[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39598-39600]
[FR Doc No: 2017-17563]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2936]

Content of Risk Information in the Major Statement in
Prescription Drug Direct-to-Consumer Broadcast Advertisements;
Establishment of a Public Docket; Request for Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for
information and comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
establishing a public docket to assist with its development of
recommendations regarding the communication of risk information in
direct-to-consumer (DTC) broadcast advertisements for prescription
drugs and biologics.

DATES: Although you can comment at any time, to ensure that the Agency
considers your comment in our development of recommendations, submit
either electronic or written information and comments by November 20,
2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2936 for ``Content of Risk Information in the Major
Statement in Prescription Drug Direct-to-Consumer Broadcast
Advertisements.'' 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.

FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs:
Julie Chronis, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding human prescription biological products: Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The prescription drug advertising regulations require that
broadcast advertisements containing product claims include information
relating to the advertised drug's major side effects and
contraindications in either the audio or audio and visual parts of the
advertisement (21 CFR 202.1(e)(1)); this is often called the major
statement. The regulations also require that broadcast advertisements
contain a brief summary of all necessary information related to side
effects and contraindications or that ``adequate provision'' be made
for dissemination of the approved package labeling in connection with
the broadcast presentation (21 CFR 202.1(e)(1)). This requirement to
make ``adequate provision'' is generally fulfilled when a firm gives
consumers the option of obtaining the FDA-required labeling or other
information via a toll-free telephone number, through print
advertisements or product brochures, through information disseminated
at health care provider offices or pharmacies, and through the
internet. See the guidance for industry entitled ``Consumer-Directed
Broadcast Advertisements,'' available at http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234622.htm.
    From a public health standpoint, FDA is interested in helping to
ensure that when firms choose to advertise directly to consumers and
patients, such advertisements provide clear and useful information to
that audience. There is concern that the major statement, as currently
implemented in DTC broadcast advertisements for prescription drugs, is
not fulfilling this purpose. Some believe it is often too long, which
may result in reduced consumer comprehension, minimization of important
risk information, and, potentially, therapeutic noncompliance caused by
fear of side effects (Ref. 1). At the same time, there is concern that
DTC broadcast advertisements do not include adequate risk information
or that they leave out important information (Refs. 2 and 3).
    The Office of Prescription Drug Promotion (OPDP) within FDA's
Center for Drug Evaluation and Research (CDER) is investigating through
empirical research the effectiveness of a limited risks plus disclosure
strategy to inform the Agency's decision making in this area. (For more
information about OPDP's proposed study, see 79 FR 9217, February 18,
2014.) Through the research and through this request for information
and comments, OPDP is exploring the usefulness of limiting the risks in
the major statement for most DTC broadcast advertisements for
prescription drugs to those that are severe (life-threatening),
serious, or actionable, coupled with a disclosure to alert consumers
that there are other product risks not included in the advertisement.
(For example, a disclosure could be, ``This is not a full list of risks
and side effects. Talk to your health care provider and read the
patient labeling for more information.'') For the purposes of this
request for information and comments, please consider the following
definitions:
     Severe risk--a serious risk that is life-threatening (see
serious risk).
     Serious risk--the risk of reactions from using the drug
that may result in inpatient hospitalization or prolonged existing
hospitalization, a persistent or significant disability or incapacity,
or a congenital anomaly or birth defect. Reactions that do not require
hospitalization, cause a disability, or cause a birth defect may still
be considered serious risks when, based on appropriate medical
judgment, they may jeopardize the patient and may require medical or
surgical intervention to prevent one of the outcomes previously listed.
     Actionable risk--a risk the patient would know (e.g., pre-
existing condition or allergy) or recognize (e.g., observable physical
or mental symptom) and can act upon to help mitigate the risk (e.g.,
get immediate medical help to prevent a bad outcome); for example,
``Stop using the product and get immediate medical help if you have
swelling of the face, lips, tongue, or throat.''
    However, we note that while some drug products may not have severe,
serious, or actionable risks as described in this document, all DTC
prescription drug broadcast advertisements are required to present a
fair balance of risk information when presenting information relating
to the effectiveness of the drug (21 CFR 202.1(e)(5)). Therefore, to
avoid a misleading presentation regarding a drug's risk-benefit
profile, prescription drug advertisements that provide information
about a drug's effectiveness would be expected to contain some risk
information, even if the risks are not severe, serious, or actionable.

II. Request for Information and Comments

    Interested persons are invited to provide detailed information and
comments on the content of risk information in DTC broadcast
advertisements for prescription drugs. FDA is particularly interested
in responses to the following questions:
    1. What data are available regarding the impact of the current
approaches to communication of risk information in DTC prescription
drug broadcast advertisements on consumer comprehension of the
information in the advertisement, including the impact on comprehension
of product benefits and risk information?
    2. What are the potential effects of only including risks from the
FDA-approved product labeling that are severe, serious, or actionable
(as previously defined) in the major statements of DTC prescription
drug broadcast advertisements? Are there other ways of characterizing
which risks should be included in the major statement? Please explain.
    3. When a DTC prescription drug broadcast advertisement presents
information relating to the effectiveness of a prescription drug that
does not have severe, serious, or actionable risks, what types of risk
could be included in the major statement?
    4. What criteria should be used to distinguish risk information
that is most

material to patient or consumer audiences versus risk information that
is material primarily to the prescriber or other health care providers?
What data are available to answer this question?
    5. What criteria should be used to determine which risk information
that is material to patient or consumer audiences to include in the
major statement for DTC prescription drug broadcast advertisements to
best protect the public health? What data are available to answer this
question?
    6. What is the potential impact of including (or conversely, of not
including), in the major statement for DTC prescription drug broadcast
advertisements, additional language that states that there are other
risks not included in the advertisement while simultaneously
encouraging dialogue between patients and their health care providers?
(For example, additional language could include, ``This is not a full
list of risks and side effects. Talk to your health care provider and
read the patient labeling for more information.'') What data are
available to answer this question?
    7. What data are available on consumers' comprehension of the
difference between levels (i.e., severity) of risk? Would it be in the
interest of public health to include a signal before the risk
information that frames and categorizes the overall level of risk
associated with the product? One approach may be to include an opening
statement tailored to the risk profile of the drug. For example, drugs
could be divided into three defined categories and include the
corresponding opening statements:
    a. For drugs with severe, life-threatening risks: ``[Drug] can
cause severe, life-threatening reactions. These include . . . .''
    b. For drugs with serious but not life-threatening risks: ``[Drug]
can cause serious reactions. These include . . . .''
    c. For drugs with no severe or serious risks: ``[Drug] can cause
reactions. These include . . . .''
    8. Should potential food and drug interactions be disclosed in DTC
prescription drug broadcast advertisements, and if so, what criteria
should be used to identify these interactions?
    FDA will consider all information and comments submitted.

