[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Proposed Rules]
[Pages 38799-38801]
[FR Doc No: 2014-16008]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0429; Directorate Identifier 2014-NM-039-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 747-400 and 747-400F series airplanes.
This proposed AD was prompted by reports of cracking in the main
equipment center (MEC) drip shield and exhaust plenum. This proposed AD
would require installing a fiberglass reinforcing overcoat on the MEC
drip shield. We are proposing this AD to prevent water penetration into
the MEC, which could result in an electrical short and potential loss
of several functions essential for safe flight.

DATES: We must receive comments on this proposed AD by August 25, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0429; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Francis Smith, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-

2014-0429; Directorate Identifier 2014-NM-039-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of this
proposed AD. We will consider all comments received by the closing date
and may amend this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of cracking in the MEC drip shield and
exhaust plenum, which have each been identified as part of the leak
path into the MEC. Multiple operators have reported a cracked MEC drip
shield. These cracks can allow water to penetrate the MEC drip shield
and enter the MEC. Water penetration into the MEC, if not detected and
corrected, could result in an electrical short and potential loss of
several functions essential for safe flight.

Related Rulemaking

    We have previously issued AD 2011-16-06, Amendment 39-16764 (76 FR
47427, August 5, 2011), for certain The Boeing Company Model 747-400
and 747-400F series airplanes. AD 2011-16-06 requires inspecting for
cracks and holes of the MEC drip shields, repairing cracks, stiffening
the drip shield top surface, and installing a fiberglass reinforcing
overcoat to the top and sides of the drip shield. We have since
received reports of additional cracking of the drip shield that is not
mitigated by AD 2011-16-06. The newly reported cracking occurs at the
lower radius of the MEC drip shield, adjacent to the floor beams.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 747-25A3640, dated
January 8, 2014. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for Docket No. FAA-2014-0429.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Explanation of ``RC'' Steps in Service Information

    The FAA worked in conjunction with industry, under the
Airworthiness Directive Implementation Aviation Rulemaking Committee,
to enhance the AD system. One enhancement was a new process for
annotating which steps in the service information are required for
compliance with an AD. Differentiating these steps from other tasks in
the service information is expected to improve an owner's/operator's
understanding of crucial AD requirements and help provide consistent
judgment in AD compliance. The actions specified in the service
information described previously include steps that are labeled as RC
(required for compliance) because these steps have a direct effect on
detecting, preventing, resolving, or eliminating an identified unsafe
condition.
    As noted in the specified service information, steps labeled as RC
must be done to comply with the proposed AD. However, steps that are
not labeled as RC are recommended. Those steps that are not labeled as
RC may be deviated from, done as part of other actions, or done using
accepted methods different from those identified in the service
information without obtaining approval of an alternative method of
compliance, provided the steps labeled as RC can be done and the
airplane can be put back in a serviceable condition. Any substitutions
or changes to steps labeled as RC will require approval of an
alternative method of compliance.

Costs of Compliance

    We estimate that this proposed AD affects 15 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Installation of a fiberglass          36 work-hours x $85 per              $0           $3,060          $45,900
 reinforcing overcoat on the MEC       hour = $3,060.
 drip shield.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2014-0429; Directorate Identifier
2014-NM-039-AD.

(a) Comments Due Date

    We must receive comments by August 25, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 747-400 and 747-400F
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin 747-25A3640, dated January 8, 2014.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
Furnishings.

(e) Unsafe Condition

    This AD was prompted by reports of cracking in the main
equipment center (MEC) drip shield and exhaust plenum. We are
issuing this AD to prevent water penetration into the MEC, which
could result in an electrical short and potential loss of several
functions essential for safe flight.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Installation

    Within 24 months after the effective date of this AD, install a
fiberglass reinforcing overcoat on the MEC drip shield, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-25A3640, dated January 8, 2014.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (i)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) If the service information contains steps that are labeled
as RC (Required for Compliance), those steps must be done to comply
with this AD; any steps that are not labeled as RC are recommended.
Those steps that are not labeled as RC may be deviated from, done as
part of other actions, or done using accepted methods different from
those identified in the specified service information without
obtaining approval of an AMOC, provided the steps labeled as RC can
be done and the airplane can be put back in a serviceable condition.
Any substitutions or changes to steps labeled as RC require approval
of an AMOC.

 (i) Related Information

    (1) For more information about this AD, Francis Smith, Aerospace
Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S,
FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW.,
Renton, WA 98057-3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 26, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-16008 Filed 7-8-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50945-50946]
[FR Doc No: 2018-21958]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3546]

Assessing the Irritation and Sensitization Potential of
Transdermal and Topical Delivery Systems for Abbreviated New Drug
Applications; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Assessing
the Irritation and Sensitization Potential of Transdermal and Topical
Delivery Systems for ANDAs.'' This draft guidance provides
recommendations for the design and conduct of studies to evaluate the
in vivo skin irritation and sensitization (I/S) potential of a proposed
transdermal or topical delivery system (collectively referred to as
TDS). The recommendations in this draft guidance relate exclusively to
studies submitted in support of an abbreviated new drug application
(ANDA).

DATES: Submit either electronic or written comments on the draft
guidance by December 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-3546 for ``Assessing the Irritation and Sensitization
Potential of Transdermal and Topical Delivery Systems for ANDAs.''
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 draft 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. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Diana Solana-Sodeinde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 2724, Silver Spring, MD 20993-0002, 240-
402-3908.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Assessing the Irritation and Sensitization Potential of
Transdermal and Topical Delivery Systems for ANDAs.''
    The components and composition of a TDS formulation, including the
nature of the drug substance and/or the occlusivity of the TDS
materials, in conjunction with other factors such as the environmental
humidity or the condition of the skin, may have the potential to
irritate the skin or lead to a sensitization reaction. Such reactions
can be unpleasant to the patient and may affect patient compliance,
skin permeability, and/or adhesion of the TDS to the skin. The
collective consequence of these potential effects could create
uncertainty about the resulting drug delivery profile and uncertainty
about the rate and extent of drug absorption from the TDS. Therefore,
applicants should perform a comparative assessment of the test (T) and
reference (R) TDS products using an appropriately designed skin I/S
study with human subjects to demonstrate that the potential for a skin
irritation or sensitization reaction with the T TDS is no worse than
the reaction observed with the R TDS.
    This draft guidance provides recommendations for the design and
conduct of studies to evaluate the in vivo skin I/S potential of a
proposed TDS. The recommendations in this draft guidance relate
exclusively to studies submitted in support of an ANDA.
    The Agency is seeking comments on the recommendations reflected in
the draft guidance announced in this notice. In addition, FDA invites
comments on the scales and any alternative approaches, including those
recommended by international regulatory agencies, that may have been
used with success for the comparative assessment of the I/S potential
for proposed generic TDS products. FDA also specifically invites
comments regarding the comparative assessment of sensitization itself,
i.e., whether there are clinical scenarios where a comparative
sensitization assessment may be uninformative when done in addition to
a comparative irritation assessment.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Assessing
the Irritation and Sensitization Potential of Transdermal and Topical
Delivery Systems for ANDAs.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft 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 21 CFR 314.94 have been approved under
OMB control number 0910-0001.

