[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Page 43123]
[FR Doc No: 2019-17859]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-2557-000]

Missisquoi, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced Missisquoi,
LLC's application for market-based rate authority, with an accompanying
rate tariff, noting that such application includes a request for
blanket authorization, under 18 CFR part 34, of future issuances of
securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 3, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-17859 Filed 8-19-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Rules and Regulations]
[Page 42619]
[FR Doc No: 2023-14156]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0552]

Safety Zones in Reentry Sites; Jacksonville, Daytona, and
Canaveral, Florida

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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

SUMMARY: The Coast Guard is activating three safety zones for the
Commercial Resupply Services (CRS-28) mission reentry, vehicle
splashdown, and recovery operations. These operations will occur in the
U.S. Exclusive Economic Zone (EEZ). Our regulation for safety zones in
reentry sites within the Seventh Coast Guard District identifies the
regulated areas for this event. No U.S.-flagged vessel may enter the
safety zones unless authorized by the Captain of the Port Jacksonville
or a designated representative. Foreign-flagged vessels are encouraged
to remain outside the safety zones.

DATES: The regulations in 33 CFR 165.T07-0806 will be enforced for the
safety zones identified in the SUPPLEMENTARY INFORMATION section below
for the dates and times specified.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Griffin Terpstra,
Sector Jacksonville, Waterways Division, U.S. Coast Guard; telephone
904-714-7616, email [email protected].

SUPPLEMENTARY INFORMATION: With this document, the Coast Guard Captain
of the Port (COTP) Jacksonville is activating a portion of the safety
zone as listed in 33 CFR 165.T07-0806(a)(1), and the safety zones
listed in (a)(2) and (a)(3) on June 30, 2023 through July 4, 2023, for
the CRS-28 Commercial Crew mission reentry vehicle splashdown, and the
associated recovery operations in the U.S. EEZ. These safety zones are
located within the COTP Jacksonville Area of Responsibility (AOR)
offshore of Jacksonville, Daytona, and Cape Canaveral, Florida. The
Coast Guard is activating these safety zones in order to protect
vessels and waterway users from the potential hazards created by
reentry vehicle splashdowns and recovery operations. In accordance with
the general regulations in 33 CFR part 165, subpart C, no U.S.-flagged
vessel may enter the safety zones unless authorized by the COTP
Jacksonville or a designated representative except as provided in Sec.
165.T07-0806(d)(3). All foreign-flagged vessels are encouraged to
remain outside the safety zones.
    There are two other safety zones listed in Sec.  165.T07-0806(a)(4)
and (a)(5), which are located within the COTP St. Petersburg AOR, in
addition to a portion of zone listed in (a)(1) that is located in the
COTP Savannah AOR, that are being simultaneously activated through a
separate notifications of enforcement of the regulation document issued
under Docket Numbers USCG-2023-0551, and USCG-2023-0553.\1\
---------------------------------------------------------------------------

    \1\ These notifications of enforcement of the regulation can be
found at: https://regulations.gov by searching for docket number
USCG-2023-0551, and USCG-2023-0553.
---------------------------------------------------------------------------

    Twenty-four hours prior to the CRS-28 recovery operations, the COTP
Jacksonville, the COTP Savannah, the COTP St. Petersburg, or designated
representative will inform the public that whether any of the five
safety zones described in Sec.  165.T07-0806, paragraph (a), will
remain activated (subject to enforcement). If one of the safety zones
described in Sec.  165.T07-0806, paragraph (a), remains activated it
will be enforced for four hours prior to the CRS-28 splashdown and
remain activated until announced by Broadcast Notice to Mariners on
VHF-FM channel 16, and/or Marine Safety Information Bulletin (as
appropriate) that the safety zone is no longer subject to enforcement.
After the CRS-28 reentry vehicle splashdown, the COTP or a designated
representative will grant general permission to come no closer than 3
nautical miles of any reentry vehicle or space support vessel engaged
in the recovery operations, within the activated safety zone described
in Sec.  165.T07-0806, paragraph (a). Once the reentry vehicle, and any
personnel involved in reentry service, are removed from the water and
secured onboard a space support vessel, the COTP or designated
representative will issue a Broadcast Notice to Mariners on VHF-FM
channel 16 announcing the activated safety zone is no longer subject to
enforcement. The recovery operations are expected to last approximately
one hour.
    The Coast Guard may be assisted by other Federal, State, or local
law enforcement agencies in enforcing this regulation.

    Dated: June 29, 2023.
Janet Espino-Young,
Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
[FR Doc. 2023-14156 Filed 6-30-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Notices]
[Pages 81483-81484]
[FR Doc No: 2020-27678]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2020-0028; OMB No. 1660-0029]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Approval and Coordination of Requirements To
Use the NETC for Extracurricular and Training Activities

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: 30-Day notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a
reinstatement, without change, of a previously approved information
collection for which approval has expired. FEMA will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before January 15, 2021.

