[Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)]
[Proposed Rules]
[Page 42069]
[FR Doc No: 2015-17379]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2337]

Alzchem AG; Filing of Food Additive Petition (Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that
Alzchem AG has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of guanidinoacetic
acid as a substance that spares arginine and serves as a precursor of
creatine in diets for broiler chickens and turkeys.

DATES: Submit either electronic or written comments on the petitioner's
request for categorical exclusion from preparing an environmental
assessment or environmental impact statement by August 17, 2015.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a
food additive petition (FAP 2292) has been filed by Alzchem AG,
Chemiepark Trostberg, Dr.-Albert-Frank-Str. 32, 83308, Trostberg,
Germany. The petition proposes to amend Title 21 of the Code of Federal
Regulations (CFR) in part 573 Food Additives Permitted in Feed and
Drinking Water of Animals (21 CFR part 573) to provide for the safe use
of guanidinoacetic acid as a substance that spares arginine and serves
as a precursor of creatine in diets for broiler chickens and turkeys.
The petitioner has requested a categorical exclusion from preparing an
environmental assessment or environmental impact statement under 21 CFR
25.32(r).
    Interested persons may submit either electronic or written comments
regarding this request for categorical exclusion to the Division of
Dockets Management (see DATES and ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 10, 2015.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2015-17379 Filed 7-15-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Page 18612]
[FR Doc No: 2016-07259]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC16-93-000.
    Applicants: Atlas Power Finance, LLC, Dynegy Inc., Energy Capital
Partners III, LLC, GDF Suez Energy North America, Inc.
    Description: Joint Application for Authorization under FPA Section
203 of Atlas Power Finance, LLC, Dynegy Inc., Energy Capital Partners
III, LLC, and GDF SUEZ Energy North America, Inc.
    Filed Date: 5/24/16.
    Accession Number: 20160325-5113.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: EC16-94-000.
    Applicants: Dynegy Inc., Energy Capital Partners III, LLC.
    Description: Joint Application under FPA Section 203 of Dynegy Inc.
and Energy Capital Partners III, LLC.
    Filed Date: 5/24/16.
    Accession Number: 20160325-5131.
    Comments Due: 5 p.m. ET 4/15/16.

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

    Docket Numbers: ER16-770-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2016-03-25 ZDB Deficiency Response
Filing to be effective 3/25/2016.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5130.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: ER16-1270-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4430; Queue Position #AB1-099 to be effective 2/24/2016.
    Filed Date: 3/24/16.
    Accession Number: 20160324-5190.
    Comments Due: 5 p.m. ET 4/14/16.

    Docket Numbers: ER16-1271-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-03-25_SA 2907 ATC-
ROCKGEN GIA (J382) to be effective 3/26/2016.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5051.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: ER16-1272-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: 2016 TACBAA Update to be
effective 6/1/2016.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5082.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: ER16-1273-000.
    Applicants: American Electric Power Service Corporation, Michigan
Electric Transmission Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: AEP submits Original
Interconnection Agreement No. 4251 with METC to be effective 3/25/2016.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5088.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: ER16-1274-000.
    Applicants: Verso Androscoggin Power LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Verso Androscoggin Power LLC.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5145.
    Comments Due: 5 p.m. ET 4/15/16.

    Docket Numbers: ER16-1275-000.
    Applicants: Innovative Solar 46, LLC.
    Description: Baseline eTariff Filing: Baseline Tariff to be
effective 12/31/9998.
    Filed Date: 3/25/16.
    Accession Number: 20160325-5192.
    Comments Due: 5 p.m. ET 4/15/16.

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

    Dated: March 25, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-07259 Filed 3-30-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36319-36320]
[FR Doc No: 2023-11769]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0322]

Action Level for Inorganic Arsenic in Apple Juice: Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Action Level
for Inorganic Arsenic in Apple Juice.'' The guidance identifies for
industry an action level for inorganic arsenic in apple juice that is
intended to help protect public health by reducing exposure to
inorganic arsenic and is achievable with the use of current good
manufacturing practices. It also describes our intended sampling and
enforcement approach. Thus, the guidance finalizes the approach
presented in the draft guidance issued in 2013.

DATES: The announcement of the guidance is published in the Federal
Register on June 2, 2023.

ADDRESSES: You may submit either electronic or written comments on FDA
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-2012-D-0322 for ``Action Level for Inorganic Arsenic in Apple
Juice: 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Plant Products and Beverages, Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>; or Denise See, Center for
Food Safety and Applied Nutrition, Office of Regulations and Policy
(HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Action Level for Inorganic Arsenic in Apple Juice.'' We are
issuing this guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The guidance represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
    In the Federal Register of July 15, 2013 (78 FR 42086), we
announced the availability of a draft guidance for industry entitled
``Arsenic in Apple Juice: Action Level.'' We also announced the
availability of two related scientific documents: a document entitled
``Supporting Document for Action Level for Arsenic in Apple Juice''
(supporting document),

