[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Notices]
[Page 68135]
[DOCID:fr04de07-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-24-000]

Florida Gas Transmission Company, LLC; Notice of Request Under
Blanket Authorization

November 27, 2007.
    Take notice that on November 13, 2007, Florida Gas Transmission
Company, LLC, (FGT), 5444 Westheimer Road, Houston Texas 77056, filed
in Docket No. CP08-24-000, a prior notice request pursuant to sections
157.205 and 157.212 of the Federal Energy Regulatory Commission's
regulations under the Natural Gas Act for authorization to construct,
own, and operate an interconnect with Kinder Morgan Louisiana Pipeline
LLC (KMLP), located in Acadia Parish, Louisiana, to receive re-
vaporized liquefied natural gas, all as more fully set forth in the
application, which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,

(202) 502-8659.
    FGT proposes the installation of a 12-inch tap and valve,
approximately 50 feet of 16-inch connecting pipe, and electronic flow
measurement. FGT estimates the cost of construction to be $226,000. FGT
states that all cost associated with such facilities will be reimbursed
by KMLP. FGT asserts that FGT will own, maintain, and operate the over-
pressure protection equipment that KMLP will install in the KMLP Meter
Station.
    Any questions regarding the application should be directed to
Stephen Veatch, Senior Director of Certificates & Tariffs, Florida Gas
Transmission Company, LLC, 5444 Westheimer Road, Houston Texas 77056,
call<PHONE_NUMBER>, fax<PHONE_NUMBER>, or by e-mail
<EMAIL_ADDRESS>
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23450 Filed 12-3-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15012-15014]
[FR Doc No: 2023-04994]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-76-000]

ANR Pipeline Company; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on February 22, 2023, ANR Pipeline Company (ANR),
700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, filed in
the above-referenced docket, a prior notice request pursuant to
sections 157.205 and 157.216(b) of the Federal Energy Regulatory
Commission's (Commission) regulations under the Natural Gas Act (NGA),
and ANR's blanket certificate issued in Docket No. CP82-480-000,\1\ for
authorization to abandon one injection/withdrawal well and appurtenant
facilities located at the Goodwell Storage Field in Newaygo County,
Michigan, all as more fully set forth in the application which is on
file with the Commission and open for public inspection.
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    \1\ See Michigan Wisconsin Pipe Line Company, 20 FERC
62,595 (1982).

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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, ANR Pipeline Company,
700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, at (832)
320-5477 or [email protected].
    Pursuant to Section 157.9 of the Commission's Rules of Practice and
Procedure,\2\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
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    \2\ 18 CFR (Code of Federal Regulations) Sec.  157.9.
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Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on May 05, 2023. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\3\ any person \4\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \3\ 18 CFR 157.205.
    \4\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\5\ and must be submitted by
the protest deadline, which is May 05, 2023. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
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    \4\ 18 cfr 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \6\ and the regulations under the NGA \7\ by the
intervention deadline for the project, which is May 05, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \6\ 18 CFR 385.214.
    \7\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before May 05, 2023. The filing of a comment alone will not serve
to make the filer a party to the proceeding. To become a party, you
must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-76-000 in your submission:
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \8\
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    \8\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
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    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-76-000.

To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory

Commission, 888 First Street NE, Washington, DC 20426
To mail via any other courier, use the following address: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: David A.
Alonzo, Manager, Project Authorizations, ANR Pipeline Company, 700
Louisiana Street, Suite 1300, Houston, TX 77002-2700 or
[email protected]. Any subsequent submissions by an intervenor
must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. 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 which 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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: March 6, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-04994 Filed 3-9-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35635]
[DOCID:fr21jn06-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-387-000]

Crossroads Pipeline Company; Notice of Proposed Changes in FERC
Gas Tariff

June 13, 2006.
    Take notice that on June 8, 2006, Crossroads Pipeline Company
(Crossroads) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume No. 1, the following revised tariff sheets with a
proposed effective date of July 8, 2006:

First Revised Sheet No. 78.
First Revised Sheet No. 79.
Original Sheet No. 79A.
First Revised Sheet No. 80.
First Revised Sheet No. 81.
First Revised Sheet No. 476.
First Revised Sheet No. 556.

    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9782 Filed 6-20-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23752-23753]
[DOCID:fr04my10-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 27, 2010.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER06-560-008.
    Applicants: Credit Suisse Energy LLC.
    Description: Notice of Non-Material Change in Status of Credit
Suisse Energy LLC.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-5092.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER06-739-026; ER02-537-029; ER03-983-026; ER06-738-
026; ER07-501-026; ER07-758-022; ER08-649-018.
    Applicants: Cogen Technologies Linden Venture, L.P., Fox Energy
Company LLC, Birchwood Power Partners, L.P., Shady Hills Power Company,
L.L.C., East Coast Power Linden Holding, LLC, EFS Parlin Holdings LLC,
Inland Empire Energy Center, LLC.
    Description: Notice of Non-Material Change in Status and Request
for Waiver of East Coast Power Linden Holding, LLC, et al.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-5124.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-662-001.
    Applicants: CER Generation, LLC.
    Description: Amendment to Application of CER Generation, LLC.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-5113.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 6, 2010.

    Docket Numbers: ER10-1091-000.
    Applicants: Northwestern Wisconsin Electric Company.
    Description: Northwestern Wisconsin Electric Co submits proposed
rate change to NWEC original FERC Rate Schedule 2.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-0218.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1092-000.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits Second
Amended and Restated Agreement for Electric Service between PNM's
Wholesale Power Marketing Department and Gallup, dated 4/18/2010.
    Filed Date: 04/22/2010.
    Accession Numbers: 20100426-0217.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 13, 2010.

    Docket Numbers: ER10-1094-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits Revised Network Integration
Transmission Service Agreement dated 4/8/2010 etc.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-0216.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1095-000.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits
Construction Agreement RS-09-0064, Construction of the Interconnection
Association, Inc to facilitate the interconnection of the new PNM
Mendoza Substations etc.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-0215.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1096-000.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits First
revised Service Agreement for Network Integration Transmission Service
Agreement et al.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100426-0214.

    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1097-000.
    Applicants: PBF Power Marketing LLC.
    Description: PBF Power Marketing LLC submits tariff filing per
35.12: Initial Market Based Rates to be effective 6/1/2010.
    Filed Date: 04/27/2010.
    Accession Numbers: 20100427-5006.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 18, 2010.

