[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 31012-31014]
[FR Doc No: 2020-10928]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88883; File No. SR-CBOE-2020-045]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule

May 15, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 1, 2020, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its Fees Schedule. 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://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its fees schedule in connection with
the fees related to orders and auction responses executed in S&P 500
Index (``SPX'') and SPX Weekly (``SPXW'') options in the Automated
Improvement Mechanism (``AIM'') Auction.
    AIM includes functionality in which a Trading Permit Holder
(``TPH'') (an ``Initiating TPH'') may electronically submit for
execution an order it represents as agent on behalf of a customer,\3\
broker dealer, or any other

person or entity (``Agency Order'') against any other order it
represents as agent, as well as against principal interest in AIM (an
``Initiating Order''), provided it submits the Agency Order for
electronic execution into an AIM Auction.\4\ The Exchange may designate
any class of options traded on Cboe Options as eligible for AIM. The
Exchange notes that all Users, other than the Initiating TPH, may
submit responses to an Auction (``AIM Responses''). AIM Auctions take
into account AIM Responses to the applicable Auction as well as contra
interest resting on the Cboe Options Book at the conclusion of the
Auction (``unrelated orders''), regardless of whether such unrelated
orders were already present on the Book when the Agency Order was
received by the Exchange or were received after the Exchange commenced
the applicable Auction. If contracts remain from one or more unrelated
orders at the time the Auction ends, they are considered for
participation in the AIM order allocation process.
---------------------------------------------------------------------------

    \3\ The term ``customer'' means a Public Customer or a broker-
dealer. The term ``Public Customer'' means a person that is not a
broker-dealer. See Rule 1.1.
    \4\ See Rule 5.37 (AIM); Rule 5.38 (Complex AIM); and Rule 5.73
(FLEX AIM).
---------------------------------------------------------------------------

    As of March 16, 2020, the Exchange suspended open outcry trading to
help prevent the spread of the novel coronavirus and is currently
operating in an all-electronic configuration. When the Exchange is
operating in a hybrid environment with open outcry and electronic
trading, the Exchange does not activate AIM in SPX and SPXW options.
However, when the Exchange suspended open outcry trading, the Exchange
activated AIM for SPX and SPXW options in an all-electronic environment
to provide TPHs with a mechanism to execute crosses electronically, as
they could no longer represent those crosses for open outcry execution.
Footnote 12 in the Fees Schedule provides specifically that in the
event the Exchange operates in a screen-based only environment, AIM may
be available for SPX and SPXW during Regular Trading Hours. In light of
the extended closure of the trading floor, the Exchange proposes to
adopt new pricing changes and update a previous fee change that the
Exchange believes is appropriate when the trading floor is inoperable
for an extended period of time.
    Specifically, the Exchange proposes to adopt an AIM Contra
Surcharge of $0.10 per contract for AIM Contra orders, and an AIM
Response Surcharge of $0.05 per contract for AIM Response orders,
executed in SPX and SPXW and applicable to all market participants. The
Exchange also proposes to amend footnote 12, which governs pricing
changes in the event the Exchange trading floor becomes inoperable, to
provide clarity in that the AIM Contra Surcharge and AIM Response
Surcharge will apply to all SPX/SPXW AIM Contra and AIM Response/
Priority Response orders, respectively, when the Exchange operates in a
screen-based only environment.
    The Exchange also proposes to amend the AIM Execution Surcharge
Fee,\5\ which also applies when the Exchange operates in a screen-based
only environment to all market participant AIM Agency/Primary orders in
SPX/SPXW,\6\ from $0.05 per contract to $0.10 per contract.
---------------------------------------------------------------------------

    \5\ Currently, this fee is displayed in one line item as ``AIM
and RFC Execution Surcharge''. In light of the proposed change only
to the AIM Execution Surcharge, the proposed fee change updates this
into two separate line items, ``AIM Agency/Primary Surcharge Fee''
and ``RFC Execution Surcharge Fee''. The Exchange also notes that it
adds ``Agency/Primary'' to the title of the AIM Execution Surcharge
Fee to add additional clarity as to which type of AIM orders the
surcharge applies (as currently noted in footnote 12 of the Fees
Schedule).
    \6\ See Cboe Options Fees Schedule, footnote 12.
---------------------------------------------------------------------------

    As stated, since the trading floor has become inoperable, the only
execution opportunities currently available for SPX and SPXW are
electronic executions. The Exchange still wishes to encourage floor
brokers to continue to conduct business on the Exchange, and, in order
to approximate the trading floor environment electronically, the
Exchange has activated AIM for SPX/SPXW, which historically have not
been designated as eligible for AIM Auctions while the trading floor is
operable. As such, the Exchange does not wish to discourage floor
brokers from executing SPX and SPXW volume via AIM when the trading
floor is inoperable, yet it also wishes to continue to assess fees for
volume usually applicable to open-outcry trading, which volume has
recently been moved to electronic channels. Due to the increased number
of orders executed via AIM as a result of the transition of SPX and
SPXW to an all-electronic trading environment, the proposed fees are
designed to allow the Exchange to recoup the costs associated with
implementing and maintaining AIM for SPX/SPXW while the trading floor
remains inoperable.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\7\ in general, and furthers the requirements
of Section 6(b)(4),\8\ in particular, as it is designed to provide for
the equitable allocation of reasonable dues, fees and other charges
among its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that its proposed adoption of a surcharge for
AIM Response and AIM Contra orders in SPX and SPXW, as well as amending
the surcharge for AIM Agency/Primary executions is consistent with
Section 6(b)(4) of the Act in that the proposal is reasonable,
equitable and not unfairly discriminatory. The Exchange believes that
it is reasonable to assess a surcharge of $0.05 for all AIM Responses,
$0.10 for all AIM Contra orders, and $0.10 for all AIM Agency/Primary
orders in SPX/SPXW while AIM is activated for SPX/SPXW in the current
screen-based only environment because it is intended to recoup the
costs associated with implementing and maintaining AIM for orders in
SPX/SPXW. Indeed, the Exchange has experienced a significant increase
in SPX/SPXW AIM orders since the activation of AIM in such classes, as
the closure of the Exchange's trading floor essentially eliminated the
sole mechanism by which TPHs could cross orders in SPX/SPXW.
    The Exchange also believes that the proposed fees in connection
with AIM Responses and AIM Contra, and AIM Agency/Primary orders are
reasonable and equitable because they do not represent a significant
departure from, or are less than, other surcharge fees provided by the
Fees Schedule for executions in SPX and other index classes. For
example, the current Fees Schedule provides for a surcharge of $0.25
exotic surcharge applicable to all Customer orders, as well as a $0.20
surcharge for Customer Maker, non-turner orders executed in VIX.\9\
Additionally, the Exchange notes that, while the trading floor remains
inoperable, it continues to assess an execution surcharge of $0.21 per
contract for non-AIM, non-Market-Maker orders executed in SPX and an
execution surcharge of $0.13 per contract for non-AIM, non-Market-Maker
orders executed in SPXW.\10\
---------------------------------------------------------------------------

