[Federal Register: April 8, 2008 (Volume 73, Number 68)]
[Notices]
[Page 19134]
[DOCID:fr08ap08-111]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Release Certain Properties From All Terms,
Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement
Between the City of Lakeland and the Federal Aviation Administration
for the Lakeland Linder Regional Airport, Lakeland, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comment.

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SUMMARY: The FAA hereby provides notice of intent to release certain
airport properties 58 acres at the Lakeland Linder Regional Airport,
Lakeland, Florida from the conditions, reservations, and restrictions
as contained in a Quitclaim Deed agreement between the FAA and the City
of Lakeland, dated September 1947 and the supplemental Quitclaim Deed
agreement, dated April 1948. The release of property will allow the
City of Lakeland to dispose of the property for other than aeronautical
purposes. The property is located in the City of Lakeland, Polk County,
Florida. The parcel is currently designated as aeronautical and non-
aeronautical use. The property will be disposed of for the purpose of
industrial use. The fair market value of the property has been
determined by appraisal to be $3,190,000. The airport will receive fair
market value for the property, which will be subsequently reinvested in
another eligible airport improvement project.
    Documents reflecting the Sponsor's request are available, by
appointment only, for inspection at the Office of the Airport Director,
Lakeland Linder Regional Airport and the FAA Airports District Office.

SUPPLEMENTARY INFORMATION: Section 125 of The Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century (AIR-21) requires the
FAA to provide an opportunity for public notice and comment prior to
the ``waiver'' or ``modification'' of a sponsor's Federal obligation to
use certain airport land for non-aeronautical purposes.

DATES: May 8, 2008.

ADDRESSES: Documents are available for review at 3900 Don Emerson
Drive, Suite 210, Lakeland, FL 33811, and the FAA Airports District
Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822.
Written comments on the Sponsor's request must be delivered or mailed
to: Gavin Fahnestock, Program Manager, Orlando Airports District
Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822-
5024.

FOR FURTHER INFORMATION CONTACT: Gavin Fahnestock, Program Manager,
Orlando Airports District Office, 5950 Hazeltine National Drive, Suite
400, Orlando, FL 32822-5024.

Bart Vernace,
Acting Manager, Orlando Airports District Office, Southern Region.
 [FR Doc. E8-7093 Filed 4-7-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Proposed Rules]
[Pages 6118-6120]
[FR Doc No: 2020-02020]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0039; Airspace Docket No. 19-ASO-18]
RIN 2120-AA66

Proposed Amendment and Removal of Air Traffic Service (ATS)
Routes; Eastern United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend 10 jet routes, and remove 8 jet
routes, in the eastern United States. This action is in support of the
Northeast Corridor Atlantic Route Project to improve the efficiency of
the National Airspace System (NAS) and reduce the dependency on ground-
based navigational systems.

DATES: Comments must be received on or before March 20, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0039; Airspace Docket No. 19-ASO-18 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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
the 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 would modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the NAS.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-
2020-0039; Airspace Docket No. 19-ASO-18) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2020-0039; Airspace Docket No. 19-ASO-18.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned

with this rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Eastern Service Center, Federal
Aviation Administration, Room 210, 1701 Columbia Ave., College Park, GA
30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to amend 10 jet routes, and remove 8 jet
routes in the eastern United States. This action would support the
Northeast Corridor Atlantic Route Project by removing or amending
certain jet routes as a result of the continuing development of new
high altitude RNAV routes (Q-routes) in the NAS. Additionally, the
proposed jet route changes would reduce aeronautical chart clutter by
removing unneeded route segments.
    Some jet routes discussed in this preamble include points that are
identified by the intersection of radials from two VOR or VORTAC
navigation facilities. In some cases, those intersections are assigned
a specific fix name that is depicted on aeronautical charts (e.g.,
TYDOE, GA). While these fix names are not stated in the regulatory
descriptions of jet routes, they are noted in the preamble text below
to assist readers in locating that point on aeronautical charts.
    The proposed route changes are as follows:
    J-14: J-14 currently extends between the Panhandle, TX, VORTAC; and
the Patuxent, MD, VORTAC. The FAA proposes to remove the route segments
between the Vulcan, AL, VORTAC and the Greensboro, NC, VORTAC. This
would split the route into two separate parts. As amended, J-14 would
extend between Panhandle, TX, and Vulcan, AL; followed by a gap in the
route, with a second part extending between Greensboro, NC, and
Patuxent, MD.
    J-20: J-20 currently extends between the Seattle, WA, VORTAC, and
the Seminole, FL, VORTAC. This action proposes to remove the segments
between the Montgomery, AL, VORTAC and Seminole, FL. The amended route
would extend between Seattle, WA, and Montgomery, AL.
    J-40: J-40 currently extends between the Montgomery, AL, VORTAC,
and the Richmond, VA, VOR/DME. The FAA proposes to remove this entire
route.
    J-41: J-41 currently extends between the Seminole, FL, VORTAC, and
the Omaha, IA, VORTAC. This action would remove the portion of the
route between the Seminole, FL, VORTAC, and Montgomery, AL. The amended
route would extend between the Montgomery, AL, VORTAC, and Omaha, IA.
    J-43: J-43 currently extends between the intersection of the Cross
City, FL VORTAC 322[deg] and the Seminole, FL, VORTAC, 359[deg]
radials, and the Carleton, MI, VOR/DME. This action would remove the
segments between the intersection of the Cross City and the Seminole
radials and the Volunteer, TN, VORTAC. The amended route would extend
between Volunteer, TN, and Carleton, MI.
    J-45: J-45 currently extends between the Alma, GA, VORTAC and the
Aberdeen, SD, VOR/DME. The action would remove the segments between the
Alma, GA, VORTAC and the Atlanta, GA, VORTAC. The amended route would
extend between Atlanta, GA and Aberdeen, SD.
    J-51: J-51 currently extends between the intersection of the
Columbia, SC, VORTAC, 042[deg] and the Flat Rock, VA, VORTAC, 212[deg]
radials, and the Yardley, NJ, VOR/DME. This action proposes to remove
the entire route.
    J-52: J-52 currently extends, in two segments, between the
Vancouver, BC, Canada, VOR/DME and the Columbia, SC, VORTAC; and
between the intersection of the Columbia 042[deg] and the Flat Rock,
VA, VORTAC, 212[deg] radials, and the Richmond, VA, VOR/DME. The FAA
proposes to remove the segments between the Vulcan, AL, VORTAC and the
intersection of the Columbia, SC, VORTAC, 042[deg] and the Flat Rock,
VA, VORTAC, 212[deg] radials. As amended J-52 would extend, in two
parts: between Vancouver, BC, Canada, and Vulcan, AL; followed by a gap
in the route, and resuming between the intersection of the Columbia, SC
042[deg] and the Flat Rock, VA, 212[deg] radials, and Richmond, VA. The
portion within Canada is excluded.
    J-53: J-53 currently extends between the intersection of the Craig,
FL 347[deg] and the Colliers, SC 174[deg] radials, and the Pulaski, VA,
VORTAC. This action would remove the entire route.
    J-73: J-73 currently extends between the intersection of the
Seminole, FL, VORTAC, 344[deg] and the Cross City, FL, VORTAC, 322[deg]
radials, and Northbrook, IL, VOR/DME. This action proposes to remove
the segment between the intersection of the Seminole, FL, 344[deg] and
the Cross City, FL, 322[deg] radials, and the La Grange, GA, VORTAC. As
amended, the route would extend between La Grange, GA, and Northbrook,
IL.
    J-75: J-75 currently extends between the Greensboro, NC, VORTAC and
the Boston, MA, VOR/DME. This action proposes to remove the entire
route.
    J-81: J-81 currently extends between the intersection of the Craig,
AL, VORTAC, 347[deg] and the Colliers, SC, VORTAC, 174[deg] radials,
and Colliers, SC. This action proposes to remove the entire route.
    J-85: J-85 currently extends between the Alma, GA, VORTAC, and the
Dryer, OH, VOR/DME. This action would remove the segments between Alma,
GA, and the Spartanburg, SC, VORTAC. As amended, J-85 would extend
between Spartanburg, SC, and Dryer, OH.
    J-89: J-89 currently extends between the intersection of the
Atlanta, GA, VORTAC, 161[deg] and the Alma, GA, VORTAC, 252[deg]
radials, and the Winnipeg, MB, Canada, VORTAC. This action would remove
the segments between the intersection of the Atlanta and the Alma
radials, and the Atlanta VORTAC. The amended route would extend between
the Atlanta, GA, VORTAC and Winnipeg, MB, Canada. The portion within
Canada is excluded.
    J-91: J-91 currently extends between the intersection of the Cross
City, FL, VORTAC, 338[deg] and the Atlanta, GA, VORTAC, 169[deg]
radials, and the Henderson, WV, VORTAC. This action would remove the
segments between the intersection of the Cross City VORTAC and the
Atlanta, GA, VORTAC radials, and the Volunteer, TN, VORTAC. The