    Docket Numbers: ER10-1098-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits an Amended and Restated Facilities Construction Agreement among
the Midwest ISO etc.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100427-0203.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1099-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison submits revisions to
Exhibit C BLY of the contract with Western Area Power Administration.
    Filed Date: 04/26/2010.
    Accession Numbers: 20100427-0205.
    Comment Date: 5 p.m. Eastern Time on Monday, May 17, 2010.

    Docket Numbers: ER10-1100-000.
    Applicants: Unitil Power Corporation.
    Description: Unitil Power Corp. submits Amended Unitil System
Agreement Annual Filing.
    Filed Date: 04/23/2010.
    Accession Numbers: 20100426-0241.
    Comment Date: 5 p.m. Eastern Time on Friday, May 14, 2010.

    Docket Numbers: ER10-1101-000.
    Applicants: Mint Energy, LLC.
    Description: Mint Energy, LLC submits tariff filing per 35.12: Rate
Schedule FERC No. 1 to be effective 6/26/2010.
    Filed Date: 04/27/2010.
    Accession Numbers: 20100427-5044.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 18, 2010.

    Docket Numbers: ER10-1102-000.
    Applicants: Madison Paper Industries.
    Description: Madison Paper Industries submits tariff filing per
35.12: Baseline Filing to be effective 3/1/2009.
    Filed Date: 04/27/2010.
    Accession Numbers: 20100427-5091.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 18, 2010.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES10-36-000.
    Applicants: Ameren Energy Generating Company.
    Description: Application for Blanket Authorization Under FPA 204
and 18 CFR Part 34 of Ameren Energy Generating Company.
    Filed Date: 04/27/2010.
    Accession Numbers: 20100427-5039.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 18, 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. 2010-10349 Filed 5-3-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Notices]
[Page 50182-50183]
[DOCID:fr30se09-41]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8964-1]

Methodology for Deriving Ambient Water Quality Criteria for the
Protection of Human Health; Technical Support Document, Volume 3:
Development of Site-Specific Bioaccumulation Factors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of final document.

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SUMMARY: In 2000, EPA announced the availability of final revisions to
the Methodology for Deriving Ambient Water Quality Criteria for the
Protection of Human Health (2000) (hereafter ``2000 Human Health
Methodology'') published pursuant to section 304(a) (1) of the Clean
Water Act (CWA). Along with the 2000 Human Health Methodology, EPA
committed to publishing several technical support documents to provide
additional detail to the Methodology document, including two documents
that describe the development of bioaccumulation factors for use in
ambient water quality criteria calculations. In 2003, EPA announced the
release of the Technical Support Document Volume 2: Development of
National Bioaccumulation Factors (hereafter ``National BAF TSD'').
Today, the Agency is releasing the Technical Support Document, Volume
3: Development of Site-Specific Bioaccumulation Factors (hereafter
``Site-Specific BAF TSD'') that accompanies the Methodology and the
National BAF TSD. EPA accepted scientific views on the draft document
in two separate Federal Register Notices. The National BAF TSD contains
technical details on how EPA develops national bioaccumulation factors
for use in deriving national recommended ambient water quality criteria
for protecting human health. The Site-Specific BAF TSD contains
technical details on how States and Tribes may develop site-specific
bioaccumulation factors for use in deriving site-specific ambient water
quality criteria for protecting human health. The goal in deriving
site-specific BAFs is to determine the most accurate estimates of
bioaccumulation feasible for each site.

FOR FURTHER INFORMATION CONTACT: Heidi L. Bethel, Health and Ecological
Criteria Division (4304T), U.S. EPA, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460;<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Where can I find additional information on this document?

    EPA solicited scientific views on the draft document in two
separate Federal Register Notices (73 FR 36866 and 73 FR 46624).
Scientific views were accepted at http://www.regulations.gov at Docket
ID No. EPA-HQ-OW-2008-0494. Publicly available docket materials are
available either electronically in http://www.regulations.gov or in
hard copy at the Office of Water Docket/EPA/DC, 1301 Constitution Ave,
NW., EPA West, Room 3334, Washington DC. This Docket Facility is open
from 8:30 a.m. until 4:30 p.m., EDT, Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the Office of Water is
(202) 566-2426.
    Scientific views received by EPA and a document indicating EPA's
response to scientific views can also be found at the docket locations
listed above. A range of scientific views were received on the
document. Views received did result in some minor changes to the
document including some changes to table and figure captions; an
example calculation correction and clarification of chemical types for
which the document applies. A comprehensive list of changes to the
document can be found in the response document. Other comments were
addressed in the comment document, but did not result in changes to the
document.

A. Does This Action Apply to Me?

    The intended audience for the Site-Specific BAF TSD includes State
and Tribal water quality staff scientists or risk assessors
(``investigators'') who are responsible for deriving State or Tribal
water quality standards, stakeholders interested in developing site-
specific BAFs, and other users interested in site-specific
bioaccumulation issues for other applications.

II. What Are Water Quality Criteria?

    Water quality criteria are scientifically derived numeric and/or
narrative values that protect applicable designated uses, e.g., aquatic
life or human health, from the deleterious effects of pollutants in
ambient water. Section 304(a)(1) of the Clean Water Act requires EPA to
develop and publish and, from time to time, revise water quality
criteria to accurately reflect the latest scientific knowledge. Water
quality criteria developed under section 304(a) are based solely on
data and scientific judgments on the relationship between pollutant
concentrations and environmental and human health effects. Section
304(a) criteria do not reflect consideration of economic impacts or the
technological feasibility of meeting the chemical concentrations in
ambient water. Section 304(a) criteria provide guidance to States and
authorized Tribes in adopting water quality standards that ultimately
provide a basis for controlling discharges or releases of pollutants.
The criteria also provide guidance to EPA when promulgating Federal
regulations

under section 303(c) when such action is necessary.
    The 2000 Human Health Methodology, along with the Technical Support
Documents, provides States and authorized Tribes with guidance to
adjust water quality criteria developed by EPA under section 304 to
reflect local conditions or to develop their own water quality criteria
using scientifically defensible methods. EPA believes that ambient
water quality criteria inherently require several risk management
decisions that are, in many cases, better made at the State, Tribal, or
regional level. EPA encourages States and authorized Tribes to use the
final Methodology and Technical Support Documents to develop site-
specific water quality criteria to appropriately reflect local
conditions. The Site-Specific BAF TSD, released with today's
announcement, will assist States and authorized Tribes in development
of site-specific BAFs for use in site-specific ambient water quality
criteria calculations.

