[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Notices]
[Page 28105-28108]
[DOCID:fr15my08-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 7, 2008.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC08-78-000.
    Applicants: Duke Energy Ohio, Inc., Cinergy Corp., Cinergy Power
Investments, Inc., Generating Facility LLCs.
    Description: Amendment to Application and Request for Extended
Notice Period for Comments of Cinergy Corp., et.al.
    Filed Date: 05/06/2008.
    Accession Number: 20080506-5107.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 27, 2008.

    Docket Numbers: EC08-85-000.
    Applicants: Mountain View Power Partners, LLC; AES Western Wind MV
Acquisition, LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities, Request for Confidential Treatment, and
Request for Expedited Action of Mountain View Power Partners, LLC, et.
al.
    Filed Date: 05/05/2008.
    Accession Number: 20080506-5007.
    Comment Date: 5 p.m. Eastern Time on Monday, May 26, 2008.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG08-70-000.
    Applicants: Consolidated Edison Energy Massachusetts, LLC.
    Description: Consolidated Edison Energy Massachusetts, LLC submits
a Notice of Name Change and Application for Redetermination of Status
as an Exempt Wholesale Generator.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0138.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

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

    Docket Numbers: ER93-465-043; ER96-417-012; ER96-1375-013; OA96-39-
020; OA97-245-013.
    Applicants: Florida Power & Light Company.
    Description: Refund Report Errata of Florida Power & Light Company.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-5032.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER97-2801-022.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits a revised Sheet to its market-based
rate tariff currently on file with FERC.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-0229.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER07-1215-003; ER07-265-001; ER08-100-001.
    Applicants: The Royal Bank of Scotland plc; Sempra Energy Solutions
LLC; Sempra Energy Trading LLC.
    Description: Sempra Energy Trading LLC et al. submits a notice of
non-material change in status and compliance filing.
    Filed Date: 05/01/2008.
    Accession Number: 20080506-0083.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-5-001.
    Applicants: Ohio Valley Electric Corporation.
    Description: Ohio Valley Electric Corp submits an executed
Interconnection Agreement with U.S. Department of Energy.
    Filed Date: 05/01/2008.
    Accession Number: 20080506-0086.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-569-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC responds to FERC's request
for additional information re its 5/15/08 deficient filing.
    Filed Date: 05/01/2008.
    Accession Number: 20080506-0085.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-638-001.
    Applicants: Crafton LLC.
    Description: Crafton LLC submits Amended Petition for Acceptance of
Initial Tariff, Waivers and Blanket Authority.
    Filed Date: 03/31/2008.
    Accession Number: 20080401-0073.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 14, 2008.

    Docket Numbers: ER08-671-001.
    Applicants: Florida Power Corporation.
    Description: Florida Power Corp submits correction filing for
Gainesville service agreement under cost-based rates tariff CR-1.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-0084.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER08-747-001.
    Applicants: Beaver Ridge Wind, LLC.
    Description: Beaver Ridge Wind, LLC submits an amendment to the
Petition for Acceptance of Initial Rate Schedule, Waivers and Blanket
Authority.
    Filed Date: 05/05/2008.
    Accession Number: 20080507-0212.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 27, 2008.

    Docket Numbers: ER08-884-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
et al. submits proposed revisions to the Congestion Management Process.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-0082.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER08-885-000.
    Applicants: Entergy Gulf States Louisiana, L.L.C.
    Description: Entergy Gulf States Louisiana LLC submits Attachment A
Notice of Termination.
    Filed Date: 04/30/2008.
    Accession Number: 20080502-0116.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-886-000.
    Applicants: The Detroit Edison Company.
    Description: The Detroit Edison Co submits copies of the Third
Revised Sheets 26, 33 and 36 of the Ancillary Services Tariff.
    Filed Date: 04/30/2008.
    Accession Number: 20080502-0128.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-887-000.
    Applicants: Interstate Power & Light Company.
    Description: Interstate Power and Light Company submits proposed
revisions to their RES-5 Wholesale Formula Rates.
    Filed Date: 04/30/2008.
    Accession Number: 20080502-0120.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-888-000.
    Applicants: Carolina Power & Light Company.
    Description: Progress Energy Carolinas Inc submits amendments to
the North Carolina Eastern Municipal Power Agency's Network Integration
Transmission Service Agreement & a Notice of Cancellation, etc.
    Filed Date: 04/30/2008.
    Accession Number: 20080502-0119.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-889-000.
    Applicants: Carolina Power & Light Company.
    Description: Carolina Power and Light Co submits revised tariff
sheets for the transmission rates under its Open Access Transmission
Tariff.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0128.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-890-000.
    Applicants: Louisiana Generating, LLC.
    Description: Louisiana Generating LLC submits a Balancing Authority
Area Agreement, Rate Schedule FERC 6 with Cottonwood Energy Company LP.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0122.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-891-000.
    Applicants: Wisconsin Power and Light Company.
    Description: Alliant Energy Corporate Services, Inc on behalf of
Wisconsin Power and Light Co submits a Wholesale Power Agreement.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0119.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-892-000.
    Applicants: Allegheny Energy Supply Company, LLC.
    Description: Allegheny Energy Supply Co, LLC submits notices of
cancellation and notices of termination.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0118.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-893-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corp. submits an
Interconnection Agreement with Indianapolis Power & Light Co.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0117.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-894-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc submits mutually-executed
Dynamic Transfer Operating Agreements.
    Filed Date: 04/30/2008.