amended route would extend between the Volunteer, TN, VORTAC and the
Henderson VORTAC.
    J-97: J-97 currently extends between lat. 39[deg]07'00'' N, long.
67[deg]00'00'' W (the SLATN Fix) and the Boston, MA, VOR/DME. This
action proposes to remove the entire route.
    J-210: J-210 currently extends between the Vance, SC, VORTAC and
the Wilmington, NC, VORTAC. This action proposes to remove the entire
route.
    J-575: J-575 currently extends between the Boston, MA, VOR/DME and
the Yarmouth, NS, Canada, VOR/DME. This action proposes to remove the
entire route.
    Jet routes are published in paragraph 2004 FAA Order 7400.11D dated
August 8, 2019, and effective September 15, 2019, which is incorporated
by reference in 14 CFR 71.1. The jet routes amended in, or removed,
respectively, from the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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 proposed 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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(f), 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 FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 2004 Jet Routes.

J-14 [Amended]

    From Panhandle, TX; via Will Rogers, OK; Little Rock, AR; to
Vulcan, AL. From Greensboro, NC; Richmond, VA; INT Richmond 039[deg]
and Patuxent, MD, 228[deg] radials; to Patuxent.

J-20 [Amended]

    From Seattle, WA, via Yakima, WA; Pendleton, OR; Donnelly, ID;
Pocatello, ID; Rock Springs, WY; Falcon, CO; Hugo, CO; Lamar, CO;
Liberal, KS; INT Liberal 137[deg] and Will Rogers, OK, 284[deg]
radials; Will Rogers; Belcher, LA; Magnolia, MS; Meridian, MS; to
Montgomery, AL.

J-40 [Remove]

J-41 [Amended]

    From Montgomery, AL; Vulcan, AL; Memphis, TN; Springfield, MO,
Kansas City, MO, to Omaha, IA.

J-43 [Amended]

    From Volunteer, TN; Falmouth, KY; Rosewood, OH; to Carleton, MI.

J-45 [Amended]

    From Atlanta, GA; Nashville, TN; St Louis, MO; Kirksville, MO;
Des Moines, IA; Sioux Falls, SD; to Aberdeen, SD.

J-51 [Remove]

J-52 [Amended]

    From Vancouver, BC, Canada; via Spokane, WA; Salmon, ID; Dubois,
ID; Rock Springs, WY; Falcon, CO; Hugo, CO; Lamar, CO; Liberal, KS;
INT Liberal 137[deg] and Ardmore, OK, 309[deg] radials; Ardmore;
Texarkana, AR; Sidon, MS; Bigbee, MS; to Vulcan, AL. From INT
Columbia 042[deg] and Flat Rock, VA 212[deg] radials; Raleigh-
Durham, NC; to Richmond, VA. The portion within Canada is excluded.

J-53 [Remove]

J-73 [Amended]

    From La Grange, GA; Nashville, TN; Pocket City, IN; to
Northbrook, IL.

J-75 [Remove]

J-81 [Remove]

J-85 [Amended]

    From Spartanburg, SC; Charleston, WV; INT Charleston 357[deg]
and Dryer, OH, 172[deg] radials; Dryer.