    \9\ Applies to all such Customer orders in VIX with a premium of
$1.00 or greater.
    \10\ See Cboe Options Fees Schedule, footnote 12.
---------------------------------------------------------------------------

    Finally, the Exchange believes that the proposed fees are equitable
and not unfairly discriminatory because the proposed fees for AIM
Responses and AIM Contra, as well as AIM Agency/Primary orders will
apply equally to all market participants, i.e., all TPHs will be
assessed the same amount per qualifying order. In addition to this, the
Exchange believes that adopting a lesser

surcharge for AIM Responses in SPX/SPXW is equitable and not unfairly
discriminatory as it is designed to encourage more Responses in AIM
while it is activated in SPX thereby increasing the opportunities for
price improvement for all orders executed during the AIM Auction. The
Exchange believes that increased opportunities for price improvement
through the AIM Auctions would, in turn, facilitate a potential
increase in SPX liquidity through the AIM Auctions, which would benefit
all participants in the market, particularly while the trading floor
remains inoperable.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on intramarket or intermarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act. The
Exchange notes the proposed changes are not intended to address any
competitive issue, but rather to address fee changes it believes are
reasonable now that the trading floor is currently inoperable, thereby
only permitting electronic participation on the Exchange. The Exchange
does not believe that the proposed rule change will impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the proposed changes
apply equally in the same manner to all market participants submitting
qualifying orders (i.e., AIM Responses and AIM Contra, as well as AIM
Agency/Primary orders) in SPX/SPXW. In addition to this, and as stated
above, the Exchange does not believe the proposed rule change to adopt
a lesser fee for AIM Responses in SPX/SPXW will impose any burden on
intramarket competition because it is designed to encourage AIM
Responses in SPX/SPXW. A high level of AIM Responses would increase the
opportunities for price improvement during the AIM Auctions, in turn,
potentially attracting further liquidity to the AIM Auctions in SPX/
SPXW to the benefit of all market participants. The Exchange does not
believe that the proposed rule change will impose any burden on
intermarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because SPX and SPXW options are
proprietary products that are only traded on Cboe Options and, in
addition to this, the proposed changes only affect trading on the
Exchange in limited circumstances.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-CBOE-2020-045 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-CBOE-2020-045. 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-CBOE-2020-045 and should be submitted on
or before June 11, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-10928 Filed 5-20-20; 8:45 am]
BILLING CODE 8011-01-P


Summary of EPA Meeting with the Synthetic Organic Chemical Manufacturers
Association (SOCMA)

March 3, 2008

On Monday, March 3, 2008, staff from the Office of Solid Waste (OSW) met
with representatives of SOCMA to discuss the draft regulatory revisions
to the definition of solid waste.  Marilyn Goode provided an update of
the rule schedule and said that EPA still expects to finalize the rule
this summer.  She also said that OSW would be unable to answer any
questions about the substantive content of the draft rule at this time.
SOCMA representatives then elaborated on their previous written comments
submitted to the docket about the types of materials that could be sent
to a tolling manufacturer under a tolling contract.  Marilyn and Tracy
said that all comments submitted during the comment period would be
given careful consideration.

Attendees were:

OSW:  Marilyn Goode, Tracy Atagi.

SOCMA:  Jeff  Gunnulfsen, Daniel Moss

Conrad Law and Policy Counsel:  James W. Conrad, Jr.


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Page 51975]
[FR Doc No: 2018-22303]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4394-DR; Docket ID FEMA-2018-0001]

South Carolina; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of South Carolina (FEMA-4394-DR), dated September 16,
2018, and related determinations.

DATES: This amendment was issued September 26, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of South Carolina is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of September 16, 2018.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-22303 Filed 10-12-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49852-49854]
[FR Doc No: 2012-20169]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In July 2012,
there were eight applications approved. Additionally, 16 approved
amendments to previously approved applications are listed.

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

SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    Public Agency: San Diego County Regional Airport Authority, San
Diego, California.
    Application Number: 12-10-C-00-SAN.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $31,299,883.
    Earliest Charge Effective Date: October 1, 2036.
    Estimated Charge Expiration Date: November 1, 2037.
    Class of Air Carriers Not Required to Collect PFC'S: Nonscheduled/
on demand air carriers filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at San Diego International Airport.
    Brief Description of Projects Approved for Collection and Use at a
$4.50 PFC Level:

Rehabilitate taxiway C.
Quieter home program--phase IV.

    Brief Description of Project Approved for Collection and Use at a
$3.00 PFC Level:

Airport master plan update.
    Brief Description of Project Approved for Collection at a $4.50 PFC
Level:

Relocate runway 09 displaced threshold.
    Decision Date: July 3, 2012.

FOR FURTHER INFORMATION CONTACT: Darlene Williams, Los Angeles Airports
District Office,<PHONE_NUMBER>.
    Public Agency: County of Gregg, Longview, Texas.
    Application Number: 12-03-C-00-GGG.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $1,178,540.
    Earliest Charge Effective Date: February 1, 2013.
    Estimated Charge Expiration Date: September 1, 2023.
    Class of Air Carriers Not Required to Collect PFC's: None.
    Brief Description of Projects Approved for Collection and Use:

Security fencing.
Planning studies.
Aircraft rescue and firefighting truck.
Acquire equipment.
Rehabilitate taxiways (taxiways B, C, D, G, L, and M).
Rehabilitate runway 18/36.
Rehabilitate runway 13/31.
Runway 13/31 safety area improvements.
Acquire snow removal equipment.
PFC application and administration fees.
    Decision Date: July 10, 2012.

FOR FURTHER INFORMATION CONTACT: Guillermo Villalobos, Texas Airports
Development Office,<PHONE_NUMBER>.
    Public Agency: City of Dayton, Ohio.
    Application Number: 12-07-C-00-DAY.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $7,439,375.
    Earliest Charge Effective Date: November 1, 2017.
    Estimated Charge Expiration Date: April 1, 2019.
    Class of Air Carriers Not Required to Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Dayton International Airport.
    Brief Description of Project Approved for Collection and Use at a
$4.50 PFC Level:

Airport terminal renovations.
    Brief Description of Project Approved for Collection and Use at a
$3.00 PFC Level:

Terminal planning study.
    Decision Date: July 11, 2012.

