[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Notices]
[Pages 63922-63923]
[FR Doc No: 2014-25472]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-1078]

National Offshore Safety Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee meetings.

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SUMMARY: The National Offshore Safety Advisory Committee and its
Subcommittees will meet on November 18 and 19, 2014, in Houston, TX, to
discuss the safety of operations and other matters affecting the
offshore oil and gas industry. These meetings are open to the public.

DATES: Subcommittees of the National Offshore Safety Advisory Committee
will meet on Tuesday, November 18, 2014, from 1 p.m. to 4 p.m. and the
full Committee will meet on Wednesday, November 19, 2014, from 8:30
a.m. to 4:30 p.m. These meetings may end early if the Committee has
completed its business, or they may be extended based on the number of
public comments. All submitted written materials, comments, and
requests to make oral presentations at the meetings should reach the
Coast Guard (see FOR FURTHER INFORMATION CONTACT) by November 1, 2014.
Any written material submitted by the public will be distributed to the
Committee and become part of the public record.

ADDRESSES: The meetings will be held in the conference room of the
American Bureau of Shipping, 15011 Katy Freeway, Suite 100, Houston,
TX, 77094,<PHONE_NUMBER>, http://www.eagle.org.
    For information on facilities or services for individuals with
disabilities, or to request special assistance at the meetings, contact
the individuals listed in FOR FURTHER INFORMATION CONTACT section, as
soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the Committee as listed in the
``Agenda'' section below. Written comments for distribution to
Committee members must be submitted no later than November 1, 2014, if
you want the Committee members to be able to review your comments
before the meeting, and must be identified by docket number USCG-2013-
1078 and submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments

(preferred method to avoid delays in processing).
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    To avoid duplication, please submit comments using only one of the
above methods.
    Instructions: All submissions must include the words ``Department
of Homeland Security'' and the docket number for this action, USCG-
2013-1078. All comments submitted will be posted without alteration at
http://www.regulations.gov including any personal information provided.
You may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, insert USCG-
2013-1078 in the Search box, press Enter, and then click on the item
you wish to view.
    A public oral comment period will be held during the meeting on
November 19, 2014, and speakers are requested to limit their comments
to 3 minutes. Contact one of the individuals listed below to register
as a speaker.

FOR FURTHER INFORMATION CONTACT: Commander Thomas Kaminski, Designated
Federal Official of the National Offshore Safety Advisory Committee,
Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr.
Avenue SE., Stop 7509, Washington, DC 20593-7509; telephone (202) 372-
1410, fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>or Mr.
Scott Hartley, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER> or 1-800-647-5527.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, Title 5 United States Code Appendix.
The National Offshore Safety Advisory Committee provides advice and
recommendations to the Department of Homeland Security on matters and
actions concerning activities directly involved with or in support of
the exploration of offshore mineral and energy resources insofar as
they relate to matters within U.S. Coast Guard jurisdiction.
    A copy of all meeting documentation will be available at https://homeport.uscg.mil/NOSAC. Alternatively, you may contact Mr. Scott
Hartley as noted in the FOR FURTHER INFORMATION CONTACT section above.

Agenda

Day 1

    The National Offshore Safety Advisory Committee Subcommittees will
meet on November 18, 2014, from 1 p.m. to 4 p.m. to review, discuss and
formulate recommendations on the following matters:
     Commercial Diving Safety on the Outer Continental Shelf;
     Offshore Supply Vessel Purpose and Offshore Workers; and
     Training of personnel on Mobile Offshore Units and
Offshore Supply Vessels working on the Outer Continental Shelf.