J-89 [Amended]

    From Atlanta, GA; Louisville, KY; Boiler, IN; Northbrook, IL;
Badger, WI; Duluth, MN; to Winnipeg, MB, Canada. The portion within
Canada is excluded.

J-91 [Amended]

    From Volunteer, TN; to Henderson, WV.

J-97 [Remove]

J-210 [Remove]

J-575 [Remove]

    Issued in Washington, DC, on January 29, 2020.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-02020 Filed 2-3-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Page 50094]
[FR Doc No: 2012-20335]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

Filings Instituting Proceedings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP12-932-000.
    Applicants: Transcontinental Gas Pipe Line Company,
    Description: August 2012 Clean-Up Filing to be effective 9/8/2012.
    Filed Date: 8/8/12.
    Accession Number: 20120808-5106.
    Comments Due: 5 p.m. ET 8/20/12.

    Docket Numbers: RP12-933-000.
    Applicants: Equitrans, L.P.
    Description: Exhibit B Addition to AGS Form of Service Agreement to
be effective 9/11/2012.
    Filed Date: 8/8/12.
    Accession Number: 20120808-5110.
    Comments Due: 5 p.m. ET 8/20/12.

    Docket Numbers: RP12-934-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Negotiate Rate Service Agreement--WGL Removal to be
effective 4/1/2012.
    Filed Date: 8/8/12.
    Accession Number: 20120808-5123.
    Comments Due: 5 p.m. ET 8/20/12.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: August 9, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-20335 Filed 8-17-12; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:		November 27, 2007

SUBJECT:		Organic Esters of Phosphoric Acid:  Environmental Fate
Disciplinary Chapter for the Issuance of the Reregistration Eligibility
Decision (RED) Document

			Case No.:  4122

			PC Code: 111286, 129079, 129080

			DP Barcode: D347009

FROM:		James Breithaupt, Agronomist

 		Risk Assessment and Science Support Branch (RASSB)

	 		Antimicrobials Division (7510P)

TO:			Heather Garvie, Chemical Review Manager

Diane Isbell, Team Leader

Mark Hartman, Chief

			Regulatory Management Branch II

			Antimicrobials Division (7510P)

THROUGH:		Richard C. Petrie, Team Leader

			Team Three

And

Norm Cook, Chief

	 		Risk Assessment and Science Support Branch

	 		Antimicrobials Division

REGISTRANT:	Interface Research Corporation

Attached is the Environmental Fate Disciplinary Chapter for Phosphoric
Acid Esters for the purpose of issuing a Reregistration Eligibility
Decision (RED).

Conclusions

The Agency considers registered uses of organic esters of phosphoric
acid to result in limited environmental exposure.  If a spill of these
organic esters acid were to occur in the environment, it is likely that
terrestrial and aquatic organisms would be exposed to a mixture of
organic esters of phosphoric acid, phosphoric acid itself, and salts of
phosphoric acid (e.g., calcium phosphate).   Salts of phosphoric acid
are generally low in water solubility and would precipitate in the
presence of water.

Mineral acids (e.g. phosphoric acid) pose a potential hazard to the
aquatic environment not because of inherent toxicity but instead due to
their ability to change the pH of receiving waters and create
eutrophication.  The pH is an important factor in the chemical and
biological systems of natural waters, and the extent of pH change will
depend on the buffering capacity of the water:sediment system, the
quantity of the spill, and the characteristics of the receiving water
body (e.g. size, depth, flushing).  In addition, eutrophication from
sudden additions of plant nutrients such as phosphorus can result in
rapid algal and aquatic plant growth in water bodies and cause oxygen
shortages which
c湡欠汩煡慵楴湡浩污⹳†഍഍഍഍഍̍഍ഄ̍഍ഄ
഍഍


[Federal Register: September 4, 2009 (Volume 74, Number 171)]
[Notices]
[Page 45847-45848]
[DOCID:fr04se09-53]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2009-0652; FRL-8949-5]

Board of Scientific Counselors, Executive Committee Meeting--
September 2009

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of a meeting of the Board of Scientific
Counselors (BOSC) Executive Committee.

DATES: The meeting will be held on Tuesday, September 15, 2009, from 8
a.m. to 5 p.m. All times noted are Eastern Daylight Time. The meeting
may adjourn early if all business is finished. Requests for the draft
agenda or for making oral presentations at the meeting will be accepted
up to one business day before the meeting.

ADDRESSES: The meeting will be held at the Washington Plaza Hotel, 10
Thomas Circle, NW., Washington, DC 20005. Submit your comments,
identified by Docket ID No. EPA-HQ-ORD-2009-0652, by one of the
following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2009-0652.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2009-0652.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Executive Committee Meeting--September 2009 Docket,
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460,
Attention Docket ID No. EPA-HQ-ORD-2009-0652.
     Hand Delivery or Courier. Deliver comments to: EPA Docket
Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. EPA-HQ-ORD-2009-
0652.

    Note:  This is not a mailing address. Such deliveries are only
accepted during the docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0652. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Board of
Scientific Counselors, Executive Committee Meeting--September 2009
Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday,

excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the ORD Docket is
(202) 566-1752.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Lorelei Kowalski, Mail Code 8104-R, Office of Science Policy,
Office of Research and Development, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460; via phone/voice
mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via e-mail at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meeting may contact Lorelei
Kowalski, the Designated Federal Officer, via any of the contact
methods listed in the FOR FURTHER INFORMATION CONTACT section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the meeting include, but are not limited
to: Executive Committee review of the BOSC Clean Air Subcommittee draft
report; update on BOSC program review subcommittees (Drinking Water);
update on the BOSC standing subcommittees (National Center for
Environmental Research, National Exposure Research Lab, and National
Center for Computational Toxicology); an ORD briefing on revisions to
the program review process; a briefing from the BOSC Decision Analysis
Workgroup and discussion of draft workgroup product; an ORD update; an
update on EPA's Science Advisory Board activities; and future issues
and plans. The meeting is open to the public.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Lorelei Kowalski<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,
please contact Lorelei Kowalski, preferably at least 10 days prior to
the meeting, to give EPA as much time as possible to process your
request.
    Notice of this meeting was originally submitted in a timely manner
and would have been published more than 15 days prior to the meeting
date. However, due to an unexpected error, the notice had to be re-
submitted for publication. Notice of this meeting is also provided on
the BOSC Web site at http://www.epa.gov/osp/bosc.