FOR FURTHER INFORMATION CONTACT: Mary Jagiello, Detroit Airports
District Office,<PHONE_NUMBER>.
    Public Agency: City of Modesto, California.
    Application Number: 12-09-C-00-MOD.
    Application Type: Impose and use a PFC.
    PEG Level: $4.50.
    Total PEG Revenue Approved in This Decision: $273,845.
    Earliest Charge Effective Date: December 1, 2012.
    Estimated Charge Expiration Date: December 1, 2015.
    Class of Air Carriers Not Required to Collect PFC'S: None.
    Brief Description of Projects Approved for Collection and Use:

Apron rehabilitation--general aviation.
Enhance runway 10R/28L safety area.

    Decision Date: July 12, 2012.

FOR FURTHER INFORMATION CONTACT: Neil Kumar, San Francisco Airports
District Office,<PHONE_NUMBER>.
    Public Agency: Bert Mooney Airport Authority, Butte, Montana.
    Application Number: 12-10-C-00-BTM.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $397,526.
    Earliest Charge Effective Date: February 1, 2013.
    Estimated Charge Expiration Date: March 1, 2017.
    Class of Air Carriers not Required to Collect PEG'S:
    Air taxi/commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Bert Mooney Airport.
    Brief Description of Projects Approved for Collection and Use:

Runway 11/29 pavement rehabilitation.
Taxiway B pavement rehabilitation.
Runway 15/33 pavement rehabilitation.
Aircraft rescue and firefighting equipment acquisition.
Security enhancements.
Rehabilitate concrete commercial apron.
General aviation apron pavement rehabilitation.
    Decision Date: July 12, 2012.

FOR FURTHER INFORMATION CONTACT: Jason Garwood, Helena Airports
District Office,<PHONE_NUMBER>.
    Public Agency: City of Waco, Texas.
    Application Number: 12-05-C-00-ACT.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $788,280.
    Earliest Charge Effective Date: December 1, 2012.
    Estimated Charge Expiration Date: January 1, 2016.
    Class of Air Carriers not Required to Collect PFC'S: Air taxi/
commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Waco Regional Airport.
    Brief Description of Project Approved for Collection and Use:

Passenger loading bridges.
Taxiway rehabilitation, phase 1.
Apron rehabilitation, phase 1.
PFC preparation.
Taxiway rehabilitation, phase 2.
Apron rehabilitation, phase 2.
    Decision Date: July 12, 2012.

FOR FURTHER INFORMATION CONTACT: Guillermo Villalobos, Texas Airports
Development Office,<PHONE_NUMBER>.
    Public Agency: City of Roswell, New Mexico.
    Application Number: 12-05-C-00-ROW.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $486,683.
    Earliest Charge Effective Date: February 1, 2019.
    Estimated Charge Expiration Date: April 1, 2022.
    Class of Air Carriers not Required to Collect PFC'S: None.
    Brief Description of Projects Approved for Collection and Use:

Terminal renovation.
Acquisition snow removal equipment--front end loader.
Wildlife hazard assessment.
Rehabilitate taxiway G, design and construction.
Rehabilitate taxiway C, design and construction.
Acquire aircraft rescue and firefighting truck.
Design and construct runway 17/35 rehabilitation.
PFC administration costs.
    Decision Date: July 13, 2012.

FOR FURTHER INFORMATION CONTACT: Mike Saupp, Louisiana/New Mexico
Airports Development Office,<PHONE_NUMBER>.
    Public Agency: City of Greenville, Mississippi.
    Application Number: 12-06-C-00-GLH.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $114,263.
    Earliest Charge Effective Date: September 1, 2012.
    Estimated Charge Expiration Date: October 1, 2015.
    Class of Air Carriers not Required to Collect PFC'S: Air taxi/
commercial operators.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Mid-Delta Regional Airport.
    Brief Description of Projects Approved for Collection and Use:

PFC update.
Airfield ramp repair.
Master plan update.
Road relocation and fencing, apron slab replacement.
Wildlife hazard assessment.
    Brief Description of Projects Approved for Collection:

Terminal security lighting.
Airport drainage improvements.
Runway 18L approach lighting.
Runway 18L136R drainage improvements, phase 1.
    Brief Description of Disapproved Project: Fire suppression system
renovation.
    Determination: Disapproved. The project does not meet the
requirements of Sec.  158.15(b).
    Decision Date: July 23, 2012.

FOR FURTHER INFORMATION CONTACT: Jonathan Linguist, Jackson Airports
District Office,<PHONE_NUMBER>.

                                           Amendments to PFC Approvals
----------------------------------------------------------------------------------------------------------------
                                                                                Original     Amended
                                            Amendment      Original         Amended      estimated    estimated
        Amendment No., City, State           approved    approved net    approved net      charge       charge
                                               date       PFC revenue     PFC revenue    exp. date    exp. date
----------------------------------------------------------------------------------------------------------------
10-08-C-01-SAV, Savannah, GA.............     05/03/12      $4,066,265      $6,669,248     04/01/16     12/01/16
*02-02-C-01-GGG, Longview, TX............     07/10/12         699,232         699,232     12/01/12     01/01/13
08-04-C-01-CHA, Chattanooga, TN..........     07/11/12       2,413,001       2,520,376     10/01/12     10/01/12
12-04-C-01-SBY, Salisbury, MD............     07/12/12         937,983         937,983     02/01/17     02/01/17
09-04-C-01-ACT, Waco, TX.................     07/12/12         790,163         754,153     09/01/12     12/01/12
11-09-C-01-GEG, Spokane, WA..............     07/13/12      10,215,000      16,365,000     09/01/14     11/01/15
09-09-C-01-EAT, Wenatchee, WA............     07/13/12         105,268         104,916     04/01/10     04/01/10
95-02-C-08-STL, Saint Louis, MO..........     07/16/12      67,032,109      73,311,090     07/01/97     07/01/97
97-03-U-05-STL, Saint Louis, MO..........     07/16/12              NA              NA     07/01/97     07/01/97
08-09-C-01-STL, Saint Louis, MO..........     07/16/12     783,625,492     755,733,688     02/01/22     02/01/22
*09-02-C-01-FLG, Flagstaff, AZ...........     07/17/12       1,157,023       1,208,991     02/01/15     04/01/15
92-01-C-02-SMF, Sacramento, CA...........     07/19/12      27,651,750      20,010,436     01/01/96     01/01/96
95-02-C-02-SMF, Sacramento, CA...........     07/19/12       2,677,360       1,390,230     03/01/97     03/01/97
02-07-C-01-SMF, Sacramento, CA...........     07/19/12       4,208,200       2,041,219     07/01/11     07/01/11
02-05-C-01-RNO, Reno, NV.................     07/19/12       6,734,192       6,940,843     02/01/03     02/01/03
08-02-C-03-PIE, Clearwater, FL...........     07/23/12       6,628,510      10,528,075     11/01/12     08/01/14
----------------------------------------------------------------------------------------------------------------
Notes: The amendments denoted by an asterisk (*) include a change to the PFC level charged from $3.00 per
  enplaned passenger to $4.50 per enplaned passenger. For Longview, TX and Flagstaff, AZ, this change is
  effective on September 1, 2012.