Day 2

    The National Offshore Safety Advisory full Committee will meet on
November 19, 2014, from 8:30 a.m. to 4:30 p.m. to review and discuss
Subcommittee progress, reports and recommendations received from the
above listed Subcommittees from their deliberations on November 18,
2014. The Committee will then use this information and consider public
comments in formulating recommendations to the U.S. Coast Guard. Public
comments or questions will be taken at the discretion of the Designated
Federal Officer during the discussion and recommendation portion of the
meeting as well as during the public comment period. A complete agenda
for November 19, 2014, is as follows:
    (1) Current Business--Presentation and discussion of progress
reports, final reports and recommendations from the Subcommittees and
subsequent actions on:
    (a) Commercial Diving Safety on the Outer Continental Shelf;
    (b) Offshore Supply Vessel Purpose and Offshore Workers; and
    (c) Training of personnel on Mobile Offshore Units and Offshore
Supply Vessels working on the Outer Continental Shelf.
    (2) Presentations and discussions of the following matters:
    (a) Offshore Service Vessel Dynamic Positioning Authority and
Dynamic Positioning Operator Certification;
    (b) NorSafe U.S.A. Lifeboat Fall Testing;
    (c) American Bureau of Shipping Liquefied Natural Gas Bunkering;
    (d) Center for Offshore Safety Activities; and
    (e) American Petroleum Institute Recommended Practice 2D Operation
and Maintenance of Offshore Cranes.
    (3) Public comment period.
    The agenda, progress reports, draft final reports, new task
statements and presentations will be available approximately 7 days
prior to the meeting at the https://homeport.uscg.mil/NOSAC Web site or
by contacting Mr. Scott Hartley.

Minutes

    Meeting minutes will be available for public view and copying
within 90 days following the meeting at the https://homeport.uscg.mil/NOSAC Web site.

Notice of Future 2014 National Offshore Safety Advisory Committee
Meetings

    To receive automatic email notices of future National Offshore
Safety Advisory Committee meetings in 2014, go to the online docket,
USCG-2013-1078 (http://www.regulations.gov/#!docketDetail:D=USCG-2013-1078), and select the sign-up-for-email-alerts option.

    Dated: October 22, 2014.
J.G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2014-25472 Filed 10-24-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71187-71188]
[FR Doc No: 2012-28869]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1267-099]

Greenwood County; Notice of Application for Amendment of License
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and waters.
    b. Project No: 1267-099.
    c. Date Filed: October 1, 2012.
    d. Applicant: Greenwood County.
    e. Name of Project: Buzzards Roost Hydroelectric Project.
    f. Location: Lake Greenwood in Greenwood County, South Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a--825r.
    h. Applicant Contact: Julie Davis, Greenwood County, Department of
Lake Management, 528 Monument Street, Room B-03, Greenwood, SC, 29646-
2691,<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: December 24, 2012.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at 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 at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
Please include the project number (P-1267-099) on any comments or
motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.

    k. Description of Application: Greenwood County requests Commission
approval to authorize Great South Partners to construct a day-use,
commercial marina within the project boundary on Lake Greenwood that
would serve patrons of a prospective restaurant to be located outside
the project boundary on the adjoining parcel. The proposed marina would
occupy an on-the-water footprint measuring 240 feet long by 136 feet
wide, consisting of two floating docks connected by a common walkway,
accommodating 64 watercraft in total. An existing seawall is located
along 330 feet of the 425 feet of shoreline frontage along this parcel.
No dredging or vegetation removal is associated with this proposal.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (P-1267) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, call 1-866-
208-3676 or email<EMAIL_ADDRESS>for TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: November 23, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-28869 Filed 11-28-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Page 78234]
[FR Doc No: 2010-31414]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13742-000; Project No. 13757-000; Project No. 13764-000;
Project No. 13786-000]

Lock+TM Hydro Friends Fund XXXIV; FFP Missouri 5, LLC;
Solia 2 Hydroelectric, LLC; Emsworth Hydro, LLC; Notice of Competing
Preliminary Permit Applications Accepted for Filing and Soliciting
Comments, and Motions to Intervene