III. Electronic Access

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

    Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21958 Filed 10-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42098-42100]
[FR Doc No: 2017-18812]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4625]

Development of a List of Pre-Dietary Supplement Health and
Education Act Dietary Ingredients; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting entitled ``Development of a List of Pre-DSHEA
Dietary Ingredients.'' The purpose of the meeting is to give interested
stakeholders an opportunity to discuss issues related to FDA's future
development of such a list.

DATES: The public meeting will be held on October 3, 2017, from 8 a.m.
to 5 p.m. Submit either electronic or written comments on this public
meeting by December 4, 2017. See the SUPPLEMENTARY INFORMATION section
for registration date and information.

ADDRESSES: The public meeting will be held at FDA's Center for Food
Safety and Applied Nutrition, Wiley Auditorium, 5001 Campus Dr.,
College Park, MD 20740.
    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 December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 4, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-4625 for ``Development of a List of Pre-DSHEA Dietary
Ingredients; Public Meeting; Request for Comments.'' 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.'' We will review this copy,
including the claimed confidential information, in our 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.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety
and Applied Nutrition (HFS-009), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 2016 (81 FR 53486), we issued
a notice announcing the availability of a revised draft guidance for
industry entitled, ``Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues.'' \1\ The revised draft guidance,
when finalized, will help industry in evaluating whether to submit a
premarket safety notification for a new dietary ingredient (NDI), or
for a dietary supplement containing an NDI, and in preparing such
premarket safety notifications (also referred to as NDI notifications).
The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub.
L. 103-417) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act)
by adding, among other provisions: (1) Section 201(ff) of the FD&C Act
(21 U.S.C. 321(ff)), which defines the term ``dietary supplement'' and
(2) section 413 of the FD&C Act (21 U.S.C. 350(b)), which describes
requirements for NDIs. Under DSHEA, dietary ingredients marketed in the
United States before October 15, 1994, are not NDIs and therefore are
not subject to the premarket notification requirements in section 413
of the FD&C Act. The revised draft guidance addressed, among other
things, considerations related to determining when a dietary ingredient
is not new and therefore does not require a NDI notification.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm.
---------------------------------------------------------------------------

    In the revised draft guidance, we stated our willingness to compile
an authoritative list of pre-October 15, 1994, dietary ingredients
based on independent and verifiable data to be supplied by industry.
Although we are aware that several trade associations and industry
groups have independently developed their own unofficial lists of
ingredients that they believe were marketed before October 15, 1994
(sometimes referred to as ``grandfathered'' or ``old'' dietary
ingredients), we are unable to verify the accuracy of those lists and
therefore have never recognized or sanctioned any of them. We also have
never compiled our own list.
    An authoritative list would provide benefits to both industry and
FDA. By providing clarity as to which ingredients do not require
notifications, it would alleviate the burden on industry of preparing
and submitting unnecessary notifications. Similarly, by eliminating
unnecessary notifications, an authoritative list would enable us to
more efficiently use our limited resources to review notifications for
truly ``new'' ingredients. In addition, an authoritative list would
allow us to better focus our enforcement efforts in alignment with our
strategic priorities of consumer safety, product integrity, and
accurate information.
    We have received and are reviewing comments on the 2016 revised
draft guidance. The comments generally support the idea that we should
develop a list of pre-DSHEA dietary ingredients, but reflect opinions
both on the standard of evidence for demonstrating that an ingredient
is pre-DSHEA and on the process by which ingredients should be added to
the list. We believe that public discussion of these issues will be
beneficial as we work toward development of a list of pre-DSHEA dietary
ingredients.

II. Topics for Discussion at the Public Meeting

    The public meeting will have two separate panels. Each panel will
be followed by an opportunity for open public comment. In addition,
there will be an opportunity for interested stakeholders to submit
additional written comments following the meeting.
    The first panel will discuss what standard of evidence is necessary
to determine that an ingredient was marketed before October 15, 1994.
This panel may address, among other things, what types and quantity of
evidence may suffice to demonstrate that a dietary ingredient was
marketed in the United States prior to October 15, 1994, as well as how
specifically or generally an ingredient on the list may be identified
depending on the evidence presented for that ingredient. In addition,
this discussion may also address whether certain botanical preparations
can be accepted as ``old'' if the plant is demonstrated to be ``old,''
and whether certain classes of ingredients can be considered ``old''
based on common documentation. During the open comment period following
this first panel, we will specifically invite comment about whether
there are any considerations specific to certain classes or types of
ingredients that should be taken into account as we develop the list.
    The second panel will discuss issues related to the process that
should be used to develop the list. This includes, but is not limited
to, the processes for nominating and reviewing ingredients; whether an
outside panel should be convened and, if so, the composition and role
of that panel; how information that is claimed to be confidential
should be treated; and what the ultimate list should look like.
    The topics discussed at the public meeting, both during the panel
discussions and during open public comment periods, as well as written
comments submitted after the meeting, will help us determine how to
develop this list of old dietary ingredients.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following Web site: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete

contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by midnight Eastern Time on September 25, 2017.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
    If you need special accommodations due to a disability, please
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later
than September 18, 2017.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. All requests
to make oral presentations must be received by September 18, 2017. We
will determine the amount of time allotted to each presenter and will
select and notify participants by September 25, 2017.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please visit the following Web site to register:
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    FDA has verified the Web site addresses, as of the date this
document publishes in the Federal Register, but Web sites are subject
to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
Internet at https://www.fda.gov/Food/DietarySupplements/default.htm.

    Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18812 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a huge number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent hours researching and dissecting these issues, but this takes time. I know that the FDA took many years to  come up with the Proposed Rule, so I do not think it is unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account.

My husband and I have both smoked traditional cigarettes for 25 years. We have had the desire to quit smoking for years. We tried the available nicotine replacement therapies- gum, patches, and lozenges as well as "cold turkey" with absolutely no success. We weren't able to go even 24 hours.  I tried an electronic cigarette about 3 years ago.  It worked okay, but it wasn't enough to help me cut my ties with traditional cigarettes.  Around March 15, 2014 my sister told me she had purchased one of the new models of personal vaporizers and had not smoked since Feb. 14, 2014. My husband and I discussed it and decided to buy them with the intent of using them when smoking a regular cigarette was not acceptable.  I do not mean inside public buildings or public spaces where cigarette smoking is not allowed.  I mean in our private spaces where it is our decision to allow smoking or not.  Imagine our surprise when we drove from the store we purchased them at to our home without lighting a cigarette.  We did not even have the desire for one. We vaped the whole way home. During the course of the next week, I smoked 11 traditional cigarettes and my husband smoked 9.  Not because we w, ere trying to quit cigarettes.  It just happened.  The personal vaporizer/electronic cigarettes filled our needs. We started by purchasing 2 bottles of high mg. eliquid (equivalent to full flavored cigarettes). One was grape flavored and one was coffee flavored.  When we went back to purchase more we decided to give the nearest lower level of nicotine a shot.  Wow.  We had no problems bumping down to the lower level nicotine. It is now May 17, 2014 and we are using the lowest mg. and are prepared to start mixing the 0 (zero) mg. eliquid with it to cut it even further.  We are weaning ourselves off of nicotine completely. We are so thankful to have had these tools available to us at a very affordable price and to have the option to choose what levels of nicotine we needed for our journey. We are thankful to have had the control to choose our levels of nicotine and time frames in which to lower them. Also, the wide variety of flavor options have played a huge role.  My favorite flavor choices are chocolates, fruits, candy, and bakery flavors.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have a fair opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Rules and Regulations]
[Page 20784]
[FR Doc No: 2014-08237]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0218]

Drawbridge Operation Regulation; Annisquam River and Blynman
Canal, Gloucester, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Blynman (SR127) Bridge across the
Annisquam River and Blynman Canal, mile 0.0, at Gloucester,
Massachusetts. The deviation is necessary to facilitate emergency
structural repairs at the bridge. This temporary deviation authorizes
the bridge to require a two hour advance notice for bridge openings for
six weeks to facilitate emergency repairs at the bridge.

DATES: This deviation is effective without actual notice from April 14,
2014 through May 2, 2014. For the purposes of enforcement, actual
notice will be used from March 31, 2014, until April 14, 2014.

ADDRESSES: The docket for this deviation, USCG-2014-0218 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation. 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
temporary deviation, call or email Mr. John McDonald, Project Officer,
First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: The Blynman (SR127) Bridge at mile 0.0,
across Annisquam River and Blynman Canal at Gloucester, Massachusetts,
has 8.2 feet of vertical clearance at mean high water and 16 feet of
vertical clearance at mean low water. The existing drawbridge operation
regulations are listed at 33 CFR 117.586.
    The owner of the bridge, Massachusetts Department of Transportation
(MDOT), requested a temporary deviation from the schedule to facilitate
emergency structural repairs at the bridge. A recent structural
inspection revealed structural deterioration of roadway deck stringers
at the bridge. As a result of the deterioration emergency vehicles and
school busses are prohibited due to weight limitations from passing
over the bridge.
    The structural repairs to the bridge deck will take approximately
six weeks to complete. The bridge owner requested a two hour advance
notice for bridge openings to allow the contractor sufficient time to
secure the bridge and remove equipment from the bridge in order to
provide bridge openings.
    The waterway supports commercial and seasonal recreational vessels
of various sizes.
    Under this temporary deviation the Blynman (SR127) Bridge at mile
0.0, across the Annisquam River and Blynman Canal may require at least
a two hour advance notice for bridge openings from March 31, 2014
through May 2, 2014. Requests for bridge openings may be made by
calling the number<PHONE_NUMBER>, posted at the bridge.
    There is an alternate route for vessel traffic to take around Cape
Ann, at Gloucester, should mariners not desire to provide the requested
two hour advance notice for bridge openings.
    The Coast Guard will also inform the users of the waterways through
our Local and Broadcast Notice to Mariners of the change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 27, 2014.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2014-08237 Filed 4-11-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50403-50408]
[FR Doc No: 2021-19296]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92847; File No. SR-LTSE-2021-05]

Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Eliminate LTSE Rule 11.420 (Order Audit Trail System (``OATS'')
Requirements)

September 1, 2021.
    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 August 30, 2021, Long-Term Stock Exchange, Inc. (``LTSE'' 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 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

    LTSE proposes to eliminate LTSE Rule 11.420 (Order Audit Trail
System (``OATS'') Requirements) to reflect that as of September 1,
2021, the Financial Industry Regulatory Authority, Inc. (``FINRA'')
will have retired OATS, and Industry Members will be effectively
reporting to the consolidated audit trail (``CAT'') adopted pursuant to
the National Market System Plan Governing the Consolidated Audit Trail
(the ``CAT NMS Plan'' or ``Plan'').\3\ LTSE has filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act,\4\ and Rule
19b4(f)(6) thereunder,\5\ which renders the proposed rule change
effective upon filing with the Commission.
---------------------------------------------------------------------------

    \3\ Unless otherwise specified, capitalized terms used in this
rule filing are defined as set forth herein, or in LTSE CAT
Compliance Rules (LTSE Rule Series 11.600) or in the CAT NMS Plan.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6).

