[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34906]
[DOCID:fr16jn06-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-4902-000]

Hoolihan, James J.; Notice of Filing

June 8, 2006.
    Take notice that on May 11, 2006, James J. Hoolihan filed an
application for authorization to hold interlocking positions pursuant
to section 305(b) of the Federal Power Act, part 45 of the Commission's
Rules of Practice and Procedure and Order No. 664.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 22, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9378 Filed 6-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Pages 73998-73999]
[FR Doc No: 2012-29946]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9525-1]

Agency Information Collection Activities OMB Responses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document announces the Office of Management and Budget
(OMB) responses to Agency Clearance requests, in compliance with the
Paperwork Reduction Act (44 U.S.C. 3501 et. seq.). 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 regulations are listed
in 40 CFR part 9 and 48 CFR chapter 15.

FOR FURTHER INFORMATION CONTACT: Rick Westlund<PHONE_NUMBER>, or email
at<EMAIL_ADDRESS>and please refer to the appropriate EPA
Information Collection Request (ICR) Number.

SUPPLEMENTARY INFORMATION:

OMB Responses to Agency Clearance Requests

OMB Approvals

    EPA ICR Number 1613.04; Data Reporting Requirements for State and
Local Vehicle Emission Inspection and Maintenance (I/M) Programs
(Renewal); 40 CFR part 51 subpart S; was approved on 11/02/2012; OMB
Number 2060-0252; expires on 11/30/2015; Approved without change.
    EPA ICR Number 1292.09; Enforcement Policy Regarding the Sale and
Use of Aftermarket Catalytic Converters (Renewal); was approved on 11/
05/2012; OMB Number 2060-0135; expires on 11/30/2015; Approved without
change.
    EPA ICR Number 0575.13; Health and Safety Data Reporting;
Submission of Lists and Copies of Health and Safety Studies; 40 CFR
part 716; was approved on 11/21/2012; OMB Number 2070-0004; expires on
11/30/2015; Approved with change.

Short Term Extension of Expiration Date

    EPA ICR Number 2288.05; Pesticides Data Call In Program; a short
term extension of the expiration date was granted by OMB on 11/21/2012;
OMB

Number 2070-0174; expires on 12/31/2012.

John Moses,
Director, Collections Strategies Division.
[FR Doc. 2012-29946 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36359-36360]
[FR Doc No: 2022-12978]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0385; FMCSA-2014-0387; FMCSA-2018-0139; FMCSA-
2019-0109]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 12
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2014-0385, FMCSA-2014-0387, FMCSA-2018-0139, or FMCSA-
2019-0109 in the keyword box, and click ``Search.'' Next, sort the
results by ``Posted (Newer-Older),'' choose the first notice listed,
and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal holidays. To be sure someone
is there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER>
before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. 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.

II. Background

    On October 1, 2021, FMCSA published a notice announcing its
decision to renew exemptions for 12 individuals from the hearing
standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate
commerce and requested comments from the public (86 FR 54503). The
public comment period ended on November 1, 2021, and no comments were
received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric

device is calibrated to American National Standard (formerly ASA
Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the 12 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
hearing requirement in Sec.  391.41(b)(11).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of October
and are discussed below:
    As of October 1, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following seven individuals have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in the FMCSRs for interstate CMV drivers (86 FR 54503):

Azulita-Jane Camacho (AZ)
Wayne Crowl (IN)
Robert Culp (FL)
Charles Davis (AL)
Christopher Fisher (WA)
Jerrell McCrary (NC)
John Price (TX)

    The drivers were included in docket number FMCSA-2014-0385 or
FMCSA-2018-0139. Their exemptions were applicable as of October 1, 2021
and will expire on October 1, 2023.
    As of October 10, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following three individuals have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in the FMCSRs for interstate CMV drivers (86 FR 54503):

Kurt Bernabei (IL); Steven Gandee (PA); Steven Robelia (WI)

    The drivers were included in docket number FMCSA-2019-0109. Their
exemptions were applicable as of October 10, 2021 and will expire on
October 10, 2023.
    As of October 22, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (86 FR 54503):

Richard Carter (MD) and Clinton Homon (IL)

    The drivers were included in docket number FMCSA-2014-0387. Their
exemptions were applicable as of October 22, 2021 and will expire on
October 22, 2023.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (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
prior to being 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(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-12978 Filed 6-15-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Notices]
[Pages 58920-58921]
[FR Doc No: 2021-23226]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0016]

Meetings To Implement Pandemic Response Voluntary Agreement Under
Section 708 of the Defense Production Act

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Announcement of meetings.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is holding a
series of meetings to implement the Voluntary Agreement for the
Manufacture and Distribution of Critical Healthcare Resources Necessary
to Respond to a Pandemic.

DATES: The first meeting took place on Tuesday, October 12, 2021, from
10:00 a.m. to 12 p.m. Eastern Time (ET). The second meeting took place
on Thursday, October 14, 2021, from 10:30 a.m. to 11 a.m. ET. The third
meeting took place on Thursday, October 21, 2021, from 10:30 a.m. to 11
a.m. ET. The fourth meeting will take place on Thursday, October 28,
2021, from 10:30 a.m. to 11 a.m. ET. The fifth meeting will take place
on Thursday, November 4, 2021, from 10:30 a.m. to 11 a.m. ET.

FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business,
Industry, Infrastructure Integration, via email at [email protected] or
via phone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of these meetings is provided as
required by section 708(h)(8) of the Defense Production Act (DPA), 50
U.S.C. 4558(h)(8), and consistent with 44 CFR part 332.
    The DPA authorizes the making of ``voluntary agreements and plans
of action'' with representatives of industry, business, and other
interests to help provide for the national defense.\1\ The President's
authority to facilitate voluntary agreements with respect to responding
to the spread of COVID-19 within the United States was delegated to the
Secretary of Homeland Security in Executive Order 13911.\2\ The
Secretary of Homeland Security further delegated this authority to the
FEMA Administrator.\3\
---------------------------------------------------------------------------

    \1\ 50 U.S.C. 4558(c)(1).
    \2\ 85 FR 18403 (Apr. 1, 2020).
    \3\ DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); DHS
Delegation Number 09052 Rev. 00 (Jan. 3, 2017).
---------------------------------------------------------------------------