December 8, 2010.
    On May 18, 2010, Lock+ Hydro Friends Fund XXXIV, FFP Missouri 5,
LLC, and Solia 2 Hydroelectric, LLC, filed applications, and on May 19,
2010, Emsworth Hydro, LLC, filed an application, pursuant to section
4(f) of the Federal Power Act, proposing to study the feasibility of
hydropower at the U.S. Army Corps of Engineers Emsworth Locks and Dam
on the Ohio River near the town of Emsworth, in Allegheny County,
Pennsylvania. 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 owners' express
permission.
    Descriptions of the proposed Emsworth Lock and Dam Projects:
    Lock+TM Hydro Friends Fund XXXIV's proposed project
(Project No. 13742-000) would consist of: (1) Two lock frame modules
109 feet long, 40 feet high, and weighing 1.16 million pounds each, and
containing 10 generating units having a total combined capacity of 36
megawatts (MW); (2) two 30-foot-high, 75-foot-long prefabricated
concrete walls attached to pilings in the river; (3) a 25-foot-long,
50-foot-wide switchyard having a transformer; and (4) a 1,500-foot-
long, 69-kilovolt (kV) transmission line to an existing substation. The
proposed project would have an average annual generation of 157.79
gigawatt-hours (GWh), which would be sold to a local utility.
    Applicant Contact: Mr. Mark R. Stover, Hydro Green Energy LLC, 5090
Richmond Avenue 390, Houston, TX 77056; phone<PHONE_NUMBER>
x709.
    FFP Missouri 5, LLC's proposed project (Project No. 13757-000)
would consist of: (1) An excavated intake and tailrace channel slightly
longer and wider than the powerhouse; (2) a 200-foot-long, 200-foot-
wide, 50-foot-high powerhouse containing five generating units having a
total installed capacity of 32.7 MW; and (3) a 1,500-foot-long, ranging
from 34.0 to 230-kV, transmission line. The proposed project would have
an average annual generation of 141.3 GWh, which would be sold to a
local utility.
    Applicant Contact: Ms. Ramya Swaminathan, Free Flow Power
Corporation, 33 Commercial Street, Gloucester, MA 01930; phone (978)
283-2822.
    Solia 2 Hydroelectric, LLC's proposed project (Project No. 13764-
000) would consist of: (1) A 300-foot-long, 160-foot-wide excavated
intake channel; (2) a 200-foot-long, 160-foot-wide excavated tailrace;
(3) a 200-foot-long, 200-foot-wide, 50-foot-high concrete powerhouse
containing two generating units with a combined capacity of 32 MW; and
(4) a 11,500-foot-long transmission line. The proposed project would
have an average annual generation of 140.0 GWh, which would be sold to
a local utility.
    Applicant Contact: Mr. Douglas Spaulding, P.E., Nelson Energy, 8441
Wayzata Blvd., Suite 101, Golden Valley, MN, 55426; phone (952) 544-
8133.
    Emsworth Hydro, LLC's proposed project (Project No. 13786-000)
would consist of: (1) A 240-foot-long, excavated power canal; (2) a
165-foot-long, excavated tailrace; (3) a powerhouse containing four
7.8-MW generating units having an estimated total capacity of 31 MW;
(4) a switchyard; and (5) a 1.6-mile-long, 69.0-kV transmission line.
The proposed project would have an average annual generation of 116.7
GWh, which would be sold to a local utility.
    Applicant Contact: Mr. Brent Smith, Symbiotics LLC., P.O. Box 535,
Rigby, ID 83442; phone<PHONE_NUMBER>.
    FERC Contact: Gaylord Hoisington,<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 at<EMAIL_ADDRESS>call toll-free at (866) 208-
3676; or, for TTY, contact<PHONE_NUMBER>. 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 the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13742-000, 13757-000, 13764-000, or 13786-
000) in the docket number field to access the document. For assistance,
contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-31414 Filed 12-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 19, 2009 (Volume 74, Number 32)]
[Notices]
[Page 7713-7714]
[DOCID:fr19fe09-82]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59379; File No. SR-CBOE-2009-002]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Broker-Dealer Transaction Fees for AIM
Executions

February 10, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, 15 U.S.C. 78s(b)(1), notice is hereby given that on January 30,
2009, Chicago Board Options Exchange, Incorporated (``CBOE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by CBOE. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.