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

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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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
    LTSE is filing with the Commission a proposed rule change to
eliminate LTSE Rule 11.420 to reflect that as of September 1, 2021,
FINRA will have retired OATS, and Industry Members will be effectively
reporting to the CAT adopted pursuant to the CAT NMS Plan.
I Background
    LTSE, FINRA, and the other national securities exchanges
(collectively, the ``Participants'') \6\ filed with the Commission,
pursuant to Section 11A of the Exchange Act \7\ and Rule 608 of
Regulation NMS thereunder,\8\ the CAT NMS Plan.\9\ The Participants
filed the Plan to comply with Rule 613 of Regulation NMS under the
Exchange Act.\10\ The Plan was published for comment in the Federal
Register on May 17, 2016,\11\ and approved by the Commission, as
modified, on November 15, 2016.\12\ LTSE Rule Series 11.600 implements
provisions of the CAT NMS Plan that are applicable to LTSE Members.\13\
---------------------------------------------------------------------------

    \6\ For a complete list of Participants, see Exhibit A to the
Limited Liability Company Agreement of Consolidated Audit Trail,
LLC, available at www.catnmsplan.com/sites/default/files/2020-07/LLC-Agreement-of-Consolidated-Audit-Trail-LLC-as-of-7.24.20.pdf.
    \7\ 15 U.S.C. 78k-1.
    \8\ 17 CFR 242.608.
    \9\ See Letter from the Participants to Brent J. Fields,
Secretary, Commission, dated September 30, 2014; and Letter from
Participants to Brent J. Fields, Secretary, Commission, dated
February 27, 2015. On December 24, 2015, the Participants submitted
an amendment to the CAT NMS Plan. See Letter from Participants to
Brent J. Fields, Secretary, Commission, dated December 23, 2015.
    \10\ 17 CFR 242.613.
    \11\ See Securities Exchange Act Rel. No. 77724 (Apr. 27, 2016),
81 FR 30614 (May 17, 2016).
    \12\ See Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016),
81 FR 84696 (Nov. 23, 2016).
    \13\ See LTSE Rule 1.160(w).
---------------------------------------------------------------------------

    The CAT NMS Plan is intended to create, implement, and maintain a
consolidated audit trail that will capture in a single consolidated
data source customer and order event information for orders in NMS
Securities and OTC Equity Securities, across all markets, from the time
of order inception through routing, cancellation, modification, or
execution.\14\ Among other things, the CAT NMS Plan, as modified by the
Commission, requires each Participant to ``file with the SEC the
relevant rule change filing to eliminate or modify its duplicative
rules within six (6) months of the SEC's approval of the CAT NMS
Plan.'' \15\ The Plan notes that ``the elimination of such rules and
the retirement of such systems [will] be effective at such time as CAT
Data meets minimum standards of accuracy and reliability.'' \16\
Specifically, the Plan requires the rule filing to discuss the
following:
---------------------------------------------------------------------------

    \14\ See, e.g., Securities Exchange Act Release No. 67457 (July
18, 2012), 77 FR 45722, 45723 (August 1, 2012).
    \15\ See CAT NMS Plan, Appendix C, Section C.9. LTSE notes that
the current filing addresses only the elimination of the OATS rule.
Any amendments to the Electronic Blue Sheets rules (LTSE Rule 8.220)
would be subject to a separate rule filing made in conjunction with
SEC rulemaking to amend Rule 17a-25 under the Exchange Act. 17 CFR
240.17a-25.
    \16\ See CAT NMS Plan, Appendix C, Section C.9.
---------------------------------------------------------------------------

     Specific accuracy and reliability standards that will
determine when duplicative systems will be retired, including, but not
limited to, whether the attainment of a certain Error Rate should
determine when a system duplicative of the CAT can be retired;
     whether the availability of certain data from Small
Industry Members \17\ two years after the Effective Date would
facilitate a more expeditious retirement of duplicative systems; and
     whether individual Industry Members can be exempted from
reporting to duplicative systems once their CAT reporting meets
specified accuracy and reliability standards, including, but not
limited to, ways in which establishing cross-system regulatory
functionality or integrating data from existing systems and the CAT
would facilitate such Individual Industry Member exemptions.\18\
---------------------------------------------------------------------------

    \17\ ``Small Industry Member'' is defined in LTSE Rule
11.610(pp) as an Industry Member that qualifies as a small broker-
dealer as defined in Rule 0-10(c) of the Exchange Act. On April 20,
2020, the Commission granted exemptive relief from certain
provisions of the CAT NMS Plan related to broker-dealers that do not
qualify as Small Industry Members solely because such broker-dealers
satisfy Rule 0-10(i)(2) under the Exchange Act in that they
introduce transactions on a fully disclosed basis to clearing firms
that are not small businesses or small organizations (referred to as
``Introducing Industry Members''). Specifically, the Commission
provided exemptive relief from requiring Introducing Industry
Members to comply with the requirements of the CAT NMS Plan that
apply to Industry Members other than Small Industry Members (``Large
Industry Members''), provided that the Participants require such
Introducing Industry Members to comply with the requirements of the
CAT NMS Plan that apply to Small Industry Members. See Securities
Exchange Act Release No. 88703 (April 20, 2020), 85 FR 23115 (April
24, 2020) (Order Granting Limited Exemptive Relief Related to
Certain Introducing Brokers From the Requirements of the CAT NMS
Plan) (the ``Introducing Brokers Exemptive Order''). As used herein,
the term ``Small Industry Member'' includes Introducing Industry
Members in accordance with the Introducing Brokers Exemptive Order.
    \18\ See supra note 16.
---------------------------------------------------------------------------

    On November 30, 2020, the Commission approved a FINRA rule filing
proposing to eliminate the FINRA OATS system once FINRA members are
effectively reporting to the CAT and the CAT's accuracy and reliability
meet certain standards.\19\ Specifically, FINRA proposed that before
OATS could be retired, the CAT generally must achieve a sustained error
rate for Industry Member reporting in five categories for a period of
at least 180 days \20\ of 5% or lower on a pre-correction basis, and 2%
or lower on a post-correction basis (measured at T+5). In addition to
the maximum error rates and matching thresholds (hereafter the
``threshold requirements''), FINRA's use of CAT Data must confirm that
(i) there are no material issues that have not been corrected, (ii) the
CAT includes all data necessary to allow FINRA to continue to meet its
surveillance obligations, and (iii) the Plan Processor is sufficiently
meeting its obligations under the CAT NMS Plan relating to the
reporting and linkage in the initial phase of reporting (``Phase 2a'')
of Industry Member Data.
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 90535 (November 30,
2020), 85 FR 78395 (December 4, 2020) (SR-FINRA-2020-024) (``OATS
Retirement Plan Order'').
    \20\ As set forth in the OATS Retirement Plan Order, the 180 day
``applicable period'' ran from October 26, 2020 to April 26, 2021.
October 26, 2020 was the date that Industry Members were required to
begin correcting all errors for inter-firm linkages and exchange/
TFR/ORF match validations.
---------------------------------------------------------------------------

