[Federal Register: November 2, 2010 (Volume 75, Number 211)]
[Notices]
[Page 67357-67358]
[DOCID:fr02no10-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

October 26, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1429-000.
    Applicants: Trans-Union Interstate Pipeline, L.P.
    Description: Trans-Union Interstate Pipeline, L.P. submits tariff
filing per 154.203: Resubmittal of Order 587-U Compliance Filing to
Modify Tariff to be effective 11/1/2010.
    Filed Date: 10/25/2010.
    Accession Number: 20101025-5125.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 28, 2010.

    Docket Numbers: RP11-1430-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Texas Eastern Transmission, LP submits tariff filing
per 154.204: Capacity Reservation to be effective 11/24/2010.
    Filed Date: 10/25/2010.
    Accession Number: 20101025-5132.
    Comment Date: 5 p.m. Eastern Time on Monday, November 8, 2010.

    Docket Numbers: RP11-1431-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits tariff filing per
154.204: 20101025 Winter Fuel Rates 2010 to be effective 11/1/2010.
    Filed Date: 10/25/2010.
    Accession Number: 20101025-5248.
    Comment Date: 5 p.m. Eastern Time on Monday, November 8, 2010.

    Docket Numbers: RP11-1432-000.
    Applicants: ETC Tiger Pipeline, LLC.
    Description: ETC Tiger Pipeline, LLC submits tariff filing per
154.203: Tiger FTSA Non-Conforming Agreement Filing to be effective 12/
1/2010.
    Filed Date: 10/25/2010.
    Accession Number: 20101025-5271.
    Comment Date: 5 p.m. Eastern Time on Monday, November 8, 2010.

    Docket Numbers: RP11-1433-000.
    Applicants: Central New York Oil and Gas, LLC.
    Description: Central New York Oil and Gas, LLC submits tariff
filing per 154.203: Compliance filing of CNYOG in Docket Nos. RP10-
1258-000 and RP10-1258-001 to be effective 10/25/2010.
    Filed Date: 10/25/2010.
    Accession Number: 20101025-5288.
    Comment Date: 5 p.m. Eastern Time on Monday, November 8, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-27649 Filed 11-1-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6865-6866]
[FR Doc No: 2016-02522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-
2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-
2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-
2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-
2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-
2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376,
FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519,
FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014,
FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018,
FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434,
FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951 for ``Medical
Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this

information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2015, through December 31,
2015. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2015,
                                            Through December 31, 2015
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                    Applicant                   Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P150010, FDA-2015-M-3256...............  Fidia Farmaceutici,        HYMOVIS[supreg].............       8/28/2015
                                          S.p.A..
P100006, FDA-2015-M-3257...............  Biomimetic Therapeutics,   Augment[supreg] Bone Graft..        9/1/2015
                                          LLC.
P140005, FDA-2015-M-3258...............  OrthogenRx, Inc..........  GenVisc 850[supreg].........        9/2/2015
P140015, FDA-2015-M-3376...............  Tandem Diabetes Care,      t:slim G4 Insulin Pump With         9/8/2015
                                          Inc..                      Dexcom G4 Platinum CGM.
P140016, FDA-2015-M-3377...............  Cook Medical Inc.........  Zenith Alpha Thoracic              9/15/2015
                                                                     Endovascular Graft.
P070015/S128, FDA-2015-M-3516..........  Abbott Vascular..........  XIENCE V and XIENCE nano           9/23/2015
                                                                     Everolimus Eluting Coronary
                                                                     Stent System.
P110019/S075, FDA-2015-M-3516..........  Abbott Vascular..........  XIENCE PRIME and XIENCE            9/23/2015
                                                                     PRIME LL Everolimus Eluting
                                                                     Coronary Stent System,
                                                                     XIENCE Xpedition, XIENCE
                                                                     Xpedition SV and XIENCE
                                                                     Xpedition LL Everolimus
                                                                     Eluting Coronary Stent
                                                                     System, and XIENCE Alpine
                                                                     Everolimus Eluting Coronary
                                                                     Stent System.
P050047/S044, FDA-2015-M-3519..........  Allergan.................  Juv[eacute]derm Ultra XC           9/30/2015
                                                                     injectable gel.
P120010/S046, FDA-2015-M-4013..........  Medtronic, Inc...........  MiniMed 530G System with           10/2/2015
                                                                     Threshold Suspend featuring
                                                                     SmartGuardTM technology.
P150003, FDA-2015-M-4014...............  Boston Scientific          SYNERGYTM Everolimus-Eluting       10/2/2015
                                          Corporation.               Platinum Chromium Coronary
                                                                     Stent System.
P150013, FDA-2015-M-3520...............  Dako North America, Inc..  PD-L1 IHC 22C3 pharmDx......       10/2/2015
P100034/S013, FDA-2015-M-4015..........  Novocure, Ltd............  OptuneTM (Formerly the             10/5/2015
                                                                     NovoTTF-100A System).
P150025, FDA-2015-M-4016...............  Dako North America, Inc..  PD-L1 IHC 28-8 pharmDx......       10/9/2015
P130009/S034, FDA-2015-M-4017..........  Edwards Lifesciences, LLC  Edwards SAPIEN XTTM                10/9/2015
                                                                     Transcatheter Heart Valve,
                                                                     model 9300TFX, and
                                                                     Accessories.
P150014, FDA-2015-M-4069...............  Roche Molecular Systems,   cobas[supreg] HBV...........      10/14/2015
                                          Inc..
P150015, FDA-2015-M-4018...............  Roche Molecular Systems,   cobas[supreg] HCV...........      10/14/2015
                                          Inc..
P140019, FDA-2015-M-4343...............  Cerapedics, Inc..........  i-FACTORTM Peptide Enhanced        11/3/2015
                                                                     Bone Graft.
P120019/S007, FDA-2015-M-4344..........  Roche Molecular Systems,   cobas[supreg] EGFR Mutation       11/13/2015
                                          Inc..                      Test v2.
P130028, FDA-2015-M-4434...............  Algostim, LLC............  Algovita Spinal Cord              11/20/2015
                                                                     Stimulation System.
P150019, FDA-2015-M-4728...............  Medtronic MiniMed........  Paradigm Real-Time Revel           12/7/2015
                                                                     System.
P010030/S056, FDA-2015-M-3521..........  ZOLL Manufacturing         LifeVest Wearable                 12/17/2015
                                          Corporation.               Cardioverter Defibrillator
                                                                     Models 3000, 3100, and 4000.
P140030, FDA-2015-M-4947...............  Biotronik, Inc...........  Astron Peripheral Self-           12/17/2015
                                                                     Expanding Nitinol Stent
                                                                     System.
P980044/S027, FDA-2015-M-4951..........  Seikagaku Corporation....  VISCO-3TM...................      12/21/2015
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: February 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02522 Filed 2-8-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Page 74021]
[FR Doc No: 2012-29931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0568]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Experimental Study: Disease
Information in Branded Promotional Material