    On August 17, 2020, after the appropriate consultations with the
Attorney General and the Chairman of the Federal Trade Commission, FEMA
completed and published in the Federal Register a ``Voluntary
Agreement, Manufacture and Distribution of Critical Healthcare
Resources Necessary to Respond to a Pandemic'' (Voluntary
Agreement).\4\ Unless terminated earlier, the Voluntary Agreement is
effective until August 17, 2025, and may be extended subject to
additional approval by the Attorney General after consultation with the
Chairman of the Federal Trade Commission. The Agreement may be used to
prepare for or respond to any pandemic, including COVID-19, during that
time.
---------------------------------------------------------------------------

    \4\ 85 FR 50035 (Aug. 17, 2020). The Attorney General, in
consultation with the Chairman of the Federal Trade Commission, made
the required finding that the purpose of the voluntary agreement may
not reasonably be achieved through an agreement having less
anticompetitive effects or without any voluntary agreement and
published the finding in the Federal Register on the same day. 85 FR
50049 (Aug. 17, 2020).
---------------------------------------------------------------------------

    On December 7, 2020, the first plan of action under the Voluntary
Agreement--the Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Personal Protective
Equipment (PPE) to Respond to COVID-19 (PPE Plan of Action)--was
finalized.\5\ The PPE Plan of Action established several sub-committees
under the Voluntary Agreement, focusing on different aspects of the PPE
Plan of Action.
---------------------------------------------------------------------------

    \5\ See 85 FR 78869 (Dec. 7, 2020). See also 85 FR 79020 (Dec.
8, 2020).
---------------------------------------------------------------------------

    On May 24, 2021, four additional plans of action under the
Voluntary Agreement--the Plan of Action to Establish a National
Strategy for the Manufacture, Allocation, and Distribution of
Diagnostic Test Kits and other Testing Components to respond to COVID-
19, the Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Drug Products, Drug
Substances, and Associated Medical Devices to respond to COVID-19, the
Plan of Action to Establish a National Strategy for the Manufacture,
Allocation, and Distribution of Medical Devices to respond to COVID-19,
and the Plan of Action to Establish a National Strategy for the
Manufacture, Allocation, and Distribution of Medical Gases to respond
to COVID-19--were finalized.\6\ These plans of action established
several sub-committees under the Voluntary Agreement, focusing on
different aspects of each plan of action.
---------------------------------------------------------------------------

    \6\ See 86 FR 27894 (May 24, 2021). See also 86 FR 28851 (May
28, 2021).
---------------------------------------------------------------------------

    The meetings were chaired by the FEMA Administrator's delegates
from the Office of Response and Recovery (ORR) and Office of Policy and
Program Analysis (OPPA), attended by the Attorney General's delegates
from the U.S. Department of Justice, and attended by the Chairman of
the Federal Trade Commission's delegates. In implementing the Voluntary
Agreement, FEMA adheres to all procedural requirements of 50 U.S.C.
4558 and 44 CFR part 332.
    Meeting Objectives: The objectives of the meetings are as follows:

    1. Meet the Sub-Committee for Oxygen under the Medical Gases
Plan of Action to establish priorities related to the COVID-19
response under the Voluntary Agreement.

    2. Gather Sub-Committee Participants and Attendees to ask
targeted questions for situational awareness related to the Sub-
Committee for Oxygen.
    3. Identify potential Objectives and Actions that should be
completed under the Sub-Committee for Oxygen.
    4. Identify pandemic-related information gaps and areas that
merit sharing by holding recurring meetings of the Sub-Committee for
Oxygen with key stakeholders.

    Meetings Closed to the Public: By default, the DPA requires
meetings held to implement a voluntary agreement or plan of action be
open to the public.\7\ However, attendance may be limited if the
Sponsor \8\ of the voluntary agreement finds that the matter to be
discussed at a meeting falls within the purview of matters described in
5 U.S.C. 552b(c), such as trade secrets and commercial or financial
information.
---------------------------------------------------------------------------

    \7\ See 50 U.S.C. 4558(h)(7).
    \8\ ``[T]he individual designated by the President in subsection
(c)(2) [of section 708 of the DPA] to administer the voluntary
agreement, or plan of action.'' 50 U.S.C. 4558(h)(7).
---------------------------------------------------------------------------

    The Sponsor of the Voluntary Agreement, the FEMA Administrator,
found that these meetings to implement the Voluntary Agreement involved
matters which fall within the purview of matters described in 5 U.S.C.
552b(c) and the meetings are therefore closed to the public.
    Specifically, these meetings may require participants to disclose
trade secrets or commercial or financial information that is privileged
or confidential. Disclosure of such information allows for meetings to
be closed to the public pursuant to 5 U.S.C. 552b(c)(4).
    The success of the Voluntary Agreement depends wholly on the
willing participation of the private sector participants. Failure to
close these meetings to the public could reduce active participation by
the signatories due to a perceived risk that sensitive company
information could be prematurely released to the public. A premature
public disclosure of a private sector participant's information could
reduce trust and support for the Voluntary Agreement.
    A resulting loss of support by the participants for the Voluntary
Agreement would significantly frustrate the implementation of the
Agency's objectives. Thus, these meeting closures are permitted
pursuant to 5 U.S.C. 552b(c)(9)(B).

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-23226 Filed 10-22-21; 8:45 am]
BILLING CODE 9111-19-P


[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Page 32420]
[FR Doc No: 2015-13873]

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SECURITIES AND EXCHANGE COMMISSION

[Extension: Form N-8B-2; OMB Control No. 3235-0186, SEC File No. 270-
186]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form N-8B-2 (17 CFR 274.12) is the form used by unit investment
trusts (``UITs'') other than separate accounts that are currently
issuing securities, including UITs that are issuers of periodic payment
plan certificates and UITs of which a management investment company is
the sponsor or depositor, to comply with the filing and disclosure
requirements imposed by section 8(b) of the Investment Company Act of
1940 (15 U.S.C. 80a-8(b)). Form N-8B-2 requires disclosure about the
organization of a UIT, its securities, the personnel and affiliated
persons of the depositor, the distribution and redemption of
securities, the trustee or custodian, and financial statements. The
Commission uses the information provided in the collection of
information to determine compliance with section 8(b) of the Investment
Company Act.
    Each registrant subject to the Form N-8B-2 filing requirement files
Form N-8B-2 for its initial filing and does not file post-effective
amendments on Form N-8B-2.\1\ The Commission staff estimates that
approximately four respondents each file one Form N-8B-2 filing
annually with the Commission. Staff estimates that the burden for
compliance with Form N-8B-2 is approximately 10 hours per filing. The
total hour burden for the Form N-8B-2 filing requirement therefore is
40 hours in the aggregate (4 respondents x one filing per respondent x
10 hours per filing).
---------------------------------------------------------------------------