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

    Chicago Board Options Exchange, Incorporated (``CBOE'' or
``Exchange'') proposes to amend its Fees Schedule regarding broker-
dealer transaction fees for Automated Improvement Mechanism (``AIM'')
executions. The text of the proposed rule change is available on the
Exchange's website (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary and at the Commission.

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

    In its filing with the Commission, CBOE 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. CBOE 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
    On December 1, 2008, the Exchange reduced the transaction fee for
non-member market-maker orders (``N'' origin code orders) executed on
AIM from $.45 per contract to $.20 per contract.\1\ In order to
encourage more use of AIM, the Exchange proposes to reduce all broker-
dealer transaction fees for orders executed on AIM from $.45 per
contract to $.20 per contract. Broker-dealer transaction fees apply to
broker-dealer orders (orders with ``B'' origin code), non-member
market-maker orders (orders with ``N'' origin code) and orders from
specialists in the underlying security (orders with ``Y'' origin
code).\2\
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    \1\ See Securities Exchange Act Release No. 59068 (December 8,
2008), 73 FR 76428 (December 16, 2008). AIM is an electronic auction
system that exposes certain orders electronically in an auction to
provide such orders with the opportunity to receive an execution at
an improved price. AIM is governed by CBOE Rule 6.74A. The fee
discount applies to non-member market-maker orders initially entered
into AIM as the contra party to an Agency Order.
    \2\ See CBOE Fees Schedule, Footnote 16.
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    The fee discount would apply to B, N and Y origin code orders
initially entered into AIM as the contra party to an Agency Order. The
Exchange proposes to implement this fee change on February 2, 2009.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Securities Exchange Act of 1934 (``Act'') \3\, in
general, and furthers the objectives of Section 6(b)(4) \4\ of the Act
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among CBOE
members and other persons using its facilities. The Exchange believes
that reducing broker-dealer transaction fees for AIM executions should
encourage more use of AIM.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)

of the Act \5\ and subparagraph (f)(2) of Rule 19b-4 \6\ thereunder. 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.
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-002 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2009-002. 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, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. 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-CBOE-2009-002 and should be
submitted on or before March 12, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Florence E. Harmon,
Deputy Secretary.
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    \7\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E9-3424 Filed 2-18-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Proposed Rules]
[Pages 51695-51696]
[FR Doc No: 2013-20414]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 770

[EPA-HQ-OPPT-2012-0018; FRL-9397-2]
RIN 2070-AJ92

Formaldehyde Emissions Standards for Composite Wood Products;
Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: EPA issued a proposed rule in the Federal Register of June 10,
2013, concerning formaldehyde emissions standards for composite wood
products. After receiving requests for an extension, EPA extended the
comment period from August 9, 2013, to September 9, 2013. EPA received
additional comments and believes it is appropriate to further extend
the comment period in order to give

stakeholders additional time to assess the impacts of the proposal,
review technical documents in the docket, and prepare comments. This
document extends the comment period from September 9, 2013, to October
9, 2013.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2012-0018, must be received on or before October 9, 2013.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of June 10, 2013.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Cindy Wheeler, National Program Chemicals Division (7404T), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 566-0484; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    This document extends the public comment period established in the
Federal Register of July 23, 2013 (78 FR 44089) (FRL-9394-1). EPA is
hereby extending the comment period, which was set to end on September
9, 2013, to October 9, 2013.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the June 10, 2013
(78 FR 34820) (FRL-9342-3), Federal Register document. If you have
questions, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

List of Subjects in 40 CFR Part 770

    Environmental protection, Formaldehyde, Reporting and recordkeeping
requirements, Toxic substances, Wood.