    In the OATS Retirement Plan Order, the Commission approved FINRA's
proposal for how it would measure the CAT Data's accuracy and
reliability. Specifically, the Commission endorsed FINRA's proposal
that FINRA's review of CAT Data and error rates would be based on data
and linkages in Phase 2a, which replicate the data in OATS today and
thus are most relevant for OATS retirement purposes. Phase 2a Data
includes all events and scenarios covered by OATS and applies only to
equities. And FINRA would not consider options order events or Phase 2c
data and validations, which are not

in OATS today, for purposes of OATS retirement.\21\
---------------------------------------------------------------------------

    \21\ See supra note 19.
---------------------------------------------------------------------------

    On June 17, 2021, FINRA made an immediately effective filing
setting forth the basis for its determination that the accuracy and
reliability of the CAT met the standards approved by the Commission in
the OATS Retirement Plan Order and designating September 1, 2021 as the
date on which FINRA would retire OATS.\22\ Specifically, FINRA
determined that the CAT met the threshold requirements endorsed by the
Commission in the OATS Retirement Plan Order for Industry Member
reporting in each of the following categories:
---------------------------------------------------------------------------

    \22\ See Securities Exchange Act Release No. 92239 (June 23,
2021), 86 FR 34293 (June 29, 2021) (SR-FINRA-2021-017) (``OATS
Retirement Filing'').
---------------------------------------------------------------------------

A. Rejection Rates and Data Validations
    As described in the OATS Retirement Filing, the Plan Processor must
perform certain basic data validations, and if a record does not pass
these basic data validations, it must be rejected and returned to the
CAT Reporter to be corrected and resubmitted.\23\ FINRA determined that
for the applicable period, aggregate rejection rates across all
Industry Member Reporters were 0.03% pre-correction and 0.01% post-
correction, which far exceeds the threshold requirements of a 5% or
lower pre-correction error rate and a 2% or lower post-correction error
rate.
---------------------------------------------------------------------------

    \23\ Appendix D of the CAT NMS Plan, Section 7.2, for example,
requires that certain file validations (e.g., file transmission and
receipt are in the correct formats, confirmation of a valid SRO-
Assigned Market Participant Identifier, etc.), and syntax and
context checks (e.g., format checks, data type checks, consistency
checks, etc.) be performed on all submitted records.
---------------------------------------------------------------------------

B. Intra-Firm Linkages
    As described in the OATS Retirement Filing, the Plan Processor must
be able to link all related order events from all CAT Reporters
involved in the lifecycle of an order. At a minimum, this requirement
includes the creation of an order lifecycle between all order events
handled within an individual CAT Reporter, including orders routed to
internal desks or departments with different functions (e.g., an
internal ATS). FINRA determined that for the applicable period, the
intra-firm linkage accuracy rates across all Industry Member Reporters
were 99.07% pre-correction and 99.99% post-correction, which far
exceeds the threshold requirements of 95% or higher pre-correction and
98% or higher post-correction (in other words, the intra-firm linkages
accuracy far exceeds the threshold requirement that there be less than
5% inaccuracy pre-correction and less than 2% inaccuracy post-
correction).
C. Inter-Firm Linkages
    As described in the OATS Retirement Filing, the Plan Processor must
be able to create the lifecycle between orders routed between broker-
dealers. FINRA determined that for the applicable period, the intra-
firm linkage accuracy rates across all Industry Member Reporters were
99.08% pre-correction and 99.84% post-correction, which far exceed the
threshold requirements of 95% or higher pre-correction and 98% or
higher post-correction (in other words, the inter-firm linkages
accuracy far exceeds the threshold requirement that there be less than
5% inaccuracy pre-correction and less than 2% inaccuracy post-
correction).
D. Order Linkage Rates
    As described in the OATS Retirement Filing, in addition to creating
linkages within and between broker-dealers, the Plan Processor must be
able to create lifecycles to link various pieces of related orders. For
example, the Plan requires linkages of order information to create an
order lifecycle from origination or receipt to cancellation or
execution. This category essentially combines all of the order-related
linkages to capture an overall snapshot of order linkages in the
CAT.\24\ FINRA determined that for the applicable period, the order-
related linkage accuracy rates across all Industry Member Reporters
were 99.66% pre-correction and 99.93% post-correction, which far exceed
the threshold requirements of 95% or higher pre-correction and 98% or
higher post-correction (in other words, the order linkages accuracy far
exceeds the threshold requirement that there be less than 5% inaccuracy
pre-correction and less than 2% inaccuracy post-correction).
---------------------------------------------------------------------------

    \24\ See Letter from Lisa C. Horrigan, Associate General
Counsel, FINRA, to Vanessa Countryman, Secretary, Commission, dated
October 29, 2020.
---------------------------------------------------------------------------

E. Exchange and TRF/ORF Match Rates
    As described in the OATS Retirement Filing, an order lifecycle must
be created to link orders routed from broker-dealers to exchanges and
executed orders and trade reports. FINRA determined that for the
applicable period, the match rate across all equity exchanges for
orders routed from Industry Members to an exchange was 99.51% pre-
correction and 99.87% post-correction. This match rate far exceeds the
threshold requirements of 95% or higher pre-correction and 98% or
higher post-correction (in other words, the match rate accuracy far
exceeds the threshold requirement that there be less than 5% inaccuracy
pre-correction and less than 2% inaccuracy post-correction).
    Based upon the accuracy and reliability of the above five
categories of CAT Data, FINRA determined that the CAT Data met the
accuracy and reliability standards required for OATS retirement.\25\
---------------------------------------------------------------------------

    \25\ See supra note 22.
---------------------------------------------------------------------------

II. FINRA's Use of CAT Data
    Additionally, the OATS Retirement Plan Order set forth that before
retiring OATS, FINRA's use of CAT data must confirm that (i) there are
no material issues that have not been corrected (e.g., delays in the
processing of data, issues with query functions, etc.); (ii) the CAT
includes all data necessary to allow FINRA to continue to meet its
surveillance obligations \26\; and (iii) the Plan Processor is
sufficiently meeting its obligations under the CAT NMS Plan relating to
the reporting and linkage of Phase 2a Data.
---------------------------------------------------------------------------