III. References

    The following references are on display in the Dockets Management
Staff office (see ADDRESSES) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.

    1. Delbaere, M. and M.C. Smith, ``Health Care Knowledge and
Consumer Learning: The Case of Direct-to-Consumer Drug
Advertising,'' Health Marketing Quarterly, vol. 23, issue 3, pp. 9-
29, 2006.
    2. Friedman, M. and J. Gould, ``Consumer Attitudes and Behaviors
Associated With Direct-to-Consumer Prescription Drug Marketing,''
Journal of Consumer Marketing, vol. 24, issue 2, pp. 100-109, 2007.
    3. Frosch, D.L., P.M. Krueger, R.C. Hornik, P.F. Cronholm, and
F.K. Barg, ``Creating Demand for Prescription Drugs: A Content
Analysis of Television Direct-to-Consumer Advertising,'' The Annals
of Family Medicine, vol. 5, issue 1, pp. 6-13, 2007.

    Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17563 Filed 8-18-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 198 (Friday, October 12, 2018)]
[Notices]
[Page 51680]
[FR Doc No: 2018-22222]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9041-7]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa/ nepa/.

Weekly receipt of Environmental Impact Statements
Filed 10/01/2018 Through 10/05/2018
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20180233, Final, EPA, AK, ADOPTION--Liberty Development and
Production Plan Beaufort Sea, Alaska Final Environmental Impact
Statement, Contact: Erin Seyfried<PHONE_NUMBER>

    The Environmental Protection Agency (EPA) has adopted the Bureau of
Ocean and Energy Management's Final EIS No. 2018019, filed 08/22/2018
with the EPA. The EPA was a cooperating agency on this project.
Therefore, recirculation of the document is not necessary under Section
1506.3(c) of the CEQ regulations.

EIS No. 20180234, Draft, BLM, NV, Deep South Expansion Project, Comment
Period Ends: 11/26/2018, Contact: Kevin Hurrell<PHONE_NUMBER>
EIS No. 20180235, Draft, USACE, VA, Draft Integrated City of Norfolk
Coastal Storm Risk Management Feasibility Study, Comment Period Ends:
11/26/2018, Contact: Kathy Perdue<PHONE_NUMBER>
EIS No. 20180236, Final, USFS, MN, HiLo Project, Review Period Ends:
11/26/2018, Contact: Linda Merriman<PHONE_NUMBER>
EIS No. 20180237, Final, USACE, AZ, Little Colorado River at Winslow,
Navajo County, Arizona, Flood Risk Management Project, Integrated
Feasibility Report and Environmental Impact Statement, Review Period
Ends: 11/13/2018, Contact: Kirk C. Brus<PHONE_NUMBER>
EIS No. 20180238, Final, FHWA, UT, S.R. 30, S.R. 23 to 1000 West,
Contact: Naomi Kisen<PHONE_NUMBER>

    Pursuant to 23 U.S.C. 139(n)(2), FHWA has issued a single FEIS and
ROD. Therefore, the 30-day wait/review period under NEPA does not apply
to this action.

EIS No. 20180239, Draft, USACE, CA, Corte Madera Creek Flood Risk
Management Project Draft EIS/EIR, Comment Period Ends: 11/27/2018,
Contact: Cynthia Jo Fowler<PHONE_NUMBER>
EIS No. 20180240, Final, NMFS, AK, ADOPTION--Atlantic Fleet Training
and Testing, Contact: Donna S. Wieting<PHONE_NUMBER>

    The National Marine Fisheries Service (NMFS) has adopted the U.S.
Department of Navy's Final EIS No. 20180210, filed 09/07/2018 with the
EPA. NMFS was a cooperating agency on this project. Therefore,
recirculation of the document is not necessary under Section 1506.3(c)
of the CEQ regulations.

EIS No. 20180241, Final, FAA, AK, ADOPTION--Modernization and
Enhancement of Ranges Airspace and Training Areas in the Joint Pacific
Alaska Range Complex in Alaska, Contact: Paula Miller<PHONE_NUMBER>

    The Federal Aviation Administration (FAA) has adopted the U.S. Air
Force's Final EIS No. 20130181, filed 06/20/2013 with the EPA. FAA was
a cooperating agency on this project. Therefore, recirculation of the
document is not necessary under Section 1506.3(c) of the CEQ
regulations.

EIS No. 20180242, Final, FAA, GA, ADOPTION--Proposed Modernization and
Expansion of Townsend Bombing Range, Contact: Paula Miller<PHONE_NUMBER>

    The Federal Aviation Administration (FAA) has adopted the U.S.
Department of Navy's Final EIS No. 20130066 filed 03/14/2013 with the
EPA. FAA was a cooperating agency on this project. Therefore,
recirculation of the document is not necessary under Section 1506.3(c)
of the CEQ regulations.

Amended Notices

EIS No. 20180207, Final, USACE, NE, Missouri River Recovery Management
Plan, Review Period Ends: 11/09/2018, Contact: Tiffany Vanosdall 402-
995-2695

    Revision to FR Notice Published 09/28/2018; Extending the Review
Period from 10/22/2018 to 11/09/2018.