    Dated: September 2, 2009.
Fred Hauchman,
Director, Office of Science Policy.
[FR Doc. E9-21517 Filed 9-2-09; 4:15 pm]

BILLING CODE 6560-50-P


[Federal Register: July 16, 2009 (Volume 74, Number 135)]
[Notices]
[Page 34611-34613]
[DOCID:fr16jy09-89]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60274; File No. SR-ISE-2009-48]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Foreign Currency Options Closing Settlement Values

July 9, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 2, 2009, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission the proposed rule change as described in Items I, II, and
III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The ISE proposes to amend its rules regarding Foreign Currency
Options (``FX Options'').\3\ The text of the proposed rule amendment is
as follows, with deletions in [brackets] and additions italicized:
---------------------------------------------------------------------------

    \3\ ISE began trading FX options on April 17, 2007 pursuant to
Commission approval. See Securities Exchange Act Release No. 55575
(April 3, 2007), 72 FR 17963 (April 10, 2007) (SR-ISE-2006-59) (the
``FX Options Filing'').
---------------------------------------------------------------------------

Rule 2212. Foreign Currency Options Closing Settlement Value
    (a) The closing settlement value for foreign currency options shall
be determined by using the WM/Reuters Intraday Spot rate [day's
announced Noon Buying Rate, as determined by the Federal Reserve Bank
of New York,] on the last trading day during expiration week. [If the
Noon Buying Rate is not announced by 5 p.m. Eastern time, the closing
settlement value will be the most recently announced Noon Buying Rate,
unless the Exchange determines to apply an alternative closing
settlement value as a result of extraordinary circumstances. In the
event the Noon Buying Rate is not published for an underlying currency,
the Exchange will apply the WM/Reuters Closing Spot rate to determine
the closing settlement value. If the Federal Reserve Bank of New York
determines to publish a Noon

Buying Rate in the future for a currency for which it currently does
not publish such rate, the Exchange will apply the Noon Buying Rate in
place of the WM/Reuters Composite Spot rate to determine the closing
settlement value for such currency.]
    (b) No Change.
    (c) The closing settlement value[, whether based on the Noon Buying
Rate or the WM/Reuters Closing Spot rate,] will also be modified using
the applicable modifier, i.e., 1, 10 or 100, that is used in
calculating the respective modified exchange rate, and will be posted
by the Exchange on its Web site.
* * * * *

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

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

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

1. Purpose
    ISE proposes to amend its rules regarding FX Options. Currently,
ISE's rule for determining closing settlement value for FX Options
states that the closing settlement value shall be the day's announced
``Noon Buying Rate,'' as determined by the Federal Reserve Bank of New
York (``FRBNY''), on the last trading day during expiration week. If
the Noon Buying Rate is not announced by 5 p.m. Eastern time, the
closing settlement value will be the most recently announced Noon
Buying Rate, unless the Exchange determines to apply an alternative
closing settlement value as a result of extraordinary circumstances.
ISE's experience with the Noon Buying Rate indicates that the FRBNY is
becoming increasingly unreliable in the timeliness of its publication
of the Noon Buying Rate. On at least one occasion earlier this year,
the FRBNY delayed publication of the Noon Buying Rate. As a result, ISE
resorted to the WM/Reuters Closing Spot rate, as permitted under
current rules, to determine the closing settlement value for expiring
FX Options.\4\
---------------------------------------------------------------------------

    \4\ Pursuant to the FX Options Filing, the Exchange has the
ability to use the WM/Reuters Closing Spot rate for six currencies
to determine their closing settlement value because the FRBNY does
not publish a Noon Buying Rate for these currencies. Those six
currencies are the Czech koruna, the Hungarian forint, the Israeli
shekel, the Korean won, the Polish zloty and the Russian ruble.
---------------------------------------------------------------------------

    ISE recently entered into an agreement with The World Markets
Company, PLC (``WM''), publisher of a number of foreign currency
reference rates, pursuant to which WM will provide ISE with the WM/
Reuters Intraday Spot rate. The calculation methodology of the Intraday
Spot rate is the same as that used for the Closing Spot rate. The only
difference between the two rates is the time and frequency at which
they are calculated. The Closing Spot rate is calculated at 16:00 UK
time while the Intraday Spot rates are calculated every hour. Going
forward, instead of using the Noon Buying Rate, the Exchange intends to
use the WM/Reuters Intraday Spot rate, as of 12 p.m., New York time, to
determine closing settlement value for all the currency pairs approved
in the FX Options Filing. As noted above, the WM/Reuters Intraday Spot
rate is calculated every hour, from Monday 7 a.m. Sydney time (Sunday 5
p.m. New York time) to Friday 10 p.m. UK time (Friday 5 p.m. New York
time). Those times are also known as the `fix' times. WM/Reuters
typically publishes its rates 15 minutes after the fix time. The
Reuters System is the primary source of spot foreign exchange rates
used in the calculation of the WM/Reuters Intraday Spot rate. WM/
Reuters, however, may use alternative sources such as a country's
Central Bank or rates from EBS, which is another major FX venue and
market data service provider for 156 currencies, including all of the
currencies approved by the FX Options Filing.
    WM/Reuters has two main methods for calculating its Intraday Spot
rate. The methodology used depends on whether a currency is determined
by WM/Reuters to be a ``trade currency'' or a ``non-trade currency.''
\5\ WM/Reuters applies a unique methodology for each category. Intraday
Spot rates for ``non-trade currencies'' are determined primarily by
using data from Reuters. This methodology involves taking snapshots of
quoted bids and offers for each currency at 15-second intervals over a
two minute period. The median is then calculated independently for each
currency's bid and offer. The midpoint of that median bid and offer
becomes the final value.
---------------------------------------------------------------------------