ADDRESSES: Submit comments at www.regulations.gov under Docket ID FEMA-
2020-0028. Follow the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy and
Security Notice that is available via a link on the homepage of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Merril Sollenberger, Administrative
Specialist, FEMA, U.S. Fire Administration,<PHONE_NUMBER>,
<EMAIL_ADDRESS>You may contact the Information
Management Division for copies of the proposed collection of
information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act), 42 U.S.C. 5121-5207,
authorizes the President to establish a program of disaster
preparedness that utilizes services of all appropriate agencies and
includes training and exercises. Section 611 of the Stafford Act (42
U.S.C. 5196) directs that the Federal Emergency Management Agency
(FEMA) may conduct training for the purpose of emergency preparedness.
In response, FEMA established the National Emergency Training Center
(NETC), located in Emmitsburg, Maryland. The NETC site has facilities
and housing available for those participating in emergency preparedness
training. For planning purposes, a request for use of these areas must
be made in advance.
    This proposed information collection previously published in the
Federal Register on August 28, 2020, at FR 85 53392 with a 60 day
public comment period. No relevant comments were received. This
information collection expired on November 30, 2020. FEMA is requesting
a reinstatement, without change, of a previously approved information
collection for which approval has expired. The purpose of this notice
is to notify the public that FEMA will submit the information
collection abstracted below to the Office of Management and Budget for
review and clearance.

Collection of Information

    Title: Approval and Coordination of Requirements to Use the NETC
for Extracurricular Training Activities.
    Type of Information Collection: Reinstatement, without change, of a
previously approved information collection for which approval has
expired.
    OMB Number: 1660-0029.
    Form Titles and Numbers: FEMA Form 119-17-1 Request for Housing
Accommodations, FEMA Form 119-17-2 Request for Use of NETC Facilities.
    Abstract: In accordance with FEMA Directive 119-3: Facility Use and
Expenses at the National Emergency Training Center, 21 May 2018, FEMA
Form 119-17-1, Request For Housing Accommodations, and FEMA Form 119-
17-2, Request for Use of NETC Facilities are applied for functions at
NETC.
    Affected Public: Individuals or households, Not-for-profit
institutions, Federal Government, State, local or Tribal Governments.
    Estimated Number of Respondents: 120.
    Estimated Number of Responses: 120.
    Estimated Total Annual Burden Hours: 12.
    Estimated Total Annual Respondent Cost: $354.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: There are no
annual start-up or capital costs for Respondents.
    Estimated Total Annual Cost to the Federal Government: $1,148.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology,

e.g., permitting electronic submission of responses.

Maile Arthur,
Acting Records Management Branch Chief, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2020-27678 Filed 12-15-20; 8:45 am]
BILLING CODE 9111-45-P


[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Page 31675]
[FR Doc No: 2016-11910]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty-Seventh Meeting: RTCA Special Committee 216 (SC-216)
Aeronautical Systems Security

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of Twenty-Seventh RTCA Special Committee 216 Meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
Twenty-Seventh RTCA Special Committee 216 meeting.

DATES: The meeting will be held June 15-17, 2016 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Karan Hofmann, Program Director, RTCA, Inc<EMAIL_ADDRESS>(202)
330-0680.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 216. The agenda
will include the following:

Wednesday, June 15, 2016 (1:00 p.m.-5:00 p.m.)

1. Welcome and Administrative Remarks
2. Introductions
3. Agenda Review
4. Meeting--Minutes Review
5. ARAC ASISP Update
6. WG-72 Update
7. Working Paper Review
8. Schedule Update
9. Date, Place and Time of Next Meeting
10. New Business
11. Adjourn Plenary

Thursday, June 16, 2016 (9:00 a.m.-5:00 p.m.)

1. Continuation of Plenary or Working Group Sessions

Friday, June 17, 2016 (9:00 a.m.-3:00 p.m.)

1. Continuation of Plenary or Working Group Sessions

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on May 16, 2016.
Latasha Robinson,
Management & Program Analyst, NextGen, Enterprise Support Services
Division, Federal Aviation Administration.
[FR Doc. 2016-11910 Filed 5-18-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Proposed Rules]
[Page 51911]
[FR Doc No: 2018-22400]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0414; FRL-9984-69]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances;
Reopening of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of comment period.

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

SUMMARY: EPA issued a proposed rule in the Federal Register of August
17, 2018 for significant new use rules (SNURs) for 27 chemical
substances. EPA is reopening the comment period because it received a
request to extend the comment period but the request was received too
late to publish an extension of the comment period before the comment
period expired.

DATES: This document reopens the comment period for the proposed rule
until October 30, 2018. Comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0414 must be received on or before October
30, 2018.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register document of August 17, 2018 (83 FR 41039) (FRL-
9981-82).

