[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32322-32324]
[FR Doc No: 2016-12062]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP16-3-000 and CP16-3-001]

Texas Eastern Transmission, LP; Supplemental Notice of Intent To
Prepare an Environmental Assessment for the Proposed Access South,
Adair Southwest, and Lebanon Extension Projects and Request for
Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Access South, Adair Southwest,
and Lebanon Extension Projects (Projects) in Docket Nos. CP16-3-000 and
CP16-3-001. The Projects involve construction, abandonment, and
operation of facilities by Texas Eastern Transmission, LP (Texas
Eastern) that would enable an additional 622,000 dekatherms per day of
natural gas transportation on Texas Eastern's existing mainline
facilities to serve markets in the Midwest and Southeast. The
Commission will use this EA in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of a second scoping period that
the Commission will use to gather input from the public on the
Projects. The Commission is opening a second scoping period for
affected landowners who were not included in the mailing list for the
original Notice of Intent (NOI) issued for the Projects on August 1,
2015 during the pre-filing review process under Docket Number PF15-17-
000. This includes landowners near twelve existing compressor stations
where Texas Eastern proposes to replace pipeline or modify facilities
to allow for reverse flow capabilities, including one compressor
station where it proposes to install additional compression facilities.
Texas Eastern's proposal is more fully described on page 3 of this
notice.
    You can make a difference by providing us with your specific
comments or concerns about the Projects. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. Your input will help
the Commission staff determine what issues they need to evaluate in the
EA. To ensure that your comments are timely and properly recorded,
please send your comments so that the Commission receives them in
Washington, DC on or before June 16, 2016.
    Landowners receiving this notice are primarily abutters to Texas
Eastern's existing compressor stations where modifications are proposed
or are within 0.5 mile of the Tompkinsville Compressor Station in
Monroe County, Kentucky, where additional compression is proposed. One
landowner receiving this notice is directly affected by the proposed
replacement pipeline at Kosciusko Compressor Station in Attala County,
Mississippi, and Texas Eastern has stated it has contacted this
landowner. The company will seek to negotiate a mutually acceptable
agreement regarding acquisition of any easements needed to construct,
operate, and maintain the replacement pipeline. However, if the
Commission approves the Projects, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (www.ferc.gov). This fact sheet addresses
a number of typically asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings.

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket numbers
(CP16-3-000 and CP16-3-001) with your submission: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Room 1A, Washington, DC 20426.

Summary of the Proposed Project

    The proposed pipeline facilities for the Projects include 15.8
miles of 36-inch-diameter pipeline loop \1\ in three segments, most of
which would be either within or adjacent to Texas Eastern's existing
rights-of-way in Athens, Meigs, Noble, and Monroe Counties, Ohio; and
0.5 mile of 16-inch-diameter replacement pipeline within an existing
right-of-way in Attala County, Mississippi. In addition two pig \2\
launcher/receivers would be relocated and two new pig launcher/
receivers would be installed in Monroe County, Ohio. Proposed
modifications to aboveground facilities would include modifications
necessary to allow for bi-directional flow and meter reversals at
twelve existing compressor stations which are proposed to be located
primarily within Texas Eastern's current footprint. In addition, a new
16,875 horsepower electric compressor would be added at the
Tompkinsville Compressor Station in Monroe County, Kentucky.
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    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
    \2\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
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    The proposed modifications at twelve existing compressor station
sites would include piping modifications to accommodate bi-directional
flow capability along Texas Eastern's existing mainline. These
modifications are proposed at the following compressor stations:
     Holbrook Compressor Station in Greene County,
Pennsylvania;
     Lebanon Compressor Station in Warren County, Ohio;
     Somerset Compressor Station in Perry County, Ohio;
     Berne Compressor Station in Monroe County, Ohio;
     Athens Compressor Station in Athens County, Ohio;
     Owingsville Compressor Station in Bath County, Kentucky;
     Danville Compressor Station in Lincoln County, Kentucky;
     Tompkinsville Compressor Station in Monroe County,
Kentucky;
     Gladeville Compressor Station in Wilson County, Tennessee;