    \5\ The Australian dollar, British pound, Canadian dollar, Czech
koruna, Danish krone, euro, Japanese yen, New Zealand dollar,
Norwegian krone, Singapore dollar, South African rand, Swedish
krona, and Swiss franc are all considered by WM/Reuters to be
``trade currencies,'' while all others are considered ``non-trade
currencies.'' All of the ``trade currencies'' have been approved for
trading by the Exchange except the Danish krone and the Singapore
dollar. See supra note 1.
---------------------------------------------------------------------------

    Intraday Spot rates for ``trade currencies'' are determined
primarily by using data from both Reuters and EBS. This methodology
involves taking snapshots of actual traded rates every second for a
period of 30 seconds before the fix to 30 seconds after the fix. Trades
are identified as a bid or offer and a spread is applied to calculate
the opposite bid or offer. The spread applied is determined by the
spread between buy and sell orders captured at the same time. The
median is then independently calculated for each currency's bid and
offer, resulting in a midpoint trade rate. The midpoint of that median
bid and offer becomes the final value.
    ISE proposes to amend its rules by replacing all references to the
FRBNY's Noon Buying Rate with WM/Reuters Intraday Spot rate. This
proposed rule change will allow the Exchange to adopt an industry-
recognized vendor for foreign currency rates and do so without causing
any disruption in the calculation of the closing settlement value for
FX Options.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations under the Act applicable to a national securities exchange
and, in particular, the requirements of Section 6(b) of the Act.\6\
Specifically, the Exchange believes the proposed rule change is
consistent with Section 6(b)(5) of the Act's \7\ requirements that the
rules of a national securities exchange be designed to promote just and
equitable principles of trade, to prevent fraudulent and manipulative
acts and, in general, to protect investors and the public interest. In
particular, the proposed rule change will allow the Exchange to adopt
an industry-recognized value to determine the closing settlement value
for FX Options traded on the Exchange.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that

is not necessary or appropriate in furtherance of the purposes of the
Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    This proposed rule change does not significantly affect the
protection of investors or the public interest, does not impose any
significant burden on competition, and, by its terms, does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest. The Exchange provided the
Commission with written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing the
proposed rule change as required by Rule 19b-4(f)(6).\8\ For the
foregoing reasons, the Exchange believes the proposed rule filing
qualifies for expedited approval as a ``non-controversial'' rule change
under paragraph (f)(6) of Rule 19b-4 of the Act.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change is non-controversial
in that it will allow the Exchange to adopt an industry-recognized
value to determine the closing settlement value for FX Options traded
on the Exchange. The Exchange also believes that the proposed rule
change does not raise any new, unique or substantive issues, and is
beneficial for competitive purposes and to promote a free and open
market for the benefit of investors.
    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2009-48 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2009-48. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of the filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-ISE-
2009-48 and should be submitted on or before August 6, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-16854 Filed 7-15-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13265-13266]
[FR Doc No: 2011-5490]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Agricultural
Aircraft Operator Certificate Application

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. Standards have been established for the certification of
agricultural aircraft. The information collected shows applicant
compliance and eligibility for certification by FAA.

DATES: Written comments should be submitted by May 9, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0049.
    Title: Agricultural Aircraft Operator Certificate Application.
    Form Numbers: FAA Form 8710-3.
    Type of Review: Renewal of an information collection.
    Background: The information on FAA Form 8710-3, Agricultural
Aircraft Operator Certificate Application, is required by FAR Part 137
from applicants who wish to be issued a commercial or private
agricultural aircraft operator certificate.
    Respondents: Approximately 3,980 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 3.5 hours.
    Estimated Total Annual Burden: 14,037 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Scott, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity

of the information collection; and (d) ways that the burden could be
minimized without reducing the quality of the collected information.
The agency will summarize and/or include your comments in the request
for OMB's clearance of this information collection.

    Issued in Washington, DC, on March 3, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-5490 Filed 3-9-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63840-63841]
[FR Doc No: 2012-25482]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming teleconference meeting of a
public advisory committee of the Food and Drug Administration (FDA). At
least one

portion of the meeting will be closed to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

DATES: Date and Time: The teleconference meeting will be held on
November 29, 2012 from 1 p.m. to 5 p.m., Eastern Time.
    Location: National Institutes of Health (NIH), Building 29A,
Conference Room 1A09, 9000 Rockville Pike, Bethesda, MD 20892. The
public is welcome to attend the meeting at the specified location where
a speakerphone will be provided. Public participation in the meeting is
limited to the use of the speakerphone in the conference room.
Important information about transportation and directions to the NIH
campus, parking, and security procedures is available on the internet
at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
Visitors must show two forms of identification, one of which must be a
government-issued photo identification such as a Federal employee
badge, driver's license, passport, green card, etc. Detailed
information about security procedures is located at http://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking,
visitors are encouraged to use public transportation.
    Contact Person: Gail Dapolito or Sheryl Clark, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville MD 20852,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: On November 29, 2012 the committee will meet in open
session to hear updates of research programs in the Gene Transfer and
Immunogenicity Branch, Office of Cellular, Tissue and Gene Therapies,
Center for Biologics Evaluation and Research, and the Laboratory of
Immunology, Office of Biotechnology Products, Center for Drug
Evaluation and Research, FDA.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On November 29, 2012, from 1 p.m. to 4 p.m. (Eastern
Time) the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Written submissions may be made to the contact
person on or before November 21, 2012. Oral presentations from the
public will be scheduled between approximately 3 p.m. and 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 14, 2012. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by November 15,
2012.
    Closed Committee Deliberations: On November 29, 2012, from 4 p.m.
to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of
intramural research programs and make recommendations regarding
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Gail Dapolito at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings. Notice of this
meeting is given under the Federal Advisory Committee Act (5 U.S.C.
app. 2).