    Issued in Washington, DC, on August 13, 2012.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2012-20169 Filed 8-16-12; 8:45 am]
BILLING CODE 4910-13-M


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Rules and Regulations]
[Pages 49501-49504]
[FR Doc No: 2017-23286]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Parts 4, 5, and 16

[Docket No. PL17-3-000]

Policy Statement on Establishing License Terms for Hydroelectric
Projects

AGENCY:  Federal Energy Regulatory Commission, Department of Energy.

ACTION:  Policy statement.

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

SUMMARY:  The Federal Energy Regulatory Commission (Commission) is
giving notice of a new policy on establishing license terms for
hydroelectric projects. In this Policy Statement, the Commission adopts
a 40-year default license term for original and new licenses for
hydropower projects located at non-federal dams. The Policy Statement
also sets forth when the Commission will consider issuing those
projects a license with a term for less or more than 40 years.

DATES:  This policy statement will be applicable as of October 26,
2017.

FOR FURTHER INFORMATION CONTACT:
Nicholas Jayjack, (Technical Information), Office of Energy Projects,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER>.
Carolyn Clarkin, (Legal Information), Office of the General Counsel--
Energy Projects, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    1. In this Policy Statement, the Commission sets forth a new policy
on establishing license terms for original and new licenses for
hydropower projects located at non-federal dams. The goal of this
action is to provide more certainty for stakeholders regarding the
Commission's regulatory process, reduce regulatory burden, increase
administrative efficiency for all stakeholders, and further encourage
licensees to negotiate settlement agreements and promptly seek
authorization to implement voluntary environmental, recreational, and
developmental enhancements.

I. Background

A. Current License Term Policy

    2. Section 6 of the Federal Power Act (FPA) \1\ provides that
hydropower licenses shall be issued for a term not to exceed 50 years.
There is no minimum license term for original licenses. FPA section
15(e) \2\ provides that any ``new license'' \3\ shall be for a term
that the Commission determines to be in the public interest, but not
less than 30 years or more than 50 years.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 799 (2012).
    \2\ 16 U.S.C. 808(e) (2012).
    \3\ ``New license'' is the term used in the FPA to refer to a
license issued to replace a project's expiring license.
---------------------------------------------------------------------------

    3. It is current Commission policy to set a 50-year term for
licenses issued for projects located at federal dams.\4\ For projects
located at non-federal dams, the Commission sets a 30-year term where
there is little or no authorized redevelopment, new construction, or
environmental mitigation and enhancement; a 40-year term for a license
involving a moderate amount of these activities; and a 50-year term
where there is an extensive amount of such activity.\5\ The Commission
previously established this policy to ease the economic impact of new
costs, promote balanced and comprehensive development of renewable
power generating resources, and encourage licensees to be good
environmental stewards.\6\
---------------------------------------------------------------------------

    \4\ City of Danville, Virginia, 58 FERC ] 61,318, at 62,020
(1992) (citing Little Falls Hydroelectric Associates, 27 FERC ]
61,376 (1984)).
    \5\ Id. (addressing original licenses); Consumers Power Co., 68
FERC ] 61,077, at 61,384 (1994) (addressing new licenses). Projects
that entail construction of a new dam have generally received 50-
year licenses. City of Danville, Virginia, 58 FERC ] 61,318 at
62,020 (citing Little Falls Hydroelectric Associates, 27 FERC ]
61,376).
    \6\ Consumers Power Co., 68 FERC ] 61,077 at 61,384.
---------------------------------------------------------------------------

    4. Determining whether the measures required under a license are
minimal, moderate, or extensive is highly case-

specific and largely based on a qualitative analysis of the record
before the Commission. In establishing the appropriate license term,
staff initially examines the nature and extent of the required measures
in the context of the project at issue,\7\ and then uses the cost of
measures as a check on a qualitative conclusion that the measures
required under the license are minimal, moderate, or extensive. The
Commission's current policy takes a forward-looking approach, such that
any measures adopted under a prior license term are not considered.\8\
It has also been the Commission's policy to coordinate, to the extent
feasible, license terms for projects in the same river basin to
maximize consideration of cumulative impacts when the projects are due
to be relicensed.\9\
---------------------------------------------------------------------------

    \7\ For example, one type of fishway may be more expensive than
another, and a fishway type that might be considered extensive for a
small project could be seen as minimal for a larger one.
    \8\ See, e.g., Duke Energy Carolinas, LLC, 156 FERC ] 61,010, at
P 19 (2016) (Duke Energy) (stating Commission's long-standing policy
is to only consider measures required in the new license) (citing
Alabama Power Co., 155 FERC ] 61,080, at P 72 (2016); Georgia Power
Co., 111 FERC ] 61,183, at P 12 (2005); Ford Motor Co., 110 FERC ]
61,236, at PP 6-8 (2005)).
    \9\ 18 CFR 2.23 (2017); see also Public Utility of District No.
1 of Chelan County, Washington, 127 FERC ] 61,152, at P 18 (2009)
(Chelan PUD).
---------------------------------------------------------------------------

    5. The length of an original license has not been contested on
rehearing for some time; however, licensees and other parties have
recently contested the length of a new license in several relicensing
proceedings. The arguments raised in these cases include that the
Commission, when establishing the license term, should have considered,
or given more weight to: Previously-authorized capacity-related
investments or environmental enhancements made by the licensee before
issuance of the new license; \10\ total cost of the relicensing
process; \11\ losses in generation value related to environmental
measures; \12\ the license terms of projects that the license applicant
states are similarly situated to its project; \13\ and the license term
provided for in settlement agreements.\14\ In each circumstance, the
Commission declined to extend the length of the license.
---------------------------------------------------------------------------

    \10\ See, e.g., Duke Energy, 156 FERC ] 61,010 at P 12; Alabama
Power Co., 155 FERC ] 61,080 at P 71; Public Utility District No. 1
of Douglas County, Washington, 143 FERC ] 61,130, at PP 12-13 (2013)
(Douglas PUD); Chelan PUD, 127 FERC ] 61,152 at PP 12-13; Georgia
Power Co., 111 FERC ] 61,183 at P 10; Ford Motor Co., 110 FERC ]
61,236 at P 6.
    \11\ See, e.g., Duke Energy, 156 FERC ] 61,010 at P 12.
    \12\ See, e.g., id.
    \13\ See, e.g., id. P 20; Alabama Power Co., 155 FERC ] 61,080
at P 71; Duke Energy Progress, Inc., 153 FERC ] 61,056, at P 39
(2015); Douglas PUD, 143 FERC ] 61,130 at P 15.
    \14\ See, e.g., Duke Energy Progress, Inc., 153 FERC ] 61,056 at
P 40; Douglas PUD, 143 FERC ] 61,130 at P 18; Chelan PUD, 127 FERC ]
61,152 at P 16.
---------------------------------------------------------------------------