and a risk assessment entitled ``A Quantitative Assessment of Inorganic
Arsenic in Apple Juice'' (the risk assessment document). We gave
interested parties an opportunity to submit comments by September 13,
2013.
    This guidance finalizes FDA's action level for inorganic arsenic in
apple juice of 10 micrograms per kilogram ([micro]g/kg) or 10 parts per
billion (ppb) and identifies FDA's intended sampling and enforcement
approach. The basis for the action level is set forth in the guidance
document, as well as the risk assessment document originally made
available on July 15, 2013, that can be accessed in the docket
referenced above at https://www.regulations.gov. The guidance reviews
data on inorganic arsenic levels in apple juice, health effects from
exposure to inorganic arsenic, and the ability of manufacturers to
achieve different levels of inorganic arsenic in apple juice. It also
explains FDA's rationale for identifying an action level of 10
[micro]g/kg or 10 ppb for inorganic arsenic in apple juice.
    Arsenic is present in the environment as a naturally occurring
substance or as a result of contamination from human activity. In
foods, arsenic may be present as inorganic arsenic (the primary toxic
form of arsenic) or organic arsenic. Exposure to inorganic arsenic is
associated with adverse human health effects, including cancer and
neurodevelopmental effects. Apple juice is one source of exposure to
arsenic from food, and a greater potential source of exposure for
children than adults, because children's dietary patterns are often
less varied than those of adults, and they consume more apple juice
relative to their body weight than do adults. We expect that the 10
[micro]g/kg or 10 ppb action level, though non-binding, will help
protect public health by encouraging manufacturers to reduce levels of
inorganic arsenic in apple juice and therefore reduce human exposure to
inorganic arsenic. We also expect that this level is achievable by
industry with the use of current good manufacturing practices. We
intend to consider the action level of 10 [micro]g/kg or 10 ppb
inorganic arsenic as an important source of information for determining
whether apple juice is adulterated within the meaning of section
402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342(a)(1)).
    In finalizing the guidance, we incorporated data from the
supporting document and added an analysis of new data on inorganic
arsenic levels in apple juice, health effects from exposure to
inorganic arsenic, and the ability of manufacturers to limit inorganic
arsenic in apple juice, in evaluating the appropriate action level. We
also made changes to the text for clarity, including explaining the
term ``added'' in this context and that ``apple juice'' includes apple
cider, and we have also revised the title of the guidance to more
clearly show that we are setting an action level. In addition, we added
information on our understanding of arsenical pesticide use in the
United States and expanded the discussion of the rationale for setting
an action level based on sampling and testing results and the
discussion of FDA's sampling and enforcement approach. We also
incorporated new references in support of these changes and to reflect
the citation of recently published FDA data and a new reference to
FDA's Closer to Zero action plan.
    We also considered all comments received during the comment period
in finalizing the document. Comments on the draft guidance requested
that we consider establishing action levels for other foods containing
arsenic, such as other apple products, other fruit juices, and rice;
that the action level be lower than 10 ppb; that we consider additional
risk management approaches; and that questioned the achievability of
the action level of 10 ppb in apple juice. We did not receive new data
from the comments supporting establishment of either a higher or lower
action level. None of the comments caused us to change the approach set
out in the draft guidance. We have clarified in the title of the final
guidance that the action level of 10 ppb applies to inorganic arsenic.
    Other comments suggested modifications to the risk assessment
document. We note that the risk assessment report underwent peer review
before we made it available to the public. (This can be found at
https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews.) None of these
comments supported a determination that the risk assessment document
needs to be modified. We will continue to monitor research developments
on adverse health effects of inorganic arsenic exposure to determine if
new data support changes to the guidance.

II. Paperwork Reduction Act of 1995

    This final guidance contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

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

    Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11769 Filed 6-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Notices]
[Pages 14352-14355]
[FR Doc No: 2021-05240]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91285; File No. SR-Phlx-2021-12)

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change to Proposed Rule
Change To Amend Options 7, Section 3, ``Rebates and Fees for Adding and
Removing Liquidity in SPY''

March 9, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 1, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``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 the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 3, ``Rebates and Fees for Adding and Removing Liquidity in
SPY.''
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    Phlx proposes to amend its pricing within Options 7, Section 3,
``Rebates and Fees for Adding and Removing Liquidity in SPY.''
Specifically, the Exchange proposes to amend Options 7, Section 3, Part
A, Simple Orders to: (1) Decrease the SPY Simple Order Customer Fee for
Removing Liquidity; and (2) amend the SPY Lead Market Maker and Market
Maker tier qualifications to earn a Simple Order Rebate for Adding
Liquidity. Each change will be described below.
Fee for Removing Liquidity
    The Exchange proposes to decrease the current $0.42 per contract
Customer Fee for Removing Liquidity in SPY to $0.38 per contract for
Simple Orders. The Exchange believes decreasing this fee will
incentivize market participants to send additional Customer Simple
Orders to Phlx in SPY.
    The Exchange is not amending any other Fees for Removing Liquidity
\3\ in SPY for Simple Orders. Customers will continue to pay the lowest
Simple Order Fee for Removing Liquidity in SPY.
---------------------------------------------------------------------------

    \3\ Today, all non-Customers pay a $0.48 per contract Fee for
Removing Liquidity in SPY.
---------------------------------------------------------------------------

Rebate for Adding Liquidity
    Today, Lead Market Makers and Market Makers are paid Simple Order
Rebates for Adding Liquidity on electronically executed Simple Order
contracts per day in a month when adding liquidity in SPY. The Simple
Order Rebate for Adding Liquidity is determined by calculating the
average daily volume of electronically executed Lead Market Maker and
Market Maker Simple Order contracts per day in a month in SPY.\4\
Today, the applicable tier schedule is as follows:
---------------------------------------------------------------------------

    \4\ This would include Lead Market Maker or Market Maker quotes
or orders that were executed.

------------------------------------------------------------------------
                                                            Rebate for
           Tiers            Average daily volume ``ADV''      adding
                                                             liquidity
------------------------------------------------------------------------
1.........................  1 to 2,499..................           $0.12
2.........................  2,500 to 4,999..............            0.15
3.........................  5,000 to 19,999.............            0.18
4.........................  20,000 to 34,999............            0.24
5.........................  35,000 to 49,999............            0.27
6.........................  greater than 49,999.........            0.32
------------------------------------------------------------------------

    The Exchange proposes to amend the current tier schedule. Instead
of utilizing average daily volume to qualify for a Lead Market Maker or
Market Maker Simple Order Rebate to Add Liquidity when adding liquidity
in SPY, the Exchange proposes to utilize a percentage of all cleared
customer volume at The Options Clearing Corporation in Multiply Listed
Equity Options and Exchange-Traded Products (``TCV''). Simple Order
Rebates to Add Liquidity will continue to be paid on electronically
executed Lead Market Maker and Market Maker Simple Order contracts per
day in a month which add liquidity in SPY. The Exchange is not amending
the Rebates for Adding Liquidity that are paid to Lead Market Makers
and Market Makers for transacting Simple Orders in SPY. Lead Market
Makers and Market Makers will be paid per the highest tier achieved
pursuant to the below tier schedule:

