[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Rules and Regulations]
[Page 54315-54317]
[DOCID:fr19se08-8]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0915]
RIN 1625-AA00

Temporary Safety Zone; Wreckage of the M/V NEW CARISSA, Pacific
Ocean 3 Nautical Miles North of the Entrance to Coos Bay, OR

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of the Pacific Ocean encompassed in the 1,000 yard radius
surrounding the wreckage of the M/V NEW CARISSA located 3 nautical
miles north of the entrance to Coos Bay, Oregon. The Captain of the
Port Portland is taking this action to safeguard individuals and
vessels involved in a salvage operation involving the M/V NEW CARISSA.
Entry into this safety zone is prohibited unless authorized by the
Captain of the Port or his designated representative.

DATES: This regulation is effective from 12:01 p.m. August 31, 2008, to
12 p.m. September 30, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0915 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and Coast Guard
Sector Portland, 6767 N. Basin Ave., Portland, OR 97217, between 8 a.m.
and 4 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call MST1 Jaime Sayers, Waterways Management, at (503)
240-9311. If you have questions on viewing the docket, call Renee V.
Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory 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 immediate action is necessary
to protect human safety of those involved in the salvage operations of
the NEW CARISSA. Such action will be taken by limiting public access to
the salvage area. For those same reasons under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

Background and Purpose

    This rule is related to the safety zone published in the Federal
Register on June 27, 2008 (73 FR 36433). In that rule the Coast Guard
established a temporary safety zone on the waters of the Pacific Ocean
encompassed in the 1,000 yard radius surrounding the wreckage of the M/
V NEW CARISSA located 3 nautical miles north of the entrance to Coos
Bay, Oregon. The Captain of the Port Portland took that action to
safeguard individuals and vessels involved in a salvage operation
involving the wreck of the M/V NEW CARISSA.
    With this rule, for the same reasons as stated above, the Coast
Guard is establishing a safety zone in the same area because
individuals involved in the salvage operation of the NEW CARISSA have
not completed their task.
    Entry into this safety zone is prohibited from 12:01 p.m. August
31, 2008 to 12 p.m. September 30, 2008, unless authorized by the
Captain of the Port or his designated representative. This safety zone
will be enforced by representatives of the Captain of the Port
Portland. The Captain of the Port may be assisted by other federal,
state, and local agencies.

Discussion of Rule

    This rule, for safety concerns, will control vessels, personnel,
and individual movements on the waters of the Pacific Ocean encompassed
in the 1,000 yard radius surrounding the wreckage of the M/V NEW
CARISSA located 3 nautical miles north of the entrance to Coos Bay,
Oregon. Entry into this safety zone is prohibited unless authorized by
the Captain of the Port or his designated representative. Coast Guard
Personnel and local law enforcement will enforce this safety zone.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this regulation restricts access
to the safety zone, the effect of this rule will not be significant
because: (i) The safety zone will be in effect for a limited duration;
(ii) the safety zone is of limited size; and (iii) the Coast Guard will
make notifications via maritime advisories so mariners can adjust their
plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), we
have considered whether this rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.

    The Coast Guard certifies under 5 U.S.C. 605(b) that this 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
may be small entities: the owners or operators of vessels intending to
transit a small area of the Pacific Ocean along the Oregon Coast
encompassed in the 1,000 yard radius surrounding the wreckage of the M/
V NEW CARISSA located 3 nautical miles north of the entrance to Coos
Bay, Oregon. This safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: the safety zone applies to a small portion of the Pacific
Ocean, entities wishing to transit in the vicinity may pass outside of
the safety zone to continue their transit. We will issue a broadcast
notice to mariners on the affected portion of the Pacific Ocean.

Assistance for Small Entities

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

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This 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.

Energy Effects

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

Technical Standards

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

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
and Department of Homeland Security Management Directive 5100.1, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that under the instruction there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because it establishes a safety zone.
    A final ``Environmental Analysis Check List'' and a final
``Categorical Exclusion Determination'' will be available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR parts 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. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. A temporary section in 165.T13-067 is added to read as follows:

Sec.  165.T13-067  Safety Zone; Wreckage of the M/V NEW CARISSA,
Pacific Ocean 3 Nautical Miles North of the Entrance to Coos Bay,
Oregon.

    (a) Location. The following area is a safety zone: The waters of
the Pacific Ocean encompassed by a 1000 yard radius surrounding the
wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to
Coos Bay, Oregon.
    (b) Enforcement period. This rule will be in effect from 12 p.m.
September 2, 2008, to 12 p.m. September 30, 2008.
    (c) Regulations. In accordance with the general regulations in
Section 165.23 of this part, entry into this safety zone is prohibited
unless authorized by the Captain of the Port or his designated
representative.

    Dated: September 2, 2008.
F.G. Myer,
Captain, U.S. Coast Guard, Captain of the Port Portland.
[FR Doc. E8-21886 Filed 9-18-08; 8:45 am]

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[Federal Register: June 29, 2009 (Volume 74, Number 123)]
[Notices]
[Page 31040-31041]
[DOCID:fr29jn09-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1843-DR; Docket ID FEMA-2008-0018]

Alaska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alaska (FEMA-1843-DR), dated June 11, 2009,
and related determinations.