     Barton Compressor Station in Colbert County, Alabama;
     Egypt Compressor Station in Monroe County, Mississippi;
and
     Kosciusko Compressor Station in Attala County,
Mississippi.
    The general location of the Projects facilities is shown in
appendix 1.\3\
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    \3\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
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Land Requirements for Construction

    Construction of the proposed facilities would disturb about 283.7
acres of land for the pipeline loops and replacement, including extra
workspace and access roads, and 341.0 acres of previously disturbed
land at compressor station facilities. Following construction, Texas
Eastern would maintain an additional 96.8 acres for permanent operation
of the Projects' facilities; the remaining acreage would be restored
and revert to former uses. The proposed loops would be located mostly
adjacent to Texas Eastern's existing pipeline rights-of-way and
construction at the compressor stations would occur at existing
facilities where no permanent expansion of the facilities would occur.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\4\ to discover and address concerns the public may have about
proposals. This process is referred to as scoping. The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
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    \4\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed Projects under these
general headings:
     Geology and soils;
     Land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     public safety; and
     cumulative impacts.
    We will also evaluate possible alternatives to the proposed
Projects or portions of the Projects, and make recommendations on how
to lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before we make our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section, beginning on page 2.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we have initiated consultation with the applicable
State Historic Preservation Offices, and to solicit their views and
those of other government agencies, interested Indian tribes, and the
public on the Projects' potential effects on historic properties.\5\ We
will define the project-specific Area of Potential Effects (APE) in
consultation with the SHPOs as the Projects develop. On natural gas
facility projects, the APE at a minimum encompasses all areas subject
to ground disturbance (examples include construction right-of-way,
contractor/pipe storage yards, compressor stations, and access roads).
Our EA for the Projects will document our findings on the impacts on
historic properties and summarize the status of consultations under
section 106.
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    \5\ The Advisory Council on Historic Preservation regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list for the Projects includes federal,
state, and local government representatives and agencies; elected
officials; environmental and public interest groups; Native American
Tribes; and local libraries and newspapers. This list also includes all
affected landowners (as defined in the Commission's regulations) who
are potential right-of-way grantors, whose property may be used
temporarily for project purposes, or who own homes within certain
distances of aboveground facilities, and anyone who submits comments on
the Projects. The mailing list for this supplemental NOI just includes
landowners who were not previously notified by the original NOI and are
abutters to Texas Eastern's compressor stations or within 0.5 mile of
the Tompkinsville Compressor Station in Monroe County, Kentucky where
additional compression is proposed. We will update the environmental
mailing list as the analysis proceeds to ensure that we send the
information related to this environmental review to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed Projects.
    If we publish and distribute the EA, copies of the EA will be sent
to the environmental mailing list for public review and comment. If you
would prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Motions to intervene are more fully described at
http://www.ferc.gov/resources/guides/how-to/intervene.asp. Instructions
for becoming an intervenor are in the ``Document-less Intervention
Guide'' under the ``e-filing'' link on the Commission's Web site.
Because you were not notified by the original NOI, you may still
intervene.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP16-

3). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of 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. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: May 17, 2016.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-12062 Filed 5-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Proposed Rules]
[Pages 1158-1162]
[FR Doc No: 2013-00086]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868 and 870

[Docket No. FDA-2012-N-1174]

Anesthesiology Devices; Reclassification of Membrane Lung for
Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit
and Accessories for Long-Term Pulmonary/Cardiac Support

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: On its own initiative, based on new information, the Food and
Drug Administration (FDA) is proposing to reclassify membrane lung
devices for long-term pulmonary support, a preamendments class III
device, into class II (special controls) for conditions where imminent
death is threatened by cardiopulmonary failure in neonates and infants
or where cardiopulmonary failure results in the inability to separate
from cardiopulmonary bypass following cardiac surgery. A membrane lung
for long-term pulmonary support refers to the oxygenator component of
an extracorporeal circuit used during long-term procedures, commonly
referred to as extracorporeal membrane oxygenation (ECMO). Because
circuit components used with the oxygenator are to be subject to the
same regulatory controls, all of the device components used in an ECMO
procedure are being considered in the scope of this proposed order, and
the title and identification of the regulation will be revised
accordingly to include extracorporeal circuit and accessories for long-
term pulmonary/cardiac support.