------------------------------------------------------------------------
                                                            Rebate for
           Tiers             Adds liquidity in SPY as a       adding
                                  percentage of TCV          liquidity
------------------------------------------------------------------------
1.........................  up to 0.02%.................           $0.12
2.........................  up to 0.04%.................            0.15
3.........................  up to 0.10%.................            0.18
4.........................  up to 0.20%.................            0.24
5.........................  up to 0.40%.................            0.27
6.........................  greater than 0.40%..........            0.32
------------------------------------------------------------------------

    Specifically, the Exchange would pay a $0.12 per contract Lead
Market Maker or Market Maker Simple Order Rebate to Add Liquidity for
TCV up to 0.02% \5\ which adds [sic] in SPY. Today, the Exchange pays a
$0.12 per contract Lead Market Maker or Market Maker Simple Order
Rebate to Add Liquidity for average daily volume up to 2,499 contracts
per day in a month which add liquidity in SPY.
---------------------------------------------------------------------------

    \5\ 0.02% TCV is representative of approximately 5,000 contracts
per day when TCV is 25,000,000 contracts per day.
---------------------------------------------------------------------------

    The Exchange proposes to pay a $0.15 per contract Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.04% \6\ which adds liquidity in SPY. Today, the Exchange pays a $0.15
per contract Lead Market Maker or Market Maker Simple Order Rebate to
Add Liquidity for average daily volume from 2,500 to 4,999 contracts
per day in a month which adds liquidity in SPY.
---------------------------------------------------------------------------

    \6\ 0.04% TCV is representative of approximately 10,000
contracts per day when TCV is 25,000,000 contracts per day.
---------------------------------------------------------------------------

    The Exchange proposes to pay a $0.18 per contract Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.10% \7\ which adds liquidity in SPY. Today, the Exchange pays a $0.18
per contract Lead Market Maker or Market Maker Simple Order Rebate to
Add Liquidity for average daily volume from 5,000 to

19,999 contracts per day in a month which adds liquidity in SPY.
---------------------------------------------------------------------------

    \7\ 0.10% TCV is representative of approximately 25,000
contracts per day when TCV is 25,000,000 contracts per day.
---------------------------------------------------------------------------

    The Exchange proposes to pay a $0.24 per contract Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.20% \8\ which adds liquidity in SPY. Today, the Exchange pays a $0.24
per contract Lead Market Maker or Market Maker Simple Order Rebate to
Add Liquidity for average daily volume from 20,000 to 34,999 contracts
per day in a month which adds liquidity in SPY.
---------------------------------------------------------------------------

    \8\ 0.20% TCV is representative of approximately 50,000
contracts per day when TCV is 25,000,000 contracts per day.
---------------------------------------------------------------------------

    The Exchange proposes to pay a $0.27 per contract Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.40% \9\ which adds liquidity in SPY. Today, the Exchange pays a $0.27
per contract Lead Market Maker or Market Maker Simple Order Rebate to
Add Liquidity for average daily volume from 35,000 to 49,999 contracts
per day in a month which adds liquidity in SPY.
---------------------------------------------------------------------------

    \9\ 0.40% TCV is representative of approximately 100,000
contracts per day when TCV is 25,000,000 contracts per day.
---------------------------------------------------------------------------

    The Exchange proposes to pay a $0.32 per contract Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity for TCV greater
than 0.40% which adds liquidity in SPY. Today, the Exchange pays a
$0.32 per contract Lead Market Maker or Market Maker Simple Order
Rebate to Add Liquidity for average daily volume greater than 49,999
contracts per day in a month which adds liquidity in SPY.
    As proposed, Lead Market Maker and Market Maker Simple Order
Rebates to Add Liquidity in SPY would require an increased amount of
electronically executed Lead Market Maker and Market Maker Simple Order
contracts per day in a month which adds liquidity in SPY to qualify for
the same tiers as members qualified in the past. For example, with this
proposal, the Tier 1 Simple Order Rebate to Add Liquidity will continue
to pay a $0.12 per contract Simple Order Lead Market Maker and Market
Maker Rebates to Add Liquidity in SPY; however, instead of executing
contracts which adds liquidity from 1 to 2,499 ADV to qualify for a
Tier 1 rebate, a Participant that executes from 1 to approximately
5,000 contracts in a day (which is the percentage of all cleared
customer volume at The Options Clearing Corporation in Multiply Listed
Equity Options and Exchange-Traded Products or ``TCV''), which adds
liquidity, would now qualify for the Tier 1 $0.12 Simple Order Lead
Market Maker and Market Maker Rebate to Add Liquidity in SPY. Today,
Participants that execute 2,500 to 4,999 ADV of Simple Order Lead
Market Maker and Market Maker contracts, which adds liquidity, would
qualify for the Tier 2 Simple Order Lead Market Maker and Market Maker
Rebate to Add Liquidity in SPY which pays $0.15 per contract. With this
proposal, those Participants that previously qualified for the Tier 2
rebate would now qualify for the Tier 1 Simple Order Lead Market Maker
and Market Maker Rebate to Add Liquidity. Likewise, with this proposal
the Tier 2 Simple Order Rebate to Add Liquidity will continue to pay a
$0.15 per contract Simple Order Lead Market Maker and Market Maker
Rebate to Add Liquidity in SPY; however, instead of executing contracts
from 2,500 to 4,999 ADV, which adds liquidity, to qualify for a Tier 2
rebate, a Participant that executes up to approximately 10,000
contracts TCV in a day, which adds liquidity, would now qualify for the
Tier 2 Simple Order Lead Market Maker and Market Maker Rebate to Add
Liquidity which pays $0.15 per contract. Today, Participants who
executed 5,000 to 19,999 ADV qualify for the higher Tier 3 Simple Order
Lead Market Maker and Market Maker Rebate to Add Liquidity of $0.18 per
contract. Each tier requirement has been increased and therefore
Participants in Tiers 2-6 would have to execute a greater amount of
Simple Order Lead Market Maker and Market Maker contracts which adds
liquidity in SPY to earn the same rebate as they previously earned.
    With this proposal, all Simple Order Rebate to Add Liquidity tiers
require a greater amount of executed contracts which add liquidity in
SPY to qualify for the same tier, except for those Participants that
today qualify for Tier 1.\10\ Phlx believes its proposal will continue
to incentivize the submission of Lead Market Maker and Market Maker
Simple Orders by continuing to offer rebates for the submission of
these orders which add liquidity in SPY. Today, the Exchange only pays
Simple Order Rebates to Add Liquidity in SPY for Lead Market Maker and
Market Maker Simple Orders which add liquidity in SPY and this will
remain the case.
---------------------------------------------------------------------------