    Dated: August 15, 2013.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-20414 Filed 8-20-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Notices]
[Pages 31957-31958]
[FR Doc No: 2011-13680]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-484-000]

Williston Basin Interstate Pipeline Company; Notice of Request
Under Blanket Authorization

    Take notice that on May 18, 2011, Williston Basin Interstate
Pipeline Company (Williston Basin) filed a prior notice request for
authorization, in accordance with 18 CFR 157.213(b) and 157.216(b) of
the Federal Energy Regulatory Commission's (Commission) Regulations
under the Natural Gas Act (NGA) and Williston Basin's blanket
certificate issued in Docket No. CP82-487-000, et al.,\1\ for the
replacement, operation and abandonment of natural gas storage
facilities in Fallon County, Montana. Specifically, Williston Basin
proposes to replace three natural gas storage wells and abandon one
additional well. Williston Basin states that the estimated cost to
construct the facilities is approximately $928,000, all as more fully
set forth in the application, which is open to the public for
inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
---------------------------------------------------------------------------

    \1\ By the Commission's Order dated February 13, 1985 in Docket
Nos. CP82-487-000, et al., (30 FERC ] 61,143), Williston Basin was
authorized to acquire and operate the interstate pipeline facilities
previously owned and operated by MDU Resources Group, Inc. (MDU),
its parent company, as well as to provide the certificated service
previously provided by MDU, effective January 1, 1985. MDU was
originally granted blanket certificate authority in Docket Nos.
CP83-1-000, et al.
---------------------------------------------------------------------------

    Any questions regarding this prior notice should be directed to
Keith A. Tiggelaar, Director of Regulatory Affairs, Williston Basin
Interstate Pipeline Company, 1250 West Century Avenue, Bismarck, North
Dakota 58503, or telephone<PHONE_NUMBER>, or by e-mail
<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right

to seek court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link. Persons unable
to file electronically should submit an original and seven copies of
the protest or intervention to the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.

    Dated: May 26, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-13680 Filed 6-1-11; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

As an e-cigarette user, ex-smoker, and as a Medical Doctor, I feel very passionate about e-cigarettes and strongly promote its health concerns, thus the rules and regulations in regards to e-cigarettes must be thought out thoroughly, clearly, and as precise as much as possible. Simply put, e-cigarettes have not only saved my life, but those around me which I am sincerely grateful for. If considered, I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Notices]
[Pages 49214-49215]
[FR Doc No: 2017-23046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5715]

Watson Laboratories, Inc., and Barr Laboratories, Inc.,
Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval
of 54 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 54 abbreviated new drug applications (ANDAs) from two applicants.
The holders of the applications notified the Agency in writing that the
drug products were no longer marketed and requested that the approval
of the applications be withdrawn.