    Dated: October 9, 2018.
Robert Tomiak, Director,
Office of Federal Activities.
[FR Doc. 2018-22222 Filed 10-11-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13193-13198]
[FR Doc No: 2020-04575]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88309; File No. SR-CboeEDGX-2020-010]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing of a Proposed Rule Change To Amend EDGX Rule 11.8(g), Which
Describes the Handling of Midpoint Discretionary Orders Entered on the
Exchange

March 2, 2020.
    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 February 19, 2020, Cboe EDGX Exchange, Inc. (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 Exchange. The Commission is publishing this
notice to solicit

comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe EDGX Exchange, Inc. (``EDGX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend EDGX Rule 11.8(g), which describes the
handling of Midpoint Discretionary Orders entered on the Exchange. The
text of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    A Midpoint Discretionary Order (``MDO'') is a Limit Order that is
executable at the national best bid (``NBB'') for an order to buy or
the national best offer (``NBO'') for an order to sell while resting on
the EDGX Book, with discretion to execute at prices to and including
the midpoint of the national best bid or offer (``NBBO'').\3\ The
purpose of the proposed rule change is to amend EDGX Rule 11.8(g) to
introduce two optional instructions that Users would be able to include
on MDOs entered on the Exchange. First, the Exchange would allow Users
to enter MDOs with an offset to the NBBO, similar to orders entered
with a Primary Peg Instruction today.\4\ Second, the Exchange would
allow Users to enter MDOs that include a Quote Depletion Protection
(``QDP'') instruction that would disable discretion for a limited
period in certain circumstances where the best bid or offer displayed
on the EDGX Book is executed or cancelled below one round lot. The
Exchange believes that both of these features would enhance the
usefulness of MDOs to members and investors, and would allow the
exchange to better compete with other national securities exchanges
that currently offer order types that include similar features.
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    \3\ See EDGX Rule 11.8(g).
    \4\ See EDGX Rule 11.6(j)(2).
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Offset Instruction
    As explained, MDOs are pegged to the same side of the NBBO, with
discretion to execute at prices to and including the midpoint of the
NBBO. An MDO is therefore similar to an order entered with both a
Primary Peg instruction and an instruction to exercise discretion to
the NBBO midpoint. It is also similar to certain order types offered by
other national securities exchanges, including Discretionary Peg Orders
offered by the Investors Exchange LLC (``IEX'').\5\ Today, Users can
include an offset on orders entered on the Exchange that include a
Primary Peg instruction, which allows them to specify that the order be
pegged to a price above or below the NBB or NBO to which the order is
pegged. Specifically, pursuant to Rule 11.6(j)(2), which defines the
Primary Peg instruction, a User may, but is not required to, select an
offset equal to or greater than one Minimum Price Variation (``MPV'')
above or below the applicable NBB or NBO. Although an offset is
generally available to Users that enter an order with the Primary Peg
instruction, it is not available for an MDO that is similarly pegged to
the same side of the NBBO--i.e., pegged to NBB for buy orders, or NBO
for sell orders. The Exchange now proposes to extend the flexibility to
include an offset instruction to MDOs, thus increasing the usefulness
of this order type.
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    \5\ See IEX Rule 11.190(b)(10). Discretionary Peg Orders on IEX
are posted at the less aggressive of one MPV less aggressive than
the primary quote or the order's limit price.
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    As proposed, MDOs entered with an offset would function in the same
manner as currently implemented for Primary Peg orders entered with an
offset pursuant to Rule 11.6(j)(2), thereby ensuring a familiar and
consistent experience for Users. First, a User entering an MDO would be
able to select an offset equal to or greater than one MPV above or
below the NBB or NBO that the order is pegged to (``Offset Amount'').
Second, the Offset Amount for an MDO that is to be displayed on the
EDGX Book would need to result in the price of such order being
inferior to or equal to the inside quote on the same side of the
market.\6\ Although the Exchange expects that some Users may continue
to want MDOs that are ranked at the same side of the NBBO without any
offset, certain other Users may find the offset functionality useful as
it would allow them to specify more or less aggressive pegged prices
for MDOs resting on the EDGX Book. The Exchange is therefore proposing
to introduce the offset functionality as an optional feature that can
be included at the preference of the User entering an MDO for trading
on the Exchange.
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    \6\ An MDO defaults to a Displayed instruction unless the User
includes a Non-Displayed instruction on the order. See EDGX Rule
11.8(g)(4). Similar to the current handling of orders entered with a
Primary Peg instruction, the Exchange is not proposing to accept
displayed MDOs with an aggressive offset at this time. Such orders
would add functionality to the Exchange that would effectively set
the NBBO through a pegged order, and the Exchange believes that this
could potentially add complexity to its System.
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    The proposed changes related to the offset instruction are included
in proposed subparagraph (9) under EDGX Rule 11.8(g). In addition, the
Exchange proposes to make conforming changes to language currently
included in EDGX Rule 11.8(g). First, rather than explaining that an
MDO is ``executable at'' the applicable NBB or NBO, the rule would
instead provide that an MDO is ``pegged to'' the NBB or NBO, ``with or
without an offset.'' Second, language that describes when an MDO is
executable at its limit price would be amended to state that an MDO to
buy (sell) with a limit price that is less (higher) than its pegged
price, including any offset, is posted to the EDGX Book at its limit
price. This change would replace references to circumstances where an
MDO is posted to the EDGX Book at its limit price due to such limit
price being less aggressive than the prevailing NBB or NBO, as the
applicable NBB or NBO is not the relevant pegged price for MDOs entered
with an offset. Third, the Exchange would amend language contained in
EDGX Rule 11.8(g)(6) and (8), which deal with limit up-limit down
(``LULD'') and locked/crossed market handling, respectively, to account
for the fact that an MDO entered with an offset would not be posted at
the NBB or NBO. Specifically, the Exchange would amend EDGA Rule
11.8(g)(6) to reference handling in situations where the applicable
LULD price band is at or through the ``the order's pegged price''
rather than ``an existing Protected Bid'' or ``an existing Protected
Offer.'' With the introduction of an offset, the

