be held
in the Ogden Conference Room, Ogden Hinckley Airport Terminal, 3909
Airport Road, Ogden, UT, 84405. (2) The meeting on Tuesday, February 1,
2011, will be held in the Conference room in the Executive Terminal,
397 North 2370 West, Salt Lake City, UT 84116. (3) The meeting on
Thursday, February 3, 2011, will be held at Utah Valley University
Aviation Flight Center, Hanger A, 1158 Mike Jense Parkway, Provo, UT
84601.
    Comments: Send comments on the proposal, in triplicate, to: John
Warner, Manager, Operations Support Group, AJV-W2, Western Service
Center, Air Traffic Organization, Federal Aviation Administration, 1601
Lind Avenue, SW., Renton WA 98057.

FOR FURTHER INFORMATION CONTACT: To obtain details including a graphic
depiction regarding this proposal, please contact Ken Whitaker, FAA
Support Manager Salt Lake City TRACON, Salt Lake City ATCT/TRACON, 1201
North 4000 West, Salt Lake City, UT 84116.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Meeting Procedures

    (a) Doors open 30 minutes prior to the beginning of each meeting.
The meetings will be informal in nature and will be conducted by one or
more representatives of the FAA. A representative from the FAA will
present a briefing on the planned modification to the Class B airspace
at Salt Lake City, UT. Each participant will be given an opportunity to
deliver comments or make a presentation, although a time limit may be
imposed. Only comments concerning the plan to modify the Class B
airspace area at Salt Lake City, UT, will be accepted.
    (b) The meetings will be open to all persons on a space-available
basis. There will be no admission fee or other charge to attend and
participate.
    (c) Any person wishing to make a presentation to the FAA panel will
be asked to sign in and estimate the amount of time needed for such
presentation. This will permit the panel to allocate an appropriate
amount of time for each presenter. These meetings will not be adjourned
until everyone on the list has had an opportunity to address the panel.
    (d) Position papers or other handout material relating to the
substance of these meetings will be accepted. Participants wishing to
submit handout material should present an original and two copies (3
copies total) to the presiding officer. There should be additional
copies of each handout available for other attendees.
    (e) These meetings will not be formally recorded. However, a
summary of comments made at the meeting will be filed in the docket.

Agenda for the Meetings

--Sign-in.
--Presentation of meeting procedures.
--FAA explanation of the planned Class B airspace area modifications.
--Solicitation of public comments.
--Closing comments.

    Issued in Washington DC, November 22, 2010.
Edith V. Parish,
Manager, Airspace Regulation and ATC Procedures Group.
[FR Doc. 2010-30091 Filed 11-29-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Page 38096]
[FR Doc No: 2013-15043]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2012-0168]

Fatality Analysis Reporting System Information Collection

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before August 26, 2013.

ADDRESSES: Comments must refer to the docket notice numbers cited at
the beginning of this notice and be submitted to Docket Management,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. Please
identify the proposed collection of information for which a comment is
provided, by referencing its OMB clearance Number. It is requested, but
not required, that 2 copies of the comment be provided. The Docket
Section is open on weekdays from 10 a.m. to 5 p.m.

FOR FURTHER INFORMATION CONTACT: Marietta Bowen, State Data Reporting
Systems Division (NVS-412), Room W53-306, 1200 New Jersey Avenue SE.,
Washington, DC 20590. Mrs. Bowen can also be reached via email at
<EMAIL_ADDRESS>or via phone at<PHONE_NUMBER>. Please identify
the relevant collection of information by referring to its OMB Control
Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    (1) Title: Fatal Analysis Reporting System (FARS).
    OMB Control Number: 2127-0006.
    Affected Public: State, Local, or Tribal Government.
    Abstract: Under both the Highway Safety Act of 1966 and the
National Traffic and Motor Vehicle Safety Act of 1966, the National
Highway Traffic Safety Administration (NHTSA) has the responsibility to
collect accident data that support the establishment and enforcement of
motor vehicle regulations and highway safety programs. These
regulations and programs are developed to reduce the severity of injury
and the property damage associated with motor vehicle accidents. The
Fatality Analysis Reporting System (FARS) is a major system that
acquires national fatality information directly from existing State
files and documents. Since FARS is an on-going data acquisition system,
reviews are conducted yearly to determine whether the data acquired are
responsive to the total user population needs. The total user
population includes Federal and State agencies and the private sector.
Annual changes in the forms are minor in terms of operation and method
of data acquisition, and do not affect the reporting burden of the
respondent (State employees utilize existing State accident files). The
changes usually involve clarification adjustments to aid statisticians
in conducting more precise analyses and to remove potential ambiguity
for the respondents.
    Estimated Annual Burden: 98,655 hours.
    Number of Respondents: 52.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

Terry T. Shelton,
Associate Administrator for National Center for Statistics and
Analysis.
[FR Doc. 2013-15043 Filed 6-24-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60217-60218]
[FR Doc No: 2023-18831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2024]

Enhanced Drug Distribution Security at the Package Level Under
the Drug Supply Chain Security Act; 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 ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act.'' This guidance clarifies the enhanced drug
distribution security requirements listed in the Federal Food, Drug,
and Cosmetic Act (FD&C Act). In addition, this guidance outlines and
makes recommendations on the system attributes necessary to enable
secure tracing of product at the package level, including allowing for
the use of verification, inference, and aggregation, as necessary. This
guidance finalizes the draft guidance of the same title issued on June
4, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on August 31, 2023.

