[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Page 20696]
[FR Doc No: 2011-8859]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1965-DR; Docket ID FEMA-2011-0001]

Tennessee; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Tennessee (FEMA-1965-DR), dated March 31,
2011, and related determinations.

DATES: Effective Date: March 31, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 31, 2011, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Tennessee resulting from severe storms, tornadoes, and flooding
during the period of February 28 to March 1, 2011, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of Tennessee.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, W. Montague Winfield, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Tennessee have been designated
as adversely affected by this major disaster:

    Franklin, Fentress, Grainger, Hamilton, Houston, Humphreys,
Jackson, Jefferson, Moore, Morgan, Pickett, Scott, and Union
Counties for Public Assistance.
    All counties within the State of Tennessee are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-8859 Filed 4-12-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Rules and Regulations]
[Pages 14689-14690]
[FR Doc No: 2012-5971]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0126]

Drawbridge Operation Regulation; Berwick Bay (Atchafalaya River),
Morgan City, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Burlington Northern Santa Fe (BNSF) Railway Company vertical lift span
bridge across Berwick Bay, mile 0.4, (Atchafalaya River, mile 17.5) at
Morgan City, St. Mary Parish, Louisiana. The deviation is necessary to
perform scheduled maintenance to the bridge. This deviation allows the
bridge to remain in the closed-to-navigation position on two dates
occurring in March of 2012.

DATES: This deviation is effective from 7:30 a.m. on Thursday, March
15, 2012 through 11:30 a.m. Thursday, March 22, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0126 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0126 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Kay Wade, Bridge Branch Office, Coast Guard; telephone
504-671-2128, email<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The BNSF Railway Company has requested a
temporary deviation from the operating schedule of the vertical lift
span railroad bridge across Berwick Bay, mile 0.4 (Atchafalaya River,
mile 17.5), at Morgan City, St. Mary Parish, Louisiana. The vertical
lift span bridge has a vertical clearance of 6.4 feet above high water,
elevation 8.2 feet Mean Sea Level in the closed-to-navigation position.
Vessels able to pass underneath the bridge in the closed-to-navigation-
position may do so.
    In accordance with 33 CFR 117.5, the bridge currently opens on
signal for the passage of vessels. This deviation allows the vertical
lift span of the bridge to remain in the closed-to-navigation position
from 7:30 a.m. through 11:30 a.m. on Thursday, March 15, 2012 and
Thursday, March 22, 2012.
    To avoid becoming a safety hazard, the closures are necessary in
order to cut and weld worn rails and chipping Conley joints. This
maintenance is essential for the continued safety and operation of the
bridge. Notices will be published in the Eighth Coast Guard District
Local Notice to Mariners and will be broadcast via the Coast Guard
Broadcast Notice to Mariners System.
    Navigation on the waterway consists of tugs with tows, fishing
vessels and recreational craft, including sailboats

and powerboats. The bridge will be able to open for emergencies, if
necessary. The Intracoastal Waterway--Morgan City to Port Allen Route
and the Landside Route, including Bayou Boeuf, are alternate waterway
routes for vessels not requiring greater than a 12 foot draft. Based on
experience and coordination with waterway users, it has been determined
that these closures will not have a significant effect on vessels that
use the waterway.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: February 23, 2012.
David M. Frank,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2012-5971 Filed 3-12-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42894]
[DOCID:fr25au09-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. QF09-524-000]

Motiva Enterprises LLC; Notice of Filing of Notice of Self-
Certification of Qualifying Status of a Cogeneration Facility