Exchange's LULD handling would only apply when the LULD price band is
at or through the pegged price of the MDO, which could be different
from the price of an existing Protected Bid or Offer. Similarly, the
Exchange would amend EDGX Rule 11.8(g)(8) to provide that an MDO's
pegged price would be adjusted to the current NBO (for bids) or NBB
(for offers), when ``an MDO posted on'' the EDGX Book is crossed by
another market. The current version of the rule references the EDGX
Book being crossed by another market since the MDO would be posted at
the best price available on the Exchange (i.e., the applicable NBB or
NBO). With the introduction of an offset, however, an MDO may be more
or less aggressive than the NBB or NBO, and this handling would apply
when the posted MDO is itself crossed by another market. Each of these
changes are meant to reflect the proposed operation of MDOs that are
entered with an offset, as previously described, and would not
otherwise impact the handling of MDOs entered on the Exchange.
Quote Depletion Protection
    The Exchange also proposes to introduce an optional instruction
that Users would be able to include on an MDO to limit the order's
ability to exercise discretion in certain circumstances: ``Quote
Depletion Protection'' or ``QDP.'' \7\ Similar to crumbling quote
features offered for Discretionary Peg Orders entered on IEX, QDP would
restrict the exercise of discretion on MDOs entered with this
instruction in circumstances where applicable market conditions
indicate that it may be less desirable to execute within an order's
discretionary range.\8\ The QDP feature would do this by tracking
significant executions or cancellations of orders that constitute the
best bid or offer on EDGX.\9\ As proposed, a ``QDP Active Period''
would be enabled or refreshed for buy (sell) MDOs if the best bid
(offer) displayed on the EDGX Book is either: (A) Executed below one
round lot; or (B) at the national best bid (offer) and cancelled below
one round lot.\10\ During this QDP Active Period, an MDO entered with a
QDP instruction would not exercise discretion for a limited period of
time. Instead, such an order would be only be executable at its ranked
price.\11\
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    \7\ Proposed changes related to the introduction of the QDP
instruction are reflected in proposed subparagraph (10) under EDGX
Rule 11.8(g).
    \8\ A Discretionary Peg order resting on IEX is only eligible to
trade at its resting price during periods of ``quote instability.''
See IEX Rule 11.190(b)(10). In turn, IEX Rule 11.190(g) describes
IEX's quote instability calculation, which uses a proprietary
mathematical formula ``to assess the probability of an imminent
change to the current Protected NBB to a lower price or Protected
NBO to a higher price.''
    \9\ The Exchange would look to the terms of any replacement
order to determine if an order modified by a cancel/replace message
pursuant to EDGA Rule 11.10(e) qualifies as a cancellation that
would trigger a QDP Active Period. For example, a cancel/replace
message that increases the size of an order would not trigger a QDP
Active Period, notwithstanding that the message cancels the order
before replacing it with greater size.
    \10\ Rule 611 of Regulation NMS generally limits executions to
prices that are at or better than the protected best bid or offer.
However, there are circumstances, such as the use of intermarket
sweep orders, where an order may be executed at an inferior price.
In these circumstances, an execution of the EDGX BBO below one round
lot would trigger a QDP Active Period even though that quotation is
inferior to the NBBO.
    \11\ An MDOs ranked price is the order's displayed or non-
displayed pegged price, which may or may not include an offset, as
proposed, or the order's limit price if that limit price is less
aggressive than the applicable pegged price.
---------------------------------------------------------------------------

    Once activated, the QDP Active Period would remain in place to
prevent the execution of MDOs within their discretionary ranges for a
specified period. Specifically, the Exchange proposes that when a QDP
Active Period is initially enabled, or refreshed by a subsequent
execution or cancellation of the best bid (offer) then displayed on the
EDGX Book, it would remain enabled for a configurable period of up to
five milliseconds. The Exchange would determine the duration of the QDP
Active Period, and would publish this value in a circular distributed
to members. As the Exchange gains experience with the proposed QDP
functionality, it may revise the chosen duration to better reflect the
needs of members and investors using the this instruction. Such changes
would be made with the goal of facilitating the protection provided by
the QDP instruction, while at the same time not unduly limiting the
ability of orders entered with this instruction to exercise discretion
and execute at more aggressive prices within the order's discretionary
range.
    Finally, since the QDP instruction is designed to protect resting
MDOs based on the execution or cancellation of the best bids and offers
displayed on the EDGX Book, the Exchange anticipates that Users may
prefer to utilize the QDP instruction along with an offset instruction
that results in the MDO being posted at a price that is inferior to the
applicable NBB or NBO (with discretion to the midpoint). The Exchange
also believes that given the less aggressive offset, and the fact that
these orders are seeking additional protection, there may be less
incentive for Users to include a Displayed instruction. As a result,
unless the User chooses otherwise, an MDO to buy (sell) entered with a
QDP instruction would default to a Non-Displayed instruction and would
include an Offset Amount equal to one Minimum Price Variation below
(above) the NBB (NBO).\12\ This implementation is similar to the
implementation of Discretionary Peg Orders on IEX but would permit
Users to change these default instructions based on their specific
needs.\13\
---------------------------------------------------------------------------

    \12\ The Exchange also proposes to amend EDGX Rule 11.8(g)(4) to
reflect the fact that MDOs entered with a QDP instruction would
default to Non-Displayed. MDOs that are not entered with the QDP
instruction would continue to default to a Displayed instruction, as
currently provided in EDGX Rule 11.8(g)(4).
    \13\ As previously discussed, Discretionary Peg Orders on IEX
are posted at the less aggressive of one MPV less aggressive than
the primary quote or the order's limit price. See supra note 5. Such
orders are also Non-Displayed. See IEX Rule 11.190(a)(3).
---------------------------------------------------------------------------

    Examples. The examples below illustrate the proposed operation of
the QDP instruction: \14\
---------------------------------------------------------------------------

    \14\ For purposes of these examples, orders are reflected in the
order in which they are received, and only the identified orders are
present on the EDGX Book.
---------------------------------------------------------------------------

    Example 1:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $10.00 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 3: Sell 1 shares @ $10.00 IOC--Time = 12:00:00:000
Order 4: Sell 100 shares @ $10.00 Midpoint Pegged IOC--Time =
12:00:00:001

    Order 2, which is an MDO to buy, is ranked at $9.99 non-displayed
with discretion to the midpoint price of $10.005. When Order 3 is
entered it will trade a single share with Order 1 at $10.00, triggering
a QDP Active Period for Order 2 because of the execution of the EDGX
Best Bid below one round lot. This restricts the ability for Order 2 to
exercise discretion for two milliseconds, and prevents the execution of
Order 4 within Order 2's discretionary range. As a result, the Order 4
would be cancelled without an execution.