    Accession Number: 20080505-0116.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: ER08-895-000.
    Applicants: Consolidated Edison Company of New York.
    Description: Consolidated Edison Company of New York, Inc submits a
Construction and Operating Agreement with New Athens Generating
Company, LLC dated as of 7/9/07.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0087.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-896-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Service Co submits amendments to
its new Localized Costs Responsibility Agreements.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0085.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-898-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits the Large
Generator Interconnection Agreement among the Blythe Energy, LL, SCE,
and the California Independent System Operator Corporation.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0076.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-899-000.
    Applicants: Ohio Power Company.
    Description: Ohio Power Company submits a Cost-Based Formula Rate
Agreement for Full Requirements Electric Service dated 4/30/08 with the
American Electric Power Company.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0077.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-901-000.
    Applicants: Saracen Energy Partners, LP.
    Description: Saracen Energy Partners, LP submits its Petition for
Acceptance of Initial Rate Schedule, Waivers and Blanket Authorization
of FERC Rate Schedule 1.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0080.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-902-000.
    Applicants: Vermont Electric Cooperative, Inc.
    Description: Vermont Electric Coop, Inc.'s 2008 Transmission
Formula Rate Update to charges produced by the formula rates applicable
to the VEC-specified Local Service Schedules of the ISO New England
Open Access Transmission Tariff, etc.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0081.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-903-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Service
Agreement for Network Integration Transmission Service with Empire
District Electric Co.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0082.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-904-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Service
Agreement for Network Integration Transmission Service with Kansas
Electric Power Coop, Inc.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0083.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-905-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Service
Agreement for Network Integration Transmission Service with Western
Farmers Electric Cooperative, Inc.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0084.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-906-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison submits Fifth Revised Sheet
54, et al. to Rate Schedule FERC 424.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0120.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-907-000.
    Applicants: Unitil Power Corp.
    Description: Unitil Power Corp. submits an Amended Unitil System
Agreement.
    Filed Date: 05/01/2008.
    Accession Number: 20080505-0121.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: ER08-908-000.
    Applicants: Florida Power Corporation.
    Description: Progress Energy Florida Inc's CD containing their
annual cost factor updates.
    Filed Date: 05/02/2008.
    Accession Number: 20080502-4003.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER08-913-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator,
Inc., et al. submits proposed revisions to Section 4.1 and 4.4 of the
Congestion Management Process of their Joint Operating Agreement, etc.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-0076.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER08-914-000.
    Applicants: Walnut Creek Energy, LLC.
    Description: Petition of Walnut Creek Energy, LLC for authorization
for affiliate sales of electric energy.
    Filed Date: 05/02/2008.
    Accession Number: 20080506-0075.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: ER08-922-000.
    Applicants: Warren Power, LLC.
    Description: Warren Power, LLC submits a notice of cancellation of
FERC Electric Tariff, Original Volume 1, etc.
    Filed Date: 05/06/2008.
    Accession Number: 20080507-0221.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 27, 2008.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES08-49-000.
    Applicants: Entergy Power, Inc.
    Description: Entergy Power, Inc. submits its Application for
Authorization to Issue Securities Pursuant to Section 204 Federal Power
Act and Part 34 of the Commission's Regulations.
    Filed Date: 05/02/2008.
    Accession Number: 20080502-5026.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:
    Docket Numbers: OA07-40-003.
    Applicants: Portland General Electric Company.
    Description: Amendment to Application of Portland General Electric
Company to correct effective dates on three tariff sheets.
    Filed Date: 05/02/2008.
    Accession Number: 20080502-5126.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: OA07-55-001.
    Applicants: Black Hills Power, Inc.; Powder River Energy Corp;
Basin Electric Power Cooperative, Inc.
    Description: Order No. 890 OATT Compliance Filing of Black Hills
Power, Inc., et al.
    Filed Date: 05/05/2008.
    Accession Number: 20080506-5029.
    Comment Date: 5 p.m. Eastern Time on Monday, May 26, 2008.

    Docket Numbers: OA07-56-002.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company submits revised and
original tariff sheets in compliance with the Order No. 890
requirements dated April 3, 2008.
    Filed Date: 05/05/2008.
    Accession Number: 20080506-5025.
    Comment Date: 5 p.m. Eastern Time on Monday, May 26, 2008.

    Docket Numbers: OA07-85-001.
    Applicants: Ohio Valley Electric Corporation.
    Description: Order No. 890 OATT Attachment C Compliance Filing of
Ohio Valley Electric Corporation.
    Filed Date: 05/02/2008.
    Accession Number: 20080502-5057.
    Comment Date: 5 p.m. Eastern Time on Friday, May 23, 2008.

    Docket Numbers: OA07-89-001.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Co submits its compliance filing
on Attachment C to its Open Access Transmission Tariff under OA07-89.
    Filed Date: 05/05/2008.
    Accession Number: 20080507-0211.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 27, 2008.

    Docket Numbers: OA07-92-001.
    Applicants: Southern Company Services, Inc.
    Description: Order No. 890 OATT Filing of Southern Company
Services, Inc., Attachment C Request for Waiver.
    Filed Date: 05/01/2008.
    Accession Number: 20080501-5200.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: OA07-96-001.
    Applicants: Idaho Power Company.
    Description: Order No. 890 OATT Attachment C Filing of Idaho Power
Company.
    Filed Date: 05/01/2008.
    Accession Number: 20080501-5067.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 22, 2008.

    Docket Numbers: OA08-114-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits a notification filing
pursuant to Order 890 and PJM Tariff Section 19.8.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0210.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    Docket Numbers: OA08-115-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits a notification filing pursuant to Order 890 and 890-A.
    Filed Date: 04/30/2008.
    Accession Number: 20080505-0211.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 21, 2008.

    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 dockets(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. E8-10834 Filed 5-14-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 8998-9000]
[FR Doc No: 2018-04181]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0338]

Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``Definitions of Suspect
Product and Illegitimate Product for Verification Obligations Under the
Drug Supply Chain Security Act.'' The draft guidance is intended to
describe FDA's interpretation of terms used in the definitions of
``suspect product'' and ``illegitimate product'' in the Drug Supply
Chain Security Act (DSCSA), for purposes of trading

partners' verification obligations (including notification). The draft
guidance lays out FDA's current understanding of the following key
terms for such purposes: Counterfeit, diverted, fraudulent transaction,
and unfit for distribution.

DATES: Submit either electronic or written comments on the draft
guidance by April 2, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-0338 for ``Definitions of Suspect Product and Illegitimate
Product for Verification Obligations Under the Drug Supply Chain
Security Act.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff office between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Venti, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act.'' On
November 27, 2013, the DSCSA (Pub. L. 113-54) was signed into law.
Section 202 of the DSCSA added section 581 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee), which sets forth
definitions for the DSCSA. ``Suspect product'' is defined in section
581(21) of the FD&C Act, and ``illegitimate product'' is defined in
section 581(8).
    FDA is announcing the availability of this draft guidance to
describe the Agency's interpretation of terms used in the definitions
of ``suspect product'' and ``illegitimate product'' in the DSCSA, for
purposes of trading partners' verification obligations (including
notification) under section 582(b)(4), (c)(4), (d)(4), and (e)(4),
respectively of the FD&C Act (21 U.S.C. 360eee-1(b)(4), (c)(4), (d)(4),
and (e)(4)). The draft guidance lays out FDA's current understanding of
the following key terms for such purposes: Counterfeit, diverted,
fraudulent transaction, and unfit for distribution.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on definitions of
suspect product and illegitimate product for verification obligations
under the DSCSA. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

II. Electronic Access

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

    Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04181 Filed 3-1-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45926-45927]
[FR Doc No: 2018-19771]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0015; FRL-9983-60-OAR]

Proposed Information Collection Request; Comment Request; Part 70
State Operating Permit Program (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Part 70 State
Operating Permit Program (Renewal)'' (EPA ICR No. 1587.14, OMB Control
No. 2060.0243) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (PRA).
Before doing so, the EPA is soliciting public comments on specific
aspects of the proposed information collection as described below. This
is a proposed extension of the ICR, which is currently approved through
March 31, 2019. 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.