August 18, 2009.
    Take notice that on August 10, 2009, Motiva Enterprises LLC
(Applicant), located at P.O. Box 2463, Houston, TX 77252-2463, filed
with the Federal Energy Regulatory Commission a notice of self-
certification of a facility as a qualifying cogeneration facility
pursuant to 18 CFR 292.207(a) of the Commission's regulations.
    The applicant is constructing a cogeneration facility (Facility) at
the site of its existing Port Arthur Refinery, located at 2555 Savannah
Avenue, Port Arthur, TX 77640, to provide steam and electric energy
primarily to meet the requirements of its Port Arthur Refinery--Crude
Expansion Project and in part to meet the requirements of its existing
Port Arthur Refinery. The Facility consist of four gas turbine
generators, with four heat recovery generators, with a combined net
electric capacity of 156 MW. The primary fuel for the Facility will be
natural gas.
    Entergy Texas Inc. is the electric utility to which the Facility
will interconnect. Generation is used primarily to meet on-site demand
of the Port Arthur Refinery--Crude Expansion Project; however, any
surplus could be sold in the available power markets.
    A notice of self-certification does not institute a proceeding
regarding qualifying facility status; a notice of self-certification
provides notice that the entity making the filing has determined the
Facility meets the applicable criteria to be a qualifying facility. Any
person seeking to challenge such qualifying facility status may do so
by filing a motion pursuant to 18 CFR 292.207(d)(iii).
    This filing is accessible online 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>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-20370 Filed 8-24-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Notices]
[Page 79297]
[FR Doc No: 2022-28126]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ23-2-000]

City of Anaheim, California; Notice of Filing

    Take notice that on November 29, 2022, City of Anaheim, California
submits tariff filing: City of Anaheim 2023 Transmission Revenue
Balancing Account Adjustment and Gross Load Update, to be effective
January 1, 2023.
    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.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on December 20, 2022.

    Dated: December 20, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-28126 Filed 12-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Pages 47482-47483]
[FR Doc No: 2015-19421]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-2367-000]

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

    This is a supplemental notice in the above-referenced proceeding of
Nittany Energy, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR

part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 24, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19421 Filed 8-6-15; 8:45 am]
BILLING CODE 6717-01-P


* * * * *
0
3. Amend Sec.  395.3 by revising paragraphs (a)(2) and (3) to read as
follows:

Sec.  395.3  Maximum driving time for property-carrying vehicles.

    (a) * * *
    (2) 14-hour period. Except as provided in paragraph (a)(3)(iii) of
this section, a driver may not drive after a period of 14 consecutive
hours after coming on duty following 10 consecutive hours off duty.
    (3) Driving time and interruptions of driving periods. (i) Driving
time. A driver may drive a total of 11 hours during the period
specified in paragraph (a)(2) of this section.
    (ii) Interruption of driving time. Except for drivers who qualify
for either of the short-haul exceptions in Sec.  395.1(e)(1) or (2),
driving is not permitted if more than 8 hours of driving time have
passed without at least a 30-minute consecutive interruption in driving
status, either off duty or on duty.
    (iii) Split duty period. (A) A driver may take one off-duty break
of at least 30 minutes, but not more than 3 hours, during the driver's
14-hour period specified in paragraph (a)(2) of this section and extend
the 14-hour period for the length of the driver's off-duty break.
    (B) An off-duty break under paragraph (a)(3)(iii)(A) of this
section does not affect the requirement that a driver take 10
consecutive hours off duty under paragraph (a)(1) of this section.
* * * * *

    Issued under authority delegated in 49 CFR 1.87 on: August 13,
2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-17810 Filed 8-21-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43449-43450]
[FR Doc No: 2017-19598]

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 DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0073]

Portland & Western Railroad's Request for Positive Train Control
Safety Plan Approval and System Certification

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document notifies the public that Portland & Western
Railroad (PNWR) submitted to FRA its Positive Train Control Safety Plan
(PTCSP) (Version 1.5, dated July 21, 2017) for its Westside Express
Service and a copy of that PTCSP is available for public review and
comment. PNWR asks FRA to approve its PTCSP and issue a Positive Train
Control System Certification for PNWR's Enhanced Automatic Train
Control (E-ATC), under the appropriate regulations.