DATES: Submit either electronic or written comments on this proposed
order by April 8, 2013. See section XI of this document for the
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1174, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1174 for this order. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1666, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended by the Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of
1990 (Pub. L. 101-629), the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices
Technical Corrections Act of 2004 (Pub. L. 108-

214), the Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-85), and Food and Drug Administration Safety and Innovation Act
(FDASIA) (Pub. L. 112-144) established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA process. Those devices remain in class III and
require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act, changing the
process for reclassifying a device from rulemaking to an administrative
order.
    Section 513(e) of the FD&C Act governs reclassification of
preamendments devices. This section provides that FDA may, by
administrative order, reclassify a device (in a proceeding that
parallels the initial classification proceeding) based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland Rantos v.
United States Department of Health, Education, and Welfare, 587 F.2d
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act
and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770
F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592
(D.C. Cir.), cert. denied, 474 U.S. 1062 (1985).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of order for devices. To be considered
in the reclassification process, the valid scientific evidence upon
which the Agency relies must be publicly available. Publicly available
information excludes trade secret and/or confidential commercial
information, e.g., the contents of a pending premarket approval
application (PMA). (See section 520(c) of the FD&C Act (21 U.S.C.
360j(c)).) Section 520(h)(4) of the FD&C Act, added by FDAMA, provides
that FDA may use, for reclassification of a device, certain information
in a PMA 6 years after the application has been approved. This includes
information from clinical and preclinical tests or studies that
demonstrate the safety or effectiveness of the device but does not
include descriptions of methods of manufacture or product composition
and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments from all affected stakeholders, including
patients, payors, and providers.
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    On November 2, 1979 (44 FR 63387), FDA published a proposed rule
for classification of membrane lungs for long-term pulmonary support as
class III requiring premarket approval. The Anesthesiology Device
Classification Panel recommended class III because the device is life
sustaining and life supporting and sufficient information did not exist
to determine the adequacy of general controls or to establish standards
to provide a reasonable assurance of the safety and effectiveness of
the device.
    No comments were received on the proposed rule and on July 16, 1982
(47 FR 31130), a final rule was published for membrane lungs for long-
term pulmonary support, classifying these devices as class III. In
1987, FDA published a final rule amending the codified language for
this device to clarify that no effective date had been established for
the requirement for premarket approval for membrane lungs for long-term
pulmonary support devices (52 FR 17732 at 17735; May 11, 1987). In
2009, FDA published an order under sections 515(i) and 519 of the FD&C
Act (21 U.S.C. 360e and 360i) for the submission of safety and
effectiveness information on a membrane lung for long-term pulmonary
support (74 FR 16214; April 9, 2009). In response to that order, FDA
received information from one device manufacturer.

III. Device Description

    A membrane lung for long-term pulmonary support refers to the
oxygenator component of an extracorporeal circuit used during long-term
procedures, commonly referred to as an ECMO. An ECMO procedure provides
assisted extracorporeal circulation and physiologic gas exchange of a
patient's blood when an acute (reversible) condition prevents the
patient's own body from providing the physiologic gas exchange needed
to sustain life. The circuit is comprised of multiple device types,
including, but