    Example 2:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $10.00 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 3: Sell 200 shares @ $9.99 ISO IOC--Time = 12:00:00:000

    This example is the same as Example 1, except that Order 3 is an
ISO IOC for

200 shares that is priced equal to the non-displayed ranked price of
Order 2, and there is no Order 4. Order 3 would trade 100 shares with
Order 1 at $10.00, triggering a QDP Active Period. However, the
triggering of a QDP Active Period would not prevent the execution of an
MDO at its ranked price. As a result, Order 3 would trade its remaining
100 shares with Order 2 at $9.99.

    Example 3:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $10.00 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 3: Sell 100 share @ $10.00 IOC--Time = 12:00:00:000
Order 4: Sell 100 shares @ $10.00 Midpoint Pegged IOC--Time =
12:00:00:003
    This example is the same as Example 1, except that Order 3 is for
100 shares and Order 4 is entered after the QDP Active Period has
concluded. In this example, Order 3 would trade 100 shares with Order 1
at $10.00, triggering a QDP Active Period. The QDP Active Period
triggered by the execution of the EDGX Best Bid below one round lot
would be disabled after two milliseconds, and Order 4 would execute 100
shares against Order 2 at $10.005.

    Example 4:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $10.00 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 3: Sell 200 shares @ $10.00 IOC--Time = 12:00:00:000
    Order 2, which is an MDO to buy, is ranked at $9.99 non-displayed
with discretion to the midpoint price of $10.005. When Order 3 is
entered it would first trade 100 shares with Order 1 at $10.00. A QDP
Active Period is then immediately enabled for Order 2 because of the
execution of the EDGX Best Bid below one round lot. This restricts the
ability for Order 2 to exercise discretion for two milliseconds, and
prevents the execution of the remaining 100 shares of Order 3 within
Order 2's discretionary range. As a result, the remaining quantity of
Order 3 would be cancelled.

    Example 5:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $10.00 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 1: Full Cancel--Time = 12:00:00:000
Order 3: Sell 200 shares @ $10.00 IOC--Time = 12:00:00:001
    This example is the same as Example 4, except that Order 1 is
cancelled one millisecond before the receipt of Order 3. Because Order
1, which establishes the EDGX Best Bid, is priced at the NBB, a QDP
Active period would be immediately enabled following its cancellation.
This restricts the ability for Order 2 to exercise discretion for two
milliseconds, and prevents the execution of Order 3 within Order 2's
discretionary range. As a result, Order 3 would be cancelled without an
execution.

    Example 6:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Sell 100 shares @ $10.01 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset= -$0.01
Order 1: Full Cancel--Time = 12:00:00:000
Order 3: Sell 200 shares @ $10.00 IOC--Time = 12:00:00:001
    This example is the same as Example 5, except that Order 1 is an
offer priced at the NBO rather than a bid at the NBB. A QDP Active
Period for an MDO would only enabled by an execution or cancellation of
an order on the same side of the market. Thus, Order 2, which is an MDO
to buy, would not be impacted by the cancellation of Order 1, which is
an order to sell. As a result, Order 3 would execute 200 shares with
Order 2 at $10.00.
    Example 7:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $9.99 Displayed
Order 2: Buy 200 shares @ $10.01--MDO with QDP, Hidden, Offset = -$0.01
Order 1: Full Cancel--Time = 12:00:00:000
Order 3: Sell 200 shares @ $10.00 IOC--Time = 12:00:00:001

    This example is the same as Example 5, except that Order 1 is
entered at a price that is inferior to the NBB. Because Order 1 is not
at the NBB, its cancellation does not trigger a QDP Active Period. As a
result, Order 3 would trade 200 shares with Order 2 at $10.00.
    Example 8:

QDP Active Period = 2 milliseconds
NBBO: $10.00 x $10.01
Order 1: Buy 100 shares @ $9.99 Displayed
Order 2: Buy 100 shares @ 10.00 Displayed
Order 3: Buy 100 shares @ $10.01--MDO with QDP, Hidden, Offset = -$0.02
Order 4: Sell 100 shares @ $10.00 IOC--Time = 12:00:00:000
Order 5: Sell 100 shares @ $9.99 ISO IOC--Time = 12:00:00:001
Order 6: Sell 100 shares @ $10.00 ISO IOC--Time = 12:00:00:002

    Order 3, which is an MDO to buy, is ranked at $9.98 non-displayed
with discretion to the midpoint price of $10.005. When Order 4 is
entered it would trade 100 shares with Order 2 at $10.00. A QDP Active
Period is then immediately enabled for Order 3 because of the execution
of the EDGX Best Bid below one round lot. This restricts the ability
for Order 3 to exercise discretion for two milliseconds. When Order 5
is entered it would trade 100 shares with Order 1, which is now the
EDGX Best Bid, at $9.99, refreshing the QDP Active Period and extending
it until 12:00:00:003. When Order 6 is entered it would be cancelled
without an execution as Order 3 would still be subject to the extended
QDP Active Period.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\15\ in general, and
Section 6(b)(5) of the Act,\16\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers. The two proposed changes would
increase the usefulness of MDOs offered by the Exchange, and would
allow the Exchange to better compete with order types on other national
securities exchanges that offer similar features to their members.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Offset Instruction for MDOs
    The Exchange believes that it is consistent with the protection of
investors and the public interest to introduce an offset instruction
that Users could choose to include on their MDOs.\17\ With this
proposed change,