DATES: FRA will consider comments received by October 16, 2017, before
taking final action on the PTCSP. FRA may consider comments received
after that date if practicable.

ADDRESSES: All communications concerning this proceeding should
identify Docket Number FRA-2010-0073 and may be submitted by any of the
following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Dr. Mark Hartong, Senior Scientific
Technical Advisor, at<PHONE_NUMBER> or<EMAIL_ADDRESS>or Mr.
David Blackmore, Staff Director, Positive Train Control Division, at
(312) 835-3903 or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In its PTCSP, PNWR asserts that its E-ATC
system is designed as a vital overlay positive train control (PTC)
system as defined in 49 CFR 236.1015(e)(2). The PTCSP describes PNWR's
E-ATC implementation and the associated E-ATC safety processes, safety
analyses, and test, validation, and verification processes used during
the development of E-ATC. The PTCSP also contains PNWR's operational
and support requirements and procedures.
    PNWR's PTCSP and the accompanying request for approval and system
certification are available for review online at http://www.regulations.gov (Docket Number FRA-2010-0073) and in person at
DOT's Docket Operations Facility, 1200 New Jersey Avenue SE., W12-140,
Washington, DC 20590. The Docket Operations Facility is open from 9
a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to comment on the PTCSP by
submitting written comments or data. During its review of the PTCSP,
FRA will consider any comments or data submitted. However, FRA may
elect not to respond to any particular comment and, under 49 CFR
236.1009(d)(3), FRA maintains the authority to approve or disapprove
the PTCSP at its sole discretion. FRA does not anticipate scheduling a
public hearing regarding PNWR's PTCSP because the circumstances do not
appear to warrant a hearing. If any interested party desires an
opportunity for oral comment, the party should notify FRA in writing
before the end of the comment period and specify the basis for his or
her request.

Privacy Act Notice

    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 49 CFR 211.3, FRA solicits comments from the public to better
inform its decisions. 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 https://www.transportation.gov/privacy. See https://www.regulations.gov/privacyNotice for the privacy
notice of regulations.gov.

    Issued in Washington, DC, on September 8, 2017.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2017-19598 Filed 9-14-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12011-12013]
[FR Doc No: 2015-05043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0303]

William F. DeLuca, Jr.; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a request
for a hearing submitted by Dr. William F. DeLuca, Jr. and is issuing an
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
debarring Dr. DeLuca for 5 years from providing

services in any capacity to a person that has an approved or pending
drug product application. FDA bases this order on a finding that Dr.
DeLuca was convicted of a misdemeanor under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act and
that the type of conduct underlying the conviction undermines the
process for the regulation of drugs. In determining the appropriateness
and period of Dr. DeLuca's debarment, FDA has considered the relevant
factors listed in the FD&C Act. Dr. DeLuca has failed to file with the
Agency information and analyses sufficient to create a basis for a
hearing concerning this action.