    \26\ FINRA conducts surveillance on behalf of LTSE pursuant to
the Regulatory Service Agreement entered into by LTSE and FINRA
(``RSA''). Therefore, any references in this rule filing to FINRA
surveillance include FINRA's use of either OATS or CAT Data in
furtherance of the regulatory services it provides on behalf of
LTSE.
---------------------------------------------------------------------------

    As set forth in FINRA's OATS Retirement Filing, by September 1,
2021, FINRA will be ready to retire its use of OATS data for cross-
market surveillance, and replace it with a newly created surveillance
data mart, the Pattern Optimized Datamart (``POD''), which incorporates
equities (and options) data submitted by both Participants such as LTSE
and Industry Members. LTSE has been reporting via the CAT technical
specifications since its launch on August 28, 2020. Full Participant
equities reporting and linkage validations commenced on June 1,
2021.\27\ Successful completion of the transition to the CAT
specification for Participants was a prerequisite for FINRA to retire
the OATS-based cross market surveillance patterns and leverage CAT Data
and linkages in POD for its surveillance patterns. FINRA has completed
all planned activities on schedule, including substantially completing
the process of integrating

CAT Data into POD and successfully running large amounts of production
CAT Data for the month of May through POD.\28\ FINRA anticipates
completing additional activities before the proposed OATS retirement
date of September 1, 2021, including planned user acceptance
testing.\29\
---------------------------------------------------------------------------

    \27\ For example, according to the CAT Reporting Technical
Specification for Participants (version 4.0.0-r4 dated April 20,
2021), additional linkage error feedback for off-exchange trade
reports was effective as of June 1, 2021. The Technical
Specifications can be found on the CAT NMS Plan website at
www.catnmsplan.com/sites/default/files/2021-04/04.20.2021-CAT-Reporting-Technical-Specifications-for-Participants-4.0.0-r4.pdf.
    \28\ See supra note 22.
    \29\ As noted in the FINRA OATS Retirement Filing, user
acceptance testing is the final stage of any software development
lifecycle and enables actual users to test the system to confirm it
is able to carry out the required tasks it was designed to address
in real-world situations.
---------------------------------------------------------------------------

    Additionally, FINRA has confirmed that all of the data required to
support the transition from OATS to CAT is available in CAT.\30\
Specifically, FINRA, supported by the Participants, conducted a mapping
of all OATS data to CAT data, and then completed a ``gap analysis'' to
address any issues with the field-level mapping of OATS to CAT data.
Furthermore, LTSE, along with other Participants, has had a very high
compliance rate in reporting CAT Data using the CAT specifications
(both in the testing and production environments).\31\ Reviewing the
Participant submitted CAT Data and matching it with Industry Member
data, FINRA determined that the data linkages in CAT are ``comparable
to the linkages between RSA exchange data and OATS data'' currently
used by FINRA.\32\ Accordingly, the CAT NMS Plan Operating Committee
approved the cutover from the RSA specification to the CAT
specification as the official source of Participant data as of June 1,
2021, and today, all Industry Member and Participant equities data
reported via the CAT specification is linked in the CAT production
environment.
---------------------------------------------------------------------------

    \30\ See supra note 22.
    \31\ For example, for the month of July 2021, LTSE's compliance
error rate for CAT Data reporting was 1.7% (i.e., 98.3% of records
were successfully reported). However, this monthly average error
rate was impacted by a single day; for all other days in that month,
LTSE's compliance error rate ranged between 0.00% and 0.05%.
    \32\ See supra note 22.
---------------------------------------------------------------------------

    Thus, FINRA will use OATS data for surveillance patterns run
through the end of the second quarter of 2021 and has already begun
using CAT Data for its surveillance patterns for review periods
beginning in the third quarter of 2021.\33\ As detailed in the OATS
Retirement Filing, FINRA will continue to conduct regular reviews to
ensure confidence in the completeness and accuracy of Industry Member
reporting, along with the ability to remediate any issues in a timely
manner.\34\
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    \33\ See supra note 22.
    \34\ See supra note 22.
---------------------------------------------------------------------------

III. OATS May Be Retired in Light of the Accuracy and Reliability of
the CAT Data
    LTSE, like FINRA, believes that the three additional standards set
forth in the OATS Retirement Order for retiring OATS have been
satisfied. With respect to the first factor, LTSE, like FINRA, does not
believe that there are any material issues that have not been corrected
(or could not be corrected in the course of operation of CAT, as
approved by the Operating Committee) that would impact FINRA's ability
to incorporate and use CAT Data in FINRA's surveillance program, which
it conducts on behalf of LTSE pursuant to the RSA. For example, the
Plan requires that raw unprocessed data that has been ingested by the
Plan Processor must be available to Participant regulatory staff and
the SEC prior to 12:00 p.m. Eastern Time on T+1, and access to all
iterations of processed data must be available to Participant
regulatory staff and the SEC between 12:00 p.m. Eastern Time on T+1 and
T+5.\35\ The Plan Processor also must ensure that regulators have
access to corrected and linked order data by 8:00 a.m. Eastern Time on
T+5.\36\ Additionally, after ingestion by the Central Repository, the
raw unprocessed data must be transformed into a format appropriate for
data querying and regulatory output.\37\ The user-defined direct
queries and bulk extracts must provide authorized users with the
ability to retrieve CAT Data via a query tool or language that allows
users to query all available attributes and data sources.\38\ FINRA's
use of the CAT Data has not uncovered any processing delays or other
material issues impacting the availability of, and FINRA's access to,
the data.\39\
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    \35\ See CAT NMS Plan, Appendix D, Section 6.2.
    \36\ See CAT NMS Plan, Appendix C, Section A.2(a).
    \37\ See CAT NMS Plan, Appendix C, Section A.1(b).
    \38\ See CAT NMS Plan, Section 6.10(c).
    \39\ See supra note 20.
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    With respect to the second factor, LTSE, like FINRA, believes that
the CAT includes all data necessary for FINRA to meet its surveillance
obligations after the retirement of OATS. FINRA must ensure that the
CAT, as the single source of order and trade data, can enable FINRA to
conduct accurate and effective market surveillance in accordance with
its regulatory obligations. As noted above, Phase 2a Data includes all
events and scenarios covered by OATS and is the most relevant for OATS
retirement purposes. FINRA's testing, analysis and use of the CAT Data
(including integration into POD), as described above, has confirmed
that the CAT includes all data necessary for FINRA to meet its
surveillance obligations and that CAT is a reliable substitute for
OATS. In addition, based on its qualitative data reviews, FINRA has
concluded that Industry Member CAT Data, in the aggregate, is a
sufficient replacement for OATS for purposes of FINRA's surveillance
program.
    With respect to the third factor, LTSE, like FINRA, believes that
the Plan Processor is sufficiently meeting its obligations under the
CAT NMS Plan relating to the reporting and linkage of Phase 2a Data. As
detailed in the Implementation Plan and Quarterly Progress Reports
submitted by the Plan Participants, the Plan Processor has met its
targeted completion dates for the milestones for Phase 2a, including,
for example, production Go-Live for Equities 2a file submission and
data integrity validation (Large Industry Members and Small OATS
Reporters) on June 22, 2020; Production Go-Live for Equities 2a
Intrafirm Linkage validations on July 27, 2020; and production go-live
for firm-to-firm linkage validations for equities (Large Industry
Members and Small OATS Reporters) and exchange and TRF/ORF linkage
validations for equities (Large Industry Members and Small OATS
Reporters) on October 26, 2020.\40\
---------------------------------------------------------------------------