MDOs would behave similarly to orders entered with a Primary Peg
instruction today in that such orders could be entered with an offset
that results in the order being pegged to a price that is more or less
aggressive than the applicable NBB or NBO on the same side of the
market (i.e., NBB for buy orders and NBO for sell orders). This change
would make MDOs a more flexible tool for members and investors.
Further, the introduction of the offset instruction on MDOs would be
similar to and competitive with features offered on other national
securities exchanges that offer similar order types. For example,
Discretionary Peg Orders offered on IEX are pegged one MPV less
aggressive than the applicable NBB or NBO when posted to the order
book, with discretion to the midpoint of the NBBO (subject to the
order's limit price). Introducing an offset instruction for MDOs
offered on EDGX would allow members and investors that trade on the
Exchange to utilize similar functionality. Such functionality could be
used for a number of purposes, including to mitigate risk by posting an
order at a price that is lower (higher) than the prevailing NBB (NBO).
At the same time, the offset instruction would be offered on a purely
voluntary basis, and with flexibility for Users to choose the amount of
any offset, thereby maintaining flexibility to continue using the
current offering, which pegs MDOs to the applicable NBB or NBO without
an offset, and to choose different offsets based on a User's specific
needs. As is the case for orders entered with a Primary Peg instruction
and an offset, displayed MDOs would not be accepted with an offset that
results in such orders being posted at a price that is better than the
applicable NBB or NBO. Users that wish to enter an MDO with an
aggressive offset would be required to enter such orders with a non-
displayed instruction, thereby ensuring that such orders would not be
eligible to set a new NBBO, which the Exchange believes may
unnecessarily increase the complexity of its System.\18\
---------------------------------------------------------------------------

    \17\ The Exchange notes that technical changes proposed to EDGX
Rule 11.8(g), including paragraphs (6) and (8) thereunder merely
reflect language changes that are necessary since an MDO would be
allowed with an offset. The Exchange believes that these changes
would promote just and equitable principles of trade as they would
ensure that MDO handling remains transparent with the introduction
of the offset instruction.
    \18\ See supra note 6.
---------------------------------------------------------------------------

Quote Depletion Protection
    The Exchange also believes that it is consistent with the
protection of investors and the public interest to introduce the QDP
instruction to provide additional protection to Users that enter MDOs
with this instruction. Similar to Discretionary Peg Orders offered by
IEX, the QDP instruction would provide Users with protective features
that would limit the order's ability to exercise discretion in certain
circumstances that may be indicative of a quotation that is moving
against the resting MDO--i.e., a buy quotation that is moving to a
lower price for MDOs to buy, or a sell quotation that is moving to a
higher price for MDOs to sell. The specific trigger for enabling a QDP
Active Period, or refreshing a QDP Active Period that has already been
enabled, would be based on the execution or cancellation of the best
bid or offer displayed by the Exchange on the same side of the market.
Any trade that results in such bid or offer being executed below one
round lot would trigger a QDP Active Period. A cancellation of the
Exchange's best bid or offer below one round lot, however, would only
trigger a QDP Active period if such best bid or offer quotation is also
at the NBBO. The Exchange believes that a cancellation of orders
displayed at the Exchange's best bid or offer, but not at the NBBO, may
not be indicative of an quotation that is about to transition to a less
aggressive price, and is therefore proposing to limit the triggering of
a QDP Active Period to instances where that quotation is at the best
price available in the market. When a QDP Active Period is enabled or
refreshed, the MDO would forgo discretion for a limited period but
would remain executable at its displayed or non-displayed ranked price.
Thus, the QDP instruction may provide additional comfort to Users
entering MDOs that would allow them to utilize discretion, and thereby
provide potential price improvement opportunities to incoming orders,
while at the same time limiting the exercise of discretion in
circumstances where an execution within the order's discretionary range
may be undesirable. The Exchange therefore believes that the
introduction of the QDP instruction would remove impediments to and
perfect the mechanism of a free and open market and a national market
system. Further, while the QDP instruction would be available to all
Users, use of this instruction would be voluntary, meaning that Users
could choose to use this instruction, or not, based on their specific
needs.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. To the contrary, the
proposal is a competitive response to similar features available on
other markets, such as IEX, and would therefore facilitate increased
competition between exchange markets. As with other national securities
exchanges, the Exchange must continually assess and improve its
offerings to compete with other exchanges and off-exchange venues. The
proposed rule change is indicative of this competition. Further, the
Exchange does not believe that the proposed rule change would implicate
any competitive concerns with respect to its Users. Both instructions
proposed to be introduced for MDOs with this filing would be available
to all Users on an equal and non-discriminatory basis. Rather than
impede competition, the proposed rule change would provide additional
tools for members and investors to facilitate their trading goals.

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

    No comments were solicited or received on the proposed rule change.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeEDGX-2020-010 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-CboeEDGX-2020-010. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGX-2020-010, and should be
submitted on or before March 27, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-04575 Filed 3-5-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Pages 48612-48614]
[FR Doc No: 2019-19984]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2019-0174; FRL 9999-82-OW]

Draft National Water Reuse Action Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Environmental Protection Agency (EPA) is requesting public
comment on a draft National Water Reuse Action Plan. This draft Action
Plan seeks to foster greater consideration of water reuse across the
water sector, such as agriculture, industry, potable water and more.
Safe and reliable water supplies for human consumption, agriculture,
business, industry, recreation, and healthy ecosystems are critical to
our Nation's communities and economy. The draft Action Plan describes
how agriculture, industry, and communities have demonstrated the value
of reusing water, largely in response to various forms of water crises
such as drought or source water contamination. Water reuse can improve
the security, sustainability, and resilience of our Nation's water
resources, especially when considered at the watershed or basin scale,
through integrated and collaborative water resource planning.
    To accelerate the consideration of water reuse approaches and build
on existing science, research, policy, technology, and both national
and international experiences, the EPA has facilitated development of
this draft National Water Reuse Action Plan across the water sector and
with federal, state, and tribal partners. The draft Action Plan is
intended to seek commitments and drive action across the various
stakeholder groups and the Nation. The plan consists of 46 proposed
actions that support consideration and implementation of water reuse
applications across ten strategic objectives.
    This action is part of a larger effort by the Administration to
better coordinate and focus taxpayer resources on some of

the Nation's most challenging water resource concerns, including
ensuring water availability and mitigating the risks posed by droughts.