DATES: Comments must be submitted on or before November 13, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0015, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Dylan C. Mataway-Novak, Air Quality
Policy Division, Office of Air Quality Planning and Standards, C504-05,
U.S. Environmental Protection Agency, Research Triangle Park, NC;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Avenue NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about the EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
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. The
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. At that time, the EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: Title V of the Clean Air Act (Act) requires states to
develop and implement a program for issuing operating permits to all
sources that fall under any Act definition of ``major'' and certain
other non-major sources that are subject to federal air quality
regulations. The Act further requires the EPA to develop regulations
that establish the minimum requirements for those state operating
permits programs and to oversee implementation of the state programs.
The EPA regulations setting forth requirements for the state operating
permit program are found at 40 CFR part 70. The part 70 program is
designed to be implemented primarily by state, local and tribal
permitting authorities in all areas where they have jurisdiction.
    In order to receive an operating permit for a major or other source
subject to the permitting program, the applicant must conduct the
necessary research, perform the appropriate analyses and prepare the
permit application with documentation to demonstrate that its facility
meets all applicable statutory and regulatory requirements. Specific
activities and requirements are listed and described in the Supporting
Statement for the 40 CFR part 70 ICR.
    Under 40 CFR part 70, state, local and tribal permitting
authorities review permit applications, provide for public review of
proposed permits, issue permits based on consideration of all technical
factors and public input and review information submittals required of
sources during the term of the permit. Also, under 40 CFR part 70, the
EPA reviews certain actions of the permitting authorities and provides
oversight of the programs to ensure that they are being adequately
implemented and enforced. Consequently, information prepared and
submitted by sources is essential for sources to receive permits, and
for federal, state, local and tribal permitting authorities to
adequately review the permit applications and thereby properly
administer and manage the program.

    Information that is collected is handled according to the EPA's
policies set forth in title 40, chapter 1, part 2, subpart B--
Confidentiality of Business Information (see 40 CFR part 2). See also
section 114(c) of the Act.
    Form Numbers: None.
    Respondents/affected entities: Industrial plants (sources); state,
local and tribal permitting authorities.
    Respondent's obligation to respond: mandatory (see 40 CFR part 70).
    Estimated number of respondents: 13,712 sources and 117 state,
local and tribal permitting authorities.
    Frequency of response: On occasion.
    Total estimated burden: 4,738,925 hours (per year). Burden is
defined at 5 CFR 1320.03(b).
    Total estimated cost: $321,878,589 (per year). There are no
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 429,890 hours per year
for the estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to updated estimates of the
number of sources and permits subject to the part 70 program, rather
than any change in federal mandates.

    Dated: August 29, 2018.
Anna Marie Wood,
Director, Air Quality Policy Division.
[FR Doc. 2018-19771 Filed 9-10-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 14, 2008 (Volume 73, Number 199)]
[Proposed Rules]
[Page 60662-60670]
[DOCID:fr14oc08-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[EPA-R10-OW-2008-0745; FRL-8728-6]

Ocean Dumping; Designation of Ocean Dredged Material Disposal
Site Offshore of the Rogue River, OR

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is withdrawing an earlier proposal to designate an ocean
dredged material disposal site near the mouth of the Rogue River,
Oregon, and is re-proposing to designate an ocean dredged material
disposal site located offshore of the Rogue River, Oregon. EPA's
proposed rule was published at 56 FR 47173 (September 18, 1991).
Changes since that time to the ocean dumping program, including changes
to the Marine Protection, Research, and Sanctuaries Act, as amended
(MPRSA), 33 U.S.C. 1401 to 1445, give rise to EPA's decision to re-
propose the site designation to take into account the statutory changes
since the original proposal and to incorporate new data about the site.
The new site is needed primarily to serve the long-term need for a
location to dispose of material dredged from the Rogue River navigation
channel, and will also serve to provide a location for the disposal of
dredged material for persons who have received a permit for such
disposal. The newly designated site will be subject to ongoing
monitoring and management to ensure continued protection of the marine
environment.

DATES: Comments on this proposed rule must be received by November 13,
2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OW-2008-0745 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: Jonathan Freedman, U.S. Environmental Protection
Agency, Region 10, Office of Ecosystems, Tribal and Public Affairs
(ETPA-183), Aquatic Resources Unit, 1200 Sixth Avenue, Suite 900,
Seattle, Washington 98101.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OW-
2008-0745. 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 the Web site, http://
www.regulations.gov, or through 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 the Web site, 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 or 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 http://
www.regulations.gov index. Although listed in the index, some
information may not be 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 in http://www.regulations.gov or in hard copy during
normal business hours at the U.S. Environmental Protection Agency,
Region 10, Library, 10th Floor, 1200 Sixth Avenue, Suite 900, Seattle,
Washington 98101. For access to the documents at the Region 10 Library,
contact the Region 10 Library Reference Desk at<PHONE_NUMBER>, between
the hours of 9 a.m. to 11:30 a.m., and between the hours of 1 p.m. to 4
p.m., Monday through Friday, excluding legal holidays, for an
appointment.