    \40\ The Implementation Plan and Quarterly Progress Reports are
available at www.catnmsplan.com/implementation-plan.
---------------------------------------------------------------------------

    Based on the foregoing, LTSE agrees with FINRA's determination that
the CAT meets the accuracy and reliability standards approved by the
Commission in the OATS Retirement Order for purposes of eliminating
OATS. FINRA has determined to retire OATS effective September 1,
2021.\41\ Firms must continue to report to OATS all order events that
occur on or prior to August 31, 2021. Reports submitted to OATS for
order events that occur after August 31, 2021 will be rejected. In
other words, August 31, 2021 will be the last ``OATS Business Day,'' as
defined under FINRA Rule 7450(b)(3), for which OATS will accept order
events and perform routine processing (including incorporation of
corrections and repairs of rejections) occurring within the normal OATS
timeframe for such activities. OATS will continue to accept reports for
order events that occur on or prior to August 31, 2021 (including, but
not limited to, late and corrected reports for such order events)
through September 16, 2021. Firms must ensure that their OATS

reporting is accurate and complete for all order events that occur on
or prior to August 31, 2021. LTSE Rule 11.420, like the FINRA OATS
Rules, will be deleted from the LTSE rulebook effective September 1,
2021.\42\
---------------------------------------------------------------------------

    \41\ See FINRA Regulatory Notice 21-21 (June 2021).
    \42\ In the unlikely event that FINRA determines it is unable to
retire OATS effective September 1, 2021, LTSE will delay the
retirement of LTSE Rule 11.420 pending the actual retirement of
FINRA OATS.
---------------------------------------------------------------------------

    In light of the foregoing, LTSE, like FINRA, believes that retiring
OATS as of September 1, 2021 is appropriate, particularly given the
potential risks of continuing to run OATS and CAT in parallel for an
additional period of time. Such potential risks may include, for
example, on an industry-wide basis: (1) Processing and storage capacity
issues from operating two systems (particularly in the event of
extraordinary market volume); (2) cybersecurity risks from having data
flow through two separate systems for a longer time period; (3) systems
issues from reporting infrastructure that is near end-of-life; and (4)
the expense and burden on CAT Reporters of dual reporting, particularly
in the event of systems issues requiring correction and/or resubmission
of data and competing resource priorities between OATS and CAT
reporting and repair activities.
    LTSE has filed the proposed rule change for immediate effectiveness
and is seeking a waiver of the 30 day operative delay to allow its OATS
rules to be retired concurrent with the September 1, 2021 retirement of
FINRA's OATS Rules. LTSE will also announce the retirement of OATS via
a trader alert to its Members.
2. Statutory Basis
    LTSE believes that the proposed rule change is consistent with the
provisions of Section 6(b)(5) of the Act, \43\ which require, among
other things, that LTSE's rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. LTSE believes that the proposed retirement of LTSE
Rule 11.420 fulfills the obligation in the CAT NMS Plan for LTSE to
submit a proposed rule change to eliminate or modify duplicative rules,
and that the CAT NMS Plan has achieved the accuracy and reliability
standards required by the Commission in the OATS Retirement Order.
---------------------------------------------------------------------------

    \43\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Additionally, as discussed in the Purpose section, LTSE believes
that the use of CAT Data, whether by LTSE directly, or by FINRA
pursuant to the RSA, will continue to allow for accurate and effective
surveillance of market activity on LTSE. Therefore, LTSE will continue
to be able to fulfill its statutory obligation to protect investors and
the public interest after the retirement of OATS.

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

    LTSE does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. LTSE notes that the proposed
rule change implements provisions of the CAT NMS Plan, facilitates the
retirement of certain existing regulatory systems, and is designed to
assist the Exchange in meeting its regulatory obligations pursuant to
the Plan. LTSE also notes that the proposed rule change will apply
equally to all firms that trade NMS Securities. In addition, all
national securities exchanges and FINRA are proposing substantially
similar rule filings. Therefore, this is not a competitive rule filing,
and, therefore, it does not impose a burden on competition.
    Furthermore, LTSE notes that FINRA undertook an economic impact
assessment of the potential costs and benefits associated with OATS
retirement and determined that CAT meets or exceeds the OATS standards.