    \1\ Post-effective amendments are filed with the Commission on
the UIT's Form S-6. Hence, respondents only file Form N-8B-2 for
their initial registration statement and not for post-effective
amendments.
---------------------------------------------------------------------------

    Estimates of the burden hours are made solely for the purposes of
the PRA and are not derived from a comprehensive or even a
representative survey or study of the costs of SEC rules and forms. The
information provided on Form N-8B-2 is mandatory. The information
provided on Form N-8B-2 will not be kept confidential. 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.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: June 2, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-13873 Filed 6-5-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81305-81306]
[FR Doc No: 2015-32692]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-35-000]

First ECA Midstream LLC; Notice of Application

    Take notice that on December 18, 2015, First ECA Midstream LLC
(FECAM), filed an application pursuant to section 7(c) of the Natural
Gas Act (NGA), and Parts 157 and 284 of the Commission's Regulations,
for a certificate of public convenience and necessity to own, operate
as an interstate pipeline, and maintain an existing approximately 16
mile, 4-16 inch diameter natural gas pipeline located in Clearfield and
Elk Counties, Pennsylvania. Also, FECAM requests Blanket Certificates
and Waivers of the tariff requirements, related accounting, and other
regulatory requirements. 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 TYY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Benjamin M. Sullivan, First ECA Midstream LLC, 500 Corporate Landing,
Charleston, West Virginia 25311, telephone<PHONE_NUMBER>, fax (304)
925-3285, email<EMAIL_ADDRESS>or Randall S. Rich, Pierce Atwood
LLP, 900 17th Street NW., Suite 350, Washington, DC 20006, phone (202)
530-6424, email<EMAIL_ADDRESS>    The existing pipeline currently is used solely for the gathering of
natural gas for delivery to the interstate pipeline system of Dominion
Transmission, Inc. (DTI) and National Fuel Gas Supply Corporation
(NFG). FECAM requests Commission's approval of using the pipeline for
the purpose of transporting natural gas in interstate commerce. The
existing pipeline not only will continue to deliver natural gas to DTI
and NFG, but also will receive natural gas from DTI. The existing
pipeline will transport certain of natural gas received from DTI to a
power plant operated by NRG REMA LLC (REMA), in Shawville,
Pennsylvania. FECAM will construct measurement and regulating
facilities to receive gas from DTI and a tap for delivery gas to the
power plant's line pursuant to the blanket certificate. FECAM, REMA,
and their affiliates have entered into an agreement for the firm

transportation of 152,000 dekatherms per day of natural gas on the
existing pipeline for an initial term of 10 years.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    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 commenters 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 commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters 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.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: 5:00 p.m. Eastern Time on January 12, 2016. .

    Dated: December 22, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-32692 Filed 12-28-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]
[Page 76622]
[DOCID:fr17de08-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12595-001; Project No. 12604-001]

Greybull Valley Irrigation District; Notice of Preliminary Permit
Applications Accepted for Filing and Soliciting Comment, Motions To
Intervene, and Competing Applications

December 9, 2008.
    On November 3, 2008, Greybull Valley Irrigation District filed
applications, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Lower Sunshine Dam and Upper
Sunshine Dam Projects, to be located on the Greybull River, Park
County, Wyoming.
    The proposed Lower Sunshine Dam Project consists of: (1) An
existing 178-foot-high, 1660-foot-long earthfill dam, (2) an existing
impoundment having a surface area of 1,049 acres, with a storage
capacity of 58,750 acre-feet and normal water surface elevation of
5,100 feet mean sea level, (3) a proposed 50-foot-long Steel Penstock,
(4) a proposed powerhouse containing two generating units with a total
installed capacity of 5.0 megawatts, (5) a proposed 1,700-foot-long, 25
kilovolt transmission line, and (6) appurtenant facilities. The project
would have an annual generation of 12.4 gigawatt-hours that would be
sold to a local utility.
    The proposed Upper Sunshine Dam Project consists of: (1) An
existing 155-foot-high, 1,050-foot-long earthfill dam, (2) an existing
impoundment having a surface area of 1,158 acres, with a storage
capacity of 53,575 acre-feet and normal water surface elevation of
5,300 feet mean sea level, (3) a proposed 50-foot-long Steel Penstock,
(4) an existing powerhouse containing a generating unit having an
installed capacity of 5 megawatts, (5) a proposed 3-mile-long, 25
kilovolt transmission line, and (6) appurtenant facilities. The project
would have an annual generation of 6 gigawatt-hours that would be sold
to a local utility.
    Applicant Contact: Mr. William B. Schlenker, Greybull Valley
Irrigation District, P.O. Box 44, Emblem, WY 82422-0044, (307) 762-
3555.
    FERC Contact: Robert Bell,<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.
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
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-12604
and P-12595) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-29853 Filed 12-16-08; 8:45 am]

BILLING CODE 6717-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Alexandra Boukedes,<PHONE_NUMBER>

SUBMISSION: Email the completed template to<EMAIL_ADDRESS> BioConsortia, Inc.

2F8991

	EPA has received a pesticide petition (2F8991) from BioConsortia, Inc., 279 Cousteau Place, Suite 100, Davis, CA 95618 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the request of a tolerance for the microbial pesticide Bacillus velenzensis strain 11604 in or on all food and feed commodities. 	 Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, BioConsortia, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by BioConsortia, Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. BioConsortia, Inc. Petition Summary        	2F8991

A. Product Name and Proposed Use Practices

	This notice of filing summarizes the information submitted by BioConsortia, Inc., in support of a request for an exemption from the requirement of a tolerance for Bacillus velenzensis strain 11604 that contains a minimum of 1x10[9] colony forming units (cfu) per gram in Crimson.