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: This document reopens the public comment
period established in the Federal Register document of August 17, 2018
(83 FR 41039) (FRL-9981-82). That document proposed SNURs for 27
chemical substances. EPA received a request to extend the comment
period for 15 days but the request was received too late to publish an
extension of the comment period before the comment period expired. EPA
is hereby reopening the comment period for 15 days.
    Note that in the August 17, 2018 issue of the Federal Register
including the proposed SNURs for 27 chemical substances, the Agency
also issued direct final SNURs for these chemical substances (83 FR
40986) (FRL-9971-37). As of the date of signature of this action to
reopen the comment period on the proposed rule, that direct final rule
was in the process of being withdrawn because of the receipt of
negative comments. EPA will address all adverse public comments in a
subsequent final rule based on the proposed rule.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
document of August 17, 2018 (83 FR 41039) (FRL-9981-82). If you have
questions, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: October 5, 2018.
Tala R. Henry,
Acting Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2018-22400 Filed 10-12-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26488-26489]
[FR Doc No: 2017-11819]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2732]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Oncologic Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to the Agency on FDA's regulatory issues.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this meeting.

DATES: The public meeting will be held on July 13, 2017, from 8 a.m. to
5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions, including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-2732. The docket will close on July 10,
2017. Submit either electronic or written comments on this public
meeting by July 10, 2017. Late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before July 10,
2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of July 10,
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
    Comments received on or before June 26, 2017, will be provided to
the committee. Comments received after that date will be taken into
consideration by the Agency.
    You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-2732 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>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 https://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.

SUPPLEMENTARY INFORMATION:
    Agenda: During the morning session, the committee will discuss
biologics license application (BLA) 761028 for ABP 215, a proposed
biosimilar to Genentech/Roche's AVASTIN (bevacizumab), submitted by
Amgen Inc. The proposed indications/uses for this product are: (1) For
the first- or second-line treatment of patients with metastatic
carcinoma of the colon or rectum in combination with intravenous 5-
fluorouracil-based chemotherapy; (2) in combination with
fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based
chemotherapy, for the second-line treatment of patients with metastatic
colorectal cancer who have progressed on a first-line ABP 215-
containing regimen; (3) for the first-line treatment of unresectable,
locally advanced, recurrent or metastatic non-squamous, non-small cell
lung cancer in combination with carboplatin and paclitaxel; (4) for the
treatment of glioblastoma with progressive disease in adult patients
following prior therapy as a single agent; (5) for the treatment of
metastatic renal cell carcinoma in combination with interferon alfa;
and (6) in combination with paclitaxel and cisplatin or paclitaxel and
topotecan for the treatment of persistent, recurrent, or metastatic
carcinoma of the cervix.
    During the afternoon session, the committee will discuss BLA 761074
for MYL-1401O, a proposed biosimilar to Genentech Inc.'s HERCEPTIN
(trastuzumab), submitted by Mylan GmbH. The proposed indications/uses
for this product are: (1) For adjuvant treatment of HER2 overexpressing
node positive or node negative (ER/PR negative or with one high risk
feature) breast cancer; (a) as part of a treatment regimen consisting
of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel;
(b) with docetaxel and carboplatin; or (c) as a single agent following
multimodality anthracycline based therapy; (2) in combination with
paclitaxel for first-line treatment of HER2-overexpressing metastatic
breast cancer; (3) as a single agent for treatment of HER2-
overexpressing breast cancer in patients who have received one or more
chemotherapy regimens for metastatic disease; and (4) in combination
with cisplatin and capecitabine or 5-fluorouracil, for the treatment of
patients with HER2 overexpressing metastatic gastric or
gastroesophageal junction adenocarcinoma who have not received prior
treatment for metastatic disease.\1\
---------------------------------------------------------------------------

    \1\ This indication is protected by orphan drug exclusivity
expiring on October 20, 2017. See the Orphan Drug Designations and
Approvals database at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm.
---------------------------------------------------------------------------

    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the docket (see the
ADDRESSES section) on or before June 26, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:45 a.m. to 11:15 a.m., and 3:45 p.m. to 4:15 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 June
16, 2017. 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 June 19, 2017.
    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
disabilities. If you require special accommodations due to a
disability, please contact Jay R. Fajiculay 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 https://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: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11819 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 23, 2007 (Volume 72, Number 36)]
[Notices]
[Page 8227-8231]
[DOCID:fr23fe07-104]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55300; File No. SR-NASDAQ-2007-002]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change, as Modified by Amendment No. 1 Thereto, To Trade the
Shares of Certain Exchange-Traded Funds Based on Fixed Income
Portfolios Pursuant to Unlisted Trading Privileges

February 15, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 29, 2007, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
On February 13, 2007, Nasdaq filed Amendment No. 1 to the proposed rule
change. This Order provides notice of the proposed rule change, as
modified by Amendment No. 1, and approves the proposed rule change, as
amended, on an accelerated basis.
---------------------------------------------------------------------------