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Experimental Study: Disease
Information in Branded Promotional Material'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 20, 2012, the Agency submitted a
proposed collection of information entitled ``Experimental Study:
Disease Information in Branded Promotional Material'' to OMB for review
and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0724. The approval expires on November 30, 2015. A
copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain gov/public/do/PRAMain.

    Dated: December 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29931 Filed 12-11-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 17, 2006 (Volume 71, Number 52)]
[Notices]
[Page 13841-13842]
[DOCID:fr17mr06-79]

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 ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2003-0246; FRL-7767-9]

Notice of Filing of a Revised Pesticide Petition for Amendment to
Regulations for the Indirect or Inadvertent Residues of the Fungicide
Boscalid in or on Various Food Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the revised filing of a pesticide
petition proposing the amendment of regulations for the indirect or
inadvertent residues of the fungicide boscalid in or on the food
commodities beet, garden, roots; beet, sugar, roots; radish, roots;
turnip, roots; and vegetable, root and tuber, leaves, Group 2.

DATES: Comments must be received on or before April 17, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2003-0246 and pesticide petition number (PP)
1F6313, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2003-0246. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2003-0246. EPA's policy is that all comments received will be included
in the public 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 http://www.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 at
regulations.gov, your e-mail address will be captured automatically and
included as part of the comment that is placed in the public 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. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm/.

     Docket: All documents in the docket are listed in the
regulation.gov index. 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, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505C), Office of Pesticide Programs, U.

S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001;<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 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. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov/. To locate this information on the home

page of EPA's Electronic Docket, select ``Quick Search'' and type the
OPP docket ID number. Once the search has located the docket, clicking
on the ``Docket ID'' will bring up a list of all documents in the
docket for the pesticide including the petition summary.

Amendment to Existing Tolerance

    PP 1F6313. BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528, proposes to amend the tolerances
in 40 CFR 180.589 by lowering the established 1.0 parts per million
(ppm) tolerances to 0.1 ppm for indirect or inadvertent residues of the
fungicide boscalid (BAS 510F); [3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro(1,1'-biphenyl)-2-yl] in or on the food commodities beet, garden,
roots; beet, sugar, roots; radish, roots; turnip, roots; and vegetable,
root and tuber, leaves, Group 2 at 0.1 ppm. For the analytical method
in plants, the parent residue is extracted using an aqueous organic
solvent mixture followed by liquid/liquid (L/L) partitioning and a
column clean-up. Quantitation is by gas chromatography using mass
spectrometry (GS/MS). For livestock, the residues are extracted with
methanol. The extract is treated with enzymes in order to release the
conjugated glucuronic acid metabolite. The residues are then isolated
by L/L partition followed by column chromatography. The hydroxylated
metabolite is acetylated followed by a column clean-up. The parent and
acetylated metabolite are quantitated by GC with electron capture
detection. The original notice of filing for PP 1F6313 was published on
February 14, 2003 (68FR7542), and the resultant final rule was
published on July 30, 2003 (68FR44640). As per the final rule and
associated notice of pesticide registration, the BASF Corporation was
conditionally required to submit more extensive field data on the
vegetable, root, Subgroup 1B. Because the conditional data will result
in lowering the 1.0 ppm tolerances established in the final rule to 0.1
ppm, a revised petition, notice of filing, final rule, and a public
comment period are required.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 7, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 06-2630 Filed 3-16-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80867-80870]
[FR Doc No: 2015-32541]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76713; File No. SR-EDGX-2015-62]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of EDGX Exchange, Inc.