not limited to, an oxygenator, blood pump, cannulae, heat exchanger,
tubing, filters, monitors/detectors, and other accessories; the circuit
components and configuration (e.g., arteriovenous, veno-venous) may
differ based on the needs of the individual patient or the condition
being treated. ECMO is intended for patients with acute reversible
respiratory or cardiac failure, unresponsive to optimal ventilation
and/or pharmacologic management.
    Because circuit components used with the oxygenator can be
appropriately regulated using the same set of regulatory controls, all
of the device components used in an ECMO procedure are being considered
in the scope of this proposed order as an extracorporeal circuit and
accessories for long-term pulmonary/cardiac support.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposed order be
reclassified from class III to class II. FDA is further proposing to
revise the title and identification of the regulation to reflect all
device components used in ECMO. In addition, FDA is proposing to remove
this regulation from 21 CFR part 868, Anesthesiology Devices, and add
the revised version to 21 CFR part 870, Cardiovascular Devices, to
better align this device type with other similar types of
cardiovascular devices and align the review responsibilities for this
device type. FDA believes that these devices can be utilized to provide
assisted extracorporeal circulation and physiologic gas exchange of a
patient's blood when an acute (reversible) condition prevents the
patient's own body from providing the physiologic gas exchange needed
to sustain life in conditions where imminent death is threatened by
cardiopulmonary failure in neonates and infants or where
cardiopulmonary failure results in the inability to separate from
cardiopulmonary bypass following cardiac surgery.
    FDA believes that the identified special controls, in addition to
general controls, are necessary to provide reasonable assurance of
safety and effectiveness. Therefore, in accordance with sections 513(e)
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information
with respect to the devices, FDA, on its own initiative, is proposing
to reclassify this preamendments class III device into class II. The
Agency has identified special controls under section 513(a) of the FD&C
Act that would provide reasonable assurance of their safety and
effectiveness. The new information includes the history of use of the
circuit components, publicly available safety and effectiveness
information (as described in Section VII of this document) and the
relatively low incidence of adverse events, as discussed in the
recommendations for reclassification from the device industry
(available in docket FDA-2009-M-0101 at http://www.regulations.gov).
FDA believes that this information is sufficient to demonstrate that
the proposed special controls can effectively mitigate the risks to
health identified in section V of this document and that these special
controls, in addition to the general controls, will provide a
reasonable assurance of safety and effectiveness for ECMO devices.
    FDA has considered membrane lung devices for long-term pulmonary
support in accordance with the reserved criteria and decided that the
device does require premarket notification. The Agency does not intend
to exempt this proposed class II device from premarket notification
(510(k)) submission as provided for under section 510(m) of the FD&C
Act.

V. Risks to Health

    After considering available information, including the
recommendations of the advisory committee (panel) for the
classification of these devices along with information submitted in
response to the 515(i) order and any additional information that FDA
has encountered, FDA has evaluated the risks to health associated with
the use of extracorporeal circuits and accessories for long-term
pulmonary/cardiac support and determined that the following risks to
health are associated with its use:
     Thrombocytopenia. Blood platelets important to the
clotting cascade may be damaged by use of the device, resulting in a
tendency toward increased bleeding.
     Hemolysis. Red blood cells may be damaged by mechanical,
material, or surface features of the extracorporeal circuit.
     Thrombosis/thromboembolism. Blood clots may form within
the extracorporeal circuit due to inadequate blood flow.
     Hemorrhage. To keep blood from clotting in the
extracorporeal circuit, anticoagulants are generally used and may cause
increased bleeding during the procedure.
     Hemodilution. Dilution of the patient's blood may be
caused by the priming of the ECMO circuit.
     Inadequate gas exchange. Mechanical failure of the circuit
components may result in inadequate gas exchange.
     Loss of mechanical integrity. Weakness in the connections
or construction of the circuit components could lead to leaks in the
extracorporeal circuit.
     Gas embolism. Air may be introduced into the
extracorporeal circuit and result in a gas embolism.
     Adverse tissue reaction. The patient-contacting materials
of the device may cause an adverse immunological or allergic reaction
in a patient if the materials are not biocompatible.
     Infection. Defects in the design or construction of the
device preventing adequate cleaning and/or sterilization may allow
pathogenic organisms to be introduced and may result in infection.
     Mechanical injury to access vessels. Mechanical injury to
vessels may be caused acutely during access, or over time due to the
long-term duration of use.