    \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

    Nasdaq is proposing to trade shares (the ``Shares'') of: (1) The
iShares Lehman TIPS Bond Fund; (2) the iShares Lehman Aggregate Bond
Fund; (3) the iShares iBoxx $ Investment Grade Corporate Bond Fund; (4)
the iShares Lehman 20+ Year Treasury Bond Fund; (5) the iShares 7-10
Year Treasury Bond Fund; (6) the iShares Lehman 1-3 Year Treasury Bond
Fund; (7) the iShares Lehman Short Treasury Bond Fund; (8) the iShares
Lehman 3-7 Year Treasury Bond Fund; (9) the iShares Lehman 10-20 Year
Treasury Bond Fund; (10) the iShares Lehman 1-3 Year Credit Bond Fund;
(11) the iShares Lehman Intermediate Credit Bond Fund; (12) the iShares
Lehman Credit Bond Fund; (13) the iShares Lehman Intermediate
Government/Credit Bond Fund; and (14) the iShares Lehman Government/
Credit Bond Fund (collectively, the ``Funds'') pursuant to unlisted
trading privileges (``UTP''). The text of the proposed rule change is
available at Nasdaq, the Commission's Public Reference Room, and
nasdaq.complinet.com.

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

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

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

1. Purpose
    Nasdaq is proposing to trade pursuant to UTP the Shares of the
Funds, which are exchange-traded funds (``ETFs'') that invest in fixed
income securities. Nasdaq represents that its current generic listing
standards for ETFs do not extend to ETFs that invest in fixed income
securities. The systems operated by Nasdaq and its affiliates currently
trade Shares of the Funds on an over-the-counter basis as facilities of
NASD.

    The iShares Lehman TIPS Bond Fund seeks investment results that
correspond generally to the price and yield performance, before fees
and expenses, of the inflation-protected sector of the U.S. Treasury
market, as defined by the Lehman Brothers U.S. TIPS Index.\3\ The
Lehman Brothers U.S. TIPS Index measures the performance of inflation-
protected public obligations of the U.S. Treasury, commonly known as
``TIPS.'' The Commission previously approved the original listing and
trading of shares of this Fund on the New York Stock Exchange, Inc.
(``NYSE'').\4\
---------------------------------------------------------------------------

    \3\ E-mail from John Yetter, Deputy General Counsel, Nasdaq, to
Edward Cho, Special Counsel, Division of Market Regulation,
Commission, on February 8, 2007 (correcting the name of the Lehman
Brothers U.S. TIPS Index).
    \4\ See Securities Exchange Act Release No. 48881 (December 4,
2003), 68 FR 69739 (December 15, 2003) (SR-NYSE-2003-39).
---------------------------------------------------------------------------

    The iShares Lehman Aggregate Bond Fund seeks investment results
that correspond generally to the price and yield performance, before
fees and expenses, of the total U.S. investment-grade bond market, as
defined by the Lehman Brothers U.S. Aggregate Index. The Lehman
Brothers U.S. Aggregate Index measures the performance of the total
U.S. investment-grade bond market, which includes investment-grade U.S.
Treasury bonds, government-related bonds, investment-grade corporate
bonds, mortgage pass-through securities, commercial mortgage-backed
securities, and asset-backed securities that are publicly offered for
sale in the United States. The Commission previously approved the
original listing and trading of shares of this Fund on the American
Stock Exchange LLC (``Amex'').\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 48534 (September 24,
2003), 68 FR 56353 (September 30, 2003) (SR-Amex-2003-75).
---------------------------------------------------------------------------

    The iShares iBoxx $ Investment Grade Corporate Bond Fund (formerly
the iShares GS $ InvesTop Corporate Bond Fund) seeks investment results
that correspond generally to the price and yield performance, before
fees and expenses, of a segment of the U.S. investment-grade corporate
bond market, as defined by the iBoxx $ Liquid Investment Grade Index
(formerly the GS $ InvesTop Index). The iBoxx $ Liquid Investment Grade
Index measures the performance of a fixed number of highly liquid,
investment-grade corporate bonds. The Commission previously approved
the original listing and trading of shares of this Fund on Amex.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 46252 (July 24,
2002), 67 FR 49715 (July 31, 2002) (SR-Amex-2001-35).
---------------------------------------------------------------------------

    The iShares Lehman 20+ Year Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the long-term sector of the U.S. Treasury
market, as defined by the Lehman Brothers 20+ Year U.S. Treasury Index.
The Lehman Brothers 20+ Year Treasury Index measures the performance of
public obligations of the U.S. Treasury that have a remaining maturity
of 20 or more years. The Commission previously approved the original
listing and trading of shares of this Fund on Amex.\7\
---------------------------------------------------------------------------

    \7\ See id.
---------------------------------------------------------------------------

    The iShares Lehman 7-10 Year Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the intermediate-term sector of the U.S.
Treasury market, as defined by the Lehman Brothers 7-10 Year U.S.
Treasury Index. The Lehman Brothers 7-10 Year Treasury Index measures
the performance of public obligations of the U.S. Treasury that have a
remaining maturity of greater than or equal to seven years and less
than ten years. The Commission previously approved the original listing
and trading of shares of this Fund on Amex.\8\
---------------------------------------------------------------------------

    \8\ See id.
---------------------------------------------------------------------------