December 21, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 17, 2015, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the Market Data section of
its fee schedule to: (i) Adopt definitions for the terms ``Non-Display
Usage'' and ``Trading Platforms''; and (ii) amend the fees for EDGX
Depth, to increase the Internal Distributor fee and adopt a new fee for
Non-Display Usage.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend the Market Data section of its fee
schedule to: (i) Adopt definitions for the terms ``Non-Display Usage''
and ``Trading Platforms''; and (ii) amend the fees for EDGX Depth to
increase the Internal Distributor fee and adopt a new fee for Non-
Display Usage.
Definitions
    The Exchange proposes to adopt definitions for the terms ``Non-
Display Usage'' and ``Trading Platforms''. The proposed definitions are
designed to provide greater transparency with regard to how the
Exchange assesses fees for market data. Non-Display Usage would be
defined as ``any method of accessing a Market Data product that
involves access or use by a machine or automated device without access
or use of a display by a natural person or persons.'' \5\ The term
Trading Platform would be defined as ``any execution platform operated
as or by a registered National Securities Exchange (as defined in
Section 3(a)(1) of the Exchange Act), an Alternative Trading System (as
defined in Rule 300(a) of Regulation ATS), or an Electronic
Communications Network (as defined in Rule 600(b)(23) of Regulation
NMS).'' \6\
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    \5\ The proposed definition of Non-Display Usage is
substantially similar to Nasdaq Stock Market LLC (``Nasdaq'') Rule
7023(a)(2)(B), which defines Non-Display Usage as ``any method of
accessing Depth-of-Book data that involves access or use by a
machine or automated device without access or use of a display by a
natural person or persons.
    \6\ The proposed definition of Trading Platform is identical the
definition of Trading Platform under Nasdaq Rule 7023(a)(7).
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EDGX Depth Fees
    EDGX Depth is an uncompressed market data feed that provides depth-
of-book quotations and execution information based on equity orders
entered into the System.\7\
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    \7\ See Exchange Rule 13.8(a).
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    Internal Distributor Fee. Currently, the Exchange charges fees for
both internal and external distribution of EDGX Depth. The cost of EDGX
Depth for an Internal Distributor \8\ is currently