    \10\ Tier 1 continues to pay the same $0.12 per contract Simple
Order Lead Market Maker and Market Maker Rebate to Add Liquidity for
Participants who submit up to approximately 5,000 TCV contracts
which add liquidity in SPY.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\11\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\12\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange's proposed changes to its Pricing Schedule are
reasonable in several respects. As a threshold matter, the Exchange is
subject to significant competitive forces in the market for options
securities transaction services that constrain its pricing
determinations in that market. The fact that this market is competitive
has long been recognized by the courts. In NetCoalition v. Securities
and Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \13\
---------------------------------------------------------------------------

    \13\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \14\
---------------------------------------------------------------------------

    \14\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options security transaction services. The Exchange is only one of
sixteen options exchanges to which market participants may direct their
order flow. Within this environment, market participants can freely and
often do shift their order flow among the Exchange and competing

venues in response to changes in their respective pricing schedules. As
such, the proposal represents a reasonable attempt by the Exchange to
increase its liquidity and market share relative to its competitors.
Fee for Removing Liquidity
    The Exchange's proposal to decrease the current $0.42 per contract
Customer Fee for Removing Liquidity in SPY to $0.38 per contract for
Simple Orders is reasonable. Decreasing the Simple Order Customer Fee
for Removing Liquidity in SPY will incentivize market participants to
send additional Customer SPY Simple Orders to Phlx. Customers will
continue to pay the lowest Simple Order Fee for Removing Liquidity in
SPY as compared to other market participants.\15\
---------------------------------------------------------------------------

    \15\ See note 3 above.
---------------------------------------------------------------------------

    The Exchange's proposal to decrease the current $0.42 per contract
Customer Fee for Removing Liquidity in SPY to $0.38 per contract for
Simple Orders is equitable and not unfairly discriminatory. Customers
would continue to receive favorable pricing as compared to other market
participants because Customer liquidity enhances liquidity on the
Exchange for the benefit of all market participants. Specifically,
Customer liquidity benefits all market participants by providing more
trading opportunities which attracts market makers. An increase in the
activity of these market participants (particularly in response to
pricing) in turn facilitates tighter spreads which may cause an
additional corresponding increase in order flow from other market
participants.
Rebate for Adding Liquidity
    The Exchange's proposal to amend the current tier schedule to
remove average daily volume as a tier qualifier for a Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity when adding
liquidity in SPY and instead utilize a percentage of all cleared
customer volume at The Options Clearing Corporation in Multiply Listed
Equity Options and Exchange-Traded Products or ``TCV'' is reasonable,
equitable and not unfairly discriminatory. The Exchange's proposal is
intended to provide a measure for the amount of contracts that would be
eligible to qualify a market participant submitting electronically
executed Lead Market Maker and Market Maker Simple Order contracts per
day in a month which add liquidity in SPY for a certain rebate. The
greater the amount of contracts submitted by the member, the larger the
Lead Market Maker or Market Maker Simple Order Rebate to Add Liquidity
when adding liquidity in SPY. The Exchange believes that measuring the
contracts as a percentage of TCV is a fair and equitable method for
calculating Simple Order Customer volume executed on Phlx when adding
liquidity in SPY. The Exchange would uniformly apply this measure to
all eligible members to determine the corresponding rebate. Lead Market
Makers and Market Makers will be paid per the highest tier achieved.
    The Exchange's proposal to amend the tier qualifications for Lead
Market Maker or Market Maker Simple Order Rebates to Add Liquidity when
adding liquidity in SPY is reasonable.\16\ As proposed, an increased
amount of electronically executed Lead Market Maker and Market Maker
Simple Order contracts per day in a month which add liquidity in SPY
would need to be submitted to qualify for the same tiers as members
qualified in the past with the exception of Tier 1.\17\ With this
proposal, all Simple Order Rebate to Add Liquidity tiers require a
greater amount of executed contracts which add liquidity in SPY to
qualify for the same rebate as the Participant had previously qualified
for prior to this proposal. Despite the increased volume
qualifications, Phlx believes its proposal will continue to incentivize
the submission of Lead Market Maker and Market Maker Simple Orders by
continuing to offer rebates for the submission of these orders which
add liquidity in SPY. Today, the Exchange only pays Simple Order
Rebates to Add Liquidity in SPY for Lead Market Maker and Market Maker
Simple Orders and this will remain the case. Lead Market Makers and
Market Makers will be paid per the highest tier achieved.
---------------------------------------------------------------------------