    Dated: October 9, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25482 Filed 10-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 222 (Tuesday, November 18, 2014)]
[Notices]
[Pages 68747-68749]
[FR Doc No: 2014-27211]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73579; File No. SR-OCC-2014-807]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of an Emergency Change to OCC's Procedures To Resize the
Clearing Fund in Response to Market Conditions

November 12, 2014.
    Pursuant to Section 806(e)(2) of Title VIII of the Dodd-Frank Wall
Street Reform and Consumer Protection Act, entitled Payment, Clearing,
and Settlement Supervision Act of 2010 (``Payment, Clearing and
Settlement Supervision Act'') \1\ and Rule 19b-4(n)(1)(i) under the
Securities Exchange Act of 1934 (``Act''),\2\ notice is hereby given
that on October 16, 2014, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'') the
emergency notice as described in Items I and II below, which Items have
been prepared by OCC. The Commission is publishing this notice to
solicit comments on the emergency notice from interested persons.
---------------------------------------------------------------------------

    \1\ 12 U.S.C. 5465(e)(2).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Emergency Notice

    This notice is filed by OCC in connection an increase in the size
of OCC's Clearing Fund that it has implemented on an emergency basis
pursuant to Section 806(e)(2) of the Payment, Clearing, and Settlement
Supervision Act.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Emergency Notice

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

(A) Clearing Agency's Statement on Comments on the Emergency Notice
Received From Members, Participants or Others

    Written comments were not and are not intended to be solicited with
respect to the emergency notice and none have been received.

(B) Emergency Notices Filed Pursuant to Section 806(e)(2) of the
Payment, Clearing and Settlement Supervision Act

Description of Change
Emergency Notice
    This notice is being filed in connection with an emergency waiver
of the provision of OCC's Rules calling for monthly adjustments of its
Clearing Fund that would otherwise have required an advance notice
under Section 806(e)(1) of the Payment, Clearing and Settlement
Supervision Act. Pursuant to Section 806(e)(2) of the Payment,
Clearing, and Settlement Supervision Act, a designated financial market
utility such as OCC may implement a change that would otherwise require
an advance notice if it determines that an emergency exists and
immediate implementation is necessary to continue to provide services
in a safe and sound manner.\3\ For the reasons discussed below, OCC
believes that the change was appropriate under this framework, and OCC
is now filing this emergency notice in accordance with

the requirements under Sections 806(e)(2)(B) and (C) of the Payment,
Clearing and Settlement Supervision Act.\4\
---------------------------------------------------------------------------

    \3\ 12 U.S.C. 5465(e)(2).
    \4\ 12 U.S.C. 5465(e)(2)(B), 12 U.S.C. 5465(e)(2)(C).
---------------------------------------------------------------------------

Sizing of the Clearing Fund
    Under Commission Rule 17Ad-22(b)(3), OCC is obligated to maintain
sufficient financial resources to withstand, at a minimum, a default by
the Clearing Member Group to which OCC has the largest exposure in
extreme but plausible market conditions.\5\ As part of OCC's ongoing
compliance with this obligation, it readjusts the size of its Clearing
Fund monthly pursuant to OCC's Rule 1001(a). Under Rule 1001(a), the
monthly readjustment is based upon daily calculations by OCC during the
preceding month of the size of the Clearing Fund that would be
necessary, within certain confidence levels, to protect OCC from loss
under simulated default scenarios. Recent increased volatility in the
financial markets has affected these calculations such that OCC's daily
results indicate that the size of the Clearing Fund should be increased
to address the potential risk that it could be underfunded in the event
of a Clearing Member default. OCC recently proposed a rule change and
advance notice that would permit the Clearing Fund to be resized intra-
month in the event that the five-day rolling average of projected draws
against the Clearing Fund are 150% or more of its then current size.\6\
Although that proposal remains pending, OCC calculates that the recent
increase in market volatility would have caused that proposed threshold
to be exceeded as of October 15, 2014 and determined that an intra-
month increase was necessary to minimize the risk of an underfunding of
the Clearing Fund.
---------------------------------------------------------------------------

    \5\ 17 CFR 240.17Ad-22(b)(3).
    \6\ See, Securities Exchange Act Release No. 72752 (August 4,
2014), 79 FR 46490 (August 8, 2014) (SR-OCC-2014-17). See also,
Securities Exchange Act Release No. 72804 (August 11, 2014), 79 FR
48276 (August 15, 2014) (SR-OCC-2014-804).
---------------------------------------------------------------------------

Nature of the Emergency and Reasons the Clearing Fund Resizing was
Necessary
    To provide OCC with the necessary flexibility to respond to these
dynamic market conditions and increase the size of its Clearing Fund
prior to the next resizing scheduled to take place on the first
business day in November, OCC has exercised certain emergency powers in
Article IX, Section 14 of its By-Laws. In emergency circumstances and
subject to certain conditions, that authority permits OCC's Board of
Directors, Executive Chairman or President to waive or suspend its By-
Laws, Rules, policies and procedures or any other rules issued by OCC
or extend the time fixed thereby for the doing of any act or acts.\7\
Consistent with that authority, OCC's Executive Chairman on October 15,
2014 determined to waive the provisions in the second sentence of Rule
1001(a) under which the Clearing Fund is readjusted monthly based upon
an average of the daily calculations performed by OCC during the
preceding calendar month. To respond to the potential risk under
prevailing market conditions that the Clearing Fund could be
underfunded, which could affect OCC's ability to continue to facilitate
prompt and accurate clearance and settlement and to operate in a safe
and sound manner, OCC increased the size of the Clearing Fund for the
remainder of October 2014 as is otherwise provided for in Rule 1001(a).
Accordingly, the original Clearing Fund sizing calculation for October
2014 of approximately $3.8 billion was suspended by OCC and the size of
the Clearing Fund was reestablished in an amount of approximately $5.6
billion. The Executive Chairman consulted with the Risk Committee of
OCC's Board of Directors and senior staff of the Commission before
making this decision. Senior staff of the U.S. Commodity Futures
Trading Commission was also informed.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 71571 (February 19,
2014), 79 FR 10581 (February 25, 2014) (SR-OCC-2013-23). As noted in
the Commission's approval order for that rule change, the change
generally aligned OCC's authority in this area with the authority of
other registered clearing agencies that already had similar rules
allowing them in comparable circumstances to waive or suspend their
rules or extend the time fixed thereby for the performance of any
act or acts.
---------------------------------------------------------------------------