DATES: Effective Date: June 11, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 11, 2009, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the damage in certain areas of the State
of Alaska resulting from flooding and ice jams beginning on April
28, 2009, and continuing, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Alaska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas and Hazard Mitigation throughout
the State. Consistent with the requirement that Federal assistance
is supplemental, any Federal funds provided under the Stafford Act
for Public Assistance, Hazard Mitigation, and Other Needs Assistance
will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that

pursuant to the authority vested in the Administrator, under Executive
Order 12148, as amended, Douglas G. Mayne, of FEMA is appointed to act
as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Alaska have been designated as
adversely affected by this major disaster:

    The Alaska Gateway Regional Educational Attendance Area (REAA),
the Kuspuk REAA, the Yukon Flats REAA, and the Yukon-Koyukuk REAA
for Individual Assistance.
    The Alaska Gateway Regional Educational Attendance Area (REAA),
the Kuspuk REAA, the Lower Kuskokwin REAA, the Matanuska-Susitna
Borough, the Yukon Flats REAA, and the Yupiit REAA for Public
Assistance.
    All boroughs and Regional Education Attendance Areas within the
State of Alaska are eligible to apply for assistance under the
Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. E9-15352 Filed 6-26-09; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10449-10451]
[FR Doc No: 2020-03574]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1216]

Electronic Common Technical Document v4.0 Technical Conformance
Guide; Food and Drug Administration Electronic Common Technical
Document v4.0 Module 1 Implementation Package; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting comment on the draft Electronic Common Technical Document
(eCTD) v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1
Implementation Package. The eCTD v4.0 Technical Conformance Guide will
provide specifications, recommendations, and general considerations on
how to submit eCTD v4.0-based electronic submissions to the Center for
Drug Evaluation and Research (CDER) or the Center for Biologics
Evaluation and Research (CBER) using the International Council for
Harmonisation eCTD v4.0 Implementation Package and the FDA eCTD v4.0
Module 1 Implementation Package. The Agency is seeking comment on the
eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1
Implementation Package for the accuracy, suitability, and
appropriateness of these specifications for the submission of eCTD v4.0
submissions. These versions of the documents are not for
implementation.

DATES: Submit either electronic or written comments by April 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 9, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instruction.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1216 for ``Electronic Common Technical Document (eCTD) v4.0
Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation
Package.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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. The eCTD v4.0 Technical Conformance
Guide and FDA eCTD v4.0 Module 1 Implementation Package are available
on FDA's eCTD v4.0 web page at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm.
    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 eCTD v4.0
Technical Conformance Guide or FDA eCTD v4.0 Module 1 Implementation
Package 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 these documents.

FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993-0002, 301-
796-7997; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0
Module 1 Implementation Package are draft versions of the eCTD standard
format. FDA will continue to only accept eCTD v3.2.2 submissions until
eCTD version 4.0 is finalized. Once eCTD v4.0 is finalized, FDA will
accept both eCTD v3.2.2 and eCTD v4.0 submissions for a lengthy phase-
in period before eventually only accepting eCTD v4.0 submissions. FDA
is requesting comments on the draft eCTD v4.0 Technical Conformance
Guide and the FDA eCTD v4.0 Module 1 Implementation Package for eCTD
v4.0 submissions only. After receiving comments, the Agency will update
the eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module
1 Implementation Package to facilitate the Agency's future acceptance
of eCTD v4.0 submissions.
    The eCTD v4.0 Technical Conformance Guide will provide
specifications, recommendations, and general considerations on how to
submit eCTD v4.0-based electronic submissions to CDER or CBER when the
Agency implements eCTD v4.0. The eCTD v4.0 Technical Conformance Guide
is organized as follows:

Section 1: Introduction

     Provides information on regulatory policy and guidance
background, purpose, document control, new features of eCTD v4.0, and
guidelines for an eCTD v4.0 submission.

Section 2: Submission Contents

     Recommends and provides details on specific topics
organized by their placement (by module) in the eCTD submission.

Section 3: Combination Products

     Recommends and provides details on device combination
product information organized by their placement in the eCTD
submission.

Section 4: Two-Way Communications

     Provides details on the two-way communication process.

Section 5: Rules for Submission Tracking Information

     Provides details on the submission tracking relationships
for an FDA eCTD submission.
    The FDA eCTD v4.0 Module 1 Implementation Package will provide the
detailed specifications to create Module 1 of an eCTD v4.0-based
electronic submission for CDER or CBER. The Implementation Package will
provide the technical specifications and the necessary components to
create a valid FDA eCTD v4.0 submission. The Implementation Package
contains the following components:

FDA eCTD Module 1 Implementation Guide

     The technical specification for the FDA eCTD v4.0 Module 1
using the Health Level Seven Regulated Product Submission Release 2,
Normative standard.

FDA Regional Genericode Controlled Vocabulary Files

     Includes region-specific vocabulary and the files intended
for implementers to use as a computable version of the controlled
vocabulary content.

FDA Regional Module XML Samples

     Includes samples of M1 eCTD v4.0 xml.

FDA Object Identifiers (OID) Listing

     Provides the OIDs to be used for the FDA Module 1
controlled vocabulary.

FDA Regional Controlled Vocabulary

     Includes region-specific vocabulary and these files are
intended as the human readable version of the controlled vocabulary
content.

FDA Regional Controlled Vocabulary for Transition Mapping Message DTD
2.01

     Provides a human readable version of the controlled
vocabulary transition mapping for the transition from Module 1 DTD
2.01.