DATES: Approval is withdrawn as of November 24, 2017.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an abbreviated application
under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
       Application No.                 Drug               Applicant
------------------------------------------------------------------------
ANDA 061717..................  Doxycycline Hyclate   Watson
                                Capsules USP,         Laboratories,
                                Equivalent to (EQ)    Inc., Subsidiary
                                50 milligrams (mg)    of Teva
                                base and EQ 100 mg    Pharmaceuticals
                                base.                 USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 062087..................  Erythromycin           Do.
                                Estolate Capsules
                                USP, EQ 250 mg base.
ANDA 062318..................  Gentamicin Injection   Do.
                                USP, EQ 10 mg base/
                                milliliter (mL) and
                                EQ 40 mg base/mL.
ANDA 062816..................  Ampicillin for         Do.
                                Injection USP, EQ
                                125 mg base/vial,
                                EQ 250 mg base/
                                vial, EQ 500 mg
                                base/vial, EQ 1
                                gram (g) base/vial,
                                and EQ 2 g base/
                                vial.
ANDA 062994..................  Ampicillin for         Do.
                                Injection USP, EQ
                                10 g base/vial.
ANDA 062999..................  Erythromycin Delayed- Barr Laboratories,
                                Release Tablets       Inc., Subsidiary
                                USP, 500 mg.          of Teva
                                                      Pharmaceuticals
                                                      USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 064036..................  Cefuroxime for        Watson
                                Injection USP, EQ     Laboratories,
                                7.5 g base/vial.      Inc., Subsidiary
                                                      of Teva
                                                      Pharmaceuticals
                                                      USA, Inc.
ANDA 070296..................  Diazepam Injection     Do.
                                USP, 5 mg/mL.
ANDA 070412..................  Furosemide Tablets     Do.
                                USP, 20 mg.
ANDA 070435..................  Ibuprofen Tablets      Do.
                                USP, 200 mg.
ANDA 070436..................  Ibuprofen Tablets      Do.
                                USP, 400 mg.
ANDA 070437..................  Ibuprofen Tablets      Do.
                                USP, 600 mg.
ANDA 070449..................  Furosemide Tablets     Do.
                                USP, 20 mg.
ANDA 070450..................  Furosemide Tablets     Do.
                                USP, 40 mg.
ANDA 070515..................  Tolazamide Tablets     Do.
                                USP, 500 mg.
ANDA 070528..................  Furosemide Tablets     Do.
                                USP, 80 mg.
ANDA 071238..................  Doxepin                Do.
                                Hydrochloride (HCl)
                                Capsules USP, EQ 50
                                mg base.
ANDA 071547..................  Ibuprofen Tablets      Do.
                                USP, 800 mg.
ANDA 072397..................  Diazepam Injection     Do.
                                USP, 5 mg/mL.
ANDA 072407..................  Fenoprofen Calcium     Do.
                                Tablets USP, EQ 600
                                mg base.
ANDA 072602..................  Fenoprofen Calcium     Do.
                                Tablets USP, EQ 600
                                mg base.
ANDA 072630..................  Albuterol Tablets      Do.
                                USP, EQ 4 mg base.
ANDA 072825..................  Baclofen Tablets       Do.
                                USP, 20 mg.
ANDA 073013..................  Metaproterenol         Do.
                                Sulfate Tablets
                                USP, 10 mg.
ANDA 073445..................  Meperidine HCl         Do.
                                Injection USP, 100
                                mg/mL.
ANDA 074025..................  Guanabenz Acetate      Do.
                                Tablets USP, EQ 4
                                mg base and EQ 8 mg
                                base.
ANDA 074114..................  Dobutamine Injection   Do.
                                USP, EQ 12.5 mg
                                base/mL.
ANDA 074163..................  Naproxen Tablets       Do.
                                USP, 250 mg, 375
                                mg, and 500 mg.
ANDA 074287..................  Piroxicam Capsules     Do.
                                USP, 10 mg and 20
                                mg.
ANDA 074303..................  Pentamidine            Do.
                                Isethionate for
                                Injection, 300 mg/
                                vial.
ANDA 074437..................  Pindolol Tablets       Do.
                                USP, 5 mg and 10 mg.
ANDA 074456..................  Alprazolam Tablets     Do.
                                USP, 0.25 mg, 0.5
                                mg, and 1 mg.
ANDA 077643..................  Topiramate Tablets     Do.
                                USP, 25 mg, 50 mg,
                                100 mg, and 200 mg.
ANDA 080728..................  Diphenhydramine HCl    Do.
                                Capsules USP, 25 mg.
ANDA 080968..................  Dexamethasone          Do.
                                Tablets USP, 0.75
                                mg.
ANDA 081040..................  Chlorzoxazone          Do.
                                Tablets USP, 500 mg.
ANDA 081149..................  Hydroxyzine HCl        Do.
                                Tablets USP, 10 mg.
ANDA 081189..................  Hydrochlorothiazide    Do.
                                Tablets USP, 25 mg.
ANDA 081216..................  Estropipate Tablets    Do.
                                USP, 6 mg.
ANDA 083232..................  Hydrochlorothiazide    Do.
                                Tablets USP, 50 mg.