Anticipated Effect on and Management of Risk
    Overall, the increase in the size the Clearing Fund reduces the
risks to OCC, its Clearing Members and the options market in general
because it provides OCC with proper flexibility under current market
conditions to establish a Clearing Fund size that OCC believes would be
sufficient to protect against losses under current market conditions
for a period of not more than 30 calendar days as specified in Article
IX, Section 14(c). The change allowed OCC to increase the overall size
of its Clearing Fund as a result of a projected increase in potential
draws. Accordingly, the change makes it less likely that the Clearing
Fund will be insufficient should OCC need to use it to manage a
Clearing Member default. The change therefore reduces OCC's overall
level of risk and facilitates its management of risk.
Consistency With the Payment, Clearing and Settlement Supervision Act
    OCC believes that the increase in the total size of the Clearing
Fund was consistent with Sections 805(b)(1) \8\ and 806(e)(2) \9\ of
the Payment, Clearing and Settlement Supervision Act. The change
promotes robust risk management \10\ by providing OCC with an amount of
financial resources it believes would be sufficient to protect OCC
against loss in an event of default. The change was appropriate on an
emergency basis because OCC determined through daily calculations
regarding the sufficiency of the Clearing Fund that increased financial
market volatility represented a potential risk that the Clearing Fund
could be underfunded if an event of default occurred. The determination
to readjust the size of the Clearing Fund as described above was
therefore necessary and advisable for the protection of OCC and in the
public interest to ensure that OCC's Clearing Fund is sufficient for
OCC to be able to provide its services in a safe and sound manner.
---------------------------------------------------------------------------

    \8\ 12 U.S.C. 5464(b)(1).
    \9\ 12 U.S.C. 5465(e)(2).
    \10\ 12 U.S.C. 5464(b)(1).
---------------------------------------------------------------------------

III. Date of Effectiveness of the Advance Notice and Timing for
Commission Action

    OCC implemented a proposed change that otherwise would be required
to be filed as an advance notice because OCC determined that (i) an
emergency existed and (ii) immediate implementation was necessary for
OCC to continue to provide its services in a safe and sound manner. The
Commission may require modification or rescission of the proposed
change if it finds it is not consistent with the purposes of the
Payment, Clearing and Settlement Supervision Act or any applicable
rules, orders, or standards prescribed under Section 805(a) of the
Payment, Clearing and Settlement Supervision Act.\11\
---------------------------------------------------------------------------

    \11\ See 12 U.S.C. 5465(e)(2)(D), 12 U.S.C. 5464(a).
---------------------------------------------------------------------------

    Pursuant to Rule 19b-4(n) under the Act,\12\ OCC shall post notice
on its Web site of proposed changes that are implemented.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(n).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2014-807 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-OCC-2014-807. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the emergency notice that are filed
with the Commission, and all written communications relating to the
emergency notice between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of OCC. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-OCC-2014-807 and should be
submitted on or before December 9, 2014.

    By the Commission.
Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2014-27211 Filed 11-17-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42965-42966]
[FR Doc No: 2013-17223]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0811]

Guidance for Industry: Enforcement Policy Regarding
Investigational New Drug Requirements for Use of Fecal Microbiota for
Transplantation To Treat Clostridium difficile Infection Not Responsive
to Standard Therapies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Enforcement
Policy Regarding IND Requirements for Use of Fecal Microbiota for
Transplantation to Treat Clostridium difficile Infection Not Responsive
to Standard Therapies,'' dated July 2013. This guidance informs members
of the medical and scientific community and other interested persons
that we intend to exercise enforcement discretion regarding the
investigational new drug (IND) requirements for the use of fecal
microbiota for transplantation (FMT) to treat C. difficile infection
not responding to standard therapies. FDA intends to exercise this
discretion provided that the treating physician obtains adequate
informed consent from the patient or his or her legally authorized
representative for the use of FMT products. Informed consent should
include, at a minimum, a statement that the use of FMT products to
treat C. difficile is investigational and a discussion of its potential
risks. This policy does not extend to other uses of FMT. FDA intends to
exercise this discretion on an interim basis while we further consider
the matter. This guidance has an immediate implementation date because
FDA has

determined that prior public participation is not feasible or
appropriate.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Enforcement Policy Regarding IND Requirements for Use of
Fecal Microbiota for Transplantation to Treat Clostridium difficile
Infection Not Responsive to Standard Therapies,'' dated July 2013. This
guidance is being issued consistent with FDA's good guidance practices
(GGP) regulation Sec.  10.115 (21 CFR 10.115). This guidance is being
implemented without prior public comment because the Agency has
determined that prior public participation is not feasible or
appropriate (Sec.  10.115(g)(2)). The Agency made this determination
because the guidance requires immediate implementation for public
health reasons. This guidance deals with an urgent issue affecting
patients with life-threatening infections with C. difficile. Although
this guidance document is immediately in effect, it remains subject to
comment in accordance with the Agency's GGPs regulation.
    Fecal microbiota collected from healthy individuals are being
investigated for use in the treatment of C. difficile infection.
Published data suggest that the use of fecal microbiota to restore
intestinal flora may be an effective therapy in the management of
refractory C. difficile infection. However, the efficacy and safety
profile of this intervention have not yet been fully evaluated in
controlled clinical trials.
    In the Federal Register of February 25, 2013 (78 FR 12763), FDA
announced a public workshop, entitled ``Fecal Microbiota for
Transplantation,'' which was held on May 2 and 3, 2013. The purpose of
the workshop was to provide a forum for the exchange of information,
knowledge, and experience among the medical and scientific community
about the regulatory and scientific issues associated with FMT. During
that workshop, and in subsequent communications, physicians and
scientists expressed concern to FDA that FMT is not appropriate for
study under the Agency's IND regulations (21 CFR part 312). Some health
care providers stated that applying IND requirements will make FMT
unavailable and suggested that an alternative regulatory approach is
needed to ensure the widespread availability of FMT for individuals
with C. difficile infection unresponsive to standard therapies.
    FDA acknowledges these concerns. The Agency intends to exercise
enforcement discretion regarding the IND requirements for the use of
FMT to treat C. difficile infection not responding to standard
therapies, provided that the treating physician obtains adequate
informed consent from the patient or his or her legally authorized
representative for the use of FMT products. Informed consent should
include, at a minimum, a statement that the use of FMT products to
treat C. difficile is investigational and a discussion of its potential
risks. FDA intends to exercise this discretion on an interim basis
while the Agency further considers the matter.
    This policy does not extend to other uses of FMT. Data related to
the use and study of FMT to treat diseases or conditions other than C.
difficile infection are limited, and study of FMT for these other uses
is not included in this enforcement policy.
    This guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov.

