[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41486-41488]
[FR Doc No: 2021-16352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0198]

Belen G. Ngo; 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 Belen G.
Ngo's (Ms. Ngo's) request for a hearing and is issuing an order under
the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ms. Ngo
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 Ms. Ngo was 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 that the type of conduct underlying the
conviction undermines the process for the regulation of drugs. In
determining the appropriateness and period of Ms. Ngo's debarment, FDA
considered the relevant factors listed in the FD&C Act. Ms. Ngo failed
to file with the Agency information and analyses sufficient to create a
basis for a hearing concerning this action.

DATES: This order is applicable August 2, 2021.

ADDRESSES: Any application for termination of debarment by Ms. Ngo
under section 306(d) of the FD&C Act (application) may be submitted as
follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All applications must include the Docket No. FDA-
2012-N-0198. Received applications 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. 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 application and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, 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 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave, Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that: (1) The individual was 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 type of conduct underlying the conviction
undermines the process for the regulation of drugs.
    On September 6, 2011, in the U.S. District Court for the Eastern
District of Virginia, Ms. Ngo pled guilty to a misdemeanor violation of
the FD&C Act, namely failing to maintain records required by section
505(i) of the FD&C Act (21 U.S.C. 355(i)) in violation of sections
301(e) and 303(a)(1) (21 U.S.C. 331(e) and 333(a)(1)). Ms. Ngo's
conviction stemmed from her actions as a clinical research coordinator
for the Norfolk Diagnostic Center, doing business as Sentara Medical
Group (Sentara). Eli Lilly Corp. (Eli Lilly) initiated a clinical study
to investigate the effectiveness of lispro insulin for the purpose of
applying for FDA approval to market lispro insulin for the treatment of
Type 2 diabetes. Eli Lilly entered into an agreement with Sentara to
conduct the ispro insulin study, and Sentara agreed to maintain records
in accordance with 21 CFR 312.62(a) and by extension, section 505(i) of
the FD&C Act. Ms. Ngo was a clinical research coordinator for the
lispro insulin study and responsible for maintaining and completing
case report forms (CRFs), which are the official records that document
volunteers' participation in the study and contain vital medical
information related to the performance of the study drug. Ms. Ngo
knowingly and repeatedly falsified CRFs.
    By letter dated April 27, 2012, FDA's Office of Regulatory Affairs
(ORA) notified Ms. Ngo of its proposal to debar her for 5 years from
providing services in any capacity to a person having an approved or
pending drug product application. The proposal explained that the
proposed debarment period was based on her misdemeanor conviction and
that the maximum debarment period is 5 years. ORA explained that her
conduct relating to the clinical trial relates to the development and
approval, including the process for development and approval, of drug
products; therefore, she was subject to debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act.
    The proposal outlined findings regarding the three applicable
factors ORA considered in determining the appropriateness and period of
debarment, as provided in section 306(c)(3) of the FD&C Act. ORA
consider the nature and seriousness of the offense and the nature and
extent of voluntary steps to mitigate the effect on the public as
unfavorable factors for Ms. Ngo and weighed these factors against the
absence of prior convictions involving matters within FDA's
jurisdiction. ORA concluded, ``Weighing all the factors, the Agency has
determined that the unfavorable factors far outweigh the favorable
factor, and therefore warrant the imposition of a five-year period of
debarment in this case, the maximum possible period of debarment.''
    By letters dated May 22 and 23, 2012, through counsel, Ms. Ngo
requested a hearing on the proposal. In her request for a hearing, Ms.
Ngo acknowledges her conviction under Federal law and does not question
the Agency's authority to debar her upon the basis of that conviction.
However, Ms. Ngo argues that she should only be subject to a 1-year
debarment, rather than FDA's proposed 5-year debarment, based on the
considerations for determining the appropriateness and period of
debarment under section 306(c)(3) of the FD&C Act. Ms. Ngo also
included specific arguments related to the considerations under section
306(c)(3) of the FD&C Act.
    Under the authority delegated by the Commissioner of Food and
Drugs, the Chief Scientist has considered Ms. Ngo's request 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 Ms. Ngo's arguments and
concluded that they are unpersuasive and fail to raise a genuine and
substantial issue of fact requiring a hearing.