VI. Summary of Reasons for Reclassification

    FDA believes that extracorporeal circuits and accessories for long-
term pulmonary/cardiac support should be reclassified into class II
because special controls, in addition to general controls, can be
established to provide reasonable assurance of the safety and
effectiveness of the device. In addition, there is now adequate
effectiveness information sufficient to establish special controls to
provide such assurance for conditions where imminent death is
threatened by cardiopulmonary failure in neonates and infants or where
cardiopulmonary failure results in the inability to separate from
cardiopulmonary bypass following cardiac surgery.
    FDA is proposing to rename this device to ``Extracorporeal circuit
and accessories for long-term pulmonary/cardiac support''; the current
classification regulation for this device is referred to as ``membrane
lung for long-term pulmonary support.'' For clarity, the new title for
this proposed order will be removed from 21 CFR part 868 and
redesignated to 21 CFR part 870. Section 870.4100 will be added to
reflect all device components used in ECMO.

VII. Summary of Data Upon Which the Reclassification Is Based

    Since the time of the Panel recommendation, sufficient evidence has
been developed to support a reclassification of extracorporeal circuits
and accessories for long-term pulmonary/cardiac support to class II
with special controls for conditions

where imminent death is threatened by cardiopulmonary failure in
neonates and infants or where cardiopulmonary failure results in the
inability to separate from cardiopulmonary bypass following cardiac
surgery. FDA is familiar with the risks associated with the use of the
components of the extracorporeal circuit because the same components
are used for short-term use (durations less than 6 hours) for
cardiopulmonary bypass. In addition, the Extracorporeal Life Support
Organization registry data (Ref. 1), which provides information on over
28,000 ECMO procedures performed since 1987, and reviews of
institutional experience (Ref. 2) demonstrate a favorable benefit-risk
profile for extracorporeal circuits and accessories when used for
conditions where imminent death is threatened by cardiopulmonary
failure in neonates and infants or where cardiopulmonary failure
results in the inability to separate from cardiopulmonary bypass
following cardiac surgery.

VIII. Proposed Special Controls

    FDA believes that the following special controls, in addition to
general controls, are sufficient to mitigate the risks to health
described in section V of this document:
     The design characteristics of the device must ensure that
the geometry and design parameters are consistent with the intended
use;
     The device must be demonstrated to be biocompatible;
     Sterility and shelf life testing must demonstrate the
sterility of patient-contacting components and the shelf-life of these
components;
     Nonclinical performance evaluation of the device must
demonstrate a reasonable assurance of safety and effectiveness for
mechanical integrity, durability, and reliability;
     In-vivo evaluation of the device must demonstrate device
performance; and
     Labeling must include a detailed summary of the
nonclinical and clinical evaluations pertinent to use of the device and
adequate instructions with respect to anticoagulation, circuit set up,
and maintenance during a procedure.
    In addition, under 21 CFR 801.109, the sale, distribution, and use
of this device are restricted to prescription use.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 are approved under OMB
control number 0910-0078; the collections of information in part 807,
subpart E, are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814, subpart B, are approved
under OMB control number 0910-0231; and the collections of information
under 21 CFR part 801 have are under OMB control number 0910-0485.

XI. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective 30 days after date of publication of the final order in the
Federal Register.

XII. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

    1. Fleming, G. M., J. G. Gurney, J. E. Donahue, et al.,
``Mechanical Component Failures in 28,171 Neonatal and Pediatric
Extracorporeal Membrane Oxygenation Courses From 1987 to 2006,''
Pediatric Critical Care Medicine Journal, vol. 10, pp. 439-444, July
2009.
    2. Cook, L. N., ``Update on Extracorporeal Membrane
Oxygenation,'' Paediatric Respiratory Reviews, vol. 5, suppl. A, pp.
S329-S337, 2004.

List of Subjects in 21 CFR Parts 868 and 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 868 and 870 be amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 868 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Sec.  868.5610  [Removed]

0
2. Remove Sec.  868.5610.

PART 870--CARDIOVASCULAR DEVICES

0
3. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
4. Add Sec.  870.4100 to subpart E to read as follows:

Sec.  870.4100  Extracorporeal circuit and accessories for long-term
pulmonary/cardiac support.