III. Background Information on the Bioaccumulation Factors Technical
Support Document Volume III (Site-Specific BAF TSD)

    In order to prevent harmful exposures to chemicals in water through
eating contaminated fish and shellfish, national section 304(a) water
quality criteria for protecting human health address chemical
bioaccumulation in aquatic organisms. Bioaccumulation occurs when
aquatic organisms accumulate chemicals in their bodies when they are
exposed to these chemicals through the surrounding media (e.g., water,
food, sediment). The extent of bioaccumulation by aquatic organisms
varies widely depending on the chemical and the species, but it can be
extremely high for some highly persistent and lipid-soluble chemicals.
For such highly bioaccumulative chemicals, concentrations in aquatic
organisms may pose unacceptable human health risks from eating fish and
shellfish even when concentrations in water are too low to cause
unacceptable health risks from drinking the water.
    EPA developed detailed procedures and guidelines described in the
2000 Human Health Methodology for estimating bioaccumulation factor
(BAF) values for use in deriving or revising ambient water quality
criteria. The National BAF TSD discusses the technical basis for
developing national BAFs, the underlying assumptions and uncertainties
inherent to the approach, and applying the bioaccumulation component of
the 2000 Human Health Methodology. The Site-Specific BAF TSD expands on
the information presented in the National BAF TSD by providing users
with specific information on how to calculate site-specific BAFs for
use in modifying the national section 304(a) criteria, and is available
on EPA's Web site at http://www.epa.gov/waterscience/criteria/
humanhealth/method/index.html. Both documents rely on a framework for
selecting the appropriate procedure for deriving BAFs that is based on
chemical properties, biological activity and scientific information.
The Site-Specific BAF TSD presents methods for States, Tribes and other
interested parties to calculate BAFs that are specific to their site.
The goal in deriving site-specific BAFs is to determine the most
accurate estimates of bioaccumulation feasible for each site.

    Dated: September 21, 2009.
Michael H. Shapiro,
Acting Assistant Administrator, Office of Water.
[FR Doc. E9-23631 Filed 9-29-09; 8:45 am]