B. Notice of Inquiry on Establishing License Terms for Hydroelectric
Projects

    6. On November 17, 2016, the Commission issued a notice of inquiry
(NOI) to seek comments on whether, and if so how, the Commission should
revise its current license term policy. The NOI invited comments on
five potential license term policy options: (1) Retain the current
policy; (2) modify the current policy to consider voluntary authorized
actions implemented under the prior license (``previously-authorized
voluntary actions''); (3) replace the current license term policy with
a policy for a 50-year default license term unless a lesser license
term would be in the public interest (for example, to better coordinate
the license terms of projects in the same river basin); (4) add a more
quantitative cost-based analysis to the current policy; and (5) alter
the current policy to accept license terms agreed upon in settlement
agreements, when appropriate. Comments on alternative policy options
were also encouraged. The NOI established January 24, 2017, as the
deadline for comments, which staff extended to March 24, 2017.
    7. Industry members, federal and state resource agencies,
environmental and recreation groups, and individuals filed comments.
Most commenters support revising the current policy. Several commenters
state that under the current policy stakeholders lack certainty, and,
consequently, license applicants lack guidance on what measures will
yield longer license terms and are deterred from proposing additional
protection, mitigation, and enhancement measures. Further, many
commenters state that because the policy is forward-looking, licensees
delay seeking authorizations for capacity upgrades and environmental
and recreational enhancements until they apply for a new license. Some
industry commenters state that under the current policy, license
applicants and settlement parties cannot use the license term as a
bargaining chip because the Commission might reject that term in the
license order. To address these concerns, many commenters recommend
that the Commission consider previously-authorized voluntary actions
and defer to the license term that was negotiated as part of a
settlement agreement.
    8. Commenters disagree on the 50-year default license term policy
option. Industry commenters generally support the 50-year default
license term because they state it would provide a clear, predictable
standard. Industry commenters add that such policy would eliminate the
current ``penalty'' for efficient, well-maintained, and relatively low-
impact projects that do not require substantial environmental or
developmental measures and therefore only receive a 30-year license.
    9. In contrast, environmental groups, individuals, and most
resource agencies oppose the 50-year default license term option.
Several resource agencies argue that this option would provide little
incentive for a license applicant to voluntarily propose or agree to
mitigation measures because such measures would no longer factor into
the Commission's license term decision. The resource agencies also
contend that such policy would result in applicants focusing their
license application study efforts on disproving project effects rather
than on identifying potential mitigation measures.
    10. Most commenters recommend against the policy option to adopt a
more quantitative cost-based analysis. Many commenters state that it
would be difficult to develop a quantitative cost-based analysis that
takes into account the diverse hydropower fleet and environmental and
recreational values.
    11. As an alternative to the five policy options, several industry
commenters recommend that the Commission adopt a 40-year default
license term with credit (up to an additional 10 years) for previously-
authorized actions and deference to settlement agreements. They state
that under this alternative, licenses should be issued for less than 40
years only when a license applicant has agreed to a settlement
agreement with a negotiated license term of less than 40 years, or
voluntarily coordinates its license term with other projects in a river
basin.

II. Discussion

    12. The extensive comments received have given the Commission a
deeper understanding of the effects that the current license term
policy has on stakeholders in hydropower licensing proceedings. The
Commission recognizes the importance of providing license applicants
and other stakeholders as much certainty as possible. License
applicants expend significant financial resources on preparing their
license applications and complying with their licenses thereafter.

Further, stakeholders need certainty to determine the protection,
mitigation, and enhancement measures that they will negotiate and
license applicants will propose.
    13. The current policy also affects the Commission's staff and
resources needed to review and process license applications. Staff
anticipate that over 300 projects will enter the relicensing process
through 2025. Under the current policy, staff would establish the
license term for each of those projects case by case.
    14. After considering this matter and the comments on the NOI, the
Commission has decided it is in the public interest to change its
license term policy. With this Policy Statement, the Commission
establishes a 40-year default license term policy for original and new
licenses for hydropower projects located at non-federal dams.\15\
---------------------------------------------------------------------------

    \15\ This policy does not apply to pilot hydrokinetic projects,
which have terms of up to five years. See FERC, Licensing
Hydrokinetic Pilot Projects, www.ferc.gov/industries/hydropower/gen-info/licensing/hydrokinetics/pdf/white_paper.pdf.
---------------------------------------------------------------------------

    15. There are three circumstances where the Commission will
consider issuing a license for less or more than 40 years. First, the
Commission will establish a shorter or longer term if necessary to
coordinate license terms for projects located in the same river basin.
Second, the Commission will defer to a shorter or longer term
explicitly agreed upon in a generally-supported comprehensive
settlement agreement, provided that such term does not conflict with
coordination. Settlement agreements that state the settlement
signatories would not oppose a certain term or would support a term
within a range of years will not be considered to include an explicitly
agreed upon license term.\16\
---------------------------------------------------------------------------

    \16\ See, e.g., Chelan PUD, 127 FERC ] 61,152 at n.27
(settlement states that the signatories do not oppose the licensee's
efforts to seek a 50-year term); Duke Energy, 156 FERC ] 61,010 at P
24 (settlement states the signatories agree to support a license
term that is not less than 40 years nor more than 50 years).
---------------------------------------------------------------------------

    16. Third, the Commission will consider a longer license term--
provided that doing so is consistent with coordinating license terms
within a basin--when a license applicant specifically requests a longer
license term based on significant measures expected to be required
under the new license or significant measures implemented during the
prior license term that were not required by that license or other
legal authority \17\ and for which the Commission has not already given
credit through an extension of the prior license term. The Commission
will consider, on a case-by-case basis, measures and actions that
enhance non-developmental project purposes (i.e., environmental,
project recreation, water supply), and those that enhance power and
developmental purposes, together with the cost of those measures and
actions to determine whether they are significant and warrant the
granting of a longer license term. Maintenance measures and measures
taken to support the licensing process will not be considered. As
guidance, we note that the Commission has found that measures including
the construction of pumped storage facilities, fish passage facilities,
fish hatcheries, substantial recreation facilities, dams, and
powerhouses warranted longer license terms.
---------------------------------------------------------------------------