ANDA 085720..................  Meprobamate Tablets    Do.
                                USP, 200 mg.
ANDA 085721..................  Meprobamate Tablets    Do.
                                USP, 400 mg.
ANDA 085778..................  Hydroxyzine HCl        Do.
                                Injection USP, 25
                                mg/mL.
ANDA 086096..................  Chlorpheniramine       Do.
                                Maleate Injection
                                USP, 10 mg/mL.
ANDA 086189..................  Ergoloid Mesylates     Do.
                                Sublingual Tablets
                                USP, 0.5 mg.
ANDA 086598..................  Nandrolone Decanoate   Do.
                                Injection USP, 100
                                mg/mL.
ANDA 086795..................  Chlorothiazide         Do.
                                Tablets USP, 250 mg.
ANDA 087183..................  Ergoloid Mesylates     Do.
                                Sublingual Tablets
                                USP, 1 mg.
ANDA 087296..................  Chlorthalidone         Do.
                                Tablets USP, 25 mg.
ANDA 087521..................  Chlorthalidone         Do.
                                Tablets USP, 50 mg.
ANDA 087772..................  Prednisone Tablets     Do.
                                USP, 50 mg.
ANDA 087979..................  Chloroquine            Do.
                                Phosphate Tablets
                                USP, EQ 150 mg base.
ANDA 088030..................  Chloroquine            Do.
                                Phosphate Tablets
                                USP, EQ 300 mg base.
ANDA 089042..................  Procainamide HCl       Do.
                                Extended-Release
                                Tablets USP, 750 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of November
24, 2017. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) may continue to be dispensed until the inventories
have been depleted or the drug products have reached their expiration
dates or otherwise become violative, whichever occurs first.

    Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23046 Filed 10-23-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Rules and Regulations]
[Pages 6793-6795]
[FR Doc No: 2018-03135]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-0370]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Non-Absorbable, Hemostatic Gauze for Temporary
Internal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the non-absorbable, hemostatic gauze for temporary internal use into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the non-absorbable, hemostatic gauze for
temporary internal use's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective February 15, 2018. The classification
was applicable on June 30, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Hudson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G434, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the non-absorbable, hemostatic
gauze for temporary internal use as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On March 16, 2016, Z-Medica, LLC, submitted a request for De Novo
classification of the D2 Dressing. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 30, 2017, FDA issued an order to the requester

classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.4454. We have named
the generic type of device non-absorbable, hemostatic gauze for
temporary internal use, and it is identified as a prescription device
intended to be placed temporarily for control of severely bleeding
wounds such as surgical wounds and traumatic injuries. The gauze is
coated or impregnated with a hemostatic material which may enhance
hemostasis by physical means. The device is intended to be removed once
the patient is stabilized.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
                      Risks and Mitigation Measures
------------------------------------------------------------------------
          Identified risks                   Mitigation measures
------------------------------------------------------------------------
Infection..........................  Shelf life testing, Sterilization
                                      validation, and Labeling.
Bleeding...........................  Animal performance testing, and
                                      Technological specifications.
     Failure of hemostasis.
     Recurrence of bleeding
Vascular obstruction...............  Animal performance testing, and
                                      Labeling.
     Ischemia..............
     Emboli formation......
Adhesion formation.................  Animal performance testing, and
                                      Labeling.
Adverse tissue reaction............  Animal performance testing, and
                                      Biocompatibility evaluation.
Device retained in body leading to   Animal performance testing, Non-
 re-operation.                        clinical performance testing, and
                                      Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k).
    At the time of classification, non-absorbable, hemostatic gauze for
temporary internal use is for prescription use only. Prescription
devices are exempt from the requirement for adequate directions for use
for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C.
502(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met (referring to 21 U.S.C. 352(f)(1)).

III. Analysis of 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.4454 to subpart E to read as follows:

Sec.  878.4454  Non-absorbable, hemostatic gauze for temporary internal
use.

    (a) Identification. A non-absorbable, hemostatic gauze for
temporary internal use is a prescription device intended to be placed
temporarily for control of severely bleeding wounds such as surgical
wounds and traumatic injuries. The gauze is coated or impregnated with
a hemostatic material which may enhance hemostasis by physical means.
The device is intended to be removed once the patient is stabilized.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Animal performance testing must demonstrate that the device
performs as intended under anticipated conditions of use. Specifically
testing must:
    (i) Demonstrate that the device is able to achieve hemostasis;
    (ii) Demonstrate that the device can be radiographically detected;
and
    (iii) Assess pertinent safety endpoints including vascular
obstruction and adhesion formation.
    (2) The device must be demonstrated to be biocompatible.
    (3) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
tests must be performed:
    (i) In vitro clot assessment;
    (ii) Particulate release testing;
    (iii) Physical characterization, including swelling percent and
particulate size;
    (iv) Chemical characterization;
    (v) Radiopacity testing; and
    (vi) Mechanical integrity testing, including tensile strength and
tear strength.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.