II. Arguments

    In support of her hearing request, Ms. Ngo makes many statements
seemingly related to the nature and seriousness of her offense. Ms. Ngo
first argues that the prosecution's failure to pursue a felony
conviction reflects its judgment that a misdemeanor conviction and the
terms of her probation or supervised release, which included an
agreement not to engage in clinical research during that period, are
sufficient to protect the public health. Ms. Ngo next argues that her
role was too small to have a significant effect on the study's results
and that, because of her ``minimal role'' in providing data, the
maximum debarment period is not appropriate. Ms. Ngo states that her
study was discontinued and Eli Lilly did not use any of her information
``in a detrimental way.'' Ms. Ngo also alleges that ``[t]here is no
evidence that her data affected the

studies or resulted in the production of the drugs affected by the
fraud'' and that ``[t]he drugs produced were free of fraud and material
false statements.'' Ms. Ngo then asserts that her lack of financial
motive for conducting her offense weighs in her favor because ``the
maximum period of debarment should be reserved for those who profit.''
    In determining the period of Ms. Ngo's debarment, whether she could
have been convicted of a felony is not relevant. Under section
306(c)(3) of the FD&C act, FDA considers the nature and seriousness of
the offense. Ms. Ngo admitted to knowingly and repeatedly falsifying
clinical trial records. Additionally, the inclusion of a provision in
Ms. Ngo's plea agreement that prevents her from engaging in clinical
research ``during any term of probation or supervised release'' evinces
concern by the prosecution that she would continue to violate the law
if involved in clinical research.
    As set forth in the proposal to debar, ``[t]he creation and
submission of falsified clinical trial data undermines FDA's
determination of safety, effectiveness, and quality of the drugs the
studies were designed to assess.'' Although the scope of conduct to
which Ms. Ngo admitted during the criminal proceedings may have been
limited to a few patients, submitting any false or fabricated data to
the FDA is a serious offense that compromises the public health.
Further, it is irrelevant that Eli Lilly ultimately did not use any of
her information ``in a detrimental way.'' Had Ms. Ngo's conduct gone
undetected and Eli Lilly submitted a new drug application containing
the falsified data, FDA might have relied on her fabricated information
to approve a new drug product, which reliance could have compromised
the public health. Additionally, Ms. Ngo's lack of financial gain from
her conduct does not diminish the nature and seriousness of her
offense. Accordingly, Ms. Ngo has failed to create a genuine and
material factual dispute with respect to the nature and seriousness of
her offense.
    Ms. Ngo next argues that, because she has not been involved in
clinical trials since entering her guilty plea, there are ``reasonable
assurances'' that ``the offense will not happen again.'' Ms. Ngo
appears to be referencing the consideration under section 306(c)(3)(D)
of the FD&C Act, where FDA must consider, where applicable, ``whether
the extent to which changes in ownership, management, or operations
have corrected the causes of any offense involved and provide
reasonable assurances that the offense will not occur in the future.''
The considerations in section 306(c)(3) of the FD&C Act are not only
for individuals but also for corporations, partnerships, and
associations subject to permissive debarment. The consideration at
issue does not typically apply to individuals because individuals are
incapable of changes in ownership or management and could only alter
the current operations of a business enterprise in which they are
currently engaged. Even assuming for the sake of argument that an
individual could point to changes in his or her current business
practices as an applicable consideration under section 306(c)(3) of the
FD&C Act, Ms. Ngo offers no actual facts to support her assertion that
there are reasonable assurances that the offense will not occur again
in the future; therefore, her unsubstantiated contention that, because
she has not been involved in clinical trials since entering her guilty
plea provides reasonable assurances that she will not commit the
offense again, fails to create a genuine and substantial issue of fact
that warrants a hearing.
    Finally, Ms. Ngo argues that the maximum period of debarment is
inappropriate for first-time offenders. While the Agency does consider
prior convictions involving matters within the FDA's jurisdiction under
section 306(c)(3)(F) of the FD&C Act, that consideration is only one of
several that FDA considers in determining the appropriateness and
period of debarment under section 306(c)(3). Ms. Ngo knowingly and
repeatedly falsified clinical data records. FDA has determined that the
conduct underlying her offense, combined with her failure to take any
voluntary steps to mitigate the effect of her offense on the public, is
sufficiently serious to warrant a 5-year period of debarment, even
though she does not have any prior convictions involving matters within
the Agency's jurisdiction.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and under the authority delegated to her by the
Commissioner of Food and Drugs, finds: (1) That Ms. Ngo 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 process for 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, Ms. Ngo 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. 335, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective August 2,
2021 (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 Ms. Ngo, in any
capacity during her period of debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Ms. Ngo, during her period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, that person will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept
or review any abbreviated new drug applications submitted by or with
the assistance of Ms. Ngo during her period of debarment (section
306(c)(1)(B) of the FD&C Act).