FOR FURTHER INFORMATION CONTACT: Jonathan Freedman, U.S. Environmental
Protection Agency, Region 10, Office of Ecosystems, Tribal and Public
Affairs (ETPA-183), Aquatic Resources Unit, 1200 Sixth Avenue, Suite
900, Seattle, Washington 98101, phone number:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or contact Jessica Winkler, U.S.
Environmental Protection Agency, Region 10, Office of Ecosystems,
Tribal and Public Affairs (ETPA-183), Aquatic Resources Unit, 1200
Sixth Avenue, Suite 900, Seattle, Washington 98101, phone number: (206)
553-7369, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

1. Potentially Affected Persons

    Persons potentially affected by this proposed action include those
who seek or might seek permits or approval by EPA to dispose of dredged
material into ocean waters pursuant to the Marine Protection, Research,
and Sanctuaries Act, as amended (MPRSA), 33 U.S.C. 1401 to 1445. EPA's
action would be relevant to persons, including organizations and
government bodies, seeking to dispose of dredged material in ocean
waters offshore of the Rogue River, Oregon. Currently, the U.S. Army
Corps of Engineers (Corps) would be most impacted by this proposed
action. Potentially affected categories and persons include:

------------------------------------------------------------------------
                                      Examples of potentially regulated
             Category                              persons
------------------------------------------------------------------------
Federal Government................  U.S. Army Corps of Engineers Civil
                                     Works Projects, and other Federal
                                     Agencies.
Industry and General Public.......  Port Authorities, Marinas and
                                     Harbors, Shipyards and Marine
                                     Repair Facilities, Berth Owners.

State, local and tribal             Governments owning and/or
 governments.                        responsible for ports, harbors, and/
                                     or berths; Government agencies
                                     requiring disposal of dredged
                                     material associated with public
                                     works projects.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding persons likely to be affected by this
action. For any questions regarding the applicability of this action to
a particular person, please refer to the contact person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

2. Background

a. History of Disposal Site Offshore of the Rogue River, Oregon

    The proposed Rogue River ocean dredged material disposal site, or
areas in the same vicinity, have been used by the Corps since
approximately 1962. When the MPRSA was enacted, the site became an
``interim'' site under the ocean dumping regulations, a status
superseded by later statutory changes to the MPRSA. The site currently
exists as a site selected by the Corps under Section 103 of the MPRSA.
EPA concurred on the selection of the site and, in 2003, approved the
Corps' request to continue to use the site through the end of the 2008
dredging season. Site designation, pursuant to Section 102 of the
MPRSA, is necessary for any use of the site to continue after 2008.
    From 1986 through 2006, over 1.1 million cubic yards (cy) of
dredged material were placed at the Rogue River site. A uniform
placement strategy, rather than point dumping, has been applied to the
disposal of material at the site and regular bathymetric surveys have
shown that persistent mounding has not occurred within the site or in
the vicinity of the site. Site capacity appears to be virtually
unlimited. Data collected at the site and modeling indicate that
material disposed at the site redistributes out of the site and is
presumed to feed the littoral cell. Consequently, the site is a sound
candidate location to propose for designation pursuant to Section 102
of the MPRSA.

b. Location and Configuration of Proposed Rogue River Ocean Dredged
Material Disposal Site

    Today, EPA withdraws the rule the Agency proposed on September 18,
1991, at 56 FR 47173 to designate a Rogue River site, and
simultaneously proposes to designate the Rogue River ocean dredged
material site at the coordinates listed below. The figure below shows
the Rogue River ocean dredged material disposal site (Rogue River ODMDS
or Site) EPA proposes to designate today. This configuration is
expected to allow dredged material disposed in shallower portions of
the site to naturally disperse into the littoral zone without creating
mounding conditions that could contribute to adverse impacts to
navigation. The proposed configuration will allow EPA to ensure that
disposal of dredged material into the Site will be managed so that as
much material as possible is retained in the active littoral drift area
to augment shoreline building processes.

[GRAPHIC] [TIFF OMITTED] TP14OC08.052

    The coordinates for the Rogue River ODMDS, as proposed today, are,
in North American Datum 83 (NAD 83):

42[deg]24[min]15.40[sec] N           124[deg]26[min]52.39[sec] W
42[deg]24[min]03.40[sec] N           124[deg]26[min]39.39[sec] W
42[deg]23[min]39.40[sec] N           124[deg]27[min]17.40[sec] W
42[deg]23[min]51.40[sec] N           124[deg]27[min]30.40[sec] W

    The Site is expected to occupy approximately 116 acres. The Site's
dimensions, as proposed, are: 1,400-feet wide by 3,600-feet long, with
Site depth ranging from approximately 50 to 90 feet. The Site generally
lies on bottom contours sloping at a rate of 8/1000 feet to the west-
southwest. The disposal area, placement area, and drop zone are
identical. Limited onshore transport of material disposed of at the
proposed Site is not expected because of the nature of the prevailing
currents and wave transport in the vicinity of the Site. Net predicted
material transport at the proposed Site is southward in the summer
months and northward during the remainder of the year. These transport
mechanisms are expected to move material into the active littoral drift
area.

c. Management and Monitoring of the Proposed Site

    The proposed Rogue River ODMDS is expected to receive sediments
dredged by the Corps to maintain the federally authorized navigation
project at the Rogue River, Oregon and dredged material from other
persons who have obtained a permit for the disposal of dredged material
at the Site. The ocean dumping regulations do not require a
modification of any existing permits. All persons using the Site are
required to follow the Site Management and Monitoring Plan (SMMP) for
the Rogue River ODMDS. The SMMP is available as a draft document for
review and comment by the public as of today's action proposing the
Rogue River ODMDS designation. The draft SMMP includes management and
monitoring requirements to ensure that dredged materials disposed at
the Site are suitable for disposal and addresses the timing of disposal
events to minimize interference with other uses of ocean waters in the
vicinity of the proposed Site.

d. MPRSA Criteria

    In proposing to designate the Rogue River ODMDS, EPA assessed the
proposed action against the criteria of the MPRSA, with particular
emphasis on the general and specific regulatory criteria of 40 CFR Part
228, to determine if the proposed site designation satisfies those
criteria.