FDA Regional Controlled Vocabulary for Transition Mapping Message DTD
3.3

     Provides a human readable version of the controlled
vocabulary transition mapping for the transition from Module 1 DTD 3.3.

II. Electronic Access

    Persons with access to the internet may obtain the eCTD v4.0
Technical Conformance Guide and the FDA eCTD v4.0 Module 1
Implementation Package at either https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm or https://www.regulations.gov.

    Dated: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03574 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23576-23578]
[FR Doc No: 2017-10532]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1848]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Cosmetic Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit either electronic or written comments on the collection
of information by July 24, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-1848 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Cosmetic Labeling Regulations.''
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 Division of Dockets Management 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 Division of Dockets Management. 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: http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office
of Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Cosmetic Labeling Regulations--21 CFR Part 701; OMB Control Number
0910-0599--Extension

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the
Fair Packaging and Labeling Act (the FPLA) require that cosmetic
manufacturers, packers, and distributors disclose information about
themselves or their products on the labels or labeling of their
products. Sections 201, 301, 502, 601, 602, 603, 701, and 704 of the
FD&C Act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections
4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA
to regulate the labeling of cosmetic products. Failure to comply with
the requirements for cosmetic labeling may render a cosmetic
adulterated under section 601 of the FD&C Act or misbranded under
section 602 of the FD&C Act.
    FDA's cosmetic labeling regulations are published in part 701 (21
CFR part 701). Four of the cosmetic labeling regulations have
information collection provisions. Section 701.3 requires the label of
a cosmetic product to bear a declaration of the ingredients in
descending order of predominance. Section 701.11 requires the principal
display panel of a cosmetic product to bear a statement of the identity
of the product. Section 701.12 requires the label of a cosmetic product
to specify the name and place of business of the manufacturer, packer,
or distributor. Section 701.13 requires the label of a cosmetic product
to declare the net quantity of contents of the product.
    FDA estimates the annual burden of this collection of information
as follows:

                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
    21 CFR section/activity         Number of      disclosures     Total annual     burden per      Total hours
                                   respondents    per respondent    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
701.3--Ingredients in order of            1,518               21          31,878               1          31,878
 predominance..................
701.11--Statement of identity..           1,518               24          36,432               1          36,432
701.12--Name and place of                 1,518               24          36,432               1          36,432
 business......................
701.13--Net quantity of                   1,518               24          36,432               1          36,432
 contents......................
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............         141,174
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The hour burden is the additional or incremental time that
establishments need to design and print labeling that includes the
following required elements: A declaration of ingredients in decreasing
order of predominance, a statement of the identity of the product, a
specification of the name and place of business of the establishment,
and a declaration of the net quantity of contents. These requirements
increase the time establishments need to design labels because they
increase the number of label elements that establishments must take
into account when designing labels. These requirements do not generate
any recurring burden per label because establishments must already
print and affix labels to cosmetic products as part of normal business
practices.
    The estimated annual third party disclosure is based on data
available to the Agency, our knowledge of and experience with cosmetic
labeling, and our communications with industry. We estimate there are
1,518 cosmetic product establishments in the United States. We
calculate label design costs based on stock keeping units (SKUs)
because each SKU has a unique product label. Based on data available to
the Agency and on communications with industry, we estimate that
cosmetic establishments will offer 94,800 SKUs for retail sale in 2017.
This corresponds to an average of 62 SKUs per establishment.
    One of the four provisions that we discuss in this information
collection, Sec.  701.3, applies only to cosmetic products offered for
retail sale. However, the other three provisions, Sec. Sec.  701.11,
701.12, and 701.13, apply to all cosmetic products, including non-
retail professional-use-only products. We estimate that including
professional-use-only cosmetic products increases the total number of
SKUs by 15 percent to 109,020. This corresponds to an average of 72
SKUs per establishment.
    Finally, based on the Agency's experience with other products, we
estimate that cosmetic establishments may redesign up to one-third of
SKUs per year. Therefore, we estimate that the number of disclosures
per respondent will be 21 (31,878 SKUs) for Sec.  701.3 and 24 each
(36,432 SKUs) for Sec. Sec.  701.11, 701.12, and 701.13.
    We estimate that each of the required label elements may add
approximately 1 hour to the label design process. We base this estimate
on the hour burdens the Agency has previously estimated for food, drug,
and medical device labeling and on the Agency's knowledge of cosmetic
labeling. Therefore, we estimate that the total hour burden on members
of the public for this information collection is 141,174 hours per
year.

    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10532 Filed 5-22-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 84010-84014]
[FR Doc No: 2023-26486]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99029; File No. SR-ISE-2023-30]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 4,
Section 5 Related to a Low Priced Stock Strike Price Interval Program

November 28, 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 November 20, 2023, Nasdaq ISE, LLC (``ISE'' or ``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 Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Options 4, Section 5, Series of
Options Contracts Open for Trading.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/ise/rules, 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 Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend Options 4, Section 5, Series of
Options Contracts Open for Trading. Miami International Securities
Exchange, LLC (``MIAX'') recently received approval to amend its Rule
404 to implement a new strike interval program for stocks that are
priced less than $2.50 and have an average daily trading volume of at
least 1,000,000 shares per day for the 3 preceding calendar months.\3\
At this time, the Exchange proposes to adopt rules substantively
identical to MIAX at new Supplementary Material .08 to Options 4,
Section 5 and also amend Supplementary Material .07 to Options 4,
Section 5 to harmonize the table to the proposed rule text.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 98917 (November 13,
2023), 88 FR 80361 (November 17, 2023) (SR-MIAX-2023-36) (Order
Approving a Proposed Rule Change To Amend Exchange Rule 404, Series
of Option Contracts Open for Trading).
---------------------------------------------------------------------------