    The iShares Lehman 1-3 Year Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the short-term sector of the U.S. Treasury
market, as defined by the Lehman Brothers 1-3 Year U.S. Treasury Index.
The Lehman Brothers 1-3 Year U.S. Treasury Index measures the
performance of public obligations of the U.S. Treasury that have a
remaining maturity of greater than or equal to one year and less than
three years. The Commission previously approved the original listing
and trading of shares of this Fund on Amex.\9\
---------------------------------------------------------------------------

    \9\ See id.
---------------------------------------------------------------------------

    The iShares Lehman Short Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the short-term sector of the U.S. Treasury
market, as defined by the Lehman Brothers Short U.S. Treasury Index.
The Lehman Brothers Short U.S. Treasury Index measures the performance
of public obligations of the U.S. Treasury that have a remaining
maturity of between one and 12 months. The Commission previously
approved the original listing and trading of shares of this Fund on
NYSE.\10\
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release No. 54916 (December 11,
2006), 71 FR 76008 (December 19, 2006) (SR-NYSE-2006-70).
---------------------------------------------------------------------------

    The iShares Lehman 3-7 Year Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the intermediate-term sector of the U.S.
Treasury market, as defined by the Lehman Brothers 3-7 Year U.S.
Treasury Index. The Lehman Brothers 3-7 Year U.S. Treasury Index
measures the performance of public obligations of the U.S. Treasury
that have a remaining maturity of greater than or equal to three years
and less than seven years. The Commission previously approved the
original listing and trading of shares of this Fund on NYSE.\11\
---------------------------------------------------------------------------

    \11\ See id.
---------------------------------------------------------------------------

    The iShares Lehman 10-20 Year Treasury Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the long-term sector of the U.S. Treasury
market, as defined by the Lehman Brothers 10-20 Year U.S. Treasury
Index. The Lehman Brothers 10-20 Year U.S. Treasury Index measures the
performance of public obligations of the U.S. Treasury that have a
remaining maturity of greater than or equal to ten years and less than
20 years. The Commission previously approved the original listing and
trading of shares of this Fund on NYSE.\12\
---------------------------------------------------------------------------

    \12\ See id.
---------------------------------------------------------------------------

    The iShares Lehman 1-3 Year Credit Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the investment-grade credit sector of the
U.S. bond market, as defined by the Lehman Brothers 1-3 Year U.S.
Credit Index. The Lehman Brothers 1-3 Year U.S. Credit Index measures
the performance of investment-grade corporate debt and sovereign,
supranational, local authority, and non-U.S. agency bonds that have a
remaining maturity of greater than or equal to one year and less than
three years. The Commission previously approved the original listing
and trading of shares of this Fund on NYSE.\13\
---------------------------------------------------------------------------

    \13\ See id.
---------------------------------------------------------------------------

    The iShares Lehman Intermediate Credit Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the investment-grade credit sector of the
U.S. bond market, as defined by the Lehman Brothers Intermediate U.S.
Credit Index. The

Lehman Brothers Intermediate U.S. Credit Index measures the performance
of investment-grade corporate debt and sovereign, supranational, local
authority, and non-U.S. agency bonds that have a remaining maturity of
greater than or equal to one year and less than ten years. The
Commission previously approved the original listing and trading of
shares of this Fund on NYSE.\14\
---------------------------------------------------------------------------

    \14\ See id.
---------------------------------------------------------------------------

    The iShares Lehman Credit Bond Fund seeks investment results that
correspond generally to the price and yield performance, before fees
and expenses, of the investment-grade credit sector of the U.S. bond
market, as defined by the Lehman Brothers U.S. Credit Index. The Lehman
Brothers U.S. Credit Index measures the performance of investment-grade
corporate debt and sovereign, supranational, local authority, and non-
U.S. agency bonds that have a remaining maturity of greater than or
equal to one year. The Commission previously approved the original
listing and trading of shares of this Fund on NYSE.\15\
---------------------------------------------------------------------------

    \15\ See id.
---------------------------------------------------------------------------

    The iShares Lehman Intermediate Government/Credit Bond Fund seeks
investment results that correspond generally to the price and yield
performance, before fees and expenses, of the investment-grade credit
sector of the U.S. bond market and the total U.S. Treasury market, as
defined by the Lehman Brothers Intermediate U.S. Government/Credit
Index. The Lehman Brothers Intermediate U.S. Government/Credit Index
measures the performance of U.S. dollar-denominated U.S. Treasury
securities and government-related and investment-grade U.S. corporate
securities that have a remaining maturity of greater than or equal to
one year and less than ten years. The Commission previously approved
the original listing and trading of shares of this Fund on NYSE.\16\
---------------------------------------------------------------------------

    \16\ See id.
---------------------------------------------------------------------------

    The iShares Lehman Government/Credit Bond Fund seeks investment
results that correspond generally to the price and yield performance,
before fees and expenses, of the U.S. government and investment-grade
U.S. corporate securities of the U.S. bond market, as defined by the
Lehman Brothers U.S. Government/Credit Index. The Lehman Brothers U.S.
Government/Credit Index measures the performance of U.S. dollar-
denominated U.S. Treasury securities and government-related and
investment-grade U.S. corporate securities that have a remaining
maturity of greater than or equal to one year. The Commission
previously approved the original listing and trading of shares of this
Fund on NYSE.\17\
---------------------------------------------------------------------------