BILLING CODE 6560-50-P


region facility species. orig stage year impinged. est entrained. est notes qc dummy dummy dummy dummy dummy  999  999 dummy dummy lake bailly alewife age01 1975 143,346 . RM# 35654 pg IV 3/ 4 mlefer lake bailly gizzard. shad age01 1975 3,168 . RM# 35654 pg IV 3/ 4 mlefer lake bailly brown. trout age01 1975 60 . RM# 35654 pg IV 3/ 4 mlefer lake bailly lake. trout age01 1975 21 . RM# 35654 pg IV 3/ 4 mlefer lake bailly coho. salmon age01 1975 25 . RM# 35654 pg IV 3/ 4 mlefer lake bailly salmonid age01 1975 4 . RM# 35654 pg IV 3/ 4 mlefer lake bailly rainbow. smelt age01 1975 926 . RM# 35654 pg IV 3/ 4 mlefer lake bailly spottail. shiner age01 1975 3,181 . RM# 35654 pg IV 3/ 4 mlefer lake bailly emerald. shiner age01 1975 8 . RM# 35654 pg IV 3/ 4 mlefer lake bailly black. bullhead age01 1975 184 . RM# 35654 pg IV 3/ 4 mlefer lake bailly channel. catfish age01 1975 4 . RM# 35654 pg IV 3/ 4 mlefer lake bailly tadpole. madtom age01 1975 5 . RM# 35654 pg IV 3/ 4 mlefer lake bailly troutperch age01 1975 662 . RM# 35654 pg IV 3/ 4 mlefer lake bailly rock. bass age01 1975 14 . RM# 35654 pg IV 3/ 4 mlefer lake bailly green. sunfish age01 1975 49 . RM# 35654 pg IV 3/ 4 mlefer lake bailly pumpkinseed age01 1975 27 . RM# 35654 pg IV 3/ 4 mlefer lake bailly bluegill age01 1975 238 . RM# 35654 pg IV 3/ 4 mlefer lake bailly black. crappie age01 1975 4 . RM# 35654 pg IV 3/ 4 mlefer lake bailly white. crappie age01 1975 14 . RM# 35654 pg IV 3/ 4 mlefer lake bailly centrarchid age01 1975 34 . RM# 35654 pg IV 3/ 4 mlefer lake bailly yellow. perch age01 1975 795 . RM# 35654 pg IV 3/ 4 mlefer lake bailly ninespine. stickleback age01 1975 145 . RM# 35654 pg IV 3/ 4 mlefer lake bailly johnny. darter age01 1975 35 . RM# 35654 pg IV 3/ 4 mlefer lake bailly mottled. sculpin age01 1975 144 . RM# 35654 pg IV 3/ 4 mlefer lake bailly slimy. sculpin age01 1975 79 . RM# 35654 pg IV 3/ 4 mlefer lake bailly sculpin. spp age01 1975 22 . RM# 35654 pg IV 3/ 4 mlefer lake bailly burbot age01 1975 54 . RM# 35654 pg IV 3/ 4 mlefer lake bailly goldfish age01 1975 8 . RM# 35654 pg IV 3/ 4 mlefer lake bailly carp age01 1975 4 . RM# 35654 pg IV 3/ 4 mlefer lake bailly white. sucker age01 1975 13 . RM# 35654 pg IV 3/ 4 mlefer lake bailly smallmouth. bass age01 1975 8 . RM# 35654 pg IV 3/ 4 mlefer lake bailly largemouth. bass age01 1975 4 . RM# 35654 pg IV 3/ 4 mlefer lake bailly alewife egg 1975 . 3,939,200,000 RM# 35654 pg IV 12 mlefer lake bailly alewife larvae 1975 . 40,800,000 RM# 35654 pg IV 12 mlefer lake bailly gizzard. shad egg 1975 . 154,600 RM# 35654 pg IV 15 mlefer lake bailly gizzard. shad larvae 1975 . 0 RM# 35654 pg IV 15 mlefer lake bailly rainbow. smelt egg 1975 . 4,631,000 RM# 35654 pg IV 17 mlefer lake bailly rainbow. smelt larvae 1975 . 313,100 RM# 35654 pg IV 17 mlefer lake bailly spottail. shiner egg 1975 . 9,150,000 RM# 35654 pg IV 17 mlefer lake bailly spottail. shiner larvae 1975 . 1,492,000 RM# 35654 pg IV 17 mlefer lake bailly yellow. perch egg 1975 . 0 RM# 35654 pg IV 21 mlefer lake bailly yellow. perch larvae 1975 . 15,000 RM# 35654 pg IV 21 mlefer lake bailly troutperch egg 1975 . 129,000 RM# 35654 pg IV 21 mlefer lake bailly troutperch larvae 1975 . 457,000 RM# 35654 pg IV 21 mlefer lake bailly carp egg 1975 . 5,800,000 RM# 35654 pg IV 22 mlefer lake bailly carp larvae 1975 . 3,400,000 RM# 35654 pg IV 22 mlefer lake bailly slimy. sculpin egg 1975 . 46,000 RM# 35654 pg IV 22 mlefer lake bailly slimy. sculpin larvae 1975 . 43,000 RM# 35654 pg IV 22 mlefer lake bailly mottled. sculpin egg 1975 . 0 RM# 35654 pg IV 22 mlefer lake bailly mottled. sculpin larvae 1975 . 5,600 RM# 35654 pg IV 22 mlefer lake bailly clupeidae egg 1975 . 0 based on RM 35654 pg IV 7 agage lake bailly clupeidae larvae 1975 . 1,650,765 based on RM 35654 pg IV 7 agage lake bailly cyprinidae egg 1975 . 622,474 based on RM 35654 pg IV 7 agage lake bailly cyprinidae larvae 1975 . 1,089,811 based on RM 35654 pg IV 7 agage lake bailly salmonidae egg 1975 . 911,844 based on RM 35654 pg IV 7 agage lake bailly salmonidae larvae 1975 . 0 based on RM 35654 pg IV 7 agage lake bailly unknown. fish egg 1975 . 2,500,808,834 based on RM 35654 pg IV 7 agage lake bailly unknown. fish larvae 1975 . 3,925,786 based on RM 35654 pg IV 7 agage species. orig stage year impinged. est entrained. est notes qc alewife eggs 1975 . 3,939,200,000 RM# 35654 pg IV 12 mlefer alewife larvae 1975 . 40,800,000 RM# 35654 pg IV 12 mlefer gizzard. shad eggs 1975 . 154,600 RM# 35654 pg IV 15 mlefer gizzard. shad larvae 1975 . 0 RM# 35654 pg IV 15 mlefer rainbow. smelt eggs 1975 . 4,631,000 RM# 35654 pg IV 17 mlefer rainbow. smelt larvae 1975 . 313,100 RM# 35654 pg IV 17 mlefer spottail. shiner eggs 1975 . 9,150,000 RM# 35654 pg IV 17 mlefer spottail. shiner larvae 1975 . 1,492,000 RM# 35654 pg IV 17 mlefer yellow. perch eggs 1975 . 0 RM# 35654 pg IV 17 mlefer yellow. perch larvae 1975 . 