    Dated: July 27, 2021.
Denise Hinton,
Chief Scientist.
[FR Doc. 2021-16352 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42353-42354]
[FR Doc No: 2023-13976]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER23-2236-000.
    Applicants: Chisholm Trail Solar Energy LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5043.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2237-000.
    Applicants: Flat Ridge 4 Wind Holdings LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5045.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2238-000.
    Applicants: Flat Ridge 4 Wind, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5046.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2239-000.
    Applicants: HQC Solar Holdings 1, LLC.
    Description: Petition for Limited Waiver of HQC Solar Holdings 1,
LLC.
    Filed Date: 6/20/23.
    Accession Number: 20230620-5304.
    Comment Date: 5 p.m. ET 7/11/23.

    Docket Numbers: ER23-2240-000.
    Applicants: Flat Ridge 5 Wind Energy Holdings LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5048.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2241-000.
    Applicants: Flat Ridge 5 Wind Energy LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5049.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2242-000.
    Applicants: Lazbuddie Wind Energy Holdings LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5050.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2243-000.
    Applicants: Lazbuddie Wind Energy LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5052.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2244-000.
    Applicants: Pixley Solar Energy Holdings LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5054.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2245-000.
    Applicants: Pixley Solar Energy LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 8/26/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5056.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2246-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2023-06-26-TSGT-Const-Finney
to Lamar 345 kV-735--0.0.0 to be effective 5/16/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5062.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2247-000.
    Applicants: Energy Prepay I, LLC.
    Description: Tariff Amendment: Cancellation entire tariff to be
effective 6/27/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5069.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2248-000.
    Applicants: MS Solar Solutions Corp.
    Description: Tariff Amendment: Cancellation entire tariff to be
effective 6/27/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5073.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2249-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Sec.  205(d) Rate Filing: Alabama Power Company
submits tariff filing per 35.13(a)(2)(iii: Lexington Solar + BESS LGIA
Filing to be effective 6/15/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5080.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2250-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Sec.  205(d) Rate Filing: Alabama Power Company
submits tariff filing per 35.13(a)(2)(iii: Wrightsville Solar + BESS
LGIA Filing to be effective 6/14/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5081.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2251-000.
    Applicants: Central Hudson Gas & Electric Corporation.
    Description: Sec.  205(d) Rate Filing: Revision to FERC Rate
Schedule 202 to be effective 6/13/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5087.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2252-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1266R14 Kansas Municipal
Energy Agency NITSA and NOA to be effective 9/1/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5092.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2253-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: IA, Ten West Link
Transmission (TOT784/RS FERC NO. 532) to be effective 6/27/2023.