General Criteria (40 CFR 228.5)
    (1) Sites must be selected to minimize interference with other
activities in the marine environment, particularly avoiding areas of
existing fisheries or shellfisheries, and regions of heavy commercial
or recreational navigation (40 CFR 228.5(a)).
    EPA's assessment of information available at the time of this
proposed rule included a review of the potential for interference with
navigation, recreation, shellfisheries, aquatic resources, commercial
fisheries, protected geologic features, and cultural and/or
historically significant areas. While limited overlap was found to
exist between disposal operations and salmon fishing, no observable
conflicts were identified. No evidence was found to suggest that the
proposed Site would cause interference with fisheries or with
navigation in the Rogue River navigation channel. The proposed Site has
been used over the past decades for dredged material disposal, most
recently pursuant to Section 103 of the MPRSA as a site selected by the
Corps, with EPA's concurrence. Mariners in this area are accustomed to
Site use.
    (2) Sites must be situated such that temporary perturbations to
water quality or other environmental conditions during initial mixing
caused by disposal operations would be reduced to normal ambient levels
or undetectable contaminant concentrations or effects before reaching
any beach, shoreline, marine sanctuary, or known geographically limited
fishery or shellfishery (40 CFR 228.5(b)).
    Dredged material found suitable for disposal into ocean waters, as
characterized by chemical and biological testing or as evaluated
according to 40 CFR 227.13, will be the only material allowed to be
disposed of at the proposed Site. Modeling work performed by the Corps
demonstrates that water column turbidity would dissipate for an
anticipated 97% of the coarser material within a few minutes of
disposal, while the remaining 3% of the material, which would be
classified as fine-grained, would dissipate within a half hour.
Therefore, based on modeling, monitoring data, and history of use, no
contaminant or water quality effects would be expected to reach any
beach, shoreline, or other area outside of the proposed Site. Over
time, some of the suitable disposed material would be expected to
migrate into the littoral system, and potentially to coastal
shorelines.
    (3) If Site designation studies show that any interim disposal
sites do not meet the site selection criteria, use of such sites shall
be terminated as soon as any alternate site can be designated (40 CFR
228.5(c)).
    There are no interim disposal sites near the proposed Rogue River
Site as defined under the Ocean Dumping regulations. The designation of
the proposed Site is necessary because no location for the disposal of
dredged material will exist in the vicinity of the proposed Site after
the end of the 2008 dredge season.
    (4) The sizes of disposal sites will be limited in order to
localize for identification and control any immediate adverse impacts,
and to permit the implementation of effective monitoring and
surveillance to prevent adverse long-range impacts. Size,
configuration, and location are to be determined as part of the
disposal site evaluation (40 CFR 228.5(d)).
    EPA sized the proposed Site to meet this criterion. The proposed
Site tends to be moderately dispersive in the near-shore area and tends
to be less dispersive farther from shore. The overall stability of the
Site, as indicated by the lack of adverse mounding, is a significant
component of the justification for the size of the Site. Data collected
by the Corps through bathymetric monitoring show the spread and
movement of material after placement. The data establish that material
from the Site eventually disperses over the footprint of the site with
seasonal movement into the littoral system. Effective monitoring of the
proposed Site is anticipated based on past practice and current ability
to monitor the location and conduct surveillance.
    (5) EPA will, wherever feasible, designate ocean dumping sites
beyond the edge of the continental shelf and other such sites where
historical disposal has occurred (40 CFR 228.5(e)).
    The proposed Site would be located where historic disposal has
occurred with only minimal impact to the environment, and to other uses
and amenities. Locations off the continental shelf in the Pacific ocean
as a general rule are inhabited by stable benthic and pelagic
ecosystems on steeper gradients that are not well adapted to frequent
disturbance events such as would occur if disposal of dredged material
took place. Monitoring and surveillance of a site located beyond the
edge of the continental shelf would be challenging and would present
safety concerns for crew transporting the material to be disposed. In
addition, dredged material disposed at a location beyond the
continental shelf would not be available to the littoral system. The
loss of material would potentially have a negative impact the mass
balance of the system with a resulting negative impact on erosion/
accretion patterns along this limited area of coastline near the Rogue
River.
Specific Criteria (40 CFR 228.6)
    (1) Geographical Position, Depth of Water, Bottom Topography and
Distance from Coast (40 CFR 228.6(a)(1)).
    Based on the data available at the time of this proposal, the
geographical position, including the depth of the proposed Site, bottom
topography, and distance from the coastline in the vicinity of the
proposed Site, indicate that designation of the proposed Site will not
cause adverse effects to the marine environment. Based on EPA's
understanding of currents at the proposed Site and their influence on
the movement of material in the area, there is a high likelihood that
much of the material disposed at the Site will be transported to the
littoral system. This movement is expected to allow for long-term
disposal without creation of adverse mounding conditions.
    (2) Location in Relation to Breeding, Spawning, Nursery, Feeding,
or Passage Areas of Living Resources in Adult or Juvenile Phases (40
CFR 228.6(a)(2)).
    The proposed Site is not located in exclusive breeding, spawning,
nursery or feeding areas for adult or juvenile phases of living
resources. Many nearshore pelagic organisms occur in the water column
over the proposed Site but these organisms are found off most of the
Pacific coast and are not unique to the proposed Site. Benthic fauna
common to nearshore, sandy, wave-influenced regions that exist along
the Pacific coast that are found at the proposed Site are generally
well-suited to survive in this dynamic environment and have been found
to adapt well to natural and human perturbations. Benthic communities
are expected to rapidly recolonize in the event of burying after
disposal. Near the proposed Site, a variety of pelagic and demersal
fish species, as well as shellfish, are found. Anadromous salmonids are
found at all seasons in the nearshore area off the mouth of the Rogue
River. Seals and sea lions also inhabit the lower Rogue River and
coastal area. Nesting areas offshore of the Rogue River entrance
channel support a variety of avian species. Whales and sea turtles are
present seasonally offshore of the coastline in this area, but are
generally observed further offshore than the proposed site. No unique
breeding, spawning, nursery, feeding, or passage habitat is located
within the proposed Site or within its