Background
    Currently, Options 4, Section 5, Series of Options Contracts Open
for Trading, describes the process and procedures for listing and
trading series of options \4\ on the Exchange. Supplementary Material
.02 to Options 4, Section 5 provides for a $2.50 Strike Price Program,
where the Exchange may select up to 60 option classes \5\ on individual
stocks for which the interval of strike prices will be $2.50 where the
strike price is greater than $25.00 but less than $50.00.\6\
Supplementary Material .01 to Options 4, Section 5 also provides for a
$1 Strike Price Interval Program, where the interval between strike
prices of series of options \7\ on individual stocks may be $1.00 or
greater provided the strike price is $50.00 or less, but not less than
$1.00.\8\ Additionally, Supplementary Katerial .05 to Options 4,
Section 5 provides for a $0.50 Strike Program.\9\ The interval of
strike prices of series of options on individual stocks may be $0.50 or
greater beginning at $0.50 where the strike price is $5.50 or less, but
only for options classes whose underlying security closed at or below
$5.00 in its primary market on the previous trading day and which have
national average daily volume that equals or exceeds 1,000 contracts
per day as determined by The Options Clearing Corporation during the
preceding three calendar months. The listing of $0.50 strike prices is
limited to options classes overlying no more than 20 individual stocks
(the ``$0.50 Strike Program'') as specifically designated by the
Exchange. The Exchange may list $0.50 strike prices on any other option
classes if those classes are specifically designated by other
securities exchanges that employ a similar $0.50 Strike Program under
their respective rules. A stock shall remain in the $0.50 Strike
Program until otherwise designated by the Exchange.\10\
---------------------------------------------------------------------------

    \4\ The term ``options contract'' means a put or a call issued,
or subject to issuance by the Clearing Corporation pursuant to the
Rules of the Clearing Corporation. See Options 1, Section 1(a)(31).
    \5\ The terms ``class of options'' means all options contracts
covering the same underlying security. See Options 1, Section
1(a)(8).
    \6\ See Supplementary Material .02 to Options 4, Section 5.
    \7\ The term ``series of options'' means all options contracts
of the same class having the same exercise price and expiration
date. See Options 1, Section 1(a)(47).
    \8\ See Supplementary Material .01(a) to Options 4, Section 5.
    \9\ See Supplementary Material .05 to Options 4, Section 5.
    \10\ Id.
---------------------------------------------------------------------------

Proposal
    At this time, the Exchange proposes to adopt a new strike interval
program for stocks that are not in the aforementioned $0.50 Strike
Program (or the Short Term Option Series Program) \11\ and that close
below $2.50 and have an average daily trading volume of at least
1,000,000 shares per day for the three (3) preceding calendar months.
The $0.50 Strike Program considers stocks that have a closing price at
or below $5.00 whereas the Exchange's proposal will consider stocks
that have a closing price below $2.50. Currently, there is a subset of
stocks that are not included in the $0.50 Strike Program as a result of
the limitations of that program which provides that the listing of
$0.50 strike prices shall be limited to option classes overlying no
more than 20 individual stocks as specifically designated by the
Exchange and requires a national average daily volume that equals or
exceeds 1,000 contracts per day as determined by The Options Clearing
Corporation during the preceding three calendar months.\12\ Therefore,
the Exchange is proposing to implement a new strike interval program
termed the ``Low Priced Stock Strike Price Interval Program.''
---------------------------------------------------------------------------

    \11\ See Supplementary Material .03 to Options 4, Section 5.
    \12\ See Supplementary Material .05 to Options 4, Section 5.
---------------------------------------------------------------------------

    To be eligible for the inclusion in the Low Priced Stock Strike
Price Interval Program, an underlying stock must (i) close below $2.50
in its primary market on the previous trading day; and (ii) have an
average daily trading volume of at least 1,000,000 shares per day for
the three (3) preceding calendar months. The Exchange notes that there
is no limit to the number of classes that will be eligible for
inclusion in the proposed program, provided, of course, that the
underlying stocks satisfy both the price

and average daily trading volume requirements of the proposed program.
    The Exchange also proposes that after a stock is added to the Low
Priced Stock Strike Price Interval Program, the Exchange may list $0.50
strike price intervals from $0.50 up to $2.00.\13\ For the purpose of
adding strikes under the Low Priced Stock Strike Price Interval
Program, the ``price of the underlying stock'' shall be measured in the
same way as ``the price of the underlying security'' as set forth in
Options 4, Section 6(b)(i).\14\ Further, no additional series in $0.50
intervals may be listed if the underlying stock closes at or above
$2.50 in its primary market. Additional series in $0.50 intervals may
not be added until the underlying stock again closes below $2.50.
---------------------------------------------------------------------------

    \13\ While the Exchange may list new strikes on underlying
stocks that meet the eligibility requirements of the new program the
Exchange will exercise its discretion and will not list strikes on
underlying stocks the Exchange believes are subject to imminent
delisting from their primary exchange.
    \14\ The Exchange notes this is the same methodology used in the
$1 Strike Price Interval Program. See Supplementary Material
.01(b)(3) of Options 4, Section 5.
---------------------------------------------------------------------------