    \17\ See id.
---------------------------------------------------------------------------

    The foregoing underlying indexes on which the Funds are based are
referred to herein collectively as the ``Indexes.'' The exact
composition and methodologies of each Index are described in detail in
the filings pursuant to which NYSE and Amex sought to originally list
and trade the Shares of the Funds.\18\
---------------------------------------------------------------------------

    \18\ See supra notes 4, 5, 6, and 10.
---------------------------------------------------------------------------

    Quotations for and last sale information regarding the Fund Shares
are disseminated through the Consolidated Tape System (``CTS''). On
each business day, the list of names and amount of each security
constituting the current Deposit Securities \19\ and the Balancing
Amount \20\ effective as of the previous business day will be made
available through the National Securities Clearing Corporation
(``NSCC''). An amount per Share representing the sum of the estimated
Balancing Amount effective through and including the previous business
day, plus the current value of the Deposit Securities in U.S. dollars,
on a per-Share basis (the Intraday Optimized Portfolio Value or
``IOPV''), will be calculated by an independent third party, such as
Bloomberg L.P., every 15 seconds during Nasdaq's regular trading hours
and disseminated every 15 seconds through the CTS. Because NSCC does
not disseminate information about the Portfolio Deposit immediately
following the end of regular market hours, an updated IOPV cannot be
calculated during Nasdaq's post-market trading session, 4:15 p.m. to 8
p.m. Eastern Time (``ET'').
---------------------------------------------------------------------------

    \19\ Deposit Securities are the designated portfolio of
securities that correspond generally to the price and yield
performance of the relevant Fund's Index to be deposited in-kind for
the purchase of blocks of 50,000 Shares, each such block referred to
as a ``Creation Unit Aggregation.''
    \20\ The Balancing Amount is an amount equal to the difference
between the net asset value (``NAV'') of the Fund and the total
aggregate market value, per Creation Unit Aggregation, of the
Deposit Securities. The deposit of the requisite Deposit Securities
and the Balancing Amount are collectively referred to as the
``Portfolio Deposit,'' which represents the minimum initial and
subsequent investment amount for a Creation Unit Aggregation.
---------------------------------------------------------------------------

    Nasdaq states that NYSE and Amex, as applicable, disseminate on a
daily basis a variety of data with respect to each Fund by means of the
Consolidated Tape Association/Consolidated Quotation High Speed Lines,
including information with respect to recent NAV for each Fund, shares
outstanding, and the estimated cash amount and total cash amount per
Creation Unit Aggregation. In addition, the iShares Web site (http://www.ishares.com/fund_info
), which is publicly accessible at no charge,

contains the following information, on a per-Share basis, for each
Fund: (1) The prior business day's NAV; (2) the mid-point of the bid-
ask price and a calculation of the premium or discount of such price
against such NAV; and (3) data in chart format displaying the frequency
distribution of discounts and premiums of the bid-ask price against the
NAV, within appropriate ranges, for each of the four previous calendar
quarters.
    The value of each Index is calculated once each trading day and is
available from major market data vendors. The NAV for each Fund is
calculated and disseminated daily through a number of sources,
including the Web sites of the original listing exchanges, as
applicable, the iShares Web site, and CTS.
    Nasdaq states that it will halt trading in the Shares of a Fund
under the conditions specified in Nasdaq Rules 4120 and 4121. The
conditions for a trading halt include a regulatory halt by the original
listing market. UTP trading in the Shares will also be governed by
provisions of Nasdaq Rule 4120 relating to temporary interruptions in
the calculation or wide dissemination of the IOPV or the value of the
Index.\21\ Additionally, the Exchange states that it may cease trading
the Shares if other unusual conditions or circumstances exist, which,
in the opinion of the Exchange, make further dealings on the Exchange
detrimental to the maintenance of a fair and orderly market. The
Exchange represents that it would follow any procedures with respect to
trading halts as set forth in Nasdaq Rule 4120(b).
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release No. 55269 (February 9,
2007), 72 FR 7490 (February 15, 2007) (SR-NASDAQ-2006-050).
---------------------------------------------------------------------------

    Nasdaq deems the Shares of the Funds to be equity securities, and
therefore, trading in the Shares will be subject to Nasdaq's existing
rules governing the trading of equity securities. The primary trading
hours for the Shares on Nasdaq will be 9:30 a.m. to 4:15 p.m. ET. The
Shares will also be traded on Nasdaq in a post-market session from 4:15
p.m. to 8 p.m. ET.\22\ Nasdaq represents that it has in place
appropriate rules to facilitate

transactions in the Shares during all trading sessions.
---------------------------------------------------------------------------