$500 per month. The Exchange also separately charges an External
Distributor \9\ of EDGX Depth a flat fee of $2,500 per month. The
Exchange does not charge Internal and External Distributors separate
display User \10\ fees. The Exchange now proposes to increase the fee
for Internal Distributors from $500 per month to $1,500 per month. The
Exchange does not proposes to amend its fees for External Distributors.
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    \8\ An ``Internal Distributor'' is defined as ``a Distributor
that receives the Exchange Market Data product and then distributes
that data to one or more Users within the Distributor's own
entity.'' See the Exchange Fee Schedule available at http://batstrading.com/support/fee_schedule/edgx/. A ``Distributor'' is
defined as ``any entity that receives the Exchange Market Data
product directly from the Exchange or indirectly through another
entity and then distributes it internally or externally to a third
party.'' Id.
    \9\ An ``External Distributor'' is defined as ``a Distributor
that receives the Exchange Market Data product and then distributes
that data to a third party or one or more Users outside the
Distributor's own entity.'' Id.
    \10\ A ``User'' is defined as ``a natural person, a
proprietorship, corporation, partnership, or entity, or device
(computer or other automated service), that is entitled to receive
Exchange data.'' Id.
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    Non-Display Usage Fee. The Exchange also proposes to adopt a new
fee for Non-Display Usage by Trading Platforms, which is similar to
fees currently being charged by Nasdaq and the New York Stock Exchange,
Inc. (``NYSE'').\11\ As proposed, subscribers to EDGX Depth would pay a
fee of $5,000 per month for Non-Display Usage of EDGX Depth by its
Trading Platforms. Trading Platforms, as defined above, include
registered National Securities Exchanges, Alternative Trading Systems
(``ATSs''), and Electronic Communications Networks (``ECNs'') as those
terms are defined in the Exchange Act and regulations and rules
thereunder. The fee would be assessed in addition to existing
Distributor fees. The fee of $5,000 per month would represent the
maximum charge per subscriber regardless of the number of Trading
Platforms the subscriber operates and receive the data for Non-Display
Usage. For example, if a subscriber operates three Trading Platforms
that receives EDGX Depth for Non-Displayed Usage, that subscriber would
continue to pay a total fee of $5,000 per month, rather than paying
$15,000 per month for its three Trading Platforms ($5,000 for each
Trading Platform).
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    \11\ See Nasdaq Rule 7023(d) (setting forth a Trading Platform
Fee of $5,000 per trading platform up to a maximum of three trading
platforms for depth-of-book data). See also NYSE Market Data Fees,
November 2015 (providing a monthly fee for non-display usage of
$5,000 for NYSE OpenBook).
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Implementation Date
    The Exchange proposes to implement the proposed changes to its fee
schedule on January 4, 2016.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\12\ in general, and
furthers the objectives of Section 6(b)(4),\13\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other recipients of
Exchange data. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
recipients of Exchange data. The Exchange believes the proposed fees
are competitive with those charged by other venues and, therefore,
reasonable and equitably allocated to recipients. Lastly, the Exchange
also believes that the proposed fees are reasonable and non-
discriminatory because they will apply uniformly to all recipients of
Exchange data.
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    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
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    The Exchange also believes that the proposed rule change is
consistent with Section 11(A) of the Act \14\ in that it supports (i)
fair competition among brokers and dealers, among exchange markets, and
between exchange markets and markets other than exchange markets and
(ii) the availability to brokers, dealers, and investors of information
with respect to quotations for and transactions in securities.
Furthermore, the proposed rule change is consistent with Rule 603 of
Regulation NMS,\15\ which provides that any national securities
exchange that distributes information with respect to quotations for or
transactions in an NMS stock do so on terms that are not unreasonably
discriminatory. In adopting Regulation NMS, the Commission granted
self-regulatory organizations and broker-dealers increased authority
and flexibility to offer new and unique market data to the public. It
was believed that this authority would expand the amount of data
available to consumers, and also spur innovation and competition for
the provision of market data.
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    \14\ 15 U.S.C. 78k-1.
    \15\ See 17 CFR 242.603.
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    In addition, the proposed fees would not permit unfair
discrimination because all of the Exchange's subscribers will be
subject to the proposed fees on an equivalent basis. EDGX Depth is
distributed and purchased on a voluntary basis, in that neither the
Exchange nor market data distributors are required by any rule or
regulation to make this data available. Accordingly, Distributors and
Users can discontinue use at any time and for any reason, including due
to an assessment of the reasonableness of fees charged. Firms have a
wide variety of alternative market data products from which to choose,
such as similar proprietary data products offered by other exchanges
and consolidated data. Moreover, the Exchange is not required to make
any proprietary data products available or to offer any specific
pricing alternatives to any customers.
    In addition, the fees that are the subject of this rule filing are
constrained by competition. As explained below in the Exchange's
Statement on Burden on Competition, the existence of alternatives to
EDGX Depth further ensures that the Exchange cannot set unreasonable
fees, or fees that are unreasonably discriminatory, when subscribers
can elect such alternatives. That is, the Exchange competes with other
exchanges (and their affiliates) that provide similar market data
products. If another exchange (or its affiliate) were to charge less to
consolidate and distribute its similar product than the Exchange
charges to consolidate and distribute EDGX Depth, prospective Users
likely would not subscribe to, or would cease subscribing to, EDGX
Depth.
    The Exchange notes that the Commission is not required to undertake
a cost-of-service or rate-making approach. The Exchange believes that,
even if it were possible as a matter of economic theory, cost-based
pricing for non-core market data would be so complicated that it could
not be done practically.\16\
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    \16\ The Exchange believes that cost-based pricing would be
impractical because it would create enormous administrative burdens
for all parties, including the Commission, to cost-regulate a large
number of participants and standardize and analyze extraordinary
amounts of information, accounts, and reports. In addition, it is
impossible to regulate market data prices in isolation from prices
charged by markets for other services that are joint products. Cost-
based rate regulation would also lead to litigation and may distort
incentives, including those to minimize costs and to innovate,
leading to further waste. Under cost-based pricing, the Commission
would be burdened with determining a fair rate of return, and the
industry could experience frequent rate increases based on
escalating expense levels. Even in industries historically subject
to utility regulation, cost-based ratemaking has been discredited.
As such, the Exchange believes that cost-based ratemaking would be
inappropriate for proprietary market data and inconsistent with
Congress's direction that the Commission use its authority to foster
the development of the national market system, and that market
forces will continue to provide appropriate pricing discipline. See
Appendix C to NYSE's comments to the Commission's 2000 Concept
Release on the Regulation of Market Information Fees and Revenues,
which can be found on the Commission's Web site at http://www.sec.gov/rules/concept/s72899/buck1.htm. See also Securities
Exchange Act Release No. 73816 (December 11, 2014), 79 FR 75200
(December 17, 2014) (SR-NYSE-2014-64) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to Establish an
Access Fee for the NYSE Best Quote and Trades Data Feed, Operative
December 1, 2014).