    (a) Identification. An extracorporeal circuit and accessories for
long-term pulmonary/cardiac support (>6 hours) is a system of devices
that provides assisted extracorporeal circulation and physiologic gas
exchange of the patient's blood in conditions where imminent death is
threatened by cardiopulmonary failure in neonates and infants or where
cardiopulmonary failure results in the inability to separate from
cardiopulmonary bypass following cardiac surgery. An acute reversible
or treatable cause of respiratory and/or cardiac failure should be
evident, and the subject should demonstrate unresponsiveness to maximum
medical or ventilation therapy. The main components of the system
include the console (hardware), software, and disposables, including
but not limited to, an oxygenator, blood pump, heat exchanger,
cannulae, tubing, filters, and other accessories (e.g., monitors,
detectors, sensors, connectors).
    (b) Class II (special controls). The special controls for this
device are:
    (1) The design characteristics of the device must ensure that the
geometry and design parameters are consistent with the intended use;
    (2) The device must be demonstrated to be biocompatible;
    (3) Sterility and shelf life testing must demonstrate the sterility
of patient-

contacting components and the shelf-life of these components;
    (4) Non-clinical performance evaluation of the device must provide
a reasonable assurance of safety and effectiveness for mechanical
integrity, durability, and reliability;
    (5) In-vivo evaluation of the device must demonstrate device
performance; and
    (6) Labeling must include a detailed summary of the nonclinical and
clinical evaluations pertinent to use of the device and adequate
instructions with respect to anticoagulation, circuit set up, and
maintenance during a procedure.

    Dated: January 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00086 Filed 1-7-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Rules and Regulations]
[Pages 30533-30534]
[FR Doc No: 2011-12846]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0949; Airspace Docket No. 10-ASO-34]

Amendment of Class E Airspace; Brunswick Malcolm-McKinnon
Airport, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at Brunswick, GA. The
McKinnon Non-Directional Beacon (NDB) has been decommissioned and new
Standard Instrument Approach Procedures (SIAPs) have been developed for
Malcolm-McKinnon Airport. The geographic coordinates for the airport
are adjusted. Also, reference to the Glynco Jetport in the airspace
designation is removed. This action enhances the safety and airspace
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, August 25, 2011. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments

FOR FURTHER INFORMATION CONTACT: Richard Horrocks, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On November 16, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E surface airspace at
Brunswick, GA (75 FR 69905) Docket No. FAA-2010-0949. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designated as surface areas are
published in Paragraph 6002 of FAA Order 7400.9U dated August 18, 2010,
and effective September 15, 2010, which is incorporated by reference in
14 CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E surface airspace to support new SIAPs developed
at Malcolm-McKinnon Airport, Brunswick, GA. Airspace reconfiguration is
necessary due to the decommissioning of the McKinnon NDB and
cancellation of the NDB approach, and for continued safety and
management of IFR operations at the airport. This action also updates
the geographic coordinates of the airport to coincide with the FAA's
aeronautical database, and reference to the Glenco Jetport is removed
from the airspace designation as the Jetport is listed separately in
the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Brunswick, GA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ASO GA E2 Brunswick Malcolm-McKinnon Airport, GA [AMENDED]

Brunswick Malcolm-McKinnon Airport, GA

    (Lat. 31[deg]09'07'' N., long. 81[deg]23'29'' W.)

    That airspace extending upward from the surface within a 4.1-
mile radius of the Brunswick Malcolm-McKinnon Airport. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in College Park, Georgia, on May 4, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-12846 Filed 5-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24472-24473]
[FR Doc No: 2011-10539]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14108-000]