immediate vicinity. Based on modeling of the water column, which
indicates that turbidity would be expected to dissipate fairly rapidly,
any avoidance behavior by any species at the proposed Site would be
short-term.
    (3) Location in Relation to Beaches and Other Amenity Areas (40 CFR
228.6(a)(3)).
    The proposed Site, although located in close proximity to the Rogue
River navigation channel, is located a sufficient distance offshore to
avoid adverse impacts to beaches and other amenity areas. The local
beaches support tourism, and recreational and commercial fishing.
Transportation of dredges or barges to and from the proposed Site to
dispose of dredged material is expected to be coordinated so as to
avoid disturbance of other activities near the Rogue River entrance
channel. Dredged material disposed of at the proposed Site is expected
to disperse into the littoral system, with a possible positive effect
over time of reducing erosion of coastal beaches.
    (4) Types and Quantities of Wastes Proposed to be Disposed of, and
Proposed Methods of Release, including Methods of Packing the Waste, if
any (40 CFR 228.6(a)(4)).
    Dredged material found suitable for disposal into ocean waters, as
characterized by chemical and biological testing or as evaluated
according to 40 CFR 227.13, will be the only material allowed to be
disposed of at the proposed Site. No material defined as ``waste''
under the MPRSA will be allowed to be disposed of at the proposed Site.
The dredged material expected to be disposed of at the Site will be
predominantly marine sand, far removed from known sources of
contamination. The physical and chemical analyses of material from the
Rogue River Navigation Channel and boat basin indicated only two
anomalies. The first is an elevated level of nickel relative to other
river drainage basins along the Oregon coast. Since elevated nickel
levels have been detected in Rogue River channel sediments
historically, those levels are believed to reflect the ambient
background for the Rogue River system. The second was an elevated level
of phenol in one sample location. The sediments associated with the
elevated phenol sample will not be dredged until further
characterization can be completed and disposal of the material at the
proposed Site will not take place unless and the material has been
found to be suitable for unconfined ocean disposal.
    With respect to proposed methods of releasing material at the
proposed Site, material will be released just below the surface from
dredges while the dredges are under power and slowly transiting the
proposed Site. This method of release is expected to spread material at
the Site to minimize mounding and to minimize impacts to the benthic
community and other species in the Site at the time of a disposal
event.
    (5) Feasibility of Surveillance and Monitoring (40 CFR
228.6(a)(5)).
    Monitoring and surveillance at the proposed Site are expected to be
feasible and easily performed from small surface research vessels. The
proposed Site is accessible for bathymetric and side-scan sonar
surveys. At a minimum, it is expected that annual bathymetric surveys
will be conducted at the proposed Site to confirm that no unacceptable
mounding is taking place within the Site or its immediate vicinity.
Routine monitoring is expected to concentrate on examining how the
distribution of material in the near-shore portions of the Site augment
littoral processes and how distribution of material in the deeper
portions of the Site avoid or minimize mounding.
    (6) Dispersal, Horizontal Transport and Vertical Mixing
Characteristics of the Area, Including Prevailing Current Direction and
Velocity, if any (40 CFR 228.6(a)(6)).
    Dispersal, horizontal transport and vertical mixing characteristics
of the area at and in the vicinity of the proposed Site are complex. In
part, this complexity is a result of rocky reefs to the north of the
proposed Site which appear to influence mass transport, and in part the
complexity can be attributed to prevailing wave-induced motion and
currents moving towards the north during much of the year. Wave-induced
motion appears to cause near-constant mobilization of bottom sediment.
The overall regional mass transport trend suggests that net littoral
transport of material is to the north from the proposed Site. That
overall littoral transport appears to be balanced by offshore transport
from the mouth of the Rogue River to the north of the proposed Site
such that there is shoreline accretion to the north and relative
equilibrium of the shoreline to the south.
    (7) Existence and Effects of Current and Previous Discharges and
Dumping in the Area (including Cumulative Effects) (40 CFR
228.6(a)(7)).
    The approximate annual loading volume of dredged material placed at
the proposed Site is expected to equal 54,000 cubic yards (cy) of
material. This average was calculated by averaging seasonal material
placement over disposal seasons from the time the site became a
selected site. EPA's evaluation of historical data and modeling
conducted by the Corps concluded that past disposal operations have not
resulted in unacceptable environmental degradation and future disposal
of dredged material is not expected to result in unacceptable
environmental degradation. Although mounding is a potential effect at
any dredged material disposal site, bathymetric surveys at the Rogue
River ODMDS have not shown persistent mounding over the 30 year site
use history. Annual monitoring of the proposed Site will be required in
the draft SMMP for the proposed Site. In the unlikely event mounding
occurred, the draft SMMP includes requirements for managing the
proposed Site to address mounding issues.
    (8) Interference with Shipping, Fishing, Recreation, Mineral
Extraction, Desalination, Fish and Shellfish Culture, Areas of Special
Scientific Importance and Other Legitimate Uses of the Ocean (40 CFR
228.6(a)(8)).
    Designation of the proposed Site is not expected to interfere with
shipping, fishing, recreation or other legitimate uses of the ocean.
Disposals at the new Site will be managed through the SMMP to minimize
interference with other legitimate uses of the ocean through careful
timing and staggering of disposals in the near-shore portion of the
proposed Site. Commercial and recreational fishing and commercial
navigation are the primary uses for which such timing will be needed.
No plans for mineral extraction offshore of the Rogue River are planned
or proposed for this area. Data indicates that magnetic anomalies
suggestive of mineral placer offshore deposits were actually
attributable to near-surface masses of bedrock. No desalination or
energy projects are planned in the vicinity of the proposed Site. Fish
and shellfish culture operations are not under consideration for the
area. There are no known areas of scientific importance in the vicinity
of the proposed Site.
    (9) The Existing Water Quality and Ecology of the Sites as
Determined by Available Data or Trend Assessment of Baseline Surveys
(40 CFR 228.6(a)(9)).
    EPA has not identified any adverse water quality impacts from ocean
disposal of dredged material as a result of disposal into the existing
103(b)-selected site at the Rogue River. The data collected for the
103(b)-selected site suggest that the pelagic and benthic communities,
which are widespread in occurrence off the Oregon coast, are not
expected to experience long-term impacts. The ability of this mobile
sand community to rapidly recolonize

supports the conclusion that long-term adverse impacts will not occur
from managed disposal of dredged material at the proposed Site.
    (10) Potentiality for the Development or Recruitment of Nuisance
Species in the Disposal Site (40 CFR 228.6(a)(10)).
    Nuisance species, considered as any undesirable organism not
previously existing at a location, have not been observed at, or in the
vicinity of, the proposed Site. Material expected to be disposed at the
proposed Site will primarily be marine sands but some fine-grained
material, finer than natural background, may also be disposed. While
this finer-grained material could have the potential to attract
nuisance species to the proposed Site, no such recruitment has occurred
while the proposed Site has been used as a 103(b)-selected site.
Evidence suggests that such fine grained material is quickly dispersed
from the site. The draft SMMP includes specific biological monitoring
requirements, which would act to identify any nuisance species, and
management requirements, which would allow EPA to direct special
studies and/or operational changes to address the issue.
    (11) Existence at or in Close Proximity to the Site of any
Significant Natural or Cultural Feature of Historical Importance (40
CFR 228.6(a)(11)).
    The proposed Site is located about two nautical miles south-
southeast from the Rogue Reef complex, an ecologically unique feature
among a system of neritic reefs off the Oregon coast. Material disposed
at the proposed Site would be clean sand that is expected to settle to
the seafloor quickly. Movement of the relatively small quantities of
disposed sand into the reef area would be anticipated to occur, if at
all, through naturally occurring littoral transport which would not be
expected to adversely affect aquatic communities in the reef areas. No
significant cultural features have been identified at, or in the
vicinity of, the proposed Site. As discussed further below, EPA
coordinated with Oregon's State Historic Preservation Officer and with
Tribes in the vicinity of the proposed Site to identify any cultural
features. None were identified. No shipwrecks were observed or
documented within the proposed Site or its immediate vicinity.
Notwithstanding heavy ship traffic supplying gold fields near this
general area in the 1800s, side-scan sonar did not detect any
shipwrecks and extensive review of shipwreck databases did not show any
shipwrecks at, or near, the proposed Site.