15,000 RM# 35654 pg IV 21 mlefer troutperch eggs 1975 . 129,000 RM# 35654 pg IV 21 mlefer troutperch larvae 1975 . 457,000 RM# 35654 pg IV 21 mlefer carp eggs 1975 . 5,800,000 RM# 35654 pg IV 22 mlefer carp larvae 1975 . 3,400,000 RM# 35654 pg IV 22 mlefer slimy. sculpin eggs 1975 . 46,000 RM# 35654 pg IV 22 mlefer slimy. sculpin larvae 1975 . 43,000 RM# 35654 pg IV 22 mlefer mottled. sculpin eggs 1975 . 0 RM# 35654 pg IV 22 mlefer mottled. sculpin larvae 1975 . 5,600 RM# 35654 pg IV 22 mlefer Number entrained per 100,000 gallons species stage nov. 1975 dec. 1975 jan. 1976 feb. 1976 mar. 1976 apr. 1976 may. 1976 jun. 1976 alewife egg 0 0 0 0 0 0 67.452 3352.4 alewife larvae 0 0 0 0 0 0 0 189.026 gizzard. shad egg 0 0 0 0 0 0 0 1.163 gizzard. shad larvae 0 0 0 0 0 0 0 0 clupeidae egg 0 0 0 0 0 0 0 0 clupeidae larvae 0 0 0 0 0 0 0 0 smelt egg 0 0 0 0 0.907 4.332 28.051 0.589 smelt larvae 0 0 0 0.696 0.165 0.303 0.672 0.537 spottail. shiner egg 0 0 0 0 0 1.053 8.741 30.052 spottail. shiner larvae 0 0 0 0.664 0 0 0 2.815 troutperch egg 0 0 0 0 0 0.125 0.115 0.137 troutperch larvae 0 1.053 0 1.482 0.268 0 0 0.033 slimy. sculpin egg 0 0 0 0 0 0 0.337 0 slimy. sculpin larvae 0 0 0 0 0 0 0 0.126 mottled. sculpin egg 0 0 0 0 0 0 0 0 mottled. sculpin larvae 0 0 0 0 0 0 0 0 carp egg 0 0 0 0 0 0 0 16.981 carp larvae 0 0 0 0 0 0 0 7.822 yellow. perch egg 0 0 0 0 0 0 0 0 yellow. perch larvae 0 0 0 0 0 0 0 0.115 cyprinidae egg 0 0 0 0 0 0 0 1.592 cyprinidae larvae 0 0 0 0 0 0 0 3.344 salmonidae egg 0 1.831 0 0 0 0 0 0 salmonidae larvae 0 0 0 0 0 0 0 0 unknown. fish egg 0 0 0 0 0 3.568 62.27 1711.059 unknown. fish larvae 0 0 0 0 0.784 0.257 0 9.207 Number entrained days/ month 20 31 31 29 31 30 31 30 alewife egg 0 0 0 0 0 0 9267365.2 445735104 alewife larvae 0 0 0 0 0 0 0 25132897 gizzard. shad egg 0 0 0 0 0 0 0 154632.48 gizzard. shad larvae 0 0 0 0 0 0 0 0 clupeidae egg 0 0 0 0 0 0 0 0 clupeidae larvae 0 0 0 0 0 0 0 0 smelt egg 0 0 0 0 124614.5 575982.7 3853983 78313.44 smelt larvae 0 0 0 89455.49 22669.68 40286.88 92327.424 71399.52 spottail. shiner egg 0 0 0 0 0 140006.9 1200943.5 3995713.9 spottail. shiner larvae 0 0 0 85342.59 0 0 0 374282.4 troutperch egg 0 0 0 0 0 16620 15800.08 18215.52 troutperch larvae 0 144673.8 0 190478.5 36821.06 0 0 4387.68 slimy. sculpin egg 0 0 0 0 0 0 46301.104 0 slimy. sculpin larvae 0 0 0 0 0 0 0 16752.96 mottled. sculpin egg 0 0 0 0 0 0 0 0 mottled. sculpin larvae 0 0 0 0 0 0 0 0 carp egg 0 0 0 0 0 0 0 2257793.8 carp larvae 0 0 0 0 0 0 0 1040013.1 yellow. perch egg 0 0 0 0 0 0 0 0 yellow. perch larvae 0 0 0 0 0 0 0 15290.4 cyprinidae egg 0 0 0 0 0 0 0 211672.32 cyprinidae larvae 0 0 0 0 0 0 0 444618.24 salmonidae egg 0 251564.8 0 0 0 0 0 0 salmonidae larvae 0 0 0 0 0 0 0 0 unknown. fish egg 0 0 0 0 0 474401.3 8555399.8 227502405 unknown. fish larvae 0 0 0 0 107715.3 34170.72 0 1224162.7 0 0 0 0 0 0 0 0 MGD 100,000gals per day jul. 1976 aug. 1976 sep. 1976 oct. 1976 nov. 1976 average source 26072.724 132.75 0.046 0 0 2278.874769 RM 35654 pg IV 7 98.341 18.338 1.067 0.35 0 23.62476923 RM 35654 pg IV 7 0 0 0 0 0 0.089461538 RM 35654 pg IV 7 0 0 0 0 0 0 RM 35654 pg IV 7 0 0 0 0 0 0 RM 35654 pg IV 7 9.693 2.291 0 0.031 0 0.924230769 RM 35654 pg IV 7 0 0 0 0 0 2.606076923 RM 35654 pg IV 7 0 0 0 0 0 0.182538462 RM 35654 pg IV 7 27.758 0 0 0 0 5.200307692 RM 35654 pg IV 7 7.31 0.234 0 0 0 0.847923077 RM 35654 pg IV 7 0 0.184 0.096 0.093 0 0.057692308 RM 35654 pg IV 7 0.041 0.418 0.229 1 0 0.348 RM 35654 pg IV 7 0 0 0 0 0 0.025923077 RM 35654 pg IV 7 0.193 0 0 0 0 0.024538462 RM 35654 pg IV 7 0 0 0 0 0 0 RM 35654 pg IV 7 0.041 0 0 0 0 0.003153846 RM 35654 pg IV 7 21.272 0 0 0.041 0 2.945692308 RM 35654 pg IV 7 9.634 0.472 0 0 0 1.379076923 RM 35654 pg IV 7 0 0 0 0 0 0 RM 35654 pg IV 7 0 0 0 0 0 0.008846154 RM 35654 pg IV 7 2.99 0 0 0 0 0.352461538 RM 35654 pg IV 7 4.696 0 0 0 0 0.618461538 RM 35654 pg IV 7 0 0 0 0 4.966 0.522846154 RM 35654 pg IV 7 0 0 0 0 0 0 RM 35654 pg IV 7 16427.758 52.538 0.093 0.025 0 1404.408538 RM 35654 pg IV 7 17.759 0.421 0.282 0.178 0 2.222153846 RM 35654 pg IV 7 31 31 30 31 10 ANNUAL TOTAL ENT sum E5 3582183696 18238788 6116.16 0 0 4,055,431,069 40554.31 13511266.7 2519494 141868.3 48087.2 0 41,353,614 413.54 0 0 0 0 0 154,632 1.55 0 0 0 0 0  0.00 0 0 0 0 0  0.00 1331740.66 314765.1 0 4259.152 0 1,650,765 16.51 0 0 0 0 0 4,632,894 46.33 0 0 0 0 0 316,139 3.16 3813727.14 0 0 0 0 9,150,391 91.50 1004335.52 32149.73 0 0 0 1,496,110 14.96 0 25280.13 12764.16 12777.46 0 101,457 1.01 5633.072 57429.86 30447.84 137392 0 607,264 6.07 0 0 0 0 0 46,301 0.46 26516.656 0 0 0 0 43,270 0.43 0 0 0 0 0  0.00 5633.072 0 0 0 0 5,633 0.06 2922602.62 0 0 5633.072 0 5,186,029 51.86 1323634.53 64849.02 0 0 0 2,428,497 24.28 0 0 0 0 0  0.00 0 0 0 0 0 15,290 0.15 410802.08 0 0 0 0 622,474 6.22 645192.832 0 0 0 0 1,089,811 10.90 0 0 0 0 220093.1 471,658 4.72 0 0 0 0 0  0.00 