DATES: Comments must be received on or before December 16, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
0174 to the Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or withdrawn. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commentingepa-dockets.

FOR FURTHER INFORMATION CONTACT: John Ravenscroft, Office of Science
and Technology, Office of Water (Mail Code 3207A), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
exception occurred on : 2019-19984.htm
exception occurred on : 2019-19984.htm
r[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

How can I get copies of this document and other related information?

    1. Docket. The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-0174. Publicly available docket materials are
available electronically through www.regulations.gov, posted online on
the EPA's water reuse website (www.epa.gov/waterreuse/water-reuse-action-plan) or in hard copy at the Water Docket in the EPA Docket
Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Avenue NW,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Water Docket is (202) 566-
2426.
    2. Electronic Access. You may access this Federal Register document
electronically from the Government Printing Office under the ``Federal
Register'' listings FDsys (http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR).

II. Why develop a water reuse action plan?

    Clean, safe, and reliable water supplies for human consumption,
agriculture, business, recreation, and healthy ecosystems are critical
to our Nation's communities and economy. Due to various pressures, it
is reported that 40 states anticipate some freshwater shortages in the
next decade. Communities, agriculture, and businesses are looking to
diversify their water supply portfolios to meet current and future
needs. Water reuse (also known as recycled or reclaimed water)
represents a major opportunity to supplement existing water supplies
from potential sources for reuse from industrial process water,
agricultural return flows, municipal wastewater, oil and gas produced
water, and stormwater, when these potential sources are appropriately
and effectively treated to meet ``fit for purpose specifications''
including appropriate public health and environmental needs.
    The goal of the draft Action Plan is to better coordinate and focus
taxpayer resources on some of the Nation's most challenging water
resource concerns, including ensuring water availability and mitigating
the risks posed by droughts. The draft Action Plan contains key actions
identified by stakeholders across the water reuse sector that can help
improve water security, sustainability, and resilience.

III. Summary of Water Reuse Action Plan Contents

    The draft National Water Reuse Action Plan is approximately 45
pages in length and is supported by extensive information in nine
Appendices. Section 1 of the draft Action Plan frames the business case
for water reuse including: Key definitions; summary of the key drivers,
opportunities, and challenges for water reuse; the potential sources
and applications for water reuse; and guiding principles and the
methodology for development of the draft Action Plan.
    Section 2 of the draft Action Plan identifies 46 proposed actions
across the following ten strategic objectives:
    1. Enable consideration of water reuse with integrated and
collaborative action at the watershed scale.
    2. Coordinate and integrate federal, state, tribal, and local water
reuse programs and policies.
    3. Compile and refine fit-for-purpose specifications.
    4. Promote technology development, deployment, and validation.
    5. Improve availability of water information.
    6. Facilitate financial support of water reuse.
    7. Integrate and coordinate research on water reuse.
    8. Improve outreach and communication on water reuse.
    9. Support a talented and dynamic workforce.
    10. Develop water reuse metrics that support goals and measure
progress.
    As explained in the methodology, these proposed actions were
identified from the following sources:
    1. Analysis and summary of the water reuse literature (greater than
150 sources).
    2. Outreach and dialogue with an estimated 2,300 participants.
    3. Public input submitted to the first public docket on the plan
(opened from April 18, 2019 until July 1, 2019).
    4. WateReuse Association expert convening report (conducted in
Spring 2019).
    5. Review of international experiences with water reuse.
    6. Review of water reuse case studies from relevant applications
throughout the United States.
    Section 3 of the draft Action Plan describes the process for going
forward to identify the highest priority actions and seeks leaders and
collaborators to describe and commit to specific actions.

IV. Solicitation of Public Comments

    The draft plan and the associated appendices can be found at:
www.epa.gov/waterreuse/water-reuse-action-plan. The EPA is soliciting
public comments to inform revisions to proposed actions, as well as to
identify their implementation steps and milestones and the
collaborators who may carry out those actions. In addition to providing
general input, commenters are encouraged to:
     Identify the most important actions they feel should be
taken in the near term.
     Identify and describe the specific attributes and
characteristics of the actions that will achieve success.
     Identify critical implementation steps and milestones
necessary to successfully implement the proposed actions.

     Commit to lead or collaborate with others on implementing
any of the proposed actions.
     Provide additional information or recommendations to
inform these or other proposed actions.
    The goal is to issue a final Action Plan that includes clear
commitments and milestones for actions that will further water reuse to
help ensure the sustainability, security, and resilience of the
Nation's water resources.

    Dated: September 6, 2019.
David P. Ross,
Assistant Administrator, Office of Water.
[FR Doc. 2019-19984 Filed 9-13-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Page 24554]
[FR Doc No: 2022-08842]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No.15237-000]