    Dated: July 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17223 Filed 7-17-13; 8:45 am]
BILLING CODE 4160-01-P


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 1/ 1/ 2006)

EPA Registration Division contact: [ Dr. Bipin Gandhi ( 703) 308 8380]

]

TEMPLATE:

[ MonoSol, LLC]

[ Insert petition number]

EPA has received a pesticide petition ([ insert petition number]) from [ MonoSol, LLC], [ 1701 County Line Road, Portage, IN 46368 ] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.960 to establish an exemption from the requirement of a tolerance for [ 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts] in or on the raw agricultural commodity [ all food commodities] at [ without numerical limitations] parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408 ( d)( 2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry MonoSol, LLC is petitioning that 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts be exempt from the requirement of a tolerance based upon the definition of a low risk polymer under 40 CFR 723.250( e). Consequently, MonoSol, LLC believes that the analytical method to determine residues, the residues present in plant material, and the magnitude of 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts in raw agricultural commodities, is not relevant.

1. Plant metabolism.

2. Analytical method. [ NA   Please Remove]

3. Magnitude of residues. [ NA   Please Remove]

B. Toxicological Profile 1. Acute toxicity. [ POLYMER EXEMPTION LANGUAGE  2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is composed of at least 3 monomer units and 1 other reactant.

 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts consists of a simple weight majority of the polymer molecules. The monomer distribution in the polymer is completely random and the distribution of the molecular weight of the polymer is due largely to the number of monomer units in the individual molecules.

 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts will not become cationic in an aquatic environment, and it contains no moieties capable of obtaining a cationic charge.

 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is composed of carbon, hydrogen and oxygen, and therefore meets the criteria of elemental composition. Sodium exists as a monatomic counterion.

 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts will not degrade, decompose or depolymerize.

 All materials used to prepare 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts are on the TSCA Chemical Substance Inventory or are manufactured under an applicable TSCA section 5 exemption.

 Although the number average molecular weight of 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts exceeds 10,000 and is hydrophilic, it does not fit the definition of a water absorbing polymer in that it does not absorb its weight of water.

 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts consists of a number average molecular weight of 36,272 with zero percent of its oligomeric material weighing below 500 daltons and zero percent of its oligomeric material weighing less than 1,000 daltons.]

2. Genotoxicty. [ NA   Please Remove.]

3. Reproductive and developmental toxicity. [ NA   Please Remove.]

4. Subchronic toxicity. [ NA   Please Remove.]

5. Chronic toxicity. [ NA   Please Remove.]

6. Animal metabolism. [ NA   Please Remove.]

7. Metabolite toxicology. [ NA   Please Remove.] 8. Endocrine disruption. [ NA   Please Remove.]

C. Aggregate Exposure 1. Dietary exposure. [ The physical and chemical characteristics of 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts leads to the conclusion that there is a reasonable certainty of no harm from exposure to the polymer from food or drinking water nor from an aggregate exposure.]

i. Food. [ NA   Please Remove.]

ii. Drinking Food. [ NA   Please Remove.]

2. Non dietary exposure. [ The physical and chemical characteristics of 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts leads to the conclusion that there is a reasonable certainty of no harm from exposure to the polymer from non dietary means.]

D. Cumulative Effects [ At this time there is no information to indicate that any toxic effects produced by 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts would be cumulative with any other chemical. Given the compound's categorization as a low risk polymer, and its proposed use in pesticide and anti microbial formulations, there is no expectation of increased risk due to cumulative exposure.]

E. Safety Determination 1. U. S. population. [ Based on the polymer's physical and chemical properties, and that it meets or exceeds the polymer exemption criteria at 40 CFR 723.250 for low risk polymers, adverse effects are not expected.]

2. Infants and children. [ Based on the polymer's physical and chemical properties, and that it meets or exceeds the polymer exemption criteria at 40 CFR 723.250 for low risk polymers, adverse effects are not expected.]

F. International Tolerances [ There are no CODEX maximum residue limits established for 2 Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salt in or on crops or commodities at this time.]


[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12563-12565]
[FR Doc No: 2020-04361]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4436]

Bone Anchors--Premarket Notification (510(k)) Submissions;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Bone Anchors--Premarket
Notification (510(k)) Submissions.'' This guidance document provides
recommendations for 510(k) submissions for bone anchor (suture anchor)
devices. FDA is clarifying and providing current thinking on the
recommended content for a bone anchor 510(k) submission, including
performance testing recommendations and device description.

DATES: The announcement of the guidance is published in the Federal
Register on March 3, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4436 for ``Bone Anchors--Premarket Notification (510(k))
Submissions.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf .
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Bone Anchors--Premarket Notification (510(k)) Submissions'' to the
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Laurence Coyne, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4512, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides recommendations for 510(k)
submissions for bone anchor (suture anchor) devices, which are
indicated for attachment of soft tissue to bone. FDA is clarifying and
providing current thinking on the recommended content for a bone anchor
510(k) submission, including performance testing recommendations and
device description. FDA considered comments received on the draft
guidance that appeared in the Federal Register of January 3, 2017 (82
FR 128). FDA revised the guidance as appropriate in response to the
comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Bone Anchors--Premarket Notification
(510(k)) Submissions.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance is also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Bone Anchors--Premarket
Notification (510(k)) Submissions'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1400005 and the complete guidance title
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following regulations have been approved by OMB as listed in the
following table:

------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------

    Dated: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04361 Filed 3-2-20; 8:45 am]
 BILLING CODE 4164-01-P