    Filed Date: 6/26/23.
    Accession Number: 20230626-5093.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2254-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2562R13 Kansas Municipal
Energy Agency NITSA NOA to be effective 9/1/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5095.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2255-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3599R2 Missouri Electric
Commission NITSA NOA to be effective 9/1/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5101.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2256-000.
    Applicants: AEP Indiana Michigan Transmission Company, Inc., PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: AEP Indiana Michigan
Transmission Company, Inc. submits tariff filing per 35.13(a)(2)(iii:
AEP and METC submit Second Amended and Restated IA, SA No. 4251 to be
effective 6/1/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5107.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2257-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Certificate of Concurrence
to Boardman to Hemingway Project Construction Funding to be effective
6/7/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5108.
    Comment Date: 5 p.m. ET 7/17/23.

    Docket Numbers: ER23-2258-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: Cancel E&P LA, Ten West Link
Transmission (TOT784/SA213) to be effective 6/27/2023.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5126.
    Comment Date: 5 p.m. ET 7/17/23.

    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. 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>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 26, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-13976 Filed 6-29-23; 8:45 am]
BILLING CODE 6717-01-P


U.S. ENVIRONMENTAL PROTECTION AGENCY

Good Neighbor Environmental Board

Meeting Day 1

June 18-19, 2008

San Diego State University

Imperial Valley Campus Library

Calexico, California

AGENDA

Wednesday, June 18, 2008

8:00 A.M.	Registration

8:30		Welcome and Introductions

		Welcome:	Paul Ganster, Chair, GNEB

			     	Rafael DeLeón, Director, OCEM

			      	Lorena Cedeño-Zambrano, Acting Designated Federal Officer

				Board Members, Attendee Self Introductions

9:00	Regional Welcome

Steven Roeder, Dean, SDSU Imperial Valley Campus

Victor Carrillo, Supervisor, Imperial County

9:30	Imperial-Mexicali Region Air Quality:  New Approaches to Pollution Reduction

		Brad Poiriez, Air Quality Officer

Imperial County

10:15		California-Baja California Border Region Energy and Renewable

Alternatives

		Alan Sweedler, Chair, Center for Energy Studies

San Diego State University

11:00		Public Comments

11:20		Endangered Species Habitat

		Christopher Brown, Associate Professor of Geography

		New Mexico State Universitry

12:00		Working Lunch

12:45		Colorado River Joint Cooperative Project, U.S. Mexico

Carlos Marin, U.S. Commissioner

International Boundary and Water Commission

1:30		Dumping on Tribal Lands:  Pala Reservation New Transfer Station

		Lenore Volturno, Director of Environmental Services

Pala Band of Mission Indians

2:15		Break

2:30		New River & Artificial Wetlands:  Using Nature to Clean Water

		Marie Barrett, Outreach Coordinator, Citizen’s Congressional Task Force

		New River Wetland Project

3:15		Board Members Report Out Presentations

4:00		 Adjourn

U.S. ENVIRONMENTAL PROTECTION AGENCY

Good Neighbor Environmental Board

Meeting Day 2

June 18-19, 2008

San Diego State University

Imperial Valley Campus Library

Calexico, California

AGENDA

Thursday, June 19, 2008

7:40 A.M .	Registration

8:00		Business Meeting Call to Order

8:10		Approval of Minutes of Washington, DC March 2008 Meeting

		Paul Ganster, Chair

FACA Developments

		Rafael De León, Director, OCEM

8:40	Approval & Discussion of GNEB Advice Letter to President George W. Bush

Luis Ramirez, Lead, Advice Letter Team

9:00		GNEB Twelfth Report

	“Innovation, Including Incentives, to Prevent/Reduce Pollution at the U.S.-Mexico Border”