e. National Environmental Policy Act (NEPA); Magnuson-Stevens Act
(MSA); Marine Mammal Protection Act (MMPA); Coastal Zone Management Act
(CZMA); Endangered Species Act (ESA); National Historic Preservation
Act (NHPA)

(1) NEPA
    Section 102 of the National Environmental Policy Act of 1969, as
amended (NEPA), 42 U.S.C. 4321 to 4370f, requires that Federal agencies
prepare an Environmental Impact Statement (EIS) for major federal
actions significantly affecting the quality of the human environment.
NEPA does not apply to EPA designations of ocean disposal sites under
the MPRSA because the courts have exempted EPA's actions under the
MPRSA from the procedural requirements of NEPA through the functional
equivalence doctrine. Under that doctrine, as EPA discussed most
recently in the Agency final rule revising the NEPA regulations, the
courts reasoned that actions under the MPRSA are functionally
equivalent to the analysis required under NEPA because such actions are
undertaken with full consideration of environmental impacts and with
opportunities for public involvement. See 72 FR 53653, September 19,
2007. EPA has, by policy, determined that the preparation of non-EIS
NEPA documents for certain EPA regulatory actions, including actions
under the MPRSA, is appropriate. EPA's ``Notice of Policy and
Procedures for Voluntary Preparation of NEPA Documents,'' (Voluntary
NEPA Policy), 63 FR 58045 (October 29, 1998), sets out both the policy
and procedures EPA uses when preparing such environmental review
documents. EPA's 2007 revisions to 40 CFR Part 6 provided the framework
EPA used to prepare the voluntary NEPA documents for this proposed
action.
    EPA's primary voluntary NEPA document for designating the proposed
Site is the Rogue River, Oregon Ocean Dredged Material Disposal Site
Evaluation Study and Environmental Assessment, 2008 (EA), jointly
prepared by EPA and the Corps. The EA and its Technical Appendices,
which are part of the docket for today's proposed action, provide the
threshold environmental review for the Site designation. The
information from the EA is used extensively, above, in the discussion
of the ocean dumping criteria. Because EPA's Voluntary NEPA Policy does
not require the preparation of an EIS for this proposed action, the EA
prepared for this Site designation is available for public comment and
a final EA will be made available at the time of final rulemaking.
Persons interested in commenting on this issue should do so at this
time. There may not be another opportunity to comment.
(2) MSA and MMPA
    In the spring of 2008, EPA initiated consultation with the National
Marine Fisheries Service (NMFS) concerning essential fish habitat and
protected marine mammals. EPA prepared an essential fish habitat (EFH)
assessment pursuant to Section 305(b), 16 U.S.C. 1855(b), of the
Magnuson-Stevens Act, as amended (MSA), 16 U.S.C. 1801 to 1891d. NMFS
is also reviewing EPA's EFH assessment and ESA Biological Assessment
for purposes of the Marine Mammal Protection Act of 1972, as amended
(MMPA), 16 U.S.C. 1361 to 1389. Consultation under both MMPA and MSA is
still underway, but is expected to conclude before EPA takes any action
to finalize today's proposed rule. Persons interested in commenting on
this issue should do so at this time. There may not be another
opportunity to comment.
(3) CZMA
    EPA initiated consultation with the state of Oregon on coastal zone
management issues in June and July of 2008. EPA prepared a consistency
determination for the Oregon Ocean and Coastal Management Program
(OCMP) to meet the requirements of the Coastal Zone Management Act, as
amended, (CZMA), 16 U.S.C. 1451 to 1465, and will submit that
determination formally to the Oregon Department of Land Conservation
and Development (DLCD) for review.
(4) ESA
    EPA initiated informal consultation with NMFS and the U.S. Fish and
Wildlife Service on its action to designate the Rogue River ODMDS
beginning in the spring of 2008. EPA prepared a Biological Assessment
to assess the potential effects of the Site designation on aquatic and
wildlife species to determine whether or not its action might adversely
affect species listed as endangered or threatened and/or adversely
modify or destroy their designated critical habitat. EPA found that its
action would not be likely to adversely affect aquatic or wildlife
species listed as endangered pursuant to the Endangered Species Act, as
amended (ESA), 16 U.S.C. 1531 to 1544, or the critical habitat of such
species. EPA found that site designation does not have a direct impact
on any of the identified ESA species but also found that indirect
impacts associated with reasonably foreseeable future disposal

activities had to be considered. These indirect impacts included a
short-term increase in suspended solids and turbidity in the water
column when dredged material was disposed at the new Site and an
accumulation of material on the ocean floor when material was disposed
at the Site. EPA concluded that while its action may affect ESA-listed
species, the action would not be likely to adversely affect ESA-listed
species or critical habitat.
    The U.S. Fish and Wildlife Service (USFWS) concurred with EPA's
finding that EPA's action to designate the proposed Rogue River ODMDS
would not likely adversely affect listed species or critical habitat.
Consultation with the USFWS for this proposed action is complete. The
National Marine Fisheries Service (NMFS) is still reviewing the
proposed action, but consultation with NMFS is expected to be completed
before EPA takes any action to finalize today's proposed rule. EPA
specifically requests that any comments concerning ESA be made at this
time. This may be the only opportunity for interested persons to
comment on this issue.
(5) NHPA
    EPA initiated consultation with the State of Oregon's Historic
Preservation Officer (SHPO) to address National Historic Preservation
Act, as amended (NHPA), 16 U.S.C. Sections 470 to 470a-2, which
requires Federal agencies to take into account the effect of their
actions on districts, sites, buildings, structures, or objects,
included in, or eligible for inclusion in the National Register. EPA
determined that no historic properties were affected, or would be
affected, by the proposed designation of the Site. EPA did not find any
historic properties within the geographic area of the proposed Site.
This determination was based on an extensive review of the National
Register of Historic Districts in Oregon, the Oregon National Register
list and an assessment of cultural resources near the proposed Site.
Side scan sonar of the proposed Site did not reveal the presence of any
shipwrecks or other cultural or historic properties. This consultation
is expected to be completed before EPA takes any action to finalize
today's proposed rule. EPA specifically requests that any comments
concerning NHPA be made at this time. This may be the only opportunity
for interested persons to comment on this issue.