DATES: The order is effective March 5, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nathan Doty, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 11, 2009, in the U.S. District Court for the Northern
District of New York, Dr. DeLuca, a physician, pled guilty to a
misdemeanor under the FD&C Act, namely misbranding a drug in violation
of sections 301(k), 502(i)(3), and 303(a)(1) of the FD&C Act (21 U.S.C.
331(k), 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this
conviction was conduct surrounding his injection of patients seeking
treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin,
distributed by Toxin Research International, Inc. BOTOX is a biological
product derived from Botulinum Toxin Type A that is manufactured by
Allergan, Inc., and was approved by FDA for use on humans for the
treatment of facial wrinkles in 1991. According to the records of the
criminal proceedings, Dr. DeLuca directed a nurse to obtain 31 vials of
TRI-toxin, an unapproved drug product, which was represented by its
distributor as ``Botulinum Toxin Type A.'' Dr. DeLuca then proceeded to
inject approximately 62 patients, who believed they were being injected
with BOTOX, with TRI-toxin as a substitute.
    Dr. DeLuca is subject to debarment based on a finding, under
section 306(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)):
(1) That he was convicted of a misdemeanor under Federal law relating
to the regulation of a drug product under the FD&C Act and (2) that the
type of conduct underlying the conviction undermines the process for
the regulation of drugs. By letter dated November 30, 2010, FDA
notified Dr. DeLuca of its proposal to debar him for 5 years from
providing services in any capacity to a person having an approved or
pending drug product application.
    In a letter dated December 28, 2010, through counsel, Dr. DeLuca
requested a hearing on the proposal. In his request for a hearing, Dr.
DeLuca acknowledges his convictions under Federal law, as alleged by
FDA. However, he argues that section 306(b)(2)(B)(i) of the FD&C Act,
which was added by the Generic Drug Enforcement Act (GDEA), does not
apply to him because he was never involved in the development,
approval, or regulation of drug products, nor was the conduct
underlying his conviction related to the development, approval, or
regulation of drug products.
    We reviewed Dr. DeLuca's request for a hearing and find that Dr.
DeLuca has not created a sufficient basis for a hearing. Hearings are
granted only if there is a genuine and substantial issue of fact.
Hearings will not be granted on issues of policy or law, on mere
allegations, denials, or general descriptions of positions and
contentions, or on data and information insufficient to justify the
factual determination urged (see 21 CFR 12.24(b)).
    The Chief Scientist has considered Dr. DeLuca's arguments and
concludes that they are unpersuasive and fail to raise a genuine and
substantial issue of fact requiring a hearing.

II. Arguments

    In support of his hearing request, Dr. DeLuca asserts that section
306(b)(2)(B)(i)(I) of the FD&C Act does not apply to him because he was
never involved in the development, approval, or regulation of drug
products, nor was the underlying conduct of his conviction related to
those activities. He argues that application of the permissive
debarment provisions to him expands the intended scope of section
306(b)(2)(b)(i)(I) of the FD&C Act beyond congressional intent. Dr.
DeLuca further asserts that the statutory provision is limited to
conduct that directly or indirectly affects FDA's regulatory efforts
associated with drug approval, that the intended targets of GDEA are
those who manufacture and distribute drugs, and that the court's
decision in Bhutani v. U.S. Food and Drug Administration, 161 Fed.
Appx. 589, 591 (7th Cir. 2006) and FDA's debarment order for Premchand
Girdhari (65 FR 3454, January 21, 2000) also expressed this limitation.
He asserts that, because his conduct did not fall within any such
activities and he was not a company manufacturing or distributing
drugs, but merely a physician using a drug, albeit an unapproved drug,
section 306(b)(2)(B)(i)(I) if the FD&C Act is inapplicable to him.
    During his criminal proceedings, Dr. DeLuca pled guilty to
misbranding and causing the misbranding of a drug in violation of
sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act by offering
TRI-toxin, a drug not approved for use, in place of an approved drug
product, BOTOX. This conduct clearly relates to the regulation of drugs
under the FD&C Act because it was in direct violation of the FD&C Act.
The conduct also undermined the process for the regulation of drugs in
that it permitted an unapproved drug to be substituted for an approved
drug without the knowledge of the patient. As a result, Dr. DeLuca is
subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act.
    Dr. DeLuca's narrow interpretation of section 306(b)(2)(B)(i) of
the FD&C Act, as well as the other provisions added to the statute by
GDEA, is unpersuasive. Under well-recognized rules of statutory
construction, the starting point in interpreting a statute is the text
of the statute itself. (BedRoc Limited LLC. v. United States, 541 U.S.
176, 183 (2004), on remand, 368 F.3 1149 (9th Cir. 2004)). It is clear
from section 306(b)(2)(B)(i) of the FD&C Act that the ``regulation of
drugs'' is not limited to activities related to the approval of drugs.
If that were the case, there would be no need for the language ``or
otherwise relating to the regulation of drug products'' as the
provision already clearly covers approval activities with the language
``relating to the development, or approval, including the process for
development or approval.'' Under rules of statutory construction, all
the words in a statute are to be given meaning and no words or
provisions are to be rendered superfluous. (Montclair v. Ramsdell, 107
U.S. 147, 152 (1883), Astoria Federal Savings and Loan Ass'n v.
Solimino, 501 U.S. 104, 112 (1991).)
    Dr. DeLuca's arguments regarding the legislative history and intent
of GDEA also are unpersuasive. Dr. DeLuca cites to the House Report for
the bill passed by the House. However, that bill did not ultimately
become section 306(b)(2)(B)(i) of the FD&C Act. If the language of the
statute is clear, there is no need to look outside the statute to its