    \22\ Nasdaq relies on the listing market to monitor
dissemination of the IOPV during Nasdaq's regular market hours (9:30
a.m. to 4:15 p.m. ET). Currently, updated Index values are not
calculated during Nasdaq's post-market session; however, if in the
future such values are calculated, Nasdaq would not trade the Fund
Shares unless such official Index values were widely disseminated.
---------------------------------------------------------------------------

    In connection with the trading of the Shares, Nasdaq will inform
its members in an Information Circular of the special characteristics
and risks associated with trading the Shares, as well as the
requirements of Nasdaq Rule 2310, which requires Nasdaq members to
determine that a particular security is suitable for a customer before
recommending a transaction in it. Nasdaq also would require its members
to deliver a prospectus or product description to investors purchasing
the Shares prior to or concurrently with a transaction in the Shares.
    Nasdaq believes that its surveillance procedures are adequate to
address any concerns about the trading of the Shares on Nasdaq. Trading
of the Shares through NASD facilities operated by Nasdaq is currently
subject to NASD's surveillance procedures for equity securities in
general and ETFs in particular. After Nasdaq begins to operate as an
exchange with respect to securities not listed on Nasdaq, NASD, on
behalf of Nasdaq, will continue to surveil Nasdaq trading, including
Nasdaq trading of the Shares. Nasdaq's transition to exchange status
will not result in any change in the surveillance process with respect
to the Shares.\23\
---------------------------------------------------------------------------

    \23\ Surveillance of all trading on NASD facilities operated by
Nasdaq is currently conducted by NASD. Following Nasdaq's transition
to exchange status, NASD will continue to surveil trading, pursuant
to a regulatory services agreement. Nasdaq is responsible for NASD's
performance under this regulatory services agreement.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposal is consistent with Section 6(b) of the Act \24\ in
general and Section 6(b)(5) of the Act \25\ in particular in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to, and perfect the mechanism of a free and open market, and, in
general, to protect investors and the public interest. In addition, the
proposal is consistent with Rule 12f-5 under the Act \26\ because
Nasdaq deems the Shares to be equity securities, thus rendering trading
in the Shares subject to the Exchange's existing rules governing the
trading of equity securities.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78f(b).
    \25\ 15 U.S.C. 78f(b)(5).
    \26\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purpose 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 neither solicited nor received written comments on
the proposed rule change.

III. 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-NASDAQ-2007-002 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2007-002. 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. Copies of such
filing also will be available for inspection and copying at the
principal offices of Nasdaq. 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-NASDAQ-2007-002 and should be submitted on or before
March 16, 2007.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\27\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\28\
which requires that an exchange have rules designed, among other
things, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and in general to protect investors and the
public interest. The Commission believes that this proposal should
benefit investors by increasing competition among markets that trade
the Shares.
---------------------------------------------------------------------------

    \27\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with Section 12(f) of the Act,\29\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\30\ The Commission notes that it previously approved the
listing and trading of the Shares on NYSE and Amex, as applicable.\31\
The Commission also finds that the proposal is consistent with Rule
12f-5 under the Act,\32\ which provides that an exchange shall not
extend UTP to a security unless the exchange has in effect a rule or
rules providing for transactions in the class or type of security to
which the exchange extends UTP. The Exchange has represented that it
meets this requirement because it deems the Shares to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules

governing the trading of equity securities.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78l(f).
    \30\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \31\ See supra notes 4, 5, 6, and 10.
    \32\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\33\ which sets forth
Congress's finding that it is in the public interest and appropriate
for the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. Quotations for and last sale information regarding the Fund
Shares are disseminated through CTS. Furthermore, an IOPV for each
Fund, updated to reflect changes in the amount of the Portfolio
Deposit, on a per-Share basis, is calculated and published by a third-
party service provider through CTS on a 15-second delayed basis during
Nasdaq's regular trading hours. Major market data vendors calculate and
disseminate once each trading day the value of each Index and the NAV
for each Fund. Amex and NYSE, as applicable, disseminate information
with respect to NAV and cash amounts per Creation Unit Aggregation, and
the iShares Web site supplies additional trading data for the Shares,
both current and historical. If the listing market halts trading in the
Shares, or the IOPV or any Index value is not being calculated or
disseminated, the Exchange would halt trading in the Shares.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission notes that, if the Shares should be delisted by the
listing exchange, the Exchange would no longer have authority to trade
the Shares pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange's surveillance procedures are adequate to address
any concerns associated with the trading of the Shares on a UTP basis.
    (2) The Exchange would inform its members in an Information
Circular of the special characteristics and risks associated with
trading the Shares, including suitability recommendation requirements.
    (3) The Exchange would require its members to deliver a prospectus
or product description to investors purchasing Shares prior to or
concurrently with a transaction in such Shares and will note this
prospectus delivery requirement in the Information Circular.
    This approval order is conditioned on the Exchange's adherence to
these representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted above, the Commission previously found that
the listing and trading of the Shares on NYSE and Amex, as applicable,
is consistent with the Act. The Commission presently is not aware of
any regulatory issue that should cause it to revisit that finding or
would preclude the trading of the Shares on the Exchange pursuant to
UTP. Furthermore, accelerated approval of this proposal will facilitate
Nasdaq's ability to continue trading certain non-Nasdaq-listed ETFs as
Nasdaq becomes an exchange with respect to non-Nasdaq-listed
securities, where there appears to be no regulatory concerns about such
trading. Therefore, accelerating approval of this proposal should
benefit investors by creating, without undue delay, additional
competition in the market for such Shares.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\34\ that the proposed rule change (SR-NASDAQ-2007-002), as
modified by Amendment No. 1, be, and it hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\35\
---------------------------------------------------------------------------