    The Exchange's proposal addresses a gap in strike coverage for low
priced stocks. The $0.50 Strike Program considers stocks that close
below $5.00 and limits the number of option classes listed to no more
than 20 individual stocks (provided that the open interest criteria is
also satisfied). Whereas, the Exchange's proposal has a narrower focus,
with respect to the underlying's stock price, and is targeted on those
stocks that close below $2.50 and does not limit the number of stocks
that may participate in the program (provided that the average daily
trading volume is also satisfied). The Exchange does not believe that
any market disruptions will be encountered with the addition of these
new strikes. The Exchange represents that it has the necessary capacity
and surveillance programs in place to support and properly monitor
trading in the proposed Low Priced Stock Strike Price Interval Program.
    The Exchange believes that its average daily trading volume
requirement of 1,000,000 shares is a reasonable threshold to ensure
adequate liquidity in eligible underlying stocks as it is substantially
greater than the thresholds used for listing options on equities,
American Depository Receipts, and broad-based indexes. Specifically,
underlying securities with respect to which put or call option
contracts are approved for listing and trading on the Exchange must
meet certain criteria as determined by the Exchange. One of those
requirements is that trading volume (in all markets in which the
underlying security is traded) has been at least 2,400,000 shares in
the preceding twelve (12) months.\15\ Options 4, Section 3(f) provides
the criteria for listing options on American Depositary Receipts
(``ADRs'') if they meet certain criteria and guidelines set forth in
Options 4, Section 3 One of the requirements is that the average daily
trading volume for the security in the U.S. markets over the three (3)
months preceding the selection of the ADR for options trading is
100,000 or more shares.\16\ Finally, the Exchange may trade options on
a broad-based index pursuant to Rule 19b-4(e) of the Act provided a
number of conditions are satisfied. One of those conditions is that
each component security that accounts for at least one percent (1%) of
the weight of the index has an average daily trading volume of at least
90,000 shares during the last six month period.\17\
---------------------------------------------------------------------------

    \15\ See Options 4, Section 3(b)(4).
    \16\ See Options 4, Section 3(f)(3)(ii).
    \17\ See Options 4A, Section 3(d)(7).
---------------------------------------------------------------------------

    Additionally, the Exchange proposes to amend the table in
Supplementary Material .07 of Options 4, Section 5 to insert a new
column to harmonize the Exchange's proposal to the strike intervals for
Short Term Options Series as described in Supplementary Material .03 to
Options 4, Section 5. The table in Supplementary Material .03 is
intended to limit the intervals between strikes for multiply listed
equity options within the Short Term Options Series program that have
an expiration date more than twenty-one days from the listing date.
Specifically, the table defines the applicable strike intervals for
options on underlying stocks given the closing price on the primary
market on the last day of the calendar quarter, and a corresponding
average daily volume of the total number of options contracts traded in
a given security for the applicable calendar quarter divided by the
number of trading days in the applicable calendar quarter.\18\ However,
the lowest share price column is titled ``less than $25.'' The Exchange
now proposes to insert a column titled ``Less than $2.50'' and to set
the strike interval at $0.50 for each average daily volume tier
represented in the table. Also, the Exchange proposes to amend the
heading of the column currently titled ``less than $25,'' to ``$2.50 to
less than $25'' as a result of the adoption of the new proposed column,
``Less than $2.50.'' The Exchange believes this change will remove any
potential conflict between the strike intervals under the Short Term
Options Series Program and those described herein under the Exchange's
proposal.
---------------------------------------------------------------------------

    \18\ See Securities Exchange Release Act No. 91125 (February 21,
2021), 86 FR 10375 (February 19, 2021) (SR-BX-2020-032) (Order
Granting Accelerated Approval of a Proposed Rule Change, as Modified
by Amendment No. 1, To Amend Options 4, Section 5, To Limit Short
Term Options Series Intervals Between Strikes That Are Available for
Quoting and Trading on BX) (``BX-2020-032'').
---------------------------------------------------------------------------

Impact of Proposal
    The Exchange recognizes that its proposal will introduce new
strikes in the marketplace and further acknowledges that there has been
significant effort undertaken by the industry to curb strike
proliferation. This initiative has been spearheaded by Nasdaq BX, Inc.
(``BX'') when it filed an initial proposal focused on the removal, and
prevention of the listing, of strikes which are extraneous and do not
add value to the marketplace (the ``Strike Interval Proposal'').\19\
The Strike Interval Proposal was intended to remove repetitive and
unnecessary strike listings across the weekly expiries. Specifically,
the Strike Interval Proposal aimed to reduce the density of strike
intervals that would be listed in the later weeks, by creating
limitations for intervals between strikes which have an expiration date
more than twenty-one days from the listing date.\20\ The Strike
Interval Proposal took into account OCC customer-cleared volume, using
it as an appropriate proxy for demand. The Strike Interval Proposal was
designed to maintain strikes where there was customer demand and
eliminate strikes where there was not demand. At the time of its
proposal, BX estimated that the Strike Interval Proposal would reduce
the number of listed strikes in the options market by approximately
81,000 strikes.\21\ The Exchange proposes to amend the table to define
the strike interval at $0.50 for underlying stocks with a share price
of less than $2.50. The Exchange believes this amendment will harmonize
the Exchange's proposal with the Strike Interval Proposal described
above.
---------------------------------------------------------------------------