    \17\ See, e.g., Chelan PUD, 127 FERC ] 61,152, at P 14 (stating
that the licensee acted in order to comply with the Endangered
Species Act, not to simply voluntarily resolve relicensing issues
early).
---------------------------------------------------------------------------

    17. There are a number of reasons for establishing a 40-year
default license term with exceptions for coordination, deference to
generally-supported comprehensive settlement agreements, and
consideration of previously-authorized voluntary actions. This policy
will provide significant certainty to licensees, resource agencies, and
other stakeholders. A 40-year default license term will provide a
simpler method for Commission staff to establish license terms, and,
thus, increase administrative efficiencies. A case-specific assessment
will only be required for those license applications that request a
longer license term, and are not explicitly supported by a generally-
supported comprehensive settlement agreement. Because many projects
would be relicensed less frequently, the policy would also lower
administrative costs for all stakeholders, provide licensees longer
license terms to recoup costs, and reduce regulatory burden. Further,
the policy will place efficient, low-impact projects that require
minimal measures--and thus, would receive a 30-year term under the
current policy--on more equal footing with projects that require more
measures.
    18. The policy may also encourage licensees to voluntarily make
capacity upgrades and enhance recreational and environmental resources
during the prior license term. Affected resources will benefit from
licensees undertaking preventative or remedial measures sooner rather
than later. In addition, the policy may further encourage license
applicants to engage with stakeholders to negotiate a license
settlement agreement. Because a generally-supported comprehensive
settlement agreements represent stakeholder values, terms negotiated as
part of those agreements are in the public interest, provided they do
not conflict with coordination.
    19. A 40-year default license term will not adversely affect
environmental and recreation resources. All of our licenses contain
extensive environmental and recreation measures. While under our new
policy some projects may be relicensed less frequently and
unanticipated project effects on environmental resources may go
unmitigated for longer durations of time than before, there are many
tools available to address these unanticipated effects in a timely
manner. The Commission may address serious, unanticipated environmental
effects using its standard reopener article,\18\ and licensees often
file applications for license amendments to address significant,
unanticipated environmental issues. Further, resource agencies
frequently reserve authority to address those effects under FPA section
4(e) (federal reservation) \19\ and section 18 (fishway
prescription),\20\ and in water quality certifications issued under
section 401 of the Clean Water Act. Stakeholders have also negotiated
with or encouraged licensees to propose measures that include adaptive
management approaches to allow for appropriate modifications as
additional information is gathered, new technologies develop, and
societal and environmental needs change.
---------------------------------------------------------------------------

    \18\ Each license incorporates a Commission L-Form that includes
standard reopener clauses to enhance fish and wildlife resources.
See Standardized Conditions for Inclusion in Preliminary Permits and
Licenses Issued Under Part I of the Federal Power Act, 54 F.P.C.
1792 (1975).
    \19\ 16 U.S.C. 797(e) (2012) (licenses for projects located on
federal reservations are subject to and contain conditions as the
Secretary of the department under whose supervision such reservation
falls shall deem necessary).
    \20\ 16 U.S.C. 811 (2012) (Secretaries of the Interior and
Commerce may prescribe fishway prescriptions).
---------------------------------------------------------------------------

    20. This Policy Statement will apply to all licenses issued
following its publication in the Federal Register with no retroactive
application. License applicants with pending license applications may
file a comprehensive settlement agreement, or addendum to an existing
agreement, that includes an explicitly agreed upon license term or may
make a filing demonstrating why the Commission should award them a
longer license term than 40 years. The Commission, however, will not
entertain applications to amend existing licenses to extend their
license terms simply on the basis of this new license term policy.
Pursuant to current policy, licensees that seek to extend existing
licenses with terms of less than 50

years, must justify such requests, for example by proposing
development, environmental, and recreation enhancements in a license
amendment application accompanied by a request that the Commission
extend their license term.\21\
---------------------------------------------------------------------------

    \21\ See, e.g., Idaho Power Co., 132 FERC ] 62,001 (2010) (10-
year extension of the license term due to the costs of replacing the
project's existing powerhouse and increasing generating capacity);
PPL Holtwood, LLC, 129 FERC ] 62,092 (2009) (16-year extension of
license term due to costs associated with the constructing a new
powerhouse, installing two turbine generating units at the existing
powerhouse, and various environmental measures).
---------------------------------------------------------------------------

III. Document Availability

    21. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5:00
p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC
20426.
    22. From FERC's Home Page on the Internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three digits of this document in the docket
number field. User assistance is available for eLibrary and the
Commission's Web site during normal business hours from FERC Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
[email protected], or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
[email protected].

    By the Commission.

    Issued: October 19, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-23286 Filed 10-25-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74452-74453]
[FR Doc No: 2016-25854]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0823]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Format and Content
Requirements for Over-the-Counter Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
November 25, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0340.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Format and Content Requirements for OTC Drug Product Labeling--21 CFR
Part 201--OMB Control Number 0910-0340--Extension

    In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999
labeling final rule), we amended our regulations governing requirements
for human drug products to establish standardized format and content
requirements for the labeling of all marketed OTC drug products in part
201 (21 CFR part 201). The regulations in part 201 require OTC drug
product labeling to include uniform headings and subheadings, presented
in a standardized order, with minimum standards for type size and other
graphical features. Specifically, the 1999 labeling final rule added
new Sec.  201.66 to part 201. Section 201.66 sets content and format
requirements for the Drug Facts portion of labels on OTC drug products.
    On June 20, 2000 (65 FR 38191), we published a Federal Register
final rule that required all OTC drug products marketed under the OTC
monograph system to comply with the labeling requirements in Sec.
201.66 by May 16, 2005, or sooner (65 FR 38191 at 38193). Currently
marketed OTC drug products are already required to be in compliance
with these labeling requirements, and thus will incur no further burden
to comply with Drug Facts labeling requirements in Sec.  201.66.
Modifications of labeling already required to be in Drug Facts format
are usual and customary as part of routine redesign practice, and thus
do not create additional burden within the meaning of the PRA.
Therefore, the burden to comply with the labeling requirements in Sec.
201.66 is a one-time burden applicable only to new OTC drug products
introduced to the marketplace under new drug applications (NDAs),
abbreviated new drug applications (ANDAs), or an OTC drug monograph,
except for products in ``convenience size'' packages.\1\ New OTC drug
products must comply with the labeling requirements in Sec.  201.66 as
they are introduced to the marketplace.
---------------------------------------------------------------------------