Proposed Use Practices: Crimson is an End Use pesticide (EP) that acts by suppressing many fungal and bacterial plant pathogens including powdery mildew, gray mold, downy mildew, Botrytis blight and root rot. Bacillus velenzensis strain 11604 is a microbial pest control agent used by suppressing a number of bacterial and fungal plant pathogens.

The end-use product, Crimson, is a preventative biofungicide that contains Bacillus velenzensis strain 11604. The product is intended for different target markets including end-use products intended for both agricultural and home garden. Crimson is intended for terrestrial, outdoor, aquatic feed and food crop use as a foliar spray and/or soil drench application and is intended for both agricultural and home garden use. The product is proposed for use against multiple foliar and soil phytodiseases including but not limited to powdery mildew, black and gray mold, bacterial leaf blights, spots and specks and root rots, and greenhouse food crop uses.

Crimson, Bacillus velenzensis strain 11604, has three modes of action toward targeted pests. Firstly, it competitively excludes soilborne pathogens by colonizing plant roots to prevent infections. Secondly, Bacillus velenzensis strain 11604 produces metabolites that inhibits or kills foliar and soilborne pathogens. Lastly, the Crimson active ingredient may induce plant resistance to foliar and soilborne pathogens.

B. Product Identity/Chemistry

 Identity of the pesticide and corresponding residues.  The microbial agent a gram-positive bacterium, designated strain 11604, was isolated from soil collected from a dry, grassy field in Northern California. The strain was identified as Bacillus velenzensis strain 11604 using phylogenetic 16S rDNA sequencing, morphological, biochemical, and physiological data. This strain is able to inhibit germination and growth of numerous plant pathogenic fungi.

	2. Magnitude of residues at the time of harvest and method used to determine the residue. A determination of the magnitude of residues at harvest is not required for residues that are exempt from tolerances.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. This petition is an exemption from the requirements of a tolerance without numerical limitation, thus an analytical detection method should not be required.

C. Mammalian Toxicological Profile

Acute Oral Toxicity (UDP) in Rats Acute oral toxicity study conducted showed a lack of toxicity to mammals (LD50 > 5000 mg/Kg), and a toxicity category IV.

Acute Dermal Toxicity in Rats Acute dermal toxicity study conducted showed a lack of toxicity to mammals (LD50 > 5000 mg/Kg), and a toxicity category IV.

Acute Intravenous Toxicity and Pathogenicity Study in Rats Acute intravenous toxicity and pathogenicity study conducted showed a lack of toxicity to mammals, Bacillus velenzensis strain 11604 showed no toxicity and is not pathogenic in the albino rat. There was no mortality and no clinical signs observed.  The conducted acute injection toxicity and pathogenicity study is classified as acceptable.  This study was conducted in accordance with the guideline recommendations for an acute injection toxicity and pathogenicity study (OCSPP 885.3200; PMRA Data code: M4.3.2; OECD Data Code: IIM 5.3.4) in the Albino rat, showing no significant adverse effects, and demonstrate that the products are non-toxic to mammals.

Acute Inhalation Toxicity in Rats Acute inhalation toxicity study conducted showed a lack of toxicity to mammals (LC50 = > 2 mg/L). Toxicity based on lack of deaths at the limit dose = EPA Toxicity Category IV. The acute inhalation study conducted satisfies the guideline requirement for an acute inhalation study (OCSPP 870.1300) in the rat, showing no significant adverse effects, and demonstrate that the products are non-toxic to mammals.

Primary Dermal Irritation in Rabbits The primary dermal irritation study conducted showed Bacillus velenzensis strain 11604 is not a dermal irritant and is EPA Toxicity Category IV, showing no significant adverse effects.

Primary Eye Irritation in Rabbits The primary eye irritation study conducted showed Bacillus velenzensis strain 11604 is practically non-irritating to the eye and a Toxicity Category IV, showing no significant adverse effects.

D. Aggregate Exposure

	1. Dietary exposure. Bacillus velenzensis strain 11604 is a soil born microbe. Dietary exposure to this microbial pesticide may occur, but the complete absence of any acute oral toxicity, infectivity, and/or pathogenicity effects, as discussed in Unit C, supports the conclusion that this active ingredient is not toxic at high exposure levels, and, therefore, establishment of a tolerance exemption for residues of Bacillus velenzensis strain 11604 is appropriate.

	i. Food. Based on the results from the toxicity studies presented in Unit C, no toxicity, infectivity, pathogenicity or other adverse effects from dietary exposure to Bacillus velenzensis strain 11604 from the proposed pesticidal uses of Bacillus Bacillus velenzensis strain 11604 are expected. Bacillus species, Bacillus velenzensis strain 11604, are commonly found in agricultural settings, and occur naturally on fresh produce with no known adverse effects. Bacillus velenzensis strain 11604 is not known to produce mammalian toxins, and no foodborne illnesses associated with Bacillus velenzensis strain 11604 have been reported.

	ii. Drinking water. Drinking water exposure. Bacillus velenzensis strain 11604 is naturally present in soils; therefore, Bacillus velenzensis strain 11604 may occur in surface water and possibly groundwater. According to the World Health Organization, Bacillus species are often detected in drinking water even after going through acceptable water treatment processes, largely because the spores are resistant to these disinfection processes (reference provided at the end of the petition exemption document via this submission). Should this microbial pesticide be present, no adverse effects are expected from exposure to Bacillus velenzensis strain 11604 through drinking water, based on the results of toxicity studies described in Unit C.

	2. Non-dietary exposure. The proposed used site is limited to agricultural sites and greenhouse.  Migration of the Bacillus velenzensis strain 11604 out of the treated fields is not expected. Therefore, there will be no nonoccupational, non-dietary exposure to the general population.

E. Cumulative Effects

	There is no other registered product containing Bacillus velenzensis strain 11604. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

Bacillus velenzensis strain 11604 variant soil does not operate via a toxic mode of action and thus does not share a common mechanism of toxicity with any other substances. Therefore, section 408(b)(2)(D)(v) does not apply.

F. Safety Determination

	1. U.S. population. There are no existing U.S. population information for Bacillus velenzensis strain 11604.

	2. Infants and children. There are no existing infants and children information for Bacillus velenzensis strain 11604. Based on the results from the toxicity studies presented in Unit C, no toxicity, infectivity, pathogenicity or other adverse effects from dietary exposure to Bacillus velenzensis strain 11604 from the proposed pesticidal uses of Bacillus velenzensis strain 11604 are expected.