    \19\ See BX-2020-032. See also https://www.nasdaq.com/solutions/bx-options-strike-proliferation-proposal.
    \20\ See BX-2020-032.
    \21\ See BX-2020-032.
---------------------------------------------------------------------------

    The Exchange recognizes that its proposal will moderately increase
the total number of option series available on the Exchange. However,
the Exchange's proposal is designed to only add strikes where there is
investor demand \22\ which will improve market

quality. Under the requirements for the Low Priced Stock Strike Price
Interval Program as described herein, MIAX determined that as of August
9, 2023, 106 symbols met the proposed criteria. Of those symbols, MIAX
noted that 36 are currently in the $1 Strike Price Interval Program
with $1.00 and $2.00 strikes listed. Under the Exchange's proposal, the
$0.50 and $1.50 strikes for these symbols would be added for the
current expiration terms. Similar to MIAX, the remaining 70 symbols
eligible under the proposal would have $0.50, $1.00, $1.50 and $2.00
strikes added to their current expiration terms. Therefore, MIAX noted
that for the 106 symbols eligible for the Low Priced Stock Strike Price
Interval Program, a total of approximately 3,250 options would be
added. As of August 9, 2023, MIAX noted it listed 1,106,550 options,
and therefore, the additional options that would be listed under this
proposal would represent a relatively minor increase of 0.294% in the
number of options listed.
---------------------------------------------------------------------------

    \22\ See proposed Supplementary Material .08(a) of Options 4,
Section 5 that requires that an underlying stock must (i) close
below $2.50 in its primary market on the previous trading day; and
(ii) have an average daily trading volume of at least 1,000,000
shares per day for the three (3) preceding calendar months.
---------------------------------------------------------------------------

    The Exchange does not believe that its proposal contravenes the
industry's efforts to curtail unnecessary strikes. The Exchange's
proposal is targeted to only underlying stocks that close at less than
$2.50 and that also meet the average daily trading volume requirement.
Additionally, because the strike increment is $0.50 there are only a
total of four strikes that may be listed under the program ($0.50,
$1.00, $1.50, and $2.00) for an eligible underlying stock. Finally, if
an eligible underlying stock is in another program (e.g., the $0.50
Strike Program or the $1 Strike Price Interval Program) the number of
strikes that may be added is further reduced if there are pre-existing
strikes as part of another strike listing program. Therefore, the
Exchange does not believe that it will list any unnecessary or
repetitive strikes as part of its program, and that the strikes that
will be listed will improve market quality and satisfy investor demand.
    The Exchange further believes that the Options Price Reporting
Authority (``OPRA''), has the necessary systems capacity to handle any
additional messaging traffic associated with this proposed rule change.
The Exchange also believes that Members will not have a capacity issue
as a result of the proposed rule change. Finally, the Exchange believes
that the additional options will serve to increase liquidity, provide
additional trading and hedging opportunities for all market
participants, and improve market quality.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\23\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\24\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with the Section
(6)(b)(5) \25\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(5).
    \25\ 15 U.S.C. 78(f)(b)(5).
---------------------------------------------------------------------------

    The Exchange believes its proposal promotes just and equitable
principles of trade and removes impediments to and perfects the
mechanisms of a free and open market and a national market system as
the Exchange has identified a subset of stocks that are trading under
$2.50 and do not have meaningful strikes available. For example, on
August 9, 2023, symbol SOND closed at $0.50 and had open interest of
over 44,000 contracts and an average daily trading volume in the
underlying stock of over 1,900,000 shares for the three preceding
calendar months.\26\ Currently the lowest strike listed is for $2.50,
making the lowest strike 400% away from the closing stock price.
Another symbol, CTXR, closed at $0.92 on August 9, 2023, and had open
interest of 63,000 contracts and an average daily trading volume in the
underlying stock of over 1,900,000 shares for the three preceding
calendar months.\27\ Similarly, the lowest strike listed is for $2.50,
making the lowest strike more than 170% away from the closing stock
price. Currently, such products have no at-the-money options, as well
as no in-the-money calls or out-of-the-money puts. The Exchange's
proposal will provide additional strikes in $0.50 increments from $0.50
up to $2.00 to provide more meaningful trading and hedging
opportunities for this subset of stocks. Given the increased
granularity of strikes as proposed under the Exchange's proposal out-
of-the-money puts and in-the-money calls will be created. The Exchange
believes this will allow market participants to tailor their investment
and hedging needs more effectively.
---------------------------------------------------------------------------

    \26\ See Yahoo! Finance, https://finance.yahoo.com/quote/SOND/history?p=SOND (last visited August 10, 2023).
    \27\ See Yahoo! Finance, https://finance.yahoo.com/quote/CTXR/history?p=CTXR (last visited August 10, 2023).
---------------------------------------------------------------------------