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-2020-D-2024 for ``Enhanced Drug Distribution Security at the
Package Level Under the Drug Supply Chain Security Act.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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: Abha Kundi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act.'' The Drug Supply Chain
Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law
on November 27, 2013.
    The DSCSA outlines critical steps to achieve electronic
pharmaceutical supply chain interoperability by November 27, 2023, that
will enhance

the identification and tracing of certain prescription drugs as they
are distributed within the United States. Section 202 of the DSCSA
added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which
established product tracing, product identifier, authorized trading
partner, and verification requirements for manufacturers, repackagers,
wholesale distributors, and dispensers to facilitate the tracing of
products through the pharmaceutical distribution supply chain. Section
582 of the FD&C Act also imposed requirements for enhanced drug
distribution security that go into effect on November 27, 2023.
    Trading partners, along with Federal and State authorities, have an
important role in ensuring the quality of prescription drugs and
protecting the integrity of the pharmaceutical distribution supply
chain. The DSCSA requirements, which have been phased in since 2013,
improve supply chain security activities by trading partners involved
in prescription drug manufacturing, repackaging, wholesale
distribution, warehousing or related logistical activities, and
dispensing. The gradual implementation of the DSCSA requirements for
product tracing, product identification, authorized trading partners,
and verification facilitates the development of electronic
interoperability to enhance the security of the pharmaceutical
distribution supply chain.
    Section 582(g)(1) of the FD&C Act sets forth the requirements for
enhanced drug distribution security as of November 27, 2023, including
(as described in that provision and generally summarized here):
     The exchange of transaction information and transaction
statements in a secure, interoperable, electronic manner.
     Transaction information that includes the product
identifier at the package level for each package included in the
transaction.
     Systems and processes for verification of product at the
package level.
     Systems and processes needed to promptly respond to
requests from FDA (or other appropriate Federal or State officials) for
product transaction information in the event of a recall or to
investigate suspect and illegitimate products.
    This guidance clarifies the enhanced drug distribution security
requirements and pursuant to section 582(h)(3) of the FD&C Act
describes recommendations for system attributes necessary for enhanced
product tracing and enhanced verification, including when the use of
aggregation and inference may be appropriate.
    This guidance finalizes the draft guidance entitled ``Enhanced Drug
Distribution Security at the Package Level Under the Drug Supply Chain
Security Act'' issued on June 4, 2021 (86 FR 30053). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include removal of the
term ``enhanced system'' when referring to the requirements in section
582(g) of the FD&C Act to avoid confusion and clarification of
recommendations addressing (1) reconciliation of transaction
information, (2) aggregation and inference, and (3) verification of
saleable returns, including a brief discussion of the sunset provisions
of section 582(k) of the FD&C Act. Changes also include clarification
of requirements for provision of certain information in response to
requests stemming from investigation of suspect or illegitimate
product. In addition, editorial changes were made to improve clarity.
    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 ``Enhanced Drug Distribution Security at the
Package Level Under the Drug Supply Chain Security Act.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance includes information collection provisions that 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). FDA intends
to solicit public comment and obtain OMB approval for any information
collections recommended in this guidance that are new or that would
represent substantive or material modifications to those previously
approved collections of information found in FDA regulations or
guidance.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18831 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Notices]
[Page 13876]
[DOCID:fr14mr08-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings 1

March 11, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-312-179
    Applicants: Tennessee Gas Pipeline Company
    Description: Tennessee Gas Pipeline Company submits a Gas
Transportation Agreement with ENI Petroleum US LLC pursuant to
Tennessee's Rate Schedule FT-A dated January, 20, 2008.
    Filed Date: 03/07/2008
    Accession Number: 20080310-0261
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 19, 2008

    Docket Numbers: RP07-99-004
    Applicants: ANR Pipeline Company
    Description: ANR Pipeline Company submits a Report of Refund for
the period of January 2007--June 2007 required by Section 154.501 of
FERC's Regulations.
    Filed Date: 03/10/2008
    Accession Number: 20080311-0002
    Comment Date: 5 p.m. Eastern Time on Monday, March 24, 2008

    Docket Numbers: RP08-267-000
    Applicants: Texas Eastern Transmission LP
    Description: Texas Eastern Transmission, LP submits First Revised
Sheet 206 et al to FERC Gas Tariff, Seventh Revised Volume 1, to become
effective May 1, 2008.
    Filed Date: 03/07/2008
    Accession Number: 20080310-0262
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 19, 2008

    Docket Numbers: RP08-268-000
    Applicants: Algonquin Gas Transmission Company
    Description: Algonquin Gas Transmission, LLC submits First Revised
Sheet 351 et al part of its FERC Gas Tariff, Fifth Revised Volume 1 an
Appendix A to be effective May 1, 2008.
    Filed Date: 03/07/2008
    Accession Number: 20080310-0263
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 19, 2008
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 St., NE., Washington, DC 20426.
    The filings in the above proceedings 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 e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-5151 Filed 3-13-08; 8:45 am]

BILLING CODE 6717-01-P