G. Effects on the Immune and Endocrine Systems

	There is no information available to suggest that Bacillus velenzensis strain 11604 has an effect on immune and endocrine system. Bacillus velenzensis strain 11604 is a ubiquitous organism in the environment and there have been no reports of the organism affecting immune and endocrine systems. Therefore, it is unlikely that this organism would have estrogenic or endocrine effects because it is practically non-toxic to mammals.

H. Existing Tolerances

	There are no existing tolerances for Bacillus velenzensis strain 11604.

I. International Tolerances

	No Codex maximum residue levels exist for Bacillus velenzensis strain 11604.


[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Pages 49307-49308]
[FR Doc No: 2013-19516]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549-0213.

Extension:
    Form ID;
    OMB Control No. 3235-0328, SEC File No. 270-291.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form ID (OMB Control No. 3235-0328; SEC File No. 270-291) is used
by companies and other entities to apply for identification numbers and
passwords used in conjunction with the EDGAR electronic filing system.
The information provided on Form ID is essential to the security of the
EDGAR system. Form ID must be filed every time a registrant or other
person obtains or changes an identification number.

Form ID is filed by individuals, companies or other for-profit
organizations that are required to file electronically. We estimate
approximately 65,784 registrants file Form ID and it takes
approximately an estimated 0.15 hours per response for a total annual
burden of 9,868 hours.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    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 control number.
    Please direct your written comment to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: August 7, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19516 Filed 8-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Rules and Regulations]
[Page 45979-45981]
[DOCID:fr08se09-2]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0787; Directorate Identifier 2009-NM-090-AD;
Amendment 39-16015; AD 2009-02-06 R1]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are revising an existing airworthiness directive (AD) that
applies to certain Boeing Model 737-300, -400, and -500 series
airplanes. That AD currently requires repetitive high frequency eddy
current inspections for cracking of the 1.04-inch nominal diameter wire
penetration hole in the frame and frame reinforcement, between
stringers S-20 and S-21, on both the left and right sides of the
airplane, and related investigative and corrective actions if
necessary. This new AD clarifies certain compliance requirements. This
AD results from reports of cracking in the frame, or in the frame and
frame reinforcement, common to the 1.04-inch nominal diameter wire
penetration hole intended for wire routing. We are issuing this AD to
detect and correct cracking in the fuselage frames and frame
reinforcements, which could reduce the structural capability of the
frames to sustain limit loads, and result in cracking in the fuselage
skin and subsequent rapid depressurization of the airplane.

DATES: This AD is effective September 23, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 15,
2009 (74 FR 10469, March 11, 2009).
    We must receive comments on this AD by November 9, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, Washington 98124-2207; telephone<PHONE_NUMBER>,
extension 1, fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Internet
https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6447; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On January 9, 2009, we issued AD 2009-02-06, amendment 39-15796 (74
FR 10469, March 11, 2009), for certain Boeing Model 737-300, -400, and
-500 series airplanes. That AD requires repetitive high frequency eddy
current inspections for cracking of the 1.04-inch nominal diameter wire
penetration hole in the frame and frame reinforcement, between
stringers S-20 and S-21, on both the left and right sides of the
airplane, and related investigative and corrective actions if
necessary. That AD resulted from reports of cracking in the frame, or
in the frame and frame reinforcement, common to the 1.04-inch nominal
diameter wire penetration hole intended for wire routing. We issued
that AD to detect and correct cracking in the fuselage frames and frame
reinforcements, which could reduce the structural capability of the
frames to sustain limit loads, and result in cracking in the fuselage
skin and subsequent rapid depressurization of the airplane.

Actions Since Existing AD Was Issued

    Since we issued AD 2009-02-06, January 9, 2009, amendment 39-15796
(74 FR 10469, March 11, 2009), we have determined that we need to
clarify certain compliance requirements in the existing AD, as follows:

     We have inserted a new paragraph (g)(1) in this AD to
state that while the service bulletin specifies compliance times in
terms of the ``date on this service bulletin,'' this AD requires
compliance within the specified compliance time ``after the effective
date of this AD.'' This paragraph appeared in the original NPRM, but
was inadvertently removed from AD 2009-02-06.
     We removed the reference to the ``Accomplishment
Instructions'' of Boeing Alert Service Bulletin 737-53A1279, dated
December 18, 2007, from paragraph (g) of this AD. Paragraphs (g)(1)
through (g)(4) of this AD do not all refer to text located in the
service bulletin Accomplishment Instructions.
     We added a reference to the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-53A1279, dated December 18, 2007, to
paragraph (i) of this AD to provide the locations of ``Part 3'' and
``Part 5,'' as referenced in that paragraph of the AD.

Changes to Existing AD

    This AD retains all the requirements of AD 2009-02-06. Since AD
2009-02-06 was issued, the AD format has been revised, and certain
paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this AD, as listed in the
following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                           Corresponding requirement in
     Requirement in AD  2009-02-06                   this AD
------------------------------------------------------------------------
Paragraph (d)..........................  Paragraph (e).
Paragraph (e)..........................  Paragraph (f).
Paragraph (f)..........................  Paragraph (g).
Paragraph (g)..........................  Paragraph (h).
Paragraph (h)..........................  Paragraph (i).
Paragraph (i)..........................  Paragraph (j).
Paragraph (j)..........................  Paragraph (k).
------------------------------------------------------------------------

FAA's Determination and Requirements of This AD

    We are issuing this AD because the unsafe condition described
previously is likely to exist or develop on other products of these
same type designs that could be registered in the United States in the
future. This AD revises AD 2009-02-06. This AD retains the requirements
of the existing AD and clarifies certain compliance requirements. Since
no new airplanes are affected by this AD and there are no new required
actions, notice and opportunity for public comment before issuing this
AD are unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2009-0787; Directorate Identifier 2009-NM-090-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing amendment 39-15796 (74 FR
10469, March 11, 2009) and adding the following new AD:

2009-02-06 R1 Boeing: Amendment 39-16015. Docket No. FAA-2009-0787;
Directorate Identifier 2009-NM-090-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective September 23,
2009.

Affected ADs

    (b) This AD revises AD 2009-02-06.