    \16\ With this proposal, Phlx would pay a $0.12 per contract
Lead Market Maker or Market Maker Simple Order Rebate to Add
Liquidity for TCV up to 0.02% which adds liquidity in SPY. Today,
the Exchange pays a $0.12 per contract Lead Market Maker or Market
Maker Simple Order Rebate to Add Liquidity for average daily volume
up to 2,499 contracts per day in a month which adds liquidity in
SPY. The Exchange proposes to pay a $0.15 per contract Lead Market
Maker or Market Maker Simple Order Rebate to Add Liquidity for TCV
up to 0.04% which adds liquidity in SPY. Today, the Exchange pays a
$0.15 per contract Lead Market Maker or Market Maker Simple Order
Rebate to Add Liquidity for average daily volume from 2,500 to 4,999
contracts per day in a month which adds liquidity in SPY. The
Exchange proposes to pay a $0.18 per contract Lead Market Maker or
Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.10% which adds in SPY. Today, the Exchange pays a $0.18 per
contract Lead Market Maker or Market Maker Simple Order Rebate to
Add Liquidity for average daily volume from 5,000 to 19,999
contracts per day in a month which adds liquidity in SPY. The
Exchange proposes to pay a $0.24 per contract Lead Market Maker or
Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.20% which adds liquidity in SPY. Today, the Exchange pays a $0.24
per contract Lead Market Maker or Market Maker Simple Order Rebate
to Add Liquidity for average daily volume from 20,000 to 34,999
contracts per day in a month which adds liquidity in SPY. The
Exchange proposes to pay a $0.27 per contract Lead Market Maker or
Market Maker Simple Order Rebate to Add Liquidity for TCV up to
0.40% which adds liquidity in SPY. Today, the Exchange pays a $0.27
per contract Lead Market Maker or Market Maker Simple Order Rebate
to Add Liquidity for average daily volume from 35,000 to 49,999
contracts per day in a month which adds liquidity in SPY.
    The Exchange proposes to pay a $0.32 per contract Lead Market
Maker or Market Maker Simple Order Rebate to Add Liquidity for TCV
greater than 0.40% which adds liquidity in SPY. Today, the Exchange
pays a $0.32 per contract Lead Market Maker or Market Maker Simple
Order Rebate to Add Liquidity for average daily volume greater than
49,999 contracts per day in a month which adds liquidity in SPY.
    \17\ Tier 1 continues to pay the same $0.12 per contract Simple
Order Lead Market Maker and Market Maker Rebate to Add Liquidity for
Participants who submit up to approximately 5,000 TCV contracts
which add liquidity in SPY.
---------------------------------------------------------------------------

    The Exchange's proposal to amend the tier qualifications for Lead
Market Maker or Market Maker Simple Order Rebates to Add Liquidity in
SPY is equitable and not unfairly discriminatory. Phlx Lead Market
Makers and Market Makers add value through continuous quoting \18\ and
are subject to additional requirements and obligations \19\ that other
market participants are not. Incentivizing Lead Market Makers and
Market Makers to provide greater liquidity benefits all market
participants through the quality of order interaction.
---------------------------------------------------------------------------

    \18\ See Options 2, Section 5.
    \19\ See Options 2, Section 4.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Inter-Market Competition
    The proposal does not impose an undue burden on intermarket
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its

fees to remain competitive with other exchanges that have been exempted
from compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees in response, and
because market participants may readily adjust their order routing
practices, the Exchange believes that the degree to which fee changes
in this market may impose any burden on competition is extremely
limited.
Intra-Market Competition
Fee for Removing Liquidity
    The Exchange's proposal to decrease the current $0.42 per contract
Customer Fee for Removing Liquidity in SPY to $0.38 per contract for
Simple Orders does not impose an undue burden on competition. Customers
would continue to receive favorable pricing as compared to other market
participants because Customer liquidity enhances liquidity on the
Exchange for the benefit of all market participants. Specifically,
Customer liquidity benefits all market participants by providing more
trading opportunities which attracts market makers. An increase in the
activity of these market participants (particularly in response to
pricing) in turn facilitates tighter spreads which may cause an
additional corresponding increase in order flow from other market
participants.
Rebate for Adding Liquidity
    The Exchange's proposal to amend the current tier schedule to
remove average daily volume as a tier qualifier for a Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity when adding
liquidity in SPY and instead utilize a percentage of all cleared
customer volume at The Options Clearing Corporation in Multiply Listed
Equity Options and Exchange-Traded Products or ``TCV'' does not impose
an undue burden on competition. The Exchange's proposal is intended to
provide a measure for the amount of contracts that would be eligible to
qualify a market participant submitting electronically executed Lead
Market Maker and Market Maker Simple Order contracts per day in a month
which add liquidity in SPY for a certain rebate. The greater the amount
of contracts submitted by the member, the larger the Lead Market Maker
or Market Maker Simple Order Rebate to Add Liquidity in SPY. The
Exchange believes that measuring the contracts as a percentage of TCV
is a fair and equitable method for calculating Customer volume executed
on Phlx when adding liquidity in SPY. The Exchange would uniformly
apply this measure to all eligible members to determine the
corresponding rebate. Lead Market Makers and Market Makers will be paid
per the highest tier achieved.
    The Exchange's proposal to amend the tier qualifications for Lead
Market Maker or Market Maker Simple Order Rebates to Add Liquidity in
SPY does not impose an undue burden on competition. Phlx Lead Market
Makers and Market Makers add value through continuous quoting \20\ and
are subject to additional requirements and obligations \21\ that other
market participants are not. Incentivizing Lead Market Makers and
Market Makers to provide greater liquidity benefits all market
participants through the quality of order interaction.
---------------------------------------------------------------------------