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    The proposed amendment to the Internal Distributor fee for EDGX
Depth is also equitable and reasonable as, despite the increase, the
fee proposed continues to be less than similar fees currently charged
by Nasdaq and NYSE for their depth-of-book data products.\17\ In
addition, the proposed Non-Display Usage fee by Trading Platforms for
EDGX Depth is equitable and reasonable as the fees proposed are equal
to, and in some cases less than, similar fees currently charged by
Nasdaq for its depth-of-book data. Like as proposed by the Exchange,
Nasdaq charges subscribers to its depth-of-book data utilized by
trading platforms on a non-displayed basis $5,000 per month.\18\
However, unlike the Exchange, a subscriber utilizing Nasdaq depth-of-
book data on more than one Trading Platform would pay $5,000 per month
for each up to a maximum fee of $15,000. The Exchange proposes to
charge the same rate regardless of the number of Trading Platforms
receiving the data for Non-Display Usage operated by that subscriber.
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    \17\ See Nasdaq Rule 7023(c) (providing for fees of $25,000 to
$500,000 to internal distributors of Nasdaq Depth-of-Book products).
See also NYSE Market Data Fees, November 2015 (providing a $5,000
per month access fee for NYSE OpenBook).
    \18\ See Nasdaq Rule 7023(d). See also NYSE Market Data Fees,
November 2015 (providing a monthly fee for non-display usage of
$5,000 for NYSE OpenBook).
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    The Trading Platform fee is also equitable and reasonable in that
it ensures that heavy users of the EDGX Depth pay an equitable share of
the total fees. Currently, External Distributors pay higher fees than
Internal Distributors based upon their assumed higher usage levels. The
Exchange believes that Trading Platforms are generally high users of
the data, using it to power a matching engine for millions or even
billions of trading messages per day.
    Lastly, the Exchange believes that the proposed definitions are
reasonable because they are designed to provide greater transparency to
Members with regard to how the Exchange would assess the proposed fee
for Non-Display Usage of EDGX Depth by Trading Platforms. The Exchange
believes that Members would benefit from clear guidance in its fee
schedule describing the manner in which is assess fees. These
definitions are intended to make the fee schedule clearer and less
confusing for investors and eliminate potential investor confusion,
thereby removing impediments to and perfecting the mechanism of a free
and open market and a national market system, and, in general,
protecting investors and the public interest. Lastly, the proposed
definitions are based on existing rules of Nasdaq.\19\
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    \19\ Nasdaq Rules 7023(a)(2)(B) and (a)(7).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange's ability to price EDGX Depth is constrained by: (i)
Competition among exchanges, other trading platforms, and Trade
Reporting Facilities (``TRF'') that compete with each other in a
variety of dimensions; (ii) the existence of inexpensive real-time
consolidated data and market-specific data and free delayed data; and
(iii) the inherent contestability of the market for proprietary data.
    The Exchange and its market data products are subject to
significant competitive forces and the proposed fees represent
responses to that competition. To start, the Exchange competes
intensely for order flow. It competes with the other national
securities exchanges that currently trade equities, with electronic
communication networks, with quotes posted in FINRA's Alternative
Display Facility, with alternative trading systems, and with securities
firms that primarily trade as principal with their customer order flow.
    In addition, EDGX Depth competes with a number of alternative
products. For instance, EDGX Depth does not provide a complete picture
of all trading activity in a security. Rather, the other national
securities exchanges, the several TRFs of FINRA, and ECNs that produce
proprietary data all produce trades and trade reports. Each is
currently permitted to produce depth-of-book information products, and
many currently do, including Nasdaq and NYSE.
    In sum, the availability of a variety of alternative sources of
information imposes significant competitive pressures on Exchange data
products and the Exchange's compelling need to attract order flow
imposes significant competitive pressure on the Exchange to act
equitably, fairly, and reasonably in setting the proposed data product
fees. The proposed data product fees are, in part, responses to that
pressure. The Exchange believes that the proposed fees would reflect an
equitable allocation of its overall costs to users of its facilities.
    In addition, when establishing the proposed fees, the Exchange
considered the competitiveness of the market for proprietary data and
all of the implications of that competition. The Exchange believes that
it has considered all relevant factors and has not considered
irrelevant factors in order to establish fair, reasonable, and not
unreasonably discriminatory fees and an equitable allocation of fees
among all Users. The existence of alternatives to EDGX Depth, including
existing similar feeds by other exchanges, consolidated data, and
proprietary data from other sources, ensures that the Exchange cannot
set unreasonable fees, or fees that are unreasonably discriminatory,
when subscribers can elect these alternatives or choose not to purchase
a specific proprietary data product if its cost to purchase is not
justified by the returns any particular vendor or subscriber would
achieve through the purchase.
    The Exchange believes the proposed increase to the Internal
Distributor fee and adoption of the fee for Non-Display Usage by
Trading Platforms for EDGX Depth would increase competition amongst the
exchanges that offer depth-of-book products. The Exchange notes that,
despite the proposed increase, the Internal Distribution fee for EDGX
Depth continues to be less than similar fees currently charged by
Nasdaq and NYSE for its depth-of-book data.\20\ In addition, the
proposed Non-Display Usage fee by Trading Platforms is equal to, and in
some cases less than, similar fees currently charged by Nasdaq for its
Depth-of-Book data.\21\
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    \20\ See supra note 17.
    \21\ See supra note 18.
---------------------------------------------------------------------------

    Lastly, the proposed definitions will not result in any burden on
competition. The Exchange believes that Members would benefit from
clear guidance in its fee schedule describing the manner in which is
assess fees. These definitions are intended to make the fee schedule
clearer and less confusing for investors and are not designed to have a
competitive impact.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \22\ and paragraph (f) of Rule 19b-4
thereunder.\23\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f).
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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-EDGX-2015-62 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-EDGX-2015-62. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2015-62, and should be
submitted on or before January 19, 2016.
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    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Brent J. Fields,
Secretary.
[FR Doc. 2015-32541 Filed 12-24-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Notices]
[Page 19381-19382]
[DOCID:fr14ap10-58]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0328; FRL-9137-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Collection Request for Control of
Evaporative Emissions From New and In-Use Portable Gasoline Containers
(Renewal), EPA ICR 2213.02, OMB Control No. 2060-0597

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on June 30, 2010. Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection as described below.