Applicability

    (c) This AD applies to Boeing Model 737-300, -400, and -500
series airplanes, certificated in any category; as identified in
Boeing Alert Service Bulletin 737-53A1279, dated December 18, 2007.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Unsafe Condition

    (e) This AD results from reports of cracking in the frame, or in
the frame and frame reinforcement, common to the 1.04-inch nominal
diameter wire penetration hole intended for wire routing. We are
issuing this AD to detect and correct cracking in the fuselage
frames and frame reinforcements, which could reduce the structural
capability of the frames to sustain limit loads, and result in
cracking in the fuselage skin and subsequent rapid depressurization
of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within

the compliance times specified, unless the actions have already been
done.

Restatement of Requirements of AD 2009-02-06 With Clarifications of
Compliance Requirements

Service Bulletin Reference Paragraph

    (g) The term ``service bulletin,'' as used in this AD, means
Boeing Alert Service Bulletin 737-53A1279, dated December 18, 2007.
    (1) Where the service bulletin specifies a compliance time after
the date on the service bulletin, this AD requires compliance within
the specified compliance time after the effective date of this AD.
    (2) The ``Condition'' column of paragraph 1.E., ``Compliance,''
of Boeing Alert Service Bulletin 737-53A1279, dated December 18,
2007, refers to total flight cycles ``at the date given on this
service bulletin.'' However, this AD applies to the airplanes with
the specified total flight cycles as of April 15, 2009 (the
effective date of AD 2009-02-06).
    (3) Where the service bulletin specifies to contact Boeing for
instructions for removing damage and repairing cracking: Before
further flight, remove the damage or repair the cracking using a
method approved in accordance with the procedures specified in
paragraph (j) of this AD.
    (4) Although the service bulletin referenced in this AD
specifies to submit information to the manufacturer, this AD does
not include that requirement.

Inspections, Related Investigative Actions, and Corrective Actions

    (h) At the applicable time specified in paragraph 1.E.,
``Compliance,'' of the service bulletin, except as specified by
paragraph (g)(1) of this AD: Do a high frequency eddy current (HFEC)
surface inspection or an HFEC hole/edge inspection for cracking of
the 1.04-inch nominal diameter wire penetration hole in the frame
and frame reinforcement, between stringer S-20 and S-21; and do all
applicable related investigative and corrective actions by
accomplishing all the actions specified in the Accomplishment
Instructions of the service bulletin, except as specified by
paragraphs (g)(3) and (g)(4) of this AD. Do all applicable related
investigative and corrective actions before further flight.
Thereafter, repeat the inspections at the applicable intervals
specified in paragraph 1.E., ``Compliance,'' of the service
bulletin.

Terminating Action

    (i) Doing the repair in Part 3 or the preventative modification
in Part 5 of the Accomplishment Instructions of the service bulletin
terminates the repetitive inspection requirements of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
Attn: Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6447; fax<PHONE_NUMBER>. Or, e-mail information to 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane and the approval must specifically refer to this AD.

Material Incorporated by Reference

    (k) You must use Boeing Alert Service Bulletin 737-53A1279,
dated December 18, 2007, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register previously approved the
incorporation by reference of Boeing Alert Service Bulletin 737-
53A1279, dated December 18, 2007, on April 15, 2009 (74 FR 10469,
March 11, 2009).
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1, fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on August 26, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E9-21311 Filed 9-4-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57739-57742]
[FR Doc No: 2019-23490]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3723]

Watson Laboratories, Inc.; Proposal To Withdraw Approval of an
Abbreviated New Drug Application for Oxycodone Hydrochloride and
Ibuprofen Tablets; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of an abbreviated new drug application (ANDA) for oxycodone
hydrochloride and ibuprofen tablets and is announcing an opportunity
for the holder of the ANDA to request a hearing on this proposal. The
basis for the proposal is that the holder of the ANDA has repeatedly
failed to submit the required data to support a finding of
bioequivalence for this ANDA.

DATES: Watson Laboratories, Inc. may submit a request for a hearing by
November 27, 2019. Submit all data, information, and analyses upon
which the request for a hearing relies by December 27, 2019. Submit
electronic or written comments by December 27, 2019.

ADDRESSES: The request for a hearing may be submitted by Watson
Laboratories, Inc. by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request 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. The request for a hearing must include the
Docket No. FDA-2019-N-3723 for ``Watson Laboratories, Inc.; Proposal to
Withdraw Approval of an Abbreviated New Drug Application for Oxycodone
Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing.'' The
request for a hearing will be placed in the docket and publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
    Watson Laboratories, Inc., may submit all data and analyses upon
which the request for a hearing relies in the same manner as the
request for a hearing except as follows:
     Confidential Submissions--To submit any data and analyses
with confidential information that you do not wish to be made publicly
available,

submit your data and analyses only as a written/paper submission. You
should submit two copies total of all data and analyses. 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 any decisions on this
matter. 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 or available at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Submit both copies to the Dockets Management Staff. Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3723 for ``Watson Laboratories, Inc.; Proposal to Withdraw
Approval of an Abbreviated New Drug Application for Oxycodone
Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing.''
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 Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Maryll W. Toufanian, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1720, Silver Spring, MD 20993-0002, 240-
402-7944.

SUPPLEMENTARY INFORMATION:

I. Background

A. Approval of ANDA 078394 for Oxycodone Hydrochloride and Ibuprofen
Tablets

    FDA's Office of Generic Drugs (OGD) approved ANDA 078394, held by
Watson Laboratories, Inc. (Watson),\1\ for a generic version of
oxycodone hydrochloride and ibuprofen tablets, 5 milligrams (mg)/400
mg, under the requirements of section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and FDA's implementing
regulations. OGD approved ANDA 078394 on November 26, 2007.
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    \1\ In correspondence dated February 23, 2017, Watson notified
FDA that Watson is an indirect, wholly-owned subsidiary of Teva
Pharmaceuticals USA, Inc.
---------------------------------------------------------------------------

    In seeking approval of its ANDA 078394, Watson relied on the
reference listed drug (RLD) product, COMBUNOX (oxycodone hydrochloride
and ibuprofen) tablets, 5 mg/400 mg, approved under new drug
application (NDA) 021378 (see Sec.  314.94 (21 CFR 314.94)). As an
applicant under section 505(j) of the FD&C Act, Watson was not required
to conduct clinical studies to demonstrate the safety and effectiveness
of its drug product. Rather, in addition to meeting the other
requirements for ANDA approval enumerated in section 505(j) of the FD&C
Act and applicable FDA regulations, Watson was required to demonstrate
that its product was bioequivalent to the RLD, COMBUNOX (see section
505(j)(2)(A)(iv) and (j)(4)(F) of the FD&C Act; Sec.  314.94(a)(7); 21
CFR 314.127(a)(6)(i)). The information that Watson submitted to show
that its ANDA 078394 was bioequivalent to the RLD included
bioequivalence studies, with the bioanalytical analysis conducted by
Cetero Research at the Houston, TX site during 2006.