    \20\ See Options 2, Section 5.
    \21\ See Options 2, Section 4.
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\22\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-PHLX-2021-12 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-PHLX-2021-12. 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-PHLX-2021-12 and should be submitted on
or before April 5, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-05240 Filed 3-12-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Page 53793]
[FR Doc No: 2015-22508]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER10-2670-009; ER10-2669-009; ER14-1219-002; ER10-
2253-013; ER10-3319-017; ER10-2674-009; ER10-2627-010; ER10-2629-011;
ER10-1546-011; ER10-1547-009; ER14-1699-002; ER10-2636-010; ER10-1974-
016; ER10-1550-010; ER10-1975-017; ER11-2424-013; ER10-2677-009; ER10-
2678-008; ER10-2638-008.
    Applicants: ANP Blackstone Energy Company, LLC, ANP Bellingham
Energy Company, LLC, Armstrong Power, LLC, Astoria Energy LLC, Astoria
Energy II LLC, Calumet Energy Team, LLC, FirstLight Hydro Generating
Company, FirstLight Power Resources Management, LLC, GDF SUEZ Energy
Marketing NA, Inc., Hopewell Cogeneration Ltd Partnership, Milford
Power, LLC, Mt. Tom Generating Company, LLC, Northeast Energy
Associates, A Limited Partnership, Northeastern Power Company, North
Jersey Energy Associates, a Limited Partnership., Pinetree Power-
Tamworth, Inc., Pleasants Energy, LLC, Troy Energy, LLC, Waterbury
Generation, LLC.
    Description: Notice of Change in Status of the GDF SUEZ MBR
Sellers.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5428.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2583-000.
    Applicants: California Independent System Operator Corporation.
    Description: Section 205(d) Rate Filing: 2015-08-31 MEEA between
CAISO and WAPA-Sierra Nevada Region to be effective 11/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5388.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2584-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Section 205(d) Rate Filing: Aug 31 2015 Membership
Filing to be effective 9/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5391.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2585-000.
    Applicants: Oklahoma Gas and Electric Company.
    Description: Tariff Cancellation: Cancellation of Cost Based
Formula Tariff to be effective 9/1/2015.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5402.
    Comments Due: 5 p.m. ET 9/21/15.

    Docket Numbers: ER15-2586-000.
    Applicants: Southern California Edison Company.
    Description: Section 205(d) Rate Filing: First Amended GIA & DSA
Eco Services Operations LLC--Rhodia Project to be effective 9/2/2015.
    Filed Date: 9/1/15.
    Accession Number: 20150901-5011.
    Comments Due: 5 p.m. ET 9/22/15.

    Docket Numbers: ER15-2587-000.
    Applicants: DR Power, LLC.
    Description: Notice of cancellation of market based tariff of DR
Power, LLC under ER15-2587.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5435.
    Comments Due: 5 p.m. ET 9/21/15.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF15-997-000.
    Applicants: Golden Renewable Energy, LLC.
    Description: Form 556 of Golden Renewable Energy, LLC.
    Filed Date: 8/31/15.
    Accession Number: 20150831-5432.
    Comments Due: None Applicable.

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

    Dated: September 1, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-22508 Filed 9-4-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]
[Page 2918-2920]
[DOCID:fr16ja08-54]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1151; FRL-8346-1]

Diiodomethyl p-tolyl sulfone (Amical 48) Risk Assessments; Notice
of Availability, and Risk Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's risk
assessments, and related documents for the pesticide Diiodomethyl p-
tolyl sulfone (Amical 48), and opens a public comment period on these
documents. The public is encouraged to suggest risk management ideas or
proposals to address the risks identified. EPA is developing a
Reregistration Eligibility Decision (RED) for Diiodomethyl p-tolyl
sulfone through a modified, 4-Phase public participation process that
the Agency uses to involve the public in developing pesticide
reregistration decisions. Through this program, EPA is ensuring that
all pesticides meet current health and safety standards.

DATES: Comments must be received on or before March 17, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1151, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.

     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1151. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: K. Avivah Jakob, Antimicrobials
Division (7501P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and
environmental fate and ecological effects risk assessments and related
documents for Diiodomethyl p-tolyl sulfone and soliciting public
comment on risk management ideas or proposals. Diiodomethyl p-tolyl
sulfone is registered as an algaecide, bactericide, and fungicide and
is used as a materials preservative and wood preservative. EPA
developed the risk assessments and risk characterization for
Diiodomethyl p-tolyl sulfone through a modified version of its public
process for making pesticide reregistration eligibility and tolerance
reassessment decisions. Through these programs, EPA is ensuring that
pesticides meet current standards under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
    Diiodomethyl p-tolyl sulfone is used as a materials preservative.
The following materials contain Diiodomethyl p-tolyl sulfone as a
preservative: Paints, air duct coatings, fire-retardant coatings,
pigment

dispersions, inks, emulsions and extender slurries, adhesives, caulks,
sealants, rubbers and plastics, textiles, leather, pulp and paper
slurries, paper/paperboard, and wetlap. Diiodomethyl p-tolyl sulfone is
also use for the preservation of wood.
    EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for Diiodomethyl p-tolyl sulfone. Such comments and input
could address, for example, the availability of additional data to
further refine the risk assessments, such as soil contamination data;
wood leaching data; confirmatory monitoring data; confirmatory
inhalation toxicity data; or could address the Agency's risk assessment
methodologies and assumptions as applied to this specific pesticide.
    Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for Diiodomethyl p-tolyl sulfone. Risks of
concern associated with the use of Diiodomethyl p-tolyl sulfone are:
Residential dermal risks of concern resulting from painting (brush/
roller and airless sprayer), application of wood preservative (brush/
roller and airless sprayer), and children playing with finger paint;
residential inhalation risks of concern resulting from application of
paint (airless sprayer); residential post-application dermal risks of
concern for children resulting from treated carpets and wood products
and oral risks of concern from treated carpets; occupational dermal
risks of concern resulting from preservation of rubber and plastics
(liquid pour and liquid pump) and preservation of leather (liquid
pour); etc. In targeting these risks of concern, the Agency solicits
information on effective and practical risk reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to Diiodomethyl p-tolyl sulfone,
compared to the general population.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
the issues, and degree of public concern associated with each
pesticide. For Diiodomethyl p-tolyl sulfone, a modified, 4-Phase
process with 1 comment period and ample opportunity for public
consultation seems appropriate in view of its refined risk assessments.
However, if as a result of comments received during this comment period
EPA finds that additional issues warranting further discussion are
raised, the Agency may lengthen the process and include a second
comment period, as needed.
    All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments
will become part of the Agency Docket for Amical 48. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory
action.''

List of Subjects

    Environmental protection, Pesticides and pests, Diiodomethyl p-
tolyl sulfone, antimicrobials.