Paul Ganster, Chair, GNEB

9:15		Approach to Case Studies

Diane Austin & Ann Marie Wolf, Members, GNEB

9:30		Discussion of Potential Case Studies

11:00		Break

11:15		Discussion of Potential Case Studies (Continued)

11:50		Selection of Case Studies and Formation of Drafting Teams

12:20		Public Comments

12:40		El Paso Public Meeting Discussion [Meeting Dates: Sept. 24-25, 2008]

		Next Steps

1:00		Adjourn


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34596-34598]
[FR Doc No: 2018-15512]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements on Content and Format of Labeling for
Human Prescription Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's requirements on content and format of labeling for human
prescription drug and biological products.

DATES: Submit either electronic or written comments on the collection
of information by September 18, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2008-N-0500 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Requirements on Content and
Format of Labeling for Human Prescription Drug and Biological
Products.'' 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products

OMB Control Number 0910-0572--Extension

    FDA's regulations governing the content and format of labeling for
human prescription drug and biological products were revised in the
Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling
rule) to require that the labeling of new and recently approved
products contain highlights of prescribing information, a table of
contents for prescribing information, reordering of certain sections,
minor content changes, and minimum graphical requirements. These
revisions were intended to make it easier for health care practitioners
to access, read, and use information in prescription drug labeling; to
enhance the safe and effective use of prescription drug products; and
to reduce the number of adverse reactions resulting from medication
errors because of misunderstood or incorrectly applied drug
information.
    Currently, Sec.  201.56 (21 CFR 201.56) requires that prescription
drug labeling contain certain information in the format specified in
either Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80),
depending on when the drug was approved for marketing. Section
201.56(a) sets forth general labeling requirements applicable to all
prescription drugs. Section 201.56(b) specifies the categories of new
and more recently approved prescription drugs subject to the revised
content and format requirements in Sec. Sec.  201.56(d) and 201.57.
Section 201.56(c) sets forth the schedule for implementing these
revised content and format requirements. Section 201.56(e) specifies
the sections and subsections, required and optional, for the labeling
of older prescription drugs not subject to the revised format and
content requirements.
    Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include a
``Highlights of Prescribing Information'' section. The ``Highlights''
section provides a concise extract of the most important information
required under Sec.  201.57(c) (the Full Prescribing Information
(FPI)), as well as certain additional information important to
prescribers. Section 201.57(b) requires a table of contents to
prescribing information entitled ``Full Prescribing Information:
Contents,'' consisting of a list of each heading and subheading along
with its identifying number to facilitate health care practitioners'
use of labeling information. Section 201.57(c) specifies the contents
of the FPI. Section 201.57(d) mandates the minimum specifications for
the format of prescription drug labeling and establishes minimum
requirements for key graphic elements such as bold type, bullet points,
type size, and spacing.
    Older drugs not subject to the revised labeling content and format
requirements in Sec.  201.57 are subject to labeling requirements at
Sec.  201.80. Section 201.80(f)(2) requires that, within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.

Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57)

    New drug product applicants must: (1) Design and create
prescription drug labeling containing ``Highlights,'' ``Contents,'' and
FPI; (2) test the designed labeling (e.g., to ensure that the designed
labeling fits into carton-enclosed products); and (3) submit it to FDA
for approval. Based on the projected data used in the January 24, 2006,
final rule, FDA estimates that it will take applicants approximately
2,327 hours to design, test, and submit prescription drug labeling to
FDA as part of a NDA or a BLA under the revised regulations. Currently,
approximately 406 applicants submit approximately 541 new applications
(NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      21 CFR part and activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents     respondent \2\     responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             406            1.332              541            2,327        1,258,907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Estimates may not sum due to rounding.

    Our estimated burden for the information collection reflects an
overall increase of 602,503 hours and a corresponding increase of 345
records. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.

    Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15512 Filed 7-19-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Page 49319]
[FR Doc No: 2019-20275]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4457-DR; Docket ID FEMA-2019-0001]

New Hampshire; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New Hampshire (FEMA-4457-DR), dated August
15, 2019, and related determinations.

DATES: The declaration was issued August 15, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, 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 August 15, 2019, 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 New Hampshire resulting from a severe storm and flooding during
the period of July 11 to July 12, 2019, 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 New Hampshire.
    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 be
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, James McPherson, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of New Hampshire have been
designated as adversely affected by this major disaster:

    Grafton County for Public Assistance.
    All areas within the State of New Hampshire are eligible 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.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-20275 Filed 9-18-19; 8:45 am]
BILLING CODE 9111-23-P


 [Federal Register Volume 76, Number 142 (Monday, July 25, 2011)] [Notices] [Page 44321] [FR Doc No: 2011-18693]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ER11-4060-000]

High Sierra Limited; 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

High Sierra Limited'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 8, 2011.

    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

14 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 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>.

    Dated: July 19, 2011.

Nathaniel J. Davis, Sr.,

 Deputy Secretary.

[FR Doc. 2011-18693 Filed 7-22-11; 8:45 am]

BILLING CODE 6717-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY
                              2565 PLYMOUTH ROAD
                        ANN ARBOR, MICHIGAN 48105-2498

                                   OFFICE OF
                               AIR AND RADIATION

May 18, 2011

MEMORANDUM

SUBJECT:	Adjusting Combined City/Highway CAFE Fleet Values to Determine Equivalent 5-Cycle Label Values

FROM:	Roberts W. French, Jr.
		Environmental Protection Specialist
		Office of Transportation and Air Quality
		U.S. Environmental Protection Agency

TO: 		U.S. Environmental Protection Agency
		Docket No. EPA-HQ-OAR-2009-0865

As explained in the preamble to the final rule, our methodology for creating a ranking system for fuel economy and greenhouse gases depends on selecting an appropriate mid-point representing the fuel economy of the average vehicle.  Given that Corporate Average Fuel Economy (CAFE) and greenhouse gas emission standards are programs with fleet average standards, these programs will essentially be determining the fuel economy of the average vehicle in any given model year for which there are standards.  Consequently, given a rating system based on MPG, we chose to use the CAFE program to define the average vehicle, and from that vehicle we determined the MPG "bins" that define the 1 to 10 rating system.

The EPA/NHTSA rulemaking that put greenhouse gas and CAFE standards in place for the 2012 through 2016 model years established the following fleet values (see 75 FR 25331, May 7, 2010). It is these numbers, shown in the following table, that form the basis for our rating system, but with some adjustment.

                                  Model Year
                                     CAFE
                                     2012
                                     28.7
                                     2013
                                     29.7
                                     2014
                                     30.6
                                     2015
                                     31.5
                                     2016
                                     32.7

The CAFE standards and the label values are determined in different ways. Congress recognized the importance of maintaining a stable method for compliance with standards and essentially fixed the test methods for CAFE such that the test results don't change over time.  However, Congress has also recognized that the label values need to reflect real-world performance, and now requires EPA to periodically evaluate how well the label test and calculation methods are reproducing real-world experience.  This memorandum details the method used to derive label values (sometimes called "5-cycle" values) from the CAFE values above (sometimes called "2-cycle" values).

In 2006 EPA promulgated a rule that established new test and calculation methods that took effect with the 2008 model year. The new method does not apply a flat, linear adjustment in the way that the previous method did.  The new method applies a higher proportional adjustment to high fuel economy values than to low fuel economy values.  Thus, although the difference could be subtle, the adjustment to the 2012 model year CAFE value of 28.7 MPG will be different than the adjustment applied to the 2016 value of 32.7.