B. Investigations Regarding Bioequivalence Studies Conducted by Cetero
Research

    In May 2010 and December 2010, FDA conducted comprehensive
inspections of bioequivalence studies conducted by Cetero Research at
the Houston, TX site. The inspections were part of FDA's Bioresearch
Monitoring

Program, which includes inspections to evaluate the conduct of
research, to confirm that data intended for submission to FDA are
reliable as a basis for FDA approval and regulatory decisions, and to
verify compliance with the bioavailability and bioequivalence
requirements in section 505 of the FD&C and Act 21 CFR part 320. The
findings of these inspections of bioequivalence studies conducted by
Cetero Research raised significant concerns about the validity of the
reported results of analytical studies conducted between April 1, 2005,
and June 15, 2010, in support of drug applications (see Ref. 1). The
inspections and a third-party audit identified significant instances of
misconduct and violations of Federal regulations, including document
falsification and sample manipulation. The pattern of misconduct was
serious enough to raise concerns about the integrity of the data that
Cetero Research generated during the 5-year time frame between 2005 and
2010. On July 26, 2011, FDA notified pharmaceutical companies that
bioanalytical studies conducted at Cetero Research between April 1,
2005, and June 15, 2010, in support of marketing applications may need
to be repeated or confirmed (see Ref. 2).
    On August 9, 2011, FDA issued a letter to Watson regarding ANDA
078394 because this drug product application was supported by
bioequivalence studies with the bioanalytical analysis conducted by
Cetero Research at the Houston, TX site between April 1, 2005, and June
15, 2010 (see Ref. 3). As FDA noted in its August 9, 2011,
correspondence, inspection findings regarding Cetero Research's
bioequivalence studies raised significant concerns about the validity
of the reported results of the analytical studies conducted between
April 2005 and June 2010 in support of drug applications, and as such,
steps needed to be taken to demonstrate the bioequivalence of Watson's
drug product approved under ANDA 078394. FDA informed Watson that ANDA
078394 needed to be supplemented by conducting new bioequivalence
studies or re-assaying the samples from the original bioequivalence
study. FDA recommended to Watson that the results of the requested
bioequivalence studies, or re-assays, be submitted to ANDA 078394
within 6 months of the date of the August 9, 2011, letter. As noted in
the August 9, 2011 correspondence, if the necessary information was not
submitted within the recommended timeframe, FDA would consider
downgrading the therapeutic equivalence evaluation of approved
applications in the Agency's ``Approved Drug Products With Therapeutic
Equivalence Evaluations'' (Orange Book) from an ``AB'' to a ``BX''
rating because of new information raising a significant question as to
bioequivalence. FDA did not receive a response from Watson to this
August 9, 2011, correspondence.
    On August 19, 2016, FDA issued another letter to Watson requesting
that, within 30 calendar days, Watson either: (1) Supplement ANDA
078394 with the requested bioequivalence data or (2) voluntarily seek
withdrawal of ANDA 078394 under Sec.  314.150 (21 CFR 314.150(d)) and
waive the opportunity for a hearing under Sec.  314.150(a) (see Ref.
4). As noted in the August 19, 2016, correspondence, if Watson did not
submit new bioequivalence data within 30 calendar days, if the new data
did not support a finding of bioequivalence, or if Watson did not agree
to voluntarily seek withdrawal of ANDA 078394 within 30 calendar days,
FDA would commence downgrading the therapeutic equivalence evaluation
of approved applications in the Orange Book from an ``AB'' to a ``BX''
rating. FDA also stated that if the aforementioned conditions were not
met, FDA would consider all other appropriate regulatory action,
including commencing steps to withdraw approval of ANDA 078394 under
section 505(e) of the FD&C Act and Sec.  314.150. FDA did not receive a
response from Watson to this August 19, 2016, correspondence.
    On April 24, 2017, FDA issued Watson a third letter notifying them
that FDA had changed the therapeutic equivalence evaluation of ANDA
078394 in the Orange Book from an ``AB'' to a ``BX'' rating (see Ref.
5). Further, in the April 24, 2017, correspondence, FDA requested that
Watson voluntarily seek withdrawal for ANDA 078394 under Sec.
314.150(d) and waive the opportunity for a hearing under Sec.
314.150(a). FDA requested that Watson provide such a withdrawal request
or a letter stating that Watson would not voluntarily seek withdrawal
of the approval of ANDA 078394 no later than May 24, 2017. As noted in
the April 24, 2017, correspondence, FDA advised Watson that if Watson
did not agree to voluntarily seek withdrawal of the approval of ANDA
078394 under Sec.  314.150(d), FDA would plan to commence steps to
withdraw approval of this ANDA under 505(e) of the FD&C Act and Sec.
314.150. FDA did not receive a response from Watson to this April 24,
2017, correspondence.
    In the June 2017 Cumulative Supplement to the 37th Edition of the
Orange Book, ANDA 078394 was moved to the Discontinued Section of the
Orange Book based on notification by Watson to the Agency that Watson
was no longer marketing its drug product approved under ANDA 078394.
Because drug products that are in the Discontinued Section of the
Orange Book do not have therapeutic equivalence codes and because ANDA
078394 is currently in the Discontinued Section of the Orange Book,
ANDA 078394 is not currently assigned a therapeutic equivalence code.