2257042527 7218301 12365.28 3434.8 0 2,500,808,834 25008.09 2439944.53 57842.03 37494.72 24455.78 0 3,925,786 39.26 0 0 0 0 0  0.00 443.2 4432 Number impinged per 100,000 gallons species stage nov. 1975 dec. 1975 jan. 1976 feb. 1976 mar. 1976 apr. 1976 may. 1976 jun. 1976 jul. 1976 alewife egg 0 0 0 0 0 0 67.452 3352.4 26072.724 alewife larvae 0 0 0 0 0 0 0 189.026 98.341 gizzard. shad egg 0 0 0 0 0 0 0 1.163 0 gizzard. shad larvae 0 0 0 0 0 0 0 0 0 clupeidae egg 0 0 0 0 0 0 0 0 0 clupeidae larvae 0 0 0 0 0 0 0 0 9.693 smelt egg 0 0 0 0 0.907 4.332 28.051 0.589 0 smelt larvae 0 0 0 0.696 0.165 0.303 0.672 0.537 0 spottail. shiner egg 0 0 0 0 0 1.053 8.741 30.052 27.758 spottail. shiner larvae 0 0 0 0.664 0 0 0 2.815 7.31 troutperch egg 0 0 0 0 0 0.125 0.115 0.137 0 troutperch larvae 0 1.053 0 1.482 0.268 0 0 0.033 0.041 slimy. sculpin egg 0 0 0 0 0 0 0.337 0 0 slimy. sculpin larvae 0 0 0 0 0 0 0 0.126 0.193 mottled. sculpin egg 0 0 0 0 0 0 0 0 0 mottled. sculpin larvae 0 0 0 0 0 0 0 0 0.041 carp egg 0 0 0 0 0 0 0 16.981 21.272 carp larvae 0 0 0 0 0 0 0 7.822 9.634 yellow. perch egg 0 0 0 0 0 0 0 0 0 yellow. perch larvae 0 0 0 0 0 0 0 0.115 0 cyprinidae egg 0 0 0 0 0 0 0 1.592 2.99 cyprinidae larvae 0 0 0 0 0 0 0 3.344 4.696 salmonidae egg 0 1.831 0 0 0 0 0 0 0 salmonidae larvae 0 0 0 0 0 0 0 0 0 unknown. fish egg 0 0 0 0 0 3.568 62.27 1711.059 16427.758 unknown. fish larvae 0 0 0 0 0.784 0.257 0 9.207 17.759 species stage nov. 1975 dec. 1975 jan. 1976 feb. 1976 mar. 1976 apr. 1976 may. 1976 jun. 1976 jul. 1976 alewife egg 0 0 0 0 0 0 1158420.6 63676443 447772962 alewife larvae 0 0 0 0 0 0 0 3590413.9 1688908.33 gizzard. shad egg 0 0 0 0 0 0 0 22090.354 0 gizzard. shad larvae 0 0 0 0 0 0 0 0 0 clupeidae egg 0 0 0 0 0 0 0 0 0 clupeidae larvae 0 0 0 0 0 0 0 0 166467.582 smelt egg 0 0 0 0 15576.82 82283.25 481747.87 11187.634 0 smelt larvae 0 0 0 12779.36 2833.71 5755.269 11540.928 10199.931 0 spottail. shiner egg 0 0 0 0 0 20000.98 150117.93 570816.27 476715.892 spottail. shiner larvae 0 0 0 12191.8 0 0 0 53468.914 125541.94 troutperch egg 0 0 0 0 0 2374.286 1975.01 2602.2171 0 troutperch larvae 0 18084.22 0 27211.21 4602.632 0 0 626.81143 704.134 slimy. sculpin egg 0 0 0 0 0 0 5787.638 0 0 slimy. sculpin larvae 0 0 0 0 0 0 0 2393.28 3314.582 mottled. sculpin egg 0 0 0 0 0 0 0 0 0 mottled. sculpin larvae 0 0 0 0 0 0 0 0 704.134 carp egg 0 0 0 0 0 0 0 322541.97 365325.328 carp larvae 0 0 0 0 0 0 0 148573.3 165454.316 yellow. perch egg 0 0 0 0 0 0 0 0 0 yellow. perch larvae 0 0 0 0 0 0 0 2184.3429 0 cyprinidae egg 0 0 0 0 0 0 0 30238.903 51350.26 cyprinidae larvae 0 0 0 0 0 0 0 63516.891 80649.104 salmonidae egg 0 31445.59 0 0 0 0 0 0 0 salmonidae larvae 0 0 0 0 0 0 0 0 0 unknown. fish egg 0 0 0 0 0 67771.61 1069425 32500344 282130316 unknown. fish larvae 0 0 0 0 13464.42 4881.531 0 174880.39 304993.066 month 6. hr. periods. per mo aug. 1976 sep. 1976 oct. 1976 nov. 1976 sum source nov. 1975 120 132.75 0.046 0 0 29625.372 RM 35654 pg IV 7 dec. 1975 124 18.338 1.067 0.35 0 307.122 RM 35654 pg IV 7 jan. 1976 124 0 0 0 0 1.163 RM 35654 pg IV 7 feb. 1976 116 0 0 0 0 0 RM 35654 pg IV 7 mar. 1976 124 0 0 0 0 0 RM 35654 pg IV 7 apr. 1976 120 2.291 0 0.031 0 12.015 RM 35654 pg IV 7 may. 1976 124 0 0 0 0 33.879 RM 35654 pg IV 7 jun. 1976 120 0 0 0 0 2.373 RM 35654 pg IV 7 jul. 1976 124 0 0 0 0 67.604 RM 35654 pg IV 7 aug. 1976 124 0.234 0 0 0 11.023 RM 35654 pg IV 7 sep. 1976 120 0.184 0.096 0.093 0 0.75 RM 35654 pg IV 7 oct. 1976 124 0.418 0.229 1 0 4.524 RM 35654 pg IV 7 nov. 1976 120 0 0 0 0 0.337 RM 35654 pg IV 7 0 0 0 0 0.319 RM 35654 pg IV 7 0 0 0 0 0 RM 35654 pg IV 7 0 0 0 0 0.041 RM 35654 pg IV 7 0 0 0.041 0 38.294 RM 35654 pg IV 7 0.472 0 0 0 17.928 RM 35654 pg IV 7 0 0 0 0 0 RM 35654 pg IV 7 0 0 0 0 0.115 RM 35654 pg IV 7 0 0 0 0 4.582 RM 35654 pg IV 7 0 0 0 0 8.04 RM 35654 pg IV 7 0 0 0 4.966 6.797 RM 35654 pg IV 7 0 0 0 0 0 RM 35654 pg IV 7 52.538 0.093 0.025 0 18257.311 RM 35654 pg IV 7 0.421 0.282 0.178 0 28.888 RM 35654 pg IV 7 aug. 1976 sep. 1976 oct. 1976 nov. 1976 sum 2279849 873.7371 0 0 514,888,548 314936.8 20266.9 6010.9 0 5,620,537 0 0 0 0 22,090 0 0 0 0  0 0 0 0  39345.63 0 532.394 0 206,346 0 0 0 0 590,796 0 0 0 0 43,109 0 0 0 0 1,217,651 4018.716 0 0 0 195,221 3160.016 1823.451 1597.182 0 13,532 7178.732 4349.691 17174 0 79,931 0 0 0 0 5,788 0 0 0 0 5,708 0 0 0 0  0 0 0 0 704 0 0 704.134 0 688,571 8106.128 0 0 0 322,134 0 0 0 0  0 0 0 0 2,184 0 0 0 0 81,589 0 0 0 0 144,166 0 0 0 220093.1 251,539 0 0 0 0  902287.6 1766.469 429.35 0 316,672,339 7230.254 5356.389 3056.972 0 513,863 sampling. periods. per. mo 6mo. periods/ sample. periods 24 5 32 3.875 32 3.875 28 4.142857143 32 3.875 28 4.285714286 32 3.875 28 4.285714286 32 3.875 32 3.875 28 4.285714286 32 3.875 12 10 Losses data for Bailly Station ( Indiana). Cooling water source: Lake Michigan Intake 316( b) Phase III A. Gage, 12/ 1/ 2003 Notes:

Impingement sampling was conducted every 4th day for a 24 hr period from Nov 1975 Nov 1976. Fish impinged on intake screens were collected & tallied.

1976, additional sampling took place. 4 replicate 5 minute samples were taken from the forebays. # of organisms was divided by the vol. of water sampled. The species clupeidae, cyprinidae, salmonidae, & unknown. fish were extrapolated using the formulas in ent. data. entry. dc QC QC'd losses and data entry, M. Lefer, 12/ 8/ 03.

extrapolations checked by dc 2/ 13/ 04. No manual ENT extrapolations are used; instead we use ENT extrapolations provided by the facility document ( spread across several species specific tables). IMP data are also not extrapolated.


[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1767]
[DOCID:fr13ja10-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

December 23, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP09-1037-002.
    Applicants: Questar Pipeline Company.
    Description: Questar Pipeline Company submits Second Substitute
Eighth Revised Sheet 8 to its FERC Gas Tariff, First Revised Volume 1,
to be effective 10/7/09.
    Filed Date: 10/22/2009.
    Accession Number: 20091023-0012.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 29, 2009.

    Docket Numbers: RP10-234-001.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits the
corrected pagination for Sheet 236, filed as Original Sheet 236 to
First Revised Sheet 236.
    Filed Date: 12/16/2009.
    Accession Number: 20091216-0125.
    Comment Date: 5 p.m. Eastern Time on Monday, December 28, 2009.

    Docket Numbers: RP10-178-001.
    Applicants: Steuben Gas Storage Company.
    Description: Steuben Gas Storage Co's filing of a revision to Order
No. 712 and Order No. 587-T Compliance Filing under RP10-178.
    Filed Date: 12/17/2009.
    Accession Number: 20091218-0202.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 29, 2009.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in on or before 5 p.m. Eastern time on the specified
comment date. Anyone filing a protest must serve a copy of that
document on all the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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. 2010-460 Filed 1-12-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Pages 20564-20567]
[FR Doc No: 2021-08038]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91560; File No. SR-C2-2021-006]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To
Eliminate Existing Rule 3.30 (Qualification and Registration) and
Incorporate by Reference Cboe Exchange, Inc. Chapter 3, Section B, in
Its Entirety

April 14, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on April 9, 2021, Cboe C2 Exchange, Inc.
(the ``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been substantially prepared
by the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to eliminate existing Rule 3.30 and
incorporate by reference Cboe Exchange, Inc. (``Cboe Options'') Chapter
3, Section B, in its

entirety. The text of the proposed rule change is provided in Exhibit
5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange previously adopted C2 Rule 3.30 (Qualification and
Registration), which provides for registration requirements to ensure
that associated persons of Trading Permit Holder (``TPH'')
organizations attain and maintain specified levels of competence and
knowledge pertinent to their functions. In general, the current rules:
(1) Require that persons engaged in a TPH organization's securities
business who are to function as representatives or principals register
with the Exchange in the category of registration appropriate to their
functions by passing one or more qualification examinations \5\ and (2)
exempt specified associated persons from the registration
requirements.\6\ The Exchange believes that current C2 Rule 3.30 is
substantively identical to corresponding Rule 3.30 on its affiliate
exchange, Cboe Options.\7\ The Exchange notes that, other than Cboe
Options Rule 3.30, the C2 rulebook incorporates by reference the
remaining rules contained in Cboe Options Chapter 3, Section B, as such
rules may be in effect from time to time.\8\ However, the Exchange's
rulebook is clear that Cboe Options Rule 3.30, which is contained in
Cboe Options Chapter 3, Section B, does not apply to C2.
---------------------------------------------------------------------------

    \5\ See C2 Options Rule 3.30(a)(1).
    \6\ See C2 Options Rule 3.30(a)(2).
    \7\ See Cboe Options Rule 3.30 (Qualification and Registration
of Trading Permit Holders and Associated Persons).
    \8\ See Exchange Act Release No. 91203 (February 24, 2021), 86
FR 12251 (March 2, 2021). As a condition of the exemption approved
by the Commission pursuant to Section 36 of the Act, the Exchange
agreed to provide written notice to its members whenever Cboe Option
proposes a change to its Chapter 3, Section B rules. The Exchange
provides such notice via a posting on the same website location
where the Exchange posts its own rule filings pursuant to Rule 19b-4
within the timeframe required by such rule. Such notice alerts
Exchange members to the proposed Cboe Options rule change and gives
them an opportunity to comment on the proposal. The Exchange
similarly informs its members in writing when the Commission
approves any such proposed change.
---------------------------------------------------------------------------

    The Exchange no longer wishes to maintain an exception of Cboe
Options Rule 3.30 to the incorporation by reference of Chapter 3,
Section B as it does not believe it is necessary and may cause
potential confusion. Additionally, Cboe Options has filed a proposed
rule change to amend its registration rules, including Cboe Options
Rule 3.30. The pending rule filing also proposes to adopt new rules
under Cboe Options Chapter 3, Section B, related to registration
requirements.\9\ As most of Cboe Options Chapter 3, Section B is
incorporated by reference into the Exchange's rulebook, the proposed
new Cboe Options rules (and amendments to existing Cboe Options rules
contained in Chapter 3, Section B other than Cboe Options Rule 3.30)
would automatically apply to C2 upon that rule filing becoming
operative. Since the Exchange does not incorporate by reference Cboe
Options Rule 3.30 however, the proposed amendments to Cboe Options Rule
3.30 would not automatically apply to C2, even though Cboe Options Rule
3.30, as amended, would relate to, and even cross-reference, the
proposed new Cboe Options rules that would apply to C2.\10\ As such,
the Exchange now proposes to eliminate the language that states Cboe
Options Rule 3.30 does not apply to C2 and remove C2 Rule 3.30, which
is identical to Cboe Options Rule 3.30, thereby incorporating by
reference Cboe Options Rule 3.30 (which becomes incorporated by
reference under the umbrella of the overall incorporation by reference
of Cboe Options Chapter 3, Section B). The Exchange believes Cboe
Options Rule 3.30 is within the same category of exchange rules
otherwise incorporated into C2 Chapter 3, Section B by reference to
Cboe Options Chapter 3, Section B (i.e. rules related to TPH
Registration). Further, the incorporation by reference of Cboe Options
Rule 3.30 into the Exchange's Chapter 3, Section B title is regulatory
in nature.\11\ The Exchange believes incorporating by reference the
entire Cboe Options Chapter 3, Section B rules maintains consistency
between C2 and Cboe Options rules, and helps ensure identical
regulation of the Exchange's TPHs that are also Cboe Options TPHs and
also ensures that C2-only TPHs are subject to consistent regulation as
Cboe Options TPHs.
---------------------------------------------------------------------------

    \9\ See SR-CBOE-2021-022.
    \10\ Id.
    \11\ Cboe Options Chapter 3, Section B rules are categories of
rules that are not trading rules. See 17 CFR 200.30-3(a)(76)
(contemplating such requests). In addition, several other Self-
Regulatory Organizations (``SROs'') incorporate by reference similar
regulatory rules of other SROs. See, e.g., Exchange Act Release Nos.
57478 (March 12, 2008), 73 FR 14521 (March 18, 2008), 53128 (January
13, 2006), 71 FR 3550 (January 23, 2006); 49260 (February 17, 2004),
69 FR 8500 (February 24, 2004).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\12\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \13\ requirements that the rules
of an exchange be designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \14\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ Id.
---------------------------------------------------------------------------