DATES: Comments must be submitted on or before June 14, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0328, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Environmental Protection Agency, EPA Docket Center
(EPA/DC), Air and Radiation Docket, Mailcode 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
     Hand Delivery: Docket Center, (EPA/DC), EPA, West Room
B102, 1301 Constitution Ave., NW., Washington, DC. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0328. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online 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 http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
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 http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public 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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: David Good, Compliance and Innovative
Strategies Division, Office of Transportation and Air Quality,
Environmental Protection Agency, 2000 Traverwood, Ann Arbor, Michigan
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2010-0328, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air Docket in
the Docket Center (EPA/DC), EPA West, EPA Headquarters Library, Room
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
202-566-1744, and the telephone number for the Air Docket is 202-566-
1742.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

Docket ID No. EPA-HQ-OAR-2010-0328

    Affected entities: Entities potentially affected by this action are
manufacturers of portable fuel containers.
    Title: Control of Evaporative Emissions from New and In-Use
Portable Gasoline Containers (Renewal).
    ICR numbers: EPA ICR No. 2213.03, OMB Control No. 2060-0597.
    ICR status: This ICR is currently scheduled to expire on June 30,
2010. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: EPA is required under Section 183(e) of the Clean Air Act
to regulate Volatile Organic Compound (VOC) emissions from the use of
consumer and commercial products. Under regulations promulgated on
February 26, 2007 (72 FR 8428) manufacturers of new portable gasoline
containers are required to obtain certificates of conformity with the
Clean Air Act, effective January 1, 2009. This ICR covers the burdens
associated with this certification process. EPA reviews information
submitted in the application for certification to determine if the
container design conforms to applicable requirements and to verify that
the required testing has been performed. The certificate holder is
required to keep records on the testing and collect and keep warranty
and defect information for annual reporting on in-use performance of
their products. The respondent must also retain records on the units
produced, apply serial numbers to individual containers, and track the
serial numbers to their certificates of conformity. Any information
submitted for which a claim of confidentiality is made is safeguarded
according to EPA regulations at 40 CFR 2.201 et seq.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 63.8
hours for an average of two responses per year. Burden means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements which have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 10.
    Frequency of response: Yearly.
    Estimated total average number of responses for each respondent: 2.
    Estimated total annual burden hours: 638
    Estimated total annual costs: $25,206. This includes an estimated
labor burden cost of $24,687 and an estimated cost of $519 for capital
investment or maintenance and operational costs.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: April 8, 2010.
Lori Stewart,
Acting Director, Office of Transpotation and Air Quality.
[FR Doc. 2010-8519 Filed 4-13-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56639-56640]
[FR Doc No: 2022-19983]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP19-502-000; CP19-502-001]

Commonwealth LNG, LLC; Notice of Availability of the Final
Environmental Impact Statement for the Proposed Commonwealth LNG
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Commonwealth LNG Project, proposed by Commonwealth LNG, LLC
(Commonwealth) in the above-referenced docket. Commonwealth requests
authorization to site, construct, and operate a natural gas
liquefaction and export terminal and an integrated Natural Gas Act
Section 3 natural gas pipeline, in Cameron Parish, Louisiana.
    The final EIS assesses the potential environmental effects of the
construction and operation of the Commonwealth LNG Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). FERC staff concludes that approval of the proposed project,
with the mitigation measures recommended in the EIS, would result in
some adverse environmental impacts. Most of these impacts on the
environment would be reduced to less than significant levels; however,
FERC staff conclude there would be significant impacts on visual
resources and impacts on environmental justice communities would be
disproportionately high and adverse. Regarding climate change impacts,
this EIS is not characterizing the proposed project's greenhouse gas
emissions as significant or insignificant because the Commission is
conducting a generic proceeding to determine whether and how the
Commission will conduct significance determinations going forward.\1\
---------------------------------------------------------------------------

    \1\ Consideration of Greenhouse Gas Emissions in Natural Gas
Infrastructure Project Reviews, 178 FERC ] 61,108 (2022); 178 FERC ]
61,197 (2022).
---------------------------------------------------------------------------