    (6) Labeling must include the following:
    (i) Instructions for use, including an instruction to remove all
visible device components by irrigation;
    (ii) The maximum amount of time the device may be left within the
body;
    (iii) A shelf life;
    (iv) A contraindication for intravascular use of the device; and
    (v) A warning regarding the potential for adhesion formation.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03135 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49782-49783]
[FR Doc No: 2014-19939]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0817]

Evaluation of Sex-Specific Data in Medical Device Clinical
Studies; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Evaluation of Sex-Specific Data
in Medical Device Clinical Studies.'' This document provides guidance
on the study and evaluation of sex-specific data in medical device
clinical studies, and it outlines the Center for Devices and
Radiological Health's (CDRH's) and Center for Biologics Evaluation and
Research's (CBER's) expectations regarding sex-specific patient
enrollment, data analysis, and reporting of device study information.
The guidance is intended to improve the quality and consistency of
available data regarding the performance of medical devices in both
sexes by encouraging appropriate enrollment by sex in clinical studies
of devices, and appropriate interpretation and assessment if data from
such studies are analyzed by sex. Evaluation of sex-specific data in
medical device clinical studies can benefit patients, their medical
providers, clinical researchers, and others.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: 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
``Evaluation of Sex-Specific Data in Medical Device Clinical Studies''
to the Office of the Center Director, 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; or the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
    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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1524, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Kathryn O'Callaghan, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
3614, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this guidance is to outline CDRH's and CBER's
expectations regarding sex-specific patient enrollment, data analysis,
and reporting of medical device study information. The intent is to
improve the quality and consistency of available data regarding the
performance of medical devices in both sexes by encouraging appropriate
enrollment by sex in clinical studies of devices, and appropriate
interpretation and assessment when data from such studies are analyzed
by sex. This information can benefit patients, their medical providers,
clinical researchers, and others. The specific objectives of this
guidance are to: (1) Encourage the consideration of sex and associated
covariates (e.g., body size, plaque morphology, etc.) during the study
design stage; (2) provide recommendations for study design and conduct
to encourage appropriate enrollment of each sex (e.g., in proportions
generally representative of the demographics of disease distribution,
if appropriate); (3) outline recommended sex-specific statistical
analyses of study data with a framework for considering sex-specific
data when interpreting overall study outcomes; and (4) specify FDA's
expectations for reporting sex-specific information in summaries and
labeling for approved or cleared medical devices.
    In the Federal Register of December 19, 2011 (76 FR 78670), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by March 19, 2012. Multiple comments
were received with recommendations pertaining to the evaluation of sex-
specific data in clinical studies. In response to these comments, FDA
revised the guidance document to clarify the processes of sex-specific
data evaluation in clinical studies and policies as appropriate. For
more clarity, a decision framework for different clinical study designs
was added to the guidance in response to comments received requesting
additional information on when various sex-specific statistical
recommendations would apply. Additionally, several comments requested
that the recommendations in the guidance apply

to the demographic subgroups of age, race, and ethnicity. However, this
is outside of the scope of the revised guidance but, where applicable,
the guidance was updated with links to other guidances and information
related to these other demographic subgroups.

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
Agency's current thinking on evaluation of sex-specific data in medical
device clinical studies. 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 statute 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 CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons
unable to download an electronic copy of ``Evaluation of Sex-Specific
Data in Medical Device Clinical Studies,'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1727 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently 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 812.25(c) have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts B and
E have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H have been
approved under OMB control number 0910-0332; and the collections of
information in 21 CFR part 822 have been approved under OMB control
number 0910-0449.

V. 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.

    Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19939 Filed 8-21-14; 8:45 am]
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