    In particular, the proposed rule change does not make any
substantive change to any of C2's rules. The proposed rule change is
merely intended to incorporate by reference the entirety of Cboe
Options Chapter 3, Section B rules in the C2 rulebook, instead of
excluding a single Cboe Options Rule from incorporation (i.e., Cboe
Options Rule 3.30) which currently is substantively identical to the
corresponding C2 Rule (i.e., C2 Rule 3.30). Indeed, the proposed rule
change makes no substantive changes to the C2 rulebook: It does not
alter any of the

current rules incorporated by reference, and it incorporates by
reference a rule (i.e., Cboe Options 3.30), which is substantively
identical to an existing rule (i.e., C2 Rule 3.30), which would be
removed. As such, the same rules currently applicable to C2 TPHs
effectively will apply to TPHs upon effectiveness of this rule filing
in the same manner, whether those rules are incorporated by reference
to Cboe Options rules or included in C2's rules.
    The Exchange also believes the proposed rule change is designed to
promote just and equitable principles of trade, removes impediments to
and perfects the mechanism of a free and open market and a national
market system, and, in general protects investors and the public
interest, by consolidating all of its rules related to TPH registration
into a single rule set. Incorporating by reference Cboe Options Rule
3.30 into the Exchange's Chapter 3, Section B title will provide an
easy reference for Exchange TPHs seeking to comply with registration
and qualification requirements of both Cboe Options and C2. The
Exchange believes the proposed change makes the Exchange's rulebook
easier to read and follow, thus allowing market participants to better
understand the rules of the Exchange, which will also result in less
burdensome and more efficient regulatory compliance for market
participants that are TPHs of both Cboe Options and C2. Also, as
discussed, TPHs will be required to continue to comply with the
substance of Cboe Options Rule 3.30, since the substance of Cboe
Options Rule 3.30 is substantively identical.
    Lastly, the Exchange believes that in light of the proposed rule
changes to corresponding Cboe Options rules discussed above,
incorporating by reference Cboe Options Rule 3.30 will promote
efficient use of the Commission's and the Exchange's resources by
avoiding duplicative rule filings that would otherwise be needed based
on simultaneous changes to identical rule text sought by more than one
SRO (i.e., Cboe Options and C2).

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposal
is not intended to address any competitive issue. Rather, the Exchange
is effectively incorporating by reference a Cboe Options rule (i.e.,
Cboe Options Rule 3.30) to replace a current substantively identical
Exchange rule (i.e., C2 Rule 3.30) that is within the same category of
exchange rules otherwise incorporated into C2 Chapter 3, Section B by
reference (i.e., Cboe Options Chapter 3, Section B, which contains
rules related to TPH Registration). The Exchange is not amending the
substance of its registration rules with this proposed rule change and
therefore no TPH is impacted.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange requested that the Commission waive the 30-day
operative delay period after which a proposed rule change under Rule
19b-4(f)(6) becomes effective so that the Exchange can immediately
update its rulebook to further align with the Cboe Options rulebook.
This further alignment of rulebooks will help avoid any potential
confusion that may be created by, as discussed above, all Cboe Options
rules in Chapter 3, Section B currently being incorporated by reference
in the C2 rulebook with the exception of Cboe Options Rule 3.30.
Additionally, and as also discussed above, Cboe Options has filed a
separate proposed rule change to amend certain registration rules,
including Cboe Options Rule 3.30.\17\ As a result, waiving the 30-day
operative delay period for this proposed rule change will allow the
separate proposed rule changes to amend the Cboe Options rulebook to
automatically apply to the C2 rulebook. This, in turn, will not only
maintain consistency between the C2 and Cboe Options rulebooks, but it
will also avoid the need for duplicative proposed rule change filings
by two separate, but related, SROs that are based on simultaneous
changes to otherwise identical rule text. For these reasons, the
Commission believes that waiver of the 30-day operative delay for this
proposal is consistent with the protection of investors and the public
interest. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposal operative upon filing.\18\
---------------------------------------------------------------------------

    \17\ See SR-CBOE-2021-022.
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-C2-2021-006 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-C2-2021-006. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule

change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change.
    Persons submitting comments are cautioned that we do not redact or
edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-C2-2021-006
and should be submitted on or before May 11, 2021.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-08038 Filed 4-19-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1620-1621]
[FR Doc No: 2018-00404]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2516 and FDA-2016-E-2514]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
13, 2018. 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 July 11, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 13, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-2516 and FDA-2016-E-2514 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    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 USPTO 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 has approved for marketing the medical device PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN. PROACT ADJUSTABLE CONTINENCE THERAPY FOR
MEN is indicated for the treatment of adult men who have stress
incontinence arising from intrinsic sphincter deficiency of at least 12
months duration following radical prostatectomy or transurethral
resection of the prostate and who have failed to respond adequately to
conservative therapy. Subsequent to this approval, the USPTO received
patent term restoration applications for PROACT ADJUSTABLE CONTINENCE
THERAPY FOR MEN (U.S. Patent Nos. 7,014,606 and 7,828,716) from
Uromedica, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated November 10, 2016, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN is 3,892 days. Of this
time, 3,179 days occurred during the testing phase of the regulatory
review period, while 713 days occurred during the approval phase. These
periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: March 31, 2005. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the FD&C Act for human tests to begin became effective on August 29,
2005. However, FDA records indicate that the IDE was determined
substantially complete for clinical studies to have begun on March 31,
2005, which represents the IDE effective date.
    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): December
12, 2013. The applicant claims June 19, 2013, as the date the premarket
approval application (PMA) for PROACT ADJUSTABLE CONTINENCE THERAPY FOR
MEN (PMA 130018) was initially submitted. However, FDA records indicate
that the PMA as submitted was not administratively complete for the
Agency to undertake a substantive review. FDA did not file this
application and notified the applicant of this fact by letter dated
September 13, 2013. The complete PMA was then submitted on December 12,
2013, which is considered to be the initially submitted date.
    3. The date the application was approved: November 24, 2015. FDA
has verified the applicant's claim that PMA 130018 was approved on
November 24, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,827 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00404 Filed 1-11-18; 8:45 am]
 BILLING CODE 4164-01-P