    \35\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-3076 Filed 2-22-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14220-14222]
[FR Doc No: 2015-06177]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0022]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
11 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective April 16, 2015. Comments must be
received on or before April 17, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2013-
0022], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of

the West Building, 1200 New Jersey Avenue SE., Washington, DC, between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
Federal Docket Management System (FDMS) is available 24 hours each day,
365 days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

II. Exemption Decision

    This notice addresses 11 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 11 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Terry R. Hunt (FL)
Sebastian G. Jachymiak (IL)
Geron Lopez-Padilla (CT)
James P. O'Berry (GA)
Mark A. Omps (WV)
Larry B. Peterson (AR)
Franklin P. Reigle III (MD)
Phillip Schaub (CO)
George Stapleton (GA)
James K. Waites (AR)
Scott Wallbank (MA)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 11 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (78 FR 12815; 78 FR 22602). Each of these 11 applicants
has requested renewal of the exemption and has submitted evidence
showing that the vision in the better eye continues to meet the
requirement specified at 49 CFR 391.41(b)(10) and that the vision
impairment is stable. In addition, a review of each record of safety
while driving with the respective vision deficiencies over the past two
years indicates each applicant continues to meet the vision exemption
requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

IV. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2013-0022), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so the Agency can contact you if it has questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number, ``FMCSA-2013-0022'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may change this notice based on your
comments.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov and in the search box insert the docket number,
``FMCSA-2013-0022'' in the ``Keyword'' box and click ``Search.'' Next,
click ``Open Docket Folder'' button choose the document listed to
review. If you do not have access to the Internet, you may view the
docket online by visiting the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

    Issued on: March 11, 2015.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-06177 Filed 3-17-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Notices]
[Page 58842-58843]
[DOCID:fr17oc07-53]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0860; FRL-8483-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Plant-Incorporated Protectants;
CBI Substantiation and Adverse Effects Reporting; EPA ICR No. 1693.05,
OMB Control No. 2070-0142

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before November 16,
2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2006-0860, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: OPP Regulatory

Public Docket (7502P), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External
Affairs Division, Office of Pesticide Programs, 7506P, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 14, 2007 (72 FR 11862), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2006-0860, which is available for online viewing at
http://www.regulations.gov, or in-person viewing at the OPP Regulatory Public

Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. This docket facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
docket telephone number is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to http://www.regulations.gov.

    Title: Plant-Incorporated Protectants; CBI Substantiation and
Adverse Effects Reporting
    ICR Numbers: EPA ICR No. 1693.05, OMB Control No. 2070-0142
    ICR Status: This ICR is scheduled to expire on October 31, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a

currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR addresses the two information collection
requirements described in regulations pertaining to pesticidal
substances that are produced by plants (plant-incorporated protectants)
and which are codified in 40 CFR part 174. A plant-incorporated
protectant is defined as ``the pesticidal substance that is intended to
be produced and used in a living plant and the genetic material
necessary for the production of such a substance.'' Many, but not all,
plant-incorporated protectants are exempt from registration
requirements under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Registrants sometimes include in a submission to EPA for
registration of a plant-incorporated protectant, information that they
claim to be confidential business information (CBI). CBI is protected
by FIFRA and generally cannot be released to the public. Under 40 CFR
part 174, whenever a registrant claims that information submitted to
EPA in support of a registration application for plant-incorporated
protectants contains CBI, the registrant must substantiate such claims
when they are made, rather than provide it later upon request by EPA.
In addition, manufacturers of plant-incorporated protectants that are
otherwise exempted from the requirements of registration must report
adverse effects of the plant-incorporated protectant to the Agency.
Such reporting will allow the Agency to determine whether further
action is needed to prevent unreasonable adverse effects to the
environment. Submission of this information is mandatory.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 7
hours for an adverse effects report and 21.5 hours for substantiation
of a CBI claim, per response. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Producers and importers of plant-
incorporated protectants.
    Estimated Number of Respondents: 14.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 303.
    Estimated Total Annual Cost: $20,879, includes no annualized
capital or O&M costs.
    Changes in the Estimates: There is no change in the number of hours
in the total estimated burden currently identified in the OMB Inventory
of Approved ICR Burdens.

    Dated: October 10, 2007.
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
[FR Doc. E7-20441 Filed 10-16-07; 8:45 am]

BILLING CODE 6560-50-P