    The Exchange believes its proposal promotes just and equitable
principles of trade and removes impediments to and perfects the
mechanisms of a free and open market and a national market system and,
in general, protects investors and the public interest by adding
strikes that improves market quality and satisfies investor demand. The
Exchange does not believe that the number of strikes that will be added
under the program will negatively impact the market. Additionally, the
proposal does not run counter to the efforts undertaken by the industry
to curb strike proliferation as that effort focused on the removal and
prevention of extraneous strikes where there was no investor demand.
The Exchange's proposal requires the satisfaction of an average daily
trading volume threshold in addition to the underlying stock closing at
a price below $2.50 to be eligible for the program. The Exchange
believes that the average daily trading volume threshold of the program
ensures that only strikes with investor demand will be listed and fills
a gap in strike interval coverage as described above. Further, being
that the strike interval is $0.50, there are only a maximum of four
strikes that may be added ($0.50, $1.00, $1.50, and $2.00). Therefore,
the Exchange does not believe that its proposal will undermine the
industry's efforts to eliminate repetitive and unnecessary strikes in
any fashion.
    The Exchange believes that its average daily trading volume
threshold promotes just and equitable principles of trade and removes
impediments to and perfects the mechanisms of a free and open market
and a national market system and, in general, protects investors and
the public interest as it is designed to permit only those stocks with
demonstrably high levels of trading activity to participate in the
program. The Exchange notes that its average daily trading volume
requirement is substantially greater than the average daily trading
requirement currently in place on the Exchange for options on

equity underlyings,\28\ ADRs,\29\ and broad-based indexes.\30\
---------------------------------------------------------------------------

    \28\ See supra note 15.
    \29\ See supra note 16.
    \30\ See supra note 17.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is consistent
with Section 6(b)(1) of the Act, which provides that the Exchange be
organized and have the capacity to be able to carry out the purposes of
the Act and the rules and regulations thereunder, and the rules of the
Exchange. The proposed rule change allows the Exchange to respond to
customer demand to provide meaningful strikes for low priced stocks.
The Exchange does not believe that the proposed rule would create any
capacity issue or negatively affect market functionality. Additionally,
the Exchange represents that it has the necessary systems capacity to
support the new options series and handle additional messaging traffic
associated with this proposed rule change. The Exchange also believes
that its Members will not experience any capacity issues as a result of
this proposal. In addition, the Exchange represents that it believes
that additional strikes for low priced stocks will serve to increase
liquidity available as well as improve price efficiency by providing
more trading opportunities for all market participants. The Exchange
believes that the proposed rule change will benefit investors by giving
them increased opportunities to execute their investment and hedging
decisions.
    Finally, the Exchange believes its proposal is designed to prevent
fraudulent and manipulative acts and practices as options may only be
listed on underlyings that satisfy the listing requirements of the
Exchange as described in Options 4, Section 3, Criteria for Underlying
Securities. Specifically, Options 4, Section 3 requires that underlying
securities for which put or call option contracts are approved for
listing and trading on the Exchange must meet the following criteria:
(1) the security must be registered and be an ``NMS stock'' as defined
in Rule 600 of Regulation NMS under the Exchange Act; (2) the security
shall be characterized by a substantial number of outstanding shares
that are widely held and actively traded.\31\ Additionally, Options 4,
Section 3 provides that absent exceptional circumstances, an underlying
security will not be selected for options transactions unless: (1)
there are a minimum of seven (7) million shares of the underlying
security which are owned by persons other than those required to report
their stock holdings under Section 16(a) of the Exchange Act; (2) there
are a minimum of 2,000 holders of the underlying security; (3) the
issuer is in compliance with any applicable requirements of the
Exchange Act; and (4) trading volume (in all markets in which the
underlying security is traded) has been at least 2,400,000 shares in
the preceding twelve (12) months.\32\ The Exchange's proposal does not
impact the eligibility of an underlying stock to have options listed on
it, but rather addresses only the listing of new additional option
classes on an underlying listed on the Exchange in accordance to the
Exchange's listings rules. As such, the Exchange believes that the
listing requirements described in Options 4, Section 3 address
potential concerns regarding possible manipulation. Additionally, in
conjunction with the proposed average daily volume requirement
described herein, the Exchange believes any possible market
manipulation is further mitigated.
---------------------------------------------------------------------------

    \31\ See Options 4, Section 3(a)(1) and (2).
    \32\ See Options 4, Section 3(b)(1), (2), (3) and (4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
    The Exchange does not believe that its proposed rule change will
impose any burden on intra-market competition as the Rules of the
Exchange apply equally to all Members of the Exchange and all Members
may trade the new proposed strikes if they so choose. Specifically, the
Exchange believes that investors and market participants will
significantly benefit from the availability of finer strike price
intervals for stocks priced below $2.50, which will allow them to
tailor their investment and hedging needs more effectively. The
Exchange's proposal is substantively identical to MIAX Interpretations
and Policies .11 and .12 to Rule 404.
    The Exchange does not believe that its proposed rule change will
impose any burden on inter-market competition, as nothing prevents
other options exchanges from proposing similar rules to list and trade
options on low priced stocks. Rather the Exchange believes that its
proposal will promote inter-market competition, as the Exchange's
proposal will result in additional opportunities for investors to
achieve their investment and trading objectives, to the benefit of
investors, market participants, and the marketplace in general.

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

    No written comments were either solicited or received.