    \1\ In a final rule published in the Federal Register of April
5, 2002, the Agency delayed the compliance dates for the 1999
labeling final rule for all OTC drug products that: (1) Contain no
more than two doses of an OTC drug and (2) because of their limited
available labeling space, would require more than 60 percent of the
total surface area available to bear labeling to meet the
requirements set forth in Sec.  201.66(d)(1) and (9) and, therefore,
qualify for the labeling modifications currently set forth in Sec.
201.66(d)(10) (67 FR 16304 at 16306). The Agency issued this delay
in order to develop additional rulemaking for these ``convenience
size'' products (December 12, 2006; 71 FR 74474). These products are
not currently subject to the requirements of Sec.  201.66. PRA
approval for any requirements to which they may be subject in the
future will be handled in a separate rulemaking.
---------------------------------------------------------------------------

    Based on a March 1, 2010, estimate provided by the Consumer
Healthcare Products Association (75 FR 49495 at 49496, August 13,
2010), we estimated that approximately 900 new OTC drug product stock-
keeping units (SKUs) are introduced to the marketplace each

year. We estimated that these SKUs are marketed by 300 manufacturers.
We estimated that the preparation of labeling for new OTC drug products
would require 12 hours to prepare, complete, and review prior to
submitting the new labeling to us. Based on this estimate, the annual
reporting burden for this type of labeling is approximately 10,800
hours.
    All currently marketed sunscreen products are required to be in
compliance with the Drug Facts labeling requirements in Sec.  201.66,
and thus will incur no further burden under the information collection
provisions in the 1999 labeling final rule. However, a new OTC
sunscreen drug product, like any new OTC drug product, will be subject
to a one-time burden to comply with Drug Facts labeling requirements in
Sec.  201.66. We estimate that 60 new SKUs of OTC sunscreen drug
products would be marketed each year (77 FR 27230 at 27234). We
estimate that these 60 SKUs would be marketed by 20 manufacturers. We
estimate that approximately 12 hours would be spent on each label,
based on the most recent estimate used for other OTC drug products to
comply with the 1999 Drug Facts labeling final rule, including public
comments received on this estimate in 2010 that addressed sunscreens.
    In determining the burden for Sec.  201.66, it is also important to
consider exemptions or deferrals of the regulation allowed products
under Sec.  201.66(e). Since publication of the 1999 labeling final
rule, we have received only one request for exemption or deferral. One
response over a 10-year period equates to an annual frequency of
response equal to 0.1. In the 1999 labeling final rule, we estimated
that a request for deferral or exemption would require 24 hours to
complete (64 FR 13254 at 13276). We continue to estimate that this type
of response will require approximately 24 hours. Multiplying the annual
frequency of response (0.1) by the number of hours per response (24)
gives a total response time for requesting exemption of deferral equal
to 3 hours.
    In the Federal Register of April 1, 2016 (81 FR 18861), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                              Table 1--Estimated Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
         21 CFR section             respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
201.66(c) and (d) for new OTC                300               3             900              12          10,800
 drug products..................
201.66(c) and (d) for new OTC                 20               3              60              12             720
 sunscreen products.............
201.66(e).......................               1           0.125            .125              24               3
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,523
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25854 Filed 10-25-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Page 25645]
[FR Doc No: 2022-09315]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0895]

Issuance of Priority Review Voucher; Material Threat Medical
Countermeasure Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a material
threat medical countermeasure (MCM) product application. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century
Cures Act (Cures Act), authorizes FDA to award priority review vouchers
to sponsors of approved material threat MCM product applications that
meet certain criteria. FDA is required to publish notice of the award
of the priority review voucher. FDA has determined that INMAZEB
(atoltivimab, maftivimab, and odesivimab-ebgn), manufactured by
Regeneron Pharmaceuticals, Inc., meets the criteria for a material
threat MCM priority review voucher.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a material
threat MCM priority review voucher to the sponsor of an approved
material threat MCM product application. Under section 565A of the FD&C
Act (21 U.S.C. 360bbb-4a), which was added by the Cures Act (Pub. L.
114-255), FDA will award priority review vouchers to sponsors of
approved material threat MCM product applications that meet certain
criteria upon approval of those applications. FDA has determined that
INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn), manufactured by
Regeneron Pharmaceuticals, Inc., meets the criteria for a material
threat MCM priority review voucher. INMAZEB was approved on October 14,
2020. mINMAZEB is a mixture of three monoclonal antibodies indicated
for the treatment of infection caused by Zaire ebolavirus (Ebola virus)
in adult and pediatric patients.
    For further information about the material threat MCM Priority
Review Voucher Program and for a link to the full text of section 565A
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation. For further information about INMAZEB
(atoltivimab, maftivimab, and odesivimab-ebgn), go to the [email protected]
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09315 Filed 4-29-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23689-23690]
[FR Doc No: 2018-10928]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0461]

Acne Vulgaris: Establishing Effectiveness of Drugs Intended for
Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Acne Vulgaris:
Establishing Effectiveness of Drugs Intended for Treatment.'' This
guidance provides recommendations to industry for establishing the
clinical effectiveness of drugs for the treatment of acne vulgaris
(acne). This guidance finalizes the draft guidance for industry
entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued
September 19, 2005.

DATES: The announcement of the guidance is published in the Federal
Register on May 22, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2005-D-0461 for ``Acne Vulgaris: Establishing Effectiveness of
Drugs Intended for Treatment; Guidance for Industry.'' 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Strother D. Dixon, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301-
796-1015.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended
for Treatment.'' This guidance provides recommendations to industry for
establishing the clinical effectiveness of drugs for the treatment of
acne. This guidance finalizes the draft guidance for industry entitled
``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19,
2005 (70 FR 54945). Comments on the draft guidance were considered
while finalizing this guidance. Changes made to the draft guidance
include reformatting into a bulleted presentation and streamlining of
information to core recommendations.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on establishing the effectiveness of drugs
intended to treat acne. 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. Electronic Access

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

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10928 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON D.C., 20460

                                                      OFFICE OF CHEMICAL SAFETY
                                                       AND POLLUTION PREVENTION

                                 02 APR  2018
MEMORANDUM

SUBJECT:	Dimethylamine 4-(2,4-dichlorophenoxy)butyrate (030819) Pesticide Label Use Summary (PLUS) Reports in Support of Registration Review Draft Risk Assessment (DRA)

FROM:	Rafael A. Prieto, Environmental Protection Specialist
            Science Information and Analysis Branch (7503-P)

TO:		Brittany Pruitt, Chemical Review Manager
                        Risk Management and Implementation Branch 3
                        Pesticide Re-evaluation Division (7508-P)

This memorandum transmits the Dimethylamine 4-(2,4-dichlorophenoxy)butyrate (030819) Usage and Label Use Reports Package in Support of Registration Review Draft Risk Assessment (DRA). This is a refined report. This report consists of two of Section 3 labels from the Label Tracking Section 3 EPA registered and accepted Section 3 registrations containing this ingredient. The information in these reports is representative of all registered use sites, application methods, and maximum use rates for this active ingredient, as of the date of this report. There are no technical and/or manufacturing use products included in this report.