legislative history in order to ascertain the statute's meaning.
(Chamber of Commerce of United States v. Whiting, 131 S. Ct. 1968
(2011).) Dr. DeLuca's conduct in misbranding Tri-toxin by holding it
for sale and administering it to patients as the approved drug BOTOX
clearly relates to FDA's regulation of approved drugs. Likewise, his
argument that section 306(b)(2)(B)(i) of the FD&C Act could not have
been intended to cover him because he did not work for a person with a
pending or approved drug product application when he was convicted or
that section 306(b)(2)(B)(i) applies to only individuals who
manufacture and distribute drugs ignores both the plain language of the
statute and the remedial purpose of the Agency's debarment authority.
Furthermore, Dr. DeLuca's argument that Bhutani v. U.S. Food and Drug
Administration, 161 Fed. Appx. 589, 591 (7th Cir. 2006), and FDA's
debarment order for Premchand Girdhari (65 FR 3454) evidence the
court's and FDA's view that the statute is to be interpreted to exclude
him is without merit. Both the court decision and FDA's debarment order
address the specific fact situations at issue. Both situations involved
persons who manufactured and distributed drugs. The decision and order
did not purport to define the full scope of section 306(b)(2)(B)(i) of
the FD&C Act or hold that conduct such as Dr. DeLuca's was not within
the scope of the statutory provision.
    Finally, Dr. DeLuca argues that FDA does not typically debar
physicians for criminal violations of the FD&C Act. FDA has, however,
debarred several other physicians under section 306(b)(2)(B)(i)(I) of
the FD&C Act for convictions under the FD&C Act on the basis of similar
conduct. (See, e.g., 77 FR 27235, May 9, 2012; 76 FR 69272, November 8,
2011; 76 FR 30947, May 27, 2011; 76 FR 21910, April 19, 2011; 76 FR
13192, March 10, 2011; 76 FR 11789, March 3, 2011 (debarring physicians
for felony violations of the FD&C Act for substituting TRI-toxin for
BOTOX); 77 FR 27236, May 9, 2012; 76 FR 66072, October 25, 2011; 76 FR
48168, August 8, 2011; 76 FR 37126, June 24, 2011; 76 FR 30946, May 27,
2011; 76 FR 18556, April 4, 2011; 76 FR 18557, April 4, 2011; 76 FR
12971, March 9, 2011 (debarring physicians for a misdemeanor violations
of the FD&C Act for substituting TRI-toxin for BOTOX).
    Dr. DeLuca's arguments do not raise any genuine and substantial
issue of fact for a hearing. Furthermore, Dr. DeLuca's legal arguments
do not create a basis for a hearing and, in any event, are
unpersuasive. Accordingly, the Chief Scientist denies Dr. DeLuca's
request for a hearing.
    As set forth in the proposal to debar and summarized in this
document, Dr. DeLuca pled guilty to a misdemeanor under the FD&C Act
for his role in offering a drug under the name of another. Based on the
undisputed record before the Agency, the consideration in section
306(c)(3)(A) and (B) of the FD&C Act with respect to the nature and
seriousness of the offense and extent in management participation
involved are unfavorable in light of Dr. DeLuca's conduct in bringing
the unapproved drug into the medical practice and his management
position in The Plastic Surgery Group. At Dr. DeLuca's sentencing
hearing, at which six other codefendants were also sentenced, the
presiding judge in addressing Dr. DeLuca stated:

And we're here because of your actions and inactions. As I said,
your mistakes were different in kind and degree from those of your
colleagues. It was you who brought this drug into the practice, and
it was your conduct and your failure to check out either the company
or the drug that you were ordering, as you should have done, your
negligence in doing that that has brought us here today in the end.

    Consistent with the proposal to debar, the record established that
the medical practice of which Dr. DeLuca was a part ultimately took
voluntary steps to mitigate the effect on the public health from its
unlawful conduct and that Dr. DeLuca had no previous criminal
convictions related to matters within FDA's jurisdictions. As such, the
considerations in sections 306(c)(3)(C) and (F) of the FD&C Act will be
treated as favorable factors.
    In light of the totality of the circumstances underlying the
foregoing four considerations, the seriousness of the offense and Dr.
DeLuca's management participation make debarment for 5 years,
consistent with the proposal to debar, appropriate in spite of the
favorable factors under 306(c)(3)(C) and (F) of the FD&C Act.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and under authority delegated to him by the Commissioner
of Food and Drugs, finds: (1) That Dr. DeLuca has been convicted of a
misdemeanor under Federal law for conduct relating to the development
or approval of a drug product or otherwise relating to the regulation
of a drug product under the FD&C Act and (2) that the conduct
underlying the conviction undermines the regulation of drugs. FDA has
considered the relevant factors listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of 5 years is appropriate.
    As a result of the foregoing findings, Dr. DeLuca is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or pending drug product application who
knowingly uses the services of Dr. DeLuca, in any capacity during his
period of debarment, will be subject to civil money penalties. If Dr.
DeLuca, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Dr. DeLuca during his period of
debarment.
    Any application by Dr. DeLuca for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0303 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents in the Docket
at http://www.regulations.gov/.

    Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015-05043 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01P


[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12186-12187]
[FR Doc No: 2021-04258]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR21-31-000.
    Applicants: Southcross CCNG Transmission Ltd.
    Description: Tariff filing per 284.123(b),(e)+(g): Revision to
Statement of Operating Conditions to be effective 2/22/2021.
    Filed Date: 2/22/2021.
    Accession Number:<PHONE_NUMBER>74
    Comments Due: 5 p.m. ET 3/15/2021
    284.123(g) Protests Due: 5 p.m. ET 4/23/2021.

    Docket Numbers: RP21-509-000.
    Applicants: Golden Pass Pipeline LLC.
    Description: Golden Pass Pipeline LLC submits tariff filing per
154.203: GPPL Annual Retainage Report for 2021 to be effective 4/1/
2021.
    Filed Date: 02/23/2021.
    Accession Number: 20210223-5118.
    Comment Date: 5 p.m. ET 3/8/2021.

    Docket Numbers: RP21-510-000.
    Applicants: Vector Pipeline L.P.
    Description: Vector Pipeline L.P. submits tariff filing per
154.204: Negotiated Rate Filing--BWEC to be effective 3/1/2021.
    Filed Date: 02/23/2021.
    Accession Number: 20210223-5145.
    Comment Date: 5 p.m. ET 3/8/2021.

    Docket Numbers: RP21-511-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: El Paso Natural Gas Company, L.L.C. submits tariff
filing per 154.204: Negotiated Rate Agreements

Filing (Sempra_Marathon) to be effective 4/1/2021.
    Filed Date: 02/23/2021.
    Accession Number: 20210223-5178.
    Comment Date: 5 p.m. ET 3/8/2021.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date(s). Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 24, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-04258 Filed 3-1-21; 8:45 am]
BILLING CODE 6717-01-P