3. Statutory and Executive Order Reviews

    This rule proposed to designate an ocean dredged material disposal
site pursuant to Section 102 of the MPRSA. This rule complies with
applicable executive orders and statutory provisions as follows:

(1) Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant,''
and therefore subject to OMB review and the requirements of the
Executive Order. The Executive Order defines ``significant regulatory
action'' as one that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more, or adversely
affect in a material way, the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs, or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order. EPA has
determined that this proposed rule is not a ``significant regulatory
action'' under the terms of Executive Order 12866 and is therefore not
subject to OMB review.

(2) Paperwork Reduction Act

    This proposed action does not impose an information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq., because this proposed rule does not establish or modify
any information or recordkeeping requirements for the regulated
community and only seeks to authorize the pre-existing requirements
under State law and imposes no additional requirements beyond those
imposed by State law.
    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;
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.
    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 are listed in 40 CFR Part 9.

(3) Regulatory Flexibility

    The Regulatory Flexibility Act (RFA), generally requires Federal
agencies to prepare a regulatory flexibility analysis of any rule
subject to notice and comment rulemaking requirements under the
Administrative Procedure Act or any other statute unless the agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities. Small entities include small
businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business defined by
the Small Business Administration's size regulations at 13 CFR Part
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district, or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field. EPA has determined that this action
will not have a significant economic impact on small entities because
the proposed rule will only have the effect of regulating the location
of a site to be used for the disposal of dredged material in ocean
waters. After considering the economic impacts of today's rule, I
certify that this action will not have a significant economic impact on
a substantial number of small entities. EPA continues to be interested
in the potential impacts of the proposed rule on small entities and
welcomes comments on issues related to such impacts.

(4) Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C.
1531 to 1538, for State, local, or tribal governments or the private
sector. This action imposes no new enforceable duty

on any State, local, or tribal governments or the private sector.
Therefore, this action is not subject to the requirements of sections
202 or 205 of the UMRA. This action is also not subject to the
requirements of section 203 of the UMRA because it contains no
regulatory requirements that might significantly or uniquely affect
small government entities. Those entities are already subject to
existing permitting requirements for the disposal of dredged material
in ocean waters.

(5) Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government.'' This rule does
not have federalism implications. It will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government, as specified in
Executive Order 13132. This rule proposes to designate a site for the
disposal of dredged material in ocean waters. Thus, Executive Order
13132 does not apply to this rule. In the spirit of Executive Order
13132, and consistent with EPA policy to promote communications between
EPA and State and local governments, EPA specifically solicits comment
on this proposed rule from State and local officials.

(6) Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This proposed rule does not have tribal implications, as specified
in Executive Order 13175 because the designation of this dredged
material disposal Site will not have a direct effect on Indian Tribes,
on the relationship between the federal government and Indian Tribes,
or on the distribution of power and responsibilities between the
federal government and Indian tribes. Thus, Executive Order 13175 does
not apply to this rule. Although Executive Order 13175 does not apply
to this proposed rule EPA consulted with tribal officials in the
development of this rule, particularly as it relates to potential
impacts to historic or cultural resources. EPA specifically solicits
additional comment on this proposed rule from tribal officials.

(7) Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks. The proposed action concerns the designation of an ocean
disposal Site and would only have the effect of providing a designated
location to use for ocean disposal of dredged material pursuant to
section 102(c) of the MPRSA.

(8) Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
``significant regulatory action'' as defined under Executive Order
12866.

(9) National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, Section 12(d) (15 U.S.C.
272), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. The proposed
action includes environmental monitoring and measurement as described
in EPA's draft SMMP. EPA will not require the use of specific,
prescribed analytic methods for monitoring and managing the proposed
Site once designated. Rather, the Agency plans to allow the use of any
method, whether it constitutes a voluntary consensus standard or not,
that meets the monitoring and measurement criteria discussed in the
final SMMP. EPA welcomes comments on this aspect of the proposed
rulemaking and, specifically, invites the public to identify
potentially-applicable voluntary consensus standards and to explain why
such standards should be used in this regulation.

(10) Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. EPA has determined that this proposed
rule will not have disproportionately high and adverse human health or
environmental effects on minority or low-income populations because it
does not affect the level of protection provided to human health or the
environment. EPA has assessed the overall protectiveness of designating
the proposed disposal Site against the criteria established pursuant to
the MPRSA to ensure that any adverse impact on the environment will be
mitigated to the greatest extent practicable.

List of Subjects in 40 CFR Part 228

    Environmental protection, Water pollution control.

    Authority: This action is issued under the authority of Section
102 of the Marine Protection, Research, and Sanctuaries Act, as
amended, 33 U.S.C. 1401, 1411, 1412.

    Dated: October 1, 2008.
Elin D. Miller,
Regional Administrator, Region 10.

    For the reasons set out in the preamble, Chapter I of title 40 is
amended as set forth below:

PART 228--[AMENDED]

    1. The authority citation for Part 228 continues to read as
follows:

    Authority: 33 U.S.C. Sections 1412 and 1418.

    2. Section 228.15 is amended by adding paragraph (n)(6) as follows:

Sec.  228.15  Dumping sites designated on a final basis.

* * * * *
    (n) * * *
    (6) Rogue River, OR--Dredged Material Site
    (i) Location: 42[deg]24[min] 5.40[sec] N, 124[deg]26[min]52.39[sec]
W; 42[deg]24[min]03.40[sec] N, 124[deg]26[min]39.39[sec] W;
42[deg]23[min]39.40[sec] N, 124[deg]27[min]17.40[sec] W;
42[deg]23[min]51.40[sec] N, 124[deg]27[min]30.40[sec] W (NAD 83)
    (ii) Size: Approximately 1.1 kilometers long and 0.4 kilometers
wide.
    (iii) Depth: Ranges from approximately 15 to 27 meters
    (iv) Primary Use: Dredged material
    (v) Period of Use: Continuing Use
    (vi) Restrictions: (1) Disposal shall be limited to dredged
material determined to be suitable for ocean disposal according to 40
CFR 227.13, from the Rogue River navigation channel and adjacent areas;
(2) Disposal shall be managed by the restrictions and requirements
contained in the currently approved Site Management and Monitoring Plan
(SMMP); (3) Monitoring, as specified in the SMMP, is required.
    (7) (reserved)

 [FR Doc. E8-24176 Filed 10-10-08; 8:45 am]

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