Western Minnesota Municipal Power Agency; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On March 8, 2011, Western Minnesota Municipal Power Agency (WMMPA)
filed an application, pursuant to section 4(f) of the Federal Power
Act, proposing to study the feasibility of a hydropower project at the
U.S. Army Corps of Engineers' (Corps) Mississippi River Lock and Dam
15 structure located on the Mississippi River, near the
Township of Davenport, in Scott County, Iowa. The Mississippi Lock and
Dam No. 15 is owned by the United States government and operated by the
U.S. Army Corps of Engineers. The sole purpose of a preliminary permit,
if issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owner's express permission.
    WMMPA's proposed Mississippi Lock and Dam 15 Project No.
14108 would consist of: (1) A 350-foot-long by 300-foot-wide intake
channel; (2) a 250-foot-long by 300-foot-wide tailrace channel; (3) a
new 190-foot-long by 280-foot-wide by 60-foot-high concrete powerhouse;
(4) six new pit-type axial flow turbine-generators units with a
combined capacity of 33.8 megawatts; (5) a new 9,700-foot-long, 69-
kilovolt transmission line; and (6) appurtenant facilities. The project
would have an estimated annual generation of 230 gigawatt-hours.

    Applicant Contact: Mr. Raymond J. Wahle, P.E., Missouri River
Energy Services, 3724 W. Avera Drive, Sioux Falls, SD 57109; (605) 330-
6963.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at 7fnl;http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14108-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

    Dated: April 26, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-10539 Filed 4-29-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49235-49236]
[FR Doc No: 2016-17736]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0022]

Technical Mapping Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
Meeting.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) Technical
Mapping Advisory Council (TMAC) will meet via conference call on
September

13 and 14, 2016. The meeting will be open to the public.

DATES: The TMAC will meet via conference call on Tuesday, September 13,
2016 from 10:00 a.m. to 5:00 p.m. Eastern Daylight Time (EDT), and on
Wednesday, September 14, 2016 from 10:00 a.m. to 5:00 p.m. EDT. Please
note that the meeting will close early if the TMAC has completed its
business.

ADDRESSES: For information on how to access to the conference call,
information on services for individuals with disabilities, or to
request special assistance for the meeting, contact the person listed
in FOR FURTHER INFORMATION CONTACT below as soon as possible. Members
of the public who wish to dial in for the meeting must register in
advance by sending an email to<EMAIL_ADDRESS>(attention
Kathleen Boyer) by 11 a.m. EDT on Monday, September 12, 2016.
    To facilitate public participation, members of the public are
invited to provide written comments on the issues to be considered by
the TMAC, as listed in the ``Supplementary Information'' section below.
The Agenda and other associated material will be available for review
at www.fema.gov/TMAC by Friday, September 9, 2016. Written comments to
be considered by the committee at the time of the meeting must be
received by Monday, September 12, 2016, identified by Docket ID FEMA-
2014-0022, and submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email: Address the email TO<EMAIL_ADDRESS>and
CC<EMAIL_ADDRESS>Include the docket number in the subject
line of the message. Include name and contact detail in the body of the
email.
     Mail: Regulatory Affairs Division, Office of Chief
Counsel, FEMA, 500 C Street SW., Room 8NE, Washington, DC 20472-3100.
    Instructions: All submissions received must include the words
``Federal Emergency Management Agency'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.
    Docket: For docket access to read background documents or comments
received by the TMAC, go to http://www.regulations.gov and search for
the Docket ID FEMA-2014-0022.
    A public comment period will be held on September 13, 2016, from
11:00-11:20 a.m. and September 14, 2016 from 11:00-11:20 a.m. EST.
Speakers are requested to limit their comments to no more than two
minutes. Each public comment period will not exceed 20 minutes. Please
note that the public comment periods may end before the time indicated,
following the last call for comments. Contact the individual listed
below to register as a speaker by close of business on Monday,
September 12, 2016.