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

    On October 13, 2021, PacifiCorp filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of Barn Canyon Pumped Storage
Project to be located about 4 miles North of Helper, Utah. 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 project would consist of the following: (1) A new
upper reservoir with a surface area of 42 acres and a total storage
capacity of 986 acre-feet at a normal maximum operating elevation of
8,355 feet average mean sea level (msl); (2) a new lower reservoir with
a surface area of 28 acres and a total storage capacity of 1,664 acre-
feet at a normal maximum operating elevation of 6,240 feet msl; (3) a
12,672-foot-long penstock, with a hydraulic head of 2,035 feet,
connecting the upper and lower reservoirs to the powerhouse; (4) a new
underground powerhouse that would be sited along the western shore of
the lower reservoir containing three Francis turbine-generator units
with a total rated capacity of 300 megawatts; (5) a new 10.2-mile-long,
345-kilovolt (kV) transmission line connecting the powerhouse to
PacifiCorp's existing Huntington-Spanish Fork substation constructed in
1979 for alternative 1; (6) a new 0.8-mile-long, 138-kV transmission
line to interconnect the powerhouse to PacifiCorp's existing Carbon
substation for alternative 2; and (7) appurtenant facilities. The
estimated annual power generation at the Barn Canyon Pumped Storage
would be 624 gigawatt-hours.
    Applicant Contact: Mr. Tim Hemstreet, Managing Director, Renewable
Energy Development PacifiCorp. 825 NE Multnomah, Suite 1800, Portland,
OR 97232, [email protected].
    FERC Contact: Ousmane Sidibe; Phone:<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.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-15237-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at https://www.ferc.gov/ferc-online/elibrary/overview. Enter the docket number (P-15237) in the docket number field
to access the document. For assistance, contact FERC Online Support.

    Dated: April 20, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-08842 Filed 4-25-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Proposed Rules]
[Pages 75952-75953]
[FR Doc No: 2015-30716]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 234 / Monday, December 7, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4344; Directorate Identifier 2015-NE-32-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
General Electric Company (GE) CF6-80C2 and CF6-80E1 turbofan engines.
This proposed AD was prompted by reports of a burn-through of the
accessory heat shield during an accessory compartment fire leading to
an engine fire. This proposed AD would require replacing the accessory
heat shield assembly. We are proposing this AD to prevent high-
temperature gas ingestion into the accessory compartment, engine fire,
and damage to the airplane.

DATES: We must receive comments on this proposed AD by February 5,
2016.

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
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>You may view this service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. 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-2015-
4344; 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: Herman Mak, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this NPRM. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-4344;
Directorate Identifier 2015-NE-32-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM 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 NPRM.

Discussion

    We received reports of a burn-through of the accessory heat shield
during an engine fire leading to an accessory compartment fire. A fire
burns through the accessory heat shield and ignites the integrated
drive generator (IDG), which supports further combustion. The existing
accessory heat shield assembly leaves a large area above the sensitive
accessories, such as the IDG and the main fuel pump, without adequate
protection. A total of five events have occurred. This condition, if
not corrected, could result in high-temperature gas ingestion into the
accessory compartment, which could lead to engine fire and damage to
the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed GE Service Bulletin (SB) No. CF6-80C2 S/B 72-1520,
dated September 22, 2015 and GE SB No. CF6-80E1 S/B 72-0525, dated
September 22, 2015. These SBs describe the procedures for removing and
replacing the accessory heat shield assembly. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or see ADDRESSES for other
ways to access this service information.

Other Related Service Information

    We reviewed GE SB No. CF6-80C2 S/B 72-1523, dated September 22,
2015. The SB describes procedures for removing and replacing the
accessory heat shield assembly.

FAA's Determination

    We are proposing this NPRM 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 NPRM would require replacing the accessory heat shield
assembly.

Costs of Compliance

    We estimate that this proposed AD affects 935 engines installed on
airplanes of U.S. registry. We also estimate that it would take about 5
hours per engine to comply with this proposed AD. The average labor
rate is $85 per hour. Parts would cost about $1,832 per engine. Based
on these figures, we estimate the total cost of this

proposed AD to U.S. operators to be $2,110,295.

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 to the extent
that it justifies making a regulatory distinction, 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):

General Electric Company: Docket No. FAA-2015-4344; Directorate
Identifier 2015-NE-32-AD.

(a) Comments Due Date

    We must receive comments by February 5, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all General Electric Company (GE) CF6-80C2
and CF6-80E1 turbofan engines.

(d) Unsafe Condition

    This AD was prompted by reports of a burn-through of the
accessory heat shield during an accessory compartment fire leading
to an engine fire. We are issuing this AD to prevent high-
temperature gas ingestion into the accessory compartment, engine
fire, and damage to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For CF6-80C2 engines, at the next engine shop visit after
the effective date of this AD, remove from service the accessory
heat shield assembly. Use Table 1 of GE Service Bulletin (SB) No.
CF6-80C2 S/B 72-1520, dated September 22, 2015 to identify the part
numbers (P/Ns) that require removal from service. Install an
accessory heat shield assembly eligible for installation.
    (2) For CF6-80E1 engines, at the next engine shop visit after
the effective date of this AD, remove from service the accessory
heat shield assembly. Use Table 1 of GE SB No. CF6-80E1 S/B 72-0525,
dated September 22, 2015 to identify the P/Ns that require removal
from service. Install an accessory heat shield assembly eligible for
installation.

(f) Installation Prohibition

    After the effective date of this AD, do not install any
accessory heat shield assembly with a P/N listed in Table 1 of GE SB
No. CF6-80C2 S/B 72-1520, dated September 22, 2015 or Table 1 of GE
SB No. CF6-80E1 S/B 72-0525, dated September 22, 2015, into any
engine.

(g) Definition

    For the purpose of this AD, an engine shop visit is defined as
the induction of an engine into the shop for maintenance involving
the separation of pairs of major mating engine flanges, except that
the separation of engine flanges solely for the purposes of
transportation without subsequent engine maintenance does not
constitute an engine shop visit.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Herman Mak,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) GE SB No. CF6-80C2 S/B 72-1520, dated September 22, 2015; GE
SB No. CF6-80C2 S/B 72-1523, dated September 22, 2015; and GE SB No.
CF6-80E1 S/B 72-0525, dated September 22, 2015 can be obtained from
GE using the contact information in paragraph (i)(3) of this
proposed AD.
    (3) For service information identified in this proposed AD,
contact General Electric Company, GE Aviation, Room 285, 1 Neumann
Way, Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on November 25, 2015.
Colleen M. D'Alessandro,
Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-30716 Filed 12-4-15; 8:45 am]
BILLING CODE 4910-13-P