One other minor issue is that the CAFE values above are Combined City/Highway values, whereas the label values are adjusted separately by test cycle, i.e., the City value is adjusted using one formula, the Highway by another, and the Combined value determined from the adjusted City and Highway values.  Because the CAFE values are fleet average standards based on the Combined City/Highway MPG, there are no separate specific City and Highway values to use to determine the real-world label value, as we would do for an individual vehicle.  If such fleet City and Highway values existed we would simply adjust these by the existing methods to get our desired label values corresponding to the above CAFE values.

To estimate Combined City/Highway label values that correspond to the above CAFE values, we used fuel economy data from the 2011 model year.  The data includes City, Highway, and Combined in unadjusted (i.e., 2-cycle values comparable to CAFE) and adjusted (i.e., 5-cycle label values).  We simply regressed the unadjusted Combined MPG values against the adjusted Combined values to determine an approximate relationship between the two.  The data and the regression equation are shown in the following figure.

As noted earlier, the existing method to adjust test results to get to label values is non-linear, thus a simple linear regression such as this should not be used for exacting purposes.  For our purposes here, however, this approach is a sufficient way to translate each of the CAFE values to average label values, rounded to a whole MPG.  For example, in the 2012 model year when the fleet is required to meet a CAFE standard of 28.7 MPG, we would expect, based on the method in this memorandum, that the similarly sales-weighted average of the label values across the fleet would be 22 MPG.  Thus the values in the "Label Average" column below are used to define the center of the rating system for these model years.  The rating system for future model years will be addressed as CAFE standards for future years become known.

                                  Model Year
                                     CAFE
                                 Label Average
                                     2012
                                     28.7
                                      22
                                     2013
                                     29.7
                                      23
                                     2014
                                     30.6
                                      23
                                     2015
                                     31.5
                                      24
                                     2016
                                     32.7
                                      25


[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Pages 8239-8240]
[FR Doc No: 2014-02866]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0134]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated November 19, 2013, the Reading Blue Mountain and Northern
Railroad (RBMN) has petitioned the Federal

Railroad Administration (FRA) for a waiver of compliance from certain
provisions of the Federal railroad safety regulations contained at 49
CFR Part 230-Steam Locomotive Inspection and Maintenance Standards. FRA
assigned the petition Docket Number FRA-2013-0134. RBMN owns and
operates No.425, a 4-6-2 Pacific class steam locomotive built in 1928
by the Baldwin Locomotive Works for the Gulf, Mobile, and Ohio
Railroad. RBMN No. 425 is operated periodically for special trains on
RBMN.
    RBMN requests relief from 49 CFR 230.16(a)(2), Fifth annual
inspection, with respect to 49 CFR 230.41, Flexible staybolts with
caps. Specifically, RBMN is petitioning for a delay of the flexible
staybolt and cap inspection for an undetermined amount of calendar days
until RBMN No. 425 has accumulated 200 service days. Inclusive of the
2013 operating season, RBMN No. 425 will have accumulated 125 service
days since the 1,472 service-day inspection was performed in December
2007. RBMN states that the flexible staybolt and cap inspection
required by 49 CFR 230.41 would require 14 man-weeks to perform and be
a burden on the RBMN steam program.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) 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 participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number 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.
    Communications received by March 28, 2014 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to 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.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2014-02866 Filed 2-10-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70198-70199]
[FR Doc No: 2011-29111]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65690; File No. SR-CBOE-2011-103]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Clarify the Process for the Qualification of
the Customer Large Trade Discount

November 4, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 28, 2011, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I, II, and III 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.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend its Customer Large Trade Discount.
The text of the proposed rule change is available on the Exchange's Web
site (http://www.cboe.org/legal), at the Exchange's Office of the
Secretary, and at the Commission.