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

    Pursuant to Section 19(b)(3)(A) of the Act \33\ and Rule 19b-
4(f)(6) \34\ thereunder, the Exchange has designated this proposal as
one that effects a change that: (i) does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) by its terms, does not
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest.\35\
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78s(b)(3)(A).
    \34\ 17 CFR 240.19b-4(f)(6).
    \35\ In addition, Rule 19b-4(f)(6) requires a self-regulatory
organization to give the Commission written notice of its intent to
file 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. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act normally does not become operative for 30 days after the date of
its filing. However, Rule 19b-4(f)(6)(iii) \36\ permits the Commission
to designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requested
that the Commission waive the 30-day operative delay so that the
proposal may become operative immediately upon filing. The Commission
notes it has approved a proposed rule change substantially identical to
the one proposed by the Exchange.\37\ The proposed change raises no
novel legal or regulatory issues. Therefore, the Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the 30-day operative delay and designates the
proposed rule change operative upon filing.\38\
---------------------------------------------------------------------------

    \36\ 17 CFR 240.19b-4(f)(6)(iii).
    \37\ See supra note 3.
    \38\ For purposes only of waiving the 30-day operative delay,
the Commission has also 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 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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-ISE-2023-30 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-ISE-2023-30. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-ISE-2023-30 and should be
submitted on or before December 22, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\39\
---------------------------------------------------------------------------

    \39\ 17 CFR 200.30-3(a)(12), (59).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-26486 Filed 11-30-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 3012-3013]
[FR Doc No: 2015-00705]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Notice of Application for Modification of Special Permit

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: List of application for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before February 5, 2015.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR
1.53(b)).

    Issued in Washington, DC, on January 8, 2015.
Donald Burger,
Chief, General Approvals and Permits.

                                          Modification Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                   Regulation(s)       Nature of special permit
    Application No.       Docket No.          Applicant               affected                  thereof
----------------------------------------------------------------------------------------------------------------
7945-M................  ..............  Pacific Scientific     49 CFR 173.304(a)(1);  To modify the special
                                         Company, Simi          175.3.                 permit to exempt
                                         Valley, CA.                                   sufficient outage when
                                                                                cylinders are full.
10427-M...............  ..............  Astrotech Space        49 CFR 173.61(a),      To modify the special
                                         Operations, Inc.,      173.301(g),            permit to authorize
                                         Titusville, FL.        173.302(a), 173.336,   additional launch
                                                                and 177.848(d).        vehicles and increase the
                                                                                amount of Anhydrous
                                                                                ammonia to 120 pounds.
11253-M...............  ..............  DPC Industries, Inc.,  49 CFR 172.101,        To modify the special
                                         Houston, TX.           Special Provision      permit to add an
                                                                B14; 173.315, Notes    additional cargo tank.
                                                                4, 24.
12084-M...............  ..............  Honeywell              49 CFR 180.209.......  To modify the special
                                         International, Inc.,                          permit to authorize an
                                         Morristown, NJ.                               additional hazardous
                                                                                material.
12116-M...............  ..............  Proserv UK Ltd., East  49 CFR 178.36........  To modify the special
                                         Tullos, Aberdeen.                             permit to authorize use
                                                                                of a stronger and more
                                                                                corrosion resistant
                                                                                material to be used to
                                                                                manufacture certain parts
                                                                                of the cylinders.
12748-M...............  ..............  Lockheed Martin Space  49 CFR 178.601(a)....  To modify the special
                                         Systems Company,                              permit to authorize
                                         Santa Cruz, CA.                               additional hazardous
                                                                                materials.
12929-M...............  ..............  Western International  49 CFR 173.301(j)(1).  To modify the special
                                         Gas & Cylinders,                              permit to change the
                                         Inc. (Western),                               refill requirements.
                                         Bellville, TX.
14301-M...............  ..............  Gascon (Pty) Ltd.,     49 CFR 178.274(b),     To modify the special
                                         Elsied River, South    178.276(b)(1).         permit to authorize
                                         Africa.                                       manufacture of UN
                                                                                portable tanks in
                                                                                accordance with ASME
                                                                                Section VIII Division 2,
                                                                                latest edition.
14625-M...............  ..............  Sun & Skin Care        49 CFR                 To modify the special
                                         Research, Inc..        173.306(a)(3)(v).      permit to include the use
                                        Cocoa, FL............                          of DOT-2P aluminum cans.
14779-M...............  ..............  Corrosion Companies    49 CFR 107.503(b) and  To modify the special
                                         Inc., Washougal, WA.   (c), 173.241,          permit to increase the
                                                                173.242, 173.243 and   tank capacity to 8500
                                                                173.345.               gallons.
15071-M...............  ..............  Orbital Sciences       49 CFR 173.62(c).....  To modify the special
                                         Corporation, Dulles,                          permit to authorize cargo
                                         VA.                                           aircraft only.
15716-M...............  ..............  Department of Energy,  49 CFR 173.310.......  To modify the special
                                         Washington, DC.                               permit to authorize an
                                                                                additional material.
15744-M...............  ..............  Praxair Distribution,  49 CFR 180.205;        To modify the special
                                         Inc., Danbury, CT.     180.209.               permit to exempt the
                                                                                notation ``DOT-SP'' 15744
                                                                                on shipping papers.
15773-M...............  ..............  Roche Molecular        49 CFR 173.242(e)(1).  To modify the special
                                         Systems, Inc.,                                permit to authorize bulk
                                         Branchburg, NJ.                               packaging.
15848-M...............  ..............  Ambri, Inc.,           49 CFR 173.222(c)(1).  To modify the special
                                         Cambridge, MA.                                permit to authorize cargo
                                                                                vessel.
----------------------------------------------------------------------------------------------------------------

Billing Code: 4909-60

[FR Doc. 2015-00705 Filed 1-20-15; 8:45 am]
BILLING CODE M