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

    Written comments were neither solicited nor received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \44\ and Rule 19b-4(f)(6) thereunder.\45\
Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \46\ and Rule 19b-
4(f)(6)(iii) thereunder.\47\
---------------------------------------------------------------------------

    \44\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \45\ 17 CFR 240.19b-4(f)(6).
    \46\ 15 U.S.C. 78s(b)(3)(A).
    \47\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and 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. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The proposed rule change would not significantly affect the
protection of investors or the public interest because it seeks to
align LTSE's retirement of its OATS rule with FINRA's September 1, 2021
retirement of the OATS system itself. Thus, this rule change would
facilitate the retirement of certain existing, duplicative, regulatory
systems. Additionally, all national securities exchanges that currently
have OATS rules are proposing substantially similar regulatory filings
retiring their respective OATS rules. Therefore, this is not a
competitive rule filing, and it does not impose a burden on
competition. Accordingly, the Exchange has filed this rule change under
Section 19(b)(3)(A) of the Act \48\ and paragraph (f)(6) of Rule 19b-4
thereunder.\49\
---------------------------------------------------------------------------

    \48\ 15 U.S.C. 78s(b)(3)(A).
    \49\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \50\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\51\ the Commission
may 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 proposal
may become operative by September 1, 2021, the first day in which FINRA
will no longer accept OATS data.\52\ As discussed above, LTSE believes
that it is appropriate for FINRA to retire OATS effective September 1,
2021. LTSE states that the use of CAT Data, whether by LTSE or by FINRA
pursuant to LTSE's RSA with FINRA, will allow for accurate and
effective surveillance of market activity on LTSE. In addition, August
31, 2021, will be the last ``OATS Business Day,'' as defined under
FINRA Rule 7450(b)(3), for which OATS will accept order events and
perform routine processing, and reports submitted to OATS for order
events that occur after August 31, 2021, will be rejected. The
Commission believes that it is

consistent with the protection of investors and the public interest for
LTSE to delete its OATS reporting rules at the same time that FINRA
retires OATS. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposal operative on September 1,
2021.\53\
---------------------------------------------------------------------------

    \50\ 17 CFR 240.19b-4(f)(6).
    \51\ 17 CFR 240.19b-4(f)(6)(iii).
    \52\ In the unlikely event that FINRA determines it is unable to
retire OATS effective September 1, 2021, LTSE will delay the
retirement of LTSE Rule 11.420 pending the actual retirement of
FINRA OATS.
    \53\ For purposed only of waiving the 30-day operative delay,
the Commission 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 this 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 will 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_ADDRESS>Please include
File Number SR-LTSE-2021-05 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-LTSE-2021-05. 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 LTSE and on its internet website
at https://longtermstockexchange.com/. 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-
LTSE-2021-05, and should be submitted on or before September 29, 2021.
---------------------------------------------------------------------------

    \54\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\54\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-19296 Filed 9-7-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Notices]
[Page 39069]
[DOCID:fr05au09-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13448-000]

McGinnis, Inc.; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

July 29, 2009.
    On April 29, 2009, McGinnis, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Marmet Hydrokinetic Project,
to be located on the Kanawha River, in Kanawha County, West Virginia.
    The sole purpose of a preliminary permit, if issued, is to grant
the permit holder priority to file a license application during the
permit term. A preliminary permit does not authorize the permit holder
to perform any land disturbing activities or otherwise enter upon lands
or waters owned by others without the owners' express permission.
    The proposed Meldahl Hydrokinetic Project consists of: (1) 10
proposed 35 kilowatt turbine-generator units having a total installed
capacity of 0.35 megawatts; (2) a 300-feet-long, 13.2 kilovolt
transmission line; and (3) appurtenant facilities. The proposed
Winfield Hydrokinetic Project would have an average annual generation
of 1.533 gigawatt-hours.
    Applicant Contact: Bruce D. McGinnis, Sr., CEO, McGinnis, Inc., 502
Second Street Ext., South Point, OH 45680; phone:<PHONE_NUMBER>.
    FERC Contact: Kim Carter,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13448) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-18635 Filed 8-4-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3335-3336]
[FR Doc No: 2017-00374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0529]

Recommended Statement for Over-the-Counter Aspirin-Containing
Drug Products Labeled With Cardiovascular Related Imagery; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Recommended
Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled
With Cardiovascular Related Imagery.'' The guidance is intended to
promote the safe use of nonprescription (also referred to as over-the-
counter or OTC) aspirin drug products by encouraging drug
manufacturers, packagers, and labelers marketing aspirin drug products
with cardiovascular related imagery to include a statement that reminds
consumers to talk to their health care provider before using aspirin
for their heart.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(a)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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-2012-D-0529 for ``Recommended Statement for Over-the-Counter
Aspirin-Containing Drug Products Labeled With Cardiovascular Related
Imagery; Guidance for Industry.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://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 http://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.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Emily Baker, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5203, Silver Spring, MD 20993-0002, 301-
796-7524<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Recommended Statement for Over-the-Counter Aspirin-
Containing Drug Products Labeled With Cardiovascular Related Imagery.''
Aspirin is a common active ingredient in many prescription and OTC drug
products. Most OTC aspirin drug products are currently marketed
pursuant to the Tentative Final Monograph (TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic (IAAA) Drug Products (53 FR 46204,
November 16, 1988) for the temporary relief of minor aches and pains
associated with a cold, headache, backache, toothache, premenstrual and
menstrual cramps; minor pain of arthritis; and reduction in fever.
    In addition to the OTC conditions of use in the IAAA TFM, FDA
regulations at Sec.  343.80 (21 CFR 343.80) also contain professional
labeling about cardiovascular uses of aspirin directed at health care
practitioners (63 FR 56802, October 23, 1998). After publication of the
professional labeling regulation for aspirin, some OTC aspirin labels
were modified to include cardiovascular related imagery (e.g., heart
image, electrocardiography graphic, stethoscope around a heart image).
However, the final rule for IAAA products at Sec.  343.80 authorizes
labeling for cardiovascular events only in professional labeling
directed to health care professionals.
    Because of the potential side effects associated with long-term
aspirin therapy, FDA recommends that any cardiovascular related imagery
on OTC aspirin labels be accompanied by a statement that reminds
consumers to talk to their health care provider before using aspirin
for the professional indication of secondary prevention of
cardiovascular events. Therefore, this draft guidance provides that FDA
does not intend to take action against manufacturers of single-
ingredient aspirin, buffered aspirin, and aspirin in combination with
an antacid, marketed pursuant to the TFM for IAAA Drug Products because
the product label includes cardiovascular related imagery (e.g., heart
image, electrocardiography graphic, stethoscope around a heart image)
if the label also includes language as described in the draft guidance
recommending that patients talk to a health care professional before
taking aspirin for cardiovascular uses and the product is otherwise
marketed in accordance with the TFM.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the 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.

II. Paperwork Reduction Act of 1995

    The recommendations in this draft guidance are not subject to
review by the Office of Management and Budget because they do not
constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00374 Filed 1-10-17; 8:45 am]
 BILLING CODE 4164-01-P