II. Conclusions and Proposed Action

    An NDA applicant must submit ``full reports of investigations'' to
show that the drug for which the applicant is seeking approval is safe
and effective. In other words, NDAs must meet the safety and
substantial evidence of effectiveness standard (see section 505(b)(1)
and (2), (c), and (d) of the FD&C Act). An NDA applicant can meet the
standard by conducting its own clinical studies (stand-alone
application) or relying, in part, on the Agency's previous finding of
safety and/or effectiveness or literature (a 505(b)(2) application). An
ANDA applicant does not submit independent clinical studies to
demonstrate safety and effectiveness. Rather, an ANDA applicant relies
on the Agency's previous finding of safety and effectiveness for its
RLD and is required to meet other requirements, such as demonstrating
bioequivalence to the RLD to support approval. In the absence of
information showing bioequivalence between the generic drug at issue
and the RLD, there is no basis for concluding that the Agency's finding
of safety and efficacy supporting approval of the RLD can be used as a
basis to support approval of the generic drug. Section 505(e) of the
FD&C Act provides FDA the authority to withdraw approval of an ANDA in
these circumstances. While the Watson application was approved on the
basis of a bioequivalence study, new information about the facility
that conducted the bioanalytical analysis for that study leads CDER to
conclude that the results of that study are not credible.
    Therefore, based on all available data and information, notice is
given to Watson Laboratories, Inc. and to all other interested persons
that the Director of CDER proposes to issue an order, under section
505(e) of the FD&C Act and Sec.  314.150, withdrawing approval of ANDA
078394 and all amendments and supplements to it on the grounds that
Watson has failed to submit the required bioequivalence data necessary
to demonstrate the bioequivalence of its drug product.

III. Hearing Procedures

    In accordance with section 505(e) of the FD&C Act, Watson
Laboratories, Inc. is hereby provided an opportunity to request a
hearing to show why approval of ANDA 078394 should not be withdrawn and
an opportunity to raise, for administrative determination, all issues
relating to the legal status of the drug product covered by this
application.
    An applicant who decides to seek a hearing must file the following:
(1) A written notice of participation and request for a hearing (see
DATES and ADDRESSES) and (2) the data, information, and analyses relied
on to demonstrate that there is a genuine and substantial issue of fact
that requires a hearing (see DATES and ADDRESSES). Any other interested
person may also submit comments on this notice. The procedures and
requirements governing this notice of opportunity for a hearing, notice
of participation and request for a hearing, the information and
analyses to justify a hearing, other comments, and a grant or denial of
a hearing are contained in Sec.  314.200 (21 CFR 314.200) and in 21 CFR
part 12.
    The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the application and constitutes a waiver of any contentions
concerning the legal status of the drug product. FDA will then withdraw
approval of the application, and the drug product may not thereafter be
lawfully introduced or delivered for introduction into interstate
commerce. Any new drug product introduced or delivered for introduction
into interstate commerce without an approved application is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
    Paper submissions under this notice of opportunity for a hearing
must be filed in two copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

IV. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

    1. Letter from Leslie Ball, FDA, to Roger Hayes, Cetero
Research, July 26, 2011.
    2. FDA, ``Notification to Pharmaceutical Companies: Acceptance
of third-party data integrity audit for Cetero studies conducted
from March 1, 2008, to August 31, 2009'' (https://wayback.archive-it.org/7993/20170113203457/http:/www.fda.gov/Drugs/DrugSafety/ucm265559.htm), accessed September 10, 2019.
    3. Letter from Keith Webber, FDA, to Watson Laboratories, Inc.,
August 9, 2011.
    4. Letter from Carol A. Holquist, FDA, to Watson Laboratories,
Inc., August 19, 2016.
    5. Letter from Carol A. Holquist, FDA, to Watson Laboratories,
Inc., April 24, 2017.

    Dated: October 21, 2019.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2019-23490 Filed 10-25-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2187-2188]
[FR Doc No: 2011-445]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63658; File No. SR-Phlx-2011-02]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
the $5 Strike Price Program

January 6, 2011.
    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 3, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Commentary .05 to Exchange Rule
1012, Series of Options Open for Trading, specifically to clarify that
the Exchange may list option classes designated by other securities
exchanges that employ a similar $5 Strike Price Program under their
respective rules.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, on the Commission's Web site
at www.sec.gov, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to modify Commentary
.05 to Exchange Rule 1012 to clarify that the Exchange may list and
trade series in intervals of $5 or greater where the strike price is
more than $200 in up to five (5) option classes on individual stocks
(``$5 Strike Price Program'') or the Exchange may list series on any
other option classes if those classes are specifically designated by
other securities exchanges that employ a similar $5 Strike Price
Program under their respective rules.
    The Exchange recently filed a proposed rule change to list and
trade series in intervals of $5 or greater where the strike price is
more than $200 in up to five (5) option classes on individual stocks
(``$5 Strike Price Program'').\3\ The Exchange is now proposing to
clarify that the options may be listed and traded in series that are
listed by the Exchange or other securities exchanges that employ a
similar $5 Strike Price Program, pursuant to the rules of the other
securities exchange. Similar reciprocity currently is permitted with
the Exchange's $1 Strike Program, $.50 Strike Program and $2.50 Strike
Price Program.\4\
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    \3\ See Securities Exchange Act Release No. 63339 (November 18,
2010), 75 FR 71771 (November 24, 2010) (SR-Phlx-2010-158).
    \4\ See Exchange Rule 1012 at Commentary .05.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed 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 Exchange believes that clarifying that the Exchange may list and
trade options in series that are listed by the Exchange or other
securities exchanges that employ a similar $5 Strike Price Program will
provide its members greater clarity on the types of options that may be
listed by the Exchange.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposed reciprocity provision is similar to
reciprocity provisions in place for other option strike price
programs,\9\ which have been previously approved by the Commission.\10\
Therefore, the Commission designates the proposal operative upon
filing.\11\
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    \9\ See Rule 1012, Commentary .05(a)(i)(A) ($1 Strike Program),
Commentary .05(a)(ii) ($0.50 Strike Program), and Commentary .05(b)
($2.50 Strike Program).
    \10\ See, e.g., Securities Exchange Act Release No. 60694
(September 18, 2009); 74 FR 49048 (September 25, 2009) (SR-Phlx-
2009-65) (approving the $0.50 Strike Program, with reciprocity
provision).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an E-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2011-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2011-02. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2011-02 and should be
submitted on or before February 2, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Elizabeth M. Murphy,
Secretary.
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    \12\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2011-445 Filed 1-11-11; 8:45 am]
BILLING CODE 8011-01-P