FOR FURTHER INFORMATION CONTACT: Kathleen Boyer, Designated Federal
Officer for the TMAC, FEMA, 500 C Street SW., Washington, DC 20024,
telephone<PHONE_NUMBER>, and email<EMAIL_ADDRESS>The
TMAC Web site is: http://www.fema.gov/TMAC.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. Appendix.
    As required by the Biggert-Waters Flood Insurance Reform Act of
2012, the TMAC makes recommendations to the FEMA Administrator on: (1)
How to improve, in a cost-effective manner, the (a) accuracy, general
quality, ease of use, and distribution and dissemination of flood
insurance rate maps and risk data; and (b) performance metrics and
milestones required to effectively and efficiently map flood risk areas
in the United States; (2) mapping standards and guidelines for (a)
flood insurance rate maps, and (b) data accuracy, data quality, data
currency, and data eligibility; (3) how to maintain, on an ongoing
basis, flood insurance rate maps and flood risk identification; (4)
procedures for delegating mapping activities to State and local mapping
partners; and (5)(a) methods for improving interagency and
intergovernmental coordination on flood mapping and flood risk
determination, and (b) a funding strategy to leverage and coordinate
budgets and expenditures across Federal agencies. Furthermore, the TMAC
is required to submit an Annual Report to the FEMA Administrator that
contains: (1) A description of the activities of the Council; (2) an
evaluation of the status and performance of flood insurance rate maps
and mapping activities to revise and update Flood Insurance Rate Maps;
and (3) a summary of recommendations made by the Council to the FEMA
Administrator.
    Agenda: On September 13 and 14, 2016, the TMAC will review and
discuss potential recommendations to be included in the required 2016
TMAC Annual Report. A brief public comment period will take place
before any deliberation and vote on each day of the meeting. A more
detailed agenda will be posted by September 9, 2016, at http://www.fema.gov/TMAC.

    Dated: July 14, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Federal
Emergency Management Agency.
[FR Doc. 2016-17736 Filed 7-26-16; 8:45 am]
BILLING CODE 9110-12-P


Lydia Wegman/RTP/USEPA/US

03/10/2008 05:38 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS> cc

<EMAIL_ADDRESS><EMAIL_ADDRESS>Susan Stone/RTP/USEPA/US@EPA, <EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA

Subject

Fw: Revised O3 NFR preamble and rule

Here is the revised preamble for the primary standard with the changes identified in redline.  Please call me if you have any questions.  Thanks.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 03/10/2008 05:36 PM -----

Karen Martin/RTP/USEPA/US

03/10/2008 05:35 PM

To

Wegman Lydia@EPA

cc

Subject

Rev ised O3 NFR preamble and rule

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


Reader’s Guide: Fluridone

CRM: Joy Schnackenbeck

EPA/OPPTS/OPP/PRD

Reader’s Guide to Fluridone Docket # EPA-HQ-2009-0160

Publication Date: September 23, 2009

The Agency is providing the “Readers Guide” to allow the reader to
more easily access and navigate the various entries contained in the
fluridone docket.

Federal Register and Docket Organizational Documents:

Docket Entry 1. Federal Register Notice:  Fluridone Reregistration
Review; Pesticide Dockets Opened for Review and Comment (September 23,
2009).

Docket Entry 2.  Reader’s Guide to Fluridone Docket #
EPA-HQ-OPP-2009-0160.

Docket Entry 3.  Fluridone Summary Document Registration Review: Initial
Docket September 2009 (September 14, 2009).

Environmental Fate and Effects Documents for Registration Review

Docket Entry 4.  Registration Review: Preliminary Problem Formulation
for Ecological Risk, Environmental Fate, and Endangered Species
Assessment for Fluridone (August 20, 2009).

This document defines the problem for the assessment, and develops a
plan for analyzing and characterizing the ecological risks.

Human Health Documents for Registration Review

Docket Entry 5.  Fluridone.  Human Health Assessment Scoping Document in
Support of Registration Review (July 16, 2009).

This document evaluates the status of the human health assessments to
determine the scope of work necessary to support the registration review
of fluridone.

Use and Usage Information for Registration Review

Docket Entry 6.  Fluridone (112900), California Department of Pesticide
Regulation Usage Data (January 8, 2009).

This document provides available estimates of pesticide usage data for
fluridone in California.

Docket Entry 7.  Appendix A: Food/Feed & Non-Food/Non-Feed Uses
Considered for Registration Review Work Planning, Fluridone (November
20, 2008).

This table lists the uses for fluridone.