    The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department
of Energy, U.S. Department of Transportation's Pipeline and Hazardous
Materials Safety Administration, U.S. Environmental Protection Agency,
U.S. Fish and Wildlife Service, and National Oceanic and Atmospheric
Administration's National Marine Fisheries Service participated as
cooperating agencies in the preparation of the final EIS. Cooperating
agencies have jurisdiction by law or special expertise with respect to
resources potentially affected by the proposal and participate in the
NEPA analysis. Although the cooperating agencies provided input to the
conclusions and recommendations presented in the final EIS, the
agencies will present their own conclusions and recommendations in
their respective Records of Decision for the project.
    The final EIS addresses the potential environmental effects of the
construction and operation of the following project facilities:
     six liquefaction trains;
     six gas pre-treatment trains;
     two flare systems (containing a total of four flares);
     six liquefied natural gas (LNG) storage tanks;
     one marine facility consisting of an LNG carrier berth and
barge dock;
     utilities (e.g., electricity generation, water, plant air,
nitrogen, hot oil system);
     operation and safety systems (e.g., access and haul roads,
storm protection structures, stormwater drainage systems, spill
containment system, fire suppression facilities, facility lighting and
security, emergency shutdown systems);
     appurtenant facilities (e.g., administrative facilities,
maintenance and warehouse buildings, marine facility operator
buildings, equipment enclosures and electrical rooms);
     3.0 miles of 42-inch-diameter pipeline;
     two interconnection facilities with existing pipelines;
and
     one metering station.
    The Commission mailed a copy of the Notice of Availability to
federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. The final EIS is only available in electronic format. It may be
viewed and downloaded from the FERC's website (www.ferc.gov), on the
natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In
addition, the final EIS may be accessed by using the eLibrary link on
the FERC's website. Click on the eLibrary link (https://

elibrary.ferc.gov/eLibrary/search) select ``General Search'' and enter
the docket number in the ``Docket Number'' field (i.e., CP19-502). Be
sure you have selected an appropriate date range. For assistance,
please contact FERC Online Support at [email protected] or
toll free at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    The final EIS is not a decision document. It presents Commission
staff's independent analysis of the environmental issues for the
Commission to consider when addressing the merits of all issues in this
proceeding.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: September 9, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19983 Filed 9-14-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77878-77879]
[FR Doc No: 2010-31240]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0014]

Determination of Regulatory Review Period for Purposes of Patent
Extension; FREESTYLE NAVIGATOR

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for FREESTYLE NAVIGATOR and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and 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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).

    FDA recently approved for marketing the medical device, FREESTYLE
NAVIGATOR. FREESTYLE NAVIGATOR is indicated for continually recording
interstitial fluid glucose levels in people (ages 18 and older) with
diabetes mellitus for the purpose of improving diabetes management.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for FREESTYLE NAVIGATOR (U.S.
Patent No. 5,262,035) from Abbott Diabetes Care Inc., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
February 17, 2010, FDA advised the Patent and Trademark Office that
this medical device had undergone a regulatory review period and that
the approval of FREESTYLE NAVIGATOR represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that the FDA determine the product's
regulatory review period. FDA has determined that the applicable
regulatory review period for FREESTYLE NAVIGATOR is 2,320 days. Of this
time, 750 days occurred during the testing phase of the regulatory
review period, while 1,570 days occurred during the approval phase.
These periods of time were derived from the following dates:
    1. The date clinical investigation on humans is begun as approved
by an institutional review board (IRB) under section 520(g)(3) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and when no
investigational device exemption (IDE) is required: November 6, 2001.
The applicant claims that investigation of the device qualified for a
non-significant risk study for the purpose of establishing clinical
data necessary to support a subsequent premarket approval under section
515 of the FD&C Act. FDA has verified the applicant's claim that the
device did not require an IDE under section 520(g) of the FD&C act, but
did require IRB approval, granted November 6, 2001, for human tests to
begin. This date represents the beginning of the testing phase of the
regulatory review period.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November
25, 2003. The applicant claims November 24, 2003, as the date the first
premarket approval application (PMA) for FREESTYLE NAVIGATOR (PMA
P030048) was initially submitted. However, FDA records indicate that
PMA P030048 was submitted on November 25, 2003.
    3. The date the application was approved: March 12, 2008. FDA has
verified the applicant's claim that PMA P050020 was approved on March
12, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,826 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 14, 2011. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by June 13, 2011. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. Comments and petitions that have not been
made publicly available on regulations.gov may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31240 Filed 12-13-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 29, 2005 (Volume 70, Number 249)]
[Notices]
[Page 77203-77204]
[DOCID:fr29de05-98]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 1-07616]

Issuer Delisting; Notice of Application of Pioneer Kabushiki
Kaisha (English Translation, Pioneer Corporation) To Withdraw Its
Common Stock (Each Represented by One American Depositary Share), From
Listing and Registration on the New York Stock Exchange, Inc.