This deliverable contains two Pesticide Label Use Summary (PLUS) Reports that can be used across the Science Divisions. The reports are intended to promote consistency in review and risk analysis.  The reports are as follows:
 Pesticides Label Use Summary Line by Line Report
 contains non-aggregated use pattern and restriction information, for individual application methods, at the maximum labeled rate for each included product label.
 Maximum Use Scenario Report
 presents an aggregation of use pattern and restriction information for aggregated application methods at the maximum rate across currently registered product labels.

SPECIAL INFORMATION ABOUT THIS REPORT

As these reports introduce a new tool to OPP, please take a moment to provide feedback on your user experience. The feedback form is attached for your convenience

Active ingredients with active registrations in the 2,4-DB chemical case also include the following. PLUS reports for the other active ingredients in the case will be forthcoming:

      2,4-DB, with chemical code 030801.

For questions, comments and other usage or label use information requests, please contact Steve Jarboe at<PHONE_NUMBER>. Other requests for information may be addressed to OPP Usage and Label Use<EMAIL_ADDRESS>
ATTACHMENTS:
 PLUS  -  Line by Line Report
 PLUS  -  Maximum Use Scenario Report
 Label Tracking
 (Read Me) New Plus Vocabulary Guide
 Screening-level Usage Analysis (SLUA)
 Feedback Form.
 Hyperlink to Labels Used to Develop the PLUS Report: H:\BEAD-EFED Link\Labels\2,4-DB\(030819) Dimethylamine 4-(2,4-dichlorophenoxy)butyrate


[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Notices]
[Page 25007]
[FR Doc No: 2022-08942]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL22-41-000]

Puget Sound Energy, Inc.; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On April 21, 2022, the Commission issued an order in Docket No.
EL22-41-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e, instituting an investigation into whether Puget Sound
Energy, Inc.'s formula rate protocols are unjust, unreasonable, unduly
discriminatory or preferential, or otherwise unlawful. Puget Sound
Energy, Inc., 179 FERC ] 61,055 (2022).
    The refund effective date in Docket No. EL22-41-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL22-41-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, in
accordance with Rule 214 of the Commission's Rules of Practice and
Procedure, 18 CFR 385.214 (2021), within 21 days of the date of
issuance of the order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (https://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. At this
time, the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
https://www.ferc.gov. In lieu of electronic filing, you may submit a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Dated: April 21, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-08942 Filed 4-26-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24315-24317]
[FR Doc No: 2018-11281]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0438]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Early Food Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant Varieties Intended for Food Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's procedures for early food safety evaluation of new non-pesticidal
proteins produced by new plant varieties intended for food use,
including bioengineered food plants.

DATES: Submit either electronic or written comments on the collection
of information by July 24, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 24, 2018. 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-2012-N-0438 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced by New Plant Varieties Intended
for Food Use.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food Use

OMB Control Number 0910-0583--Extension

    Since May 29, 1992, when FDA issued a policy statement on foods
derived from new plant varieties, including those varieties that are
developed through biotechnology, we have encouraged developers of new
plant varieties to consult with us early in the development process to
discuss possible scientific and regulatory issues that might arise (57
FR 22984). The guidance entitled ``Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use'' continues to foster early
communication by encouraging developers to submit to us their
evaluation of the food safety of their new protein. Such communication
helps to ensure that any potential food safety issues regarding a new
protein in a new plant variety are resolved early in development, prior
to any possible inadvertent introduction into the food supply of
material from that plant variety.
    We believe that any food safety concern related to such material
entering the food supply would be limited to the potential that a new
protein in food from the plant variety could cause an allergic reaction
in susceptible individuals or could be a toxin in people or animals.
The guidance describes the procedures for early food safety evaluation
of new proteins produced by new plant varieties, including
bioengineered food plants, and the procedures for

communicating with us about the safety evaluation.
    Interested persons may use Form FDA 3666 to transmit their
submissions to the Office of Food Additive Safety in the Center for
Food Safety and Applied Nutrition. Form FDA 3666 is entitled ``Early
Food Safety Evaluation of a New Non-Pesticidal Protein Produced by a
New Plant Variety (New Protein Consultation)'' (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350010.pdf) and may be
used in lieu of a cover letter for a New Protein Consultation (NPC).
Form FDA 3666 prompts a submitter to include certain elements of a NPC
in a standard format and helps the respondent organize their submission
to focus on the information needed for our safety review. The form, and
elements that would be prepared as attachments to the form, may be
submitted in electronic format via the Electronic Submission Gateway
(https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm), paper format, or as electronic files on physical media
with a paper signature page. FDA uses this information to evaluate the
food safety of a specific new protein produced by a new plant variety.
    Description of Respondents: The respondents to this collection of
information are developers of new plant varieties intended for food
use.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Category                           FDA Form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components..............................            3666               6               1               6               4              24
Two other data components...............................            3666               6               1               6              16              96
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............             120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. The estimated number of annual responses and average burden
per response are based on our experience with early food safety
evaluations. Completing an early food safety evaluation for a new
protein from a new plant variety is a one-time burden (one evaluation
per new protein). Many developers of novel plants may choose not to
submit an evaluation because the field testing of a plant containing a
new protein is conducted in such a way (e.g., on such a small scale, or
in such isolated conditions, etc.) that cross-pollination with
traditional crops or commingling of plant material is not likely to be
an issue. Also, other developers may have previously communicated with
us about the food safety of a new plant protein, for example, when the
same protein was expressed in a different crop.
    We estimate the annual number of NPCs submitted by developers will
be six or fewer. The early food safety evaluation for new proteins
includes six main data components. Four of these data components are
easily and quickly obtainable, having to do with the identity and
source of the protein. We estimate that completing these data
components will take about 4 hours per NPC. We estimate the reporting
burden for the first four data components to be 24 hours (4 hours x 6
responses).
    Two data components ask for original data to be generated. One data
component consists of a bioinformatics analysis that can be performed
using publicly available databases. The other data component involves
``wet'' lab work to assess the new protein's stability and the
resistance of the protein to enzymatic degradation using appropriate in
vitro assays (protein digestibility study). The paperwork burden of
these two data components consists of the time it takes the company to
assemble the information on these two data components and include it in
a NPC. We estimate that completing these data components will take
about 16 hours per NPC. We estimate the reporting burden for the two
other data components to be 96 hours (16 hours x 6 responses). Thus, we
estimate the total annual burden for this collection of information to
be 120 hours.

    Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11281 Filed 5-24-18; 8:45 am]
BILLING CODE 4164-01-P