    Dated: January 10, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E8-674 Filed 1-15-08; 8:45 am]

BILLING CODE 6560-50-S


Attachment A PM2.5 Data Files on CD Study Data file Peters et al., 2000 PM_ HICOR. DAT Peters et al., 2001 PM_ HICOR. DAT Neas et al., 1995 uniontown FP ave data. xls Neas et al., 1996 statecollege FP data. xls Neas et al., 1999 Phila 1992 1995 daily Mass Pby. csv Schwartz et al., 1994 Dichot~ 1. dat


[Federal Register Volume 79, Number 18 (Tuesday, January 28, 2014)]
[Notices]
[Pages 4531-4532]
[FR Doc No: 2014-01320]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2001-9258; FMCSA-2001-9561; FMCSA-2003-15268; FMCSA-
2005-21254; FMCSA-2009-0121; FMCSA-2011-0140; FMCSA-2011-0141]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
41 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective January 29, 2014. Comments must be
received on or before February 27, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2001-
9258; FMCSA-2001-9561; FMCSA-2003-15268; FMCSA-2005-21254; FMCSA-2009-
0121; FMCSA-2011-0140; FMCSA-2011-0141], using any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue, SE., Room W64-
224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5
p.m. Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 41 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 41 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Danny F. Burnley (KY)
Domenic J. Carassai (NJ)
Ronald J. Claud (NY)
Stewart K. Clayton (TX)
Sean R. Conorman (MI)
Kenneth D. Daniels (PA)
Fred W. Duran (MS)
Jackie E. Frederick (AL)
Robert E. Graves (NE)
Bruce E. Hemmer (WI)
Steven P. Holden (MD)
James Howard (CA)
Christopher G. Jarvela (MI)
Donald L. Jensen (SD)
Donald M. Jenson (SD)
Dennis D. Lesperance (OR)
Brad L. Mathna (PA)
Dean A. Maystead (MI)
Ramon Melendez (NJ)
Brian P. Millard (SC)
Vincent P. Miller (SC)
Carl V. Murphy, Jr. (TX)
Steven D. Nash (MN)
Matthew D. Nelson (FL)
Jesse A. Nosbush (MN)
Warren J. Nyland (MI)
Mark A. Pirl (NC)
Dennis M. Prevas (WI)
Merle M. Price (IA)
Thomas D. Reynolds (NC)
Greg L. Riles (IA)
Terrence F. Ryan (FL)
Kirby R. Sands (IA)
Dennis W. Stubrich (PA)
Thomas L. Swatley (TN)
Calvin D. Tomlinson (KY)
Wesley E. Turner (TX)
Mona J. Van Krieken (OR)
Stephen W. Verrette (MI)
Leslie H. Wylie (ID)
Paul S. Yocum (IN)
    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical

examination every year (a) by an ophthalmologist or optometrist who
attests that the vision in the better eye continues to meet the
requirements in 49 CFR 391.41(b)(10), and (b) by a medical examiner who
attests that the individual is otherwise physically qualified under 49
CFR 391.41; (2) that each individual provides a copy of the
ophthalmologist's or optometrist's report to the medical examiner at
the time of the annual medical examination; and (3) that each
individual provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file and retains a
copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 41 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (66 FR 17743; 66 FR 30502; 66 FR 33990; 66 FR 41654; 68 FR
35772; 68 FR 37197; 68 FR 44837; 68 FR 48989; 70 FR 30999; 70 FR 33937;
70 FR 41811; 70 FR 42615; 70 FR 46567; 72 FR 32705; 72 FR 40359; 72 FR
40360; 74 FR 26461; 74 FR 34074; 74 FR 34630; 74 FR 34632; 76 FR 37169;
76 FR 40445; 76 FR 44653; 76 FR 49531; 76 FR 50318; 76 FR 53710). Each
of these 41 applicants has requested renewal of the exemption and has
submitted evidence showing that the vision in the better eye continues
to meet the requirement specified at 49 CFR 391.41(b)(10) and that the
vision impairment is stable. In addition, a review of each record of
safety while driving with the respective vision deficiencies over the
past two years indicates each applicant continues to meet the vision
exemption requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by February 27, 2014.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 41 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2001-9258; FMCSA-
2001-9561; FMCSA-2003-15268; FMCSA-2005-21254; FMCSA-2009-0121; FMCSA-
2011-0140; FMCSA-2011-0141 and click the search button. When the new
screen appears, click on the blue ``Comment Now!'' button on the right
hand side of the page. On the new page, enter information required
including the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation. If
you submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2001-9258; FMCSA-2001-9561; FMCSA-2003-15268; FMCSA-2005-21254;
FMCSA-2009-0121; FMCSA-2011-0140; FMCSA-2011-0141 and click ``Search.''
Next, click ``Open Docket Folder'' and you will find all documents and
comments related to the proposed rulemaking.

    Issued on: January 2, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-01320 Filed 1-27-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31449-31450]
[FR Doc No: 2017-14269]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2017-0492]
RIN 1625-AA08

[Regattas and Marine Parades; Great Lakes Annual Marine Events

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce various special local regulations
for annual regattas and marine parades in the Captain of the Port
Detroit zone. Enforcement of these regulations is necessary and
intended to ensure safety of life on the navigable waters immediately
prior to, during, and after

these regattas or marine parades. During the aforementioned period, the
Coast Guard will enforce restrictions upon, and control movement of,
vessels in a specified area immediately prior to, during, and after
regattas or marine parades.