December 22, 2005.
    On December 13, 2005, Pioneer Kabushiki Kaisha (English
translation, Pioneer Corporation), a company incorporated under the
laws of Japan (``Issuer''), filed an application with the Securities
and Exchange Commission (``Commission''), pursuant to Section 12(d) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock (each represented by one
American Depositary Share) (``Security''), from listing and
registration on the New York Stock Exchange, Inc. (``NYSE'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    On December 8, 2005, the Board of Directors (``Board'') of the
Issuer approved a resolution to withdraw the Security from listing and
registration on the NYSE. The Issuer stated that the Board decided to
withdraw the Security from listing on NYSE as part of a global
restructuring of the Issuer's operations which includes, among other
initiatives, maintaining the listing of the Security solely on the
Tokyo Stock Exchange. The Issuer stated that the Security will continue
to list on the Tokyo Stock Exchange, its principal trading market.
    The Issuer stated in its application that it has complied with the
NYSE's rules governing an issuer's voluntary withdrawal of a security
from listing and registration by complying with all applicable laws in
effect in Japan, and by providing the NYSE with the required documents
governing the removal of securities from listing and registration on
the NYSE.
    The Issuer's application relates solely to the withdrawal of the
Security from listing on NYSE and from registration under Section 12(b)
of the Act,\3\ and shall not affect its obligation to be registered
under Section 12(g) of the Act.\4\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78l(b).
    \4\ 15 U.S.C. 78l(g).
---------------------------------------------------------------------------

    Any interested person may, on or before January 17, 2006, comment
on the facts bearing upon whether the application has been made in

accordance with the rules of NYSE, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/delist.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

the File Number 1-07616 or;

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 450 Fifth Street, NW.,
Washington, DC 20549-0609.

All submissions should refer to File Number 1-07616. This file number
should be included on the subject line if e-mail is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
Internet Web site (http://www.sec.gov/rules/delist.shtml). Comments are

also available for public inspection and copying in the Commission's
Public Reference Room. All comments received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
[FR Doc. E5-8057 Filed 12-28-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Page 13175]
[FR Doc No: 2020-04582]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4473-DR; Docket ID FEMA-2020-0001]

Puerto Rico; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Puerto Rico (FEMA-4473-DR), dated January 16,
2020, and related determinations.

DATES: This amendment was issued February 14, 2020.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Puerto Rico is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of January 16, 2020.

    The municipalities of Adjuntas, Jayuya, Juana D[iacute]az,
Lajas, Las Mar[iacute]as, Mayag[uuml]ez, Sabana Grande, and Utuado
for debris removal and emergency protective measures (Categories A
and B), including direct federal assistance, under the Public
Assistance program (already designated for Individual Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-04582 Filed 3-5-20; 8:45 am]
BILLING CODE 9111-23-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request 2. OMB control number b. None U. S. Environmental Protection Agency, Office of Air and a. 2 0 6 0   0 3 9 3 Radiation 3. Type of information collection ( check one) 4. Type of review requested ( check one)

a. New collection a. X Regular b. Revision of a currently approved collection b. Emergency  Approval requested by: / /

c. X Extension of a currently approved collection c. Delegated d. Reinstatement, without change, of a previously 5. Small entities approved collection for which approval has expired Will this information collection have a significant economic impact on a e. Reinstatement, with change, of a previously substantial number of small entities? Yes X No approved collection for which approval has expired f. Existing collection in use without OMB control 6. Requested expiration date number a. X Three years from approval date For b   f, note Item A2 of Supporting Statement Instructions b. Other Specify: /

7. Title National Volatile Organic Compound Emission Standards for Architectural Coatings ( 40 CFR part 59, subpart D) ( Renewal)

8. Agency form number( s) ( if applicable)

EPA ICR No. 1750.04 9. Keywords Architectural coatings, volatile organic compounds, emission standards 10. Abstract The EPA is regulating architectural coating manufacturers and importers under the Authority of Section 183( e) of the Clean Air Act. The Architectural Coatings rule requires manufacturers and importers of architectural coatings to submit a one time initial notification report, and meet labeling requirements. Optional provisions, such as the recycled coating provision, the tonnage exemption, and the exceedance fee provision, contain additional recordkeeping, reporting and labeling requirements. The EPA will use this information to monitor compliance with the standards.

11. Affected public 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms a. Voluntary b. P Business or other for profit e. Federal Government b. X Required to obtain or retain benefits c. Not for profit institutions f. X State, Local or Tribal c. P Mandatory Government 13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Number of respondents 500 a. Total annualized capital/ startup costs 0 b. Total annual responses 855 b. Total annual costs ( O& M) 0 1. Percentage of these responses c. Total annualized cost requested 0 collected electronically 0 % d. Current OMB inventory 0 c. Total annual hours requested 22,761 e. Difference 0 d. Current OMB inventory 23,411 f. Explanation of difference e. Difference ( 650) 1. Program change 0 f. Explanation of difference 2. Adjustment 0 1. Program change 0 2. Adjustment ( 650)

15. Purpose of information collection 16. Frequency of recordkeeping or reporting ( check all that apply)

( Mark primary with " P" and all others that apply with " X") a. X Recordkeeping b. Third party disclosure a. Application for benefits e. Program planning or c. X Reporting b. Program evaluation management 1. X On occasion 2. Weekly c. General purpose statistics f. Research 3. Monthly 4. Quarterly d. Audit g. P Regulatory or compliance 5. Semi annually 6. X Annually compliance 7. Biennially 8. Other 17. Statistical methods NO 18. Agency contact ( person who can best answer questions regarding the Dave Salman, OAQPS/ ESD; ( 919) 541 0859 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Date Director, Regulatory Information Division OMB 83 I 10/ 95