DATES: The regulations in 33 CFR 100.914, 100.915, 100.919, 100.927,
100.928 will be enforced without actual notice at specified dates and
times from July 7, 2017 until September 23, 2017. For the purposes of
enforcement, actual notice will be used from June 23, 2017, until July
7, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email Tracy Girard, Prevention Department, telephone
(313) 568-9564, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the following
special local regulations listed in 33 CFR part 100, Safety of Life on
Navigable Waters, on the following dates and times:
    (1) Sec.  100.919 International Bay City Grand Prix (formerly Bay
City River Roar), Bay City, MI. This special local regulation will be
enforced from 10 a.m. to 7 p.m. each day from June 23 through June 25,
2017.
    (2) Sec.  100.914 Trenton Rotary Roar on the River, Trenton, MI.
This special local regulation will be enforced from 8 a.m. to 8 p.m.
each day from July 14 through July 16, 2017.
    (3) Sec.  100.915 St. Clair River Classic Offshore Race, St. Clair,
MI. This special local regulation will be enforced from 10 a.m. to 7
p.m. each day from July 24 through July 30, 2017.
    (4) Sec.  100.928 Frogtown Race Regatta, Toledo, OH. This special
local regulation will be enforced from 5 a.m. to 7 p.m. on September
23, 2017.
    (5) Sec.  100.927 Partnership in Education, Dragon Boat Festival,
Toledo, OH. This special local regulation will be enforced from 6 a.m.
to 6 p.m. on July 22, 2017.

Special Local Regulations

    In accordance with Sec.  100.901, entry into, transiting, or
anchoring within these regulated areas is prohibited unless authorized
by the Coast Guard patrol commander (PATCOM). The PATCOM may restrict
vessel operation within the regulated area to vessels having particular
operating characteristics.
    Vessels permitted to enter this regulated area must operate at a
no-wake speed and in a manner that will not endanger race participants
or any other craft.
    The PATCOM may direct the anchoring, mooring, or movement of any
vessel within this regulated area. A succession of sharp, short signals
by whistle or horn from vessels patrolling the area under the direction
of the PATCOM shall serve as a signal to stop. Vessels so signaled
shall stop and shall comply with the orders of the PATCOM. Failure to
do so may result in expulsion from the area, a Notice of Violation for
failure to comply, or both.
    If it is deemed necessary for the protection of life and property,
the PATCOM may terminate the marine event or the operation of any
vessel within the regulated area.
    In accordance with the general regulations in Sec.  100.35 of this
part, the Coast Guard will patrol the regatta area under the direction
of a designated Coast Guard Patrol Commander (PATCOM). The PATCOM may
be contacted on Channel 16 (156.8 MHz) by the call sign ``Coast Guard
Patrol Commander.''
    Under the provisions of 33 CFR 100.928, vessels transiting within
the regulated area shall travel at a no-wake speed and remain vigilant
for event participants and safety craft. Additionally, vessels shall
yield right-of-way for event participants and event safety craft and
shall follow directions given by the Coast Guard's on-scene
representative or by event representatives during the event.
    The ``on-scene representative'' of the Captain of the Port Detroit
is any Coast Guard commissioned, warrant, or petty officer who has been
designated by the Captain of the Port Detroit to act on his behalf. The
on-scene representative of the Captain of the Port Detroit will be
aboard either a Coast Guard or Coast Guard Auxiliary vessel. The
Captain of the Port Detroit or his designated on scene representative
may be contacted via VHF Channel 16.
    The rules in this section shall not apply to vessels participating
in the event or to government vessels patrolling the regulated area in
the performance of their assigned duties.
    This document is issued under authority of 33 CFR 100.35 and 5
U.S.C. 552(a). If the Captain of the Port determines that any of these
special local regulations need not be enforced for the full duration
stated in this document, he may suspend such enforcement and notify the
public of the suspension via a Broadcast Notice to Mariners.

    Dated: June 29, 2017.
J.W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2017-14269 Filed 7-6-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76017-76018]
[FR Doc No: 2010-30570]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0275]

Determination That GLEEVEC (Imatinib Mesylate) Capsules, 50
Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
GLEEVEC (imatinib mesylate) Capsules, 50 milligrams (mg) and 100 mg,
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for imatinib mesylate capsules, 50 mg and 100 mg,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Rochelle Chodock Fink, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6236, Silver Spring, MD 20993-0002, 301-
796-0838.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which
authorized the approval of duplicate versions of drug products approved
under an ANDA procedure. ANDA applicants must, with certain exceptions,
show that the drug for which they are seeking approval contains the
same active ingredient in the same strength and dosage form as the
``listed drug,'' which is a version of the drug that was previously
approved. ANDA applicants do not have to repeat the extensive clinical
testing otherwise necessary to gain approval of a new drug application
(NDA). The only clinical data required in an ANDA are data to show that
the drug that is the subject of the ANDA is bioequivalent to the listed
drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
    GLEEVEC (imatinib mesylate) Capsules, 50 mg and 100 mg, are the
subject of NDA 21-335, held by Novartis Pharmaceutical Corp., and
initially approved on May 10, 2001. GLEEVEC is a protein-tyrosine
kinase inhibitor used in the treatment of a variety of malignancies,
including Ph+ chronic myeloid leukemia and acute lymphoblastic
leukemia, myelodysplastic/myeloproliferative diseases, aggressive
systemic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic
leukemia, dermatofibrosarcoma protuberans, and gastrointestinal stromal
tumors. FDA has moved GLEEVEC (imatinib mesylate) Capsules, 50 mg and
100 mg, to the ``Discontinued Drug Product List'' section of the Orange
Book.
    Hyman, Phelps & McNamara, PC, submitted a citizen petition dated
June 3, 2010 (Docket No. FDA-2010-P-0275), under 21 CFR 10.30,
requesting that the Agency determine whether GLEEVEC (imatinib
mesylate) Capsules, 50 mg and 100 mg, were withdrawn from sale for
reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec.  314.161 that GLEEVEC (imatinib
mesylate) Capsules, 50 mg and 100 mg were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that GLEEVEC (imatinib mesylate) Capsules, 50 mg
and 100 mg, were withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of GLEEVEC (imatinib mesylate) capsules, 50 mg and 100 mg, from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events and have found no information
that would indicate that these products were withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GLEEVEC (imatinib
mesylate) Capsules, 50 mg and 100 mg, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to GLEEVEC (imatinib mesylate)
Capsules, 50 mg and 100 mg, may be approved by the Agency as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for these drug products
should be revised to meet current standards, the Agency will advise
ANDA applicants to submit such labeling.

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30570 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P