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

    In its filing with the Commission, 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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange recently amended its Fees Schedule to clarify the
process for the qualification of a customer order for the Customer
Large Trade Discount (the ``Discount''), which is intended to cap fees
on large customer trades (the quantity of contracts necessary for a
large customer trade to qualify for the Discount varies by product).\3\
The Exchange now proposes to amend the Fees Schedule once again to
further clarify the process for qualification of a customer order for
the Discount.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 65491 (October 6,
2011), 76 FR 63680 (October 13, 2011) (SR-CBOE-2011-093).
---------------------------------------------------------------------------

    Currently, to qualify for the Discount, an entire customer order
quantity must be tied to a single order ID either within the CBOEdirect
system or in FBW or PULSe or in the front end system used to transmit
the order (provided the Exchange is granted access to effectively audit
such front end system). The order must be entered in its entirety on
one system so that the Exchange can clearly identify the total size of
the order.\4\ There is a minor contradiction in the wording in regards
to the entry of a customer order large enough to qualify for the
Discount (a ``Large Customer Order'') entered into a front end system,
which may be a non-CBOE system (a system used by a broker) that is used
to enter orders. Under the current language, the entire order quantity
must be tied to a single order ID within the front end system used to
transmit the order. However, in the parenthetical that follows, the
language states that the order must be entered in its entirety on one
system; it does not state that the order has to be transmitted from
that system. It has come to the Exchange's attention that some brokers
receive Large Customer Orders from customers and enter those Large
Customer Orders into their front end systems, but then telephone or
otherwise transmit those orders to the CBOE trading floor. This process
would qualify the Large Customer Order for the Discount under the
parenthetical (since the Large Customer Order is entered in its
entirety into the front end system), but technically would not qualify
the Large Customer Order for the Discount under the previous sentence,
since it is the telephone call, and not the front end system itself,
that transmits that order to the Exchange.
---------------------------------------------------------------------------

    \4\ See Exchange Fees Schedule, Section 18.
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    The Exchange therefore proposes to eliminate this contradiction in
the language by clarifying that, to qualify for the Discount, an entire
customer order quantity must be tied to a single order ID within the
front end system that is used to enter and/or transmit the order. This
clarifies that, if a broker receives a Large Customer Order from a
customer, enters it into their own front end system, and then
telephones the order into the Exchange, the Large Customer Order will
still qualify for the Discount. Any party that requests that an order
entered in this process be granted the Discount will still have to
grant the Exchange access to effectively audit the front end system,
and will have to submit a customer large trade discount request which
identifies all necessary trade-related information to the Exchange
within 3 business days of the transactions.\5\
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    \5\ See Note 4.
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    The proposed rule change would clear up any confusion regarding the
entry and qualification of Large Customer Orders and thereby make it
easier for brokers to ensure that their Large Customer Orders qualify
for the Discount.
    The proposed change is to take effect on November 1, 2011.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\6\ in general, and furthers the objectives of Section 6(b)(5) \7\
of the Act in particular, in that it is designed 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. By clarifying the process for the qualification of Large
Customer Orders for the Discount and eliminating a contradiction in the
Fees Schedule language regarding such process, the proposed rule change
eliminates confusion, thereby removing an impediment to and perfecting
the mechanism of a free and open market system. The clarification of
this process will also make it easier for CBOE to administer the
Discount and ensure that it is appropriately assessed when it is
applicable.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition 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 solicited or received with respect to the
proposed rule change.

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

    The proposed rule change is designated by the Exchange as
establishing or changing a due, fee, or other charge, thereby
qualifying for effectiveness on filing pursuant to Section 19(b)(3)(A)
of the Act \8\ and subparagraph (f)(2) of Rule 19b-4 \9\ thereunder. 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.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2011-103 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-CBOE-2011-103. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the 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
10:00 a.m. and 3:00 p.m. Copies of such filing will also 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 No. SR-CBOE-2011-103 and should be
submitted on or before December 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-29111 Filed 11-9-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32881-32882]
[FR Doc No: 2018-15096]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]

Scientific Conference: Opioid and Nicotine Use, Dependence, and
Recovery--Influences of Sex and Gender; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of
Women's Health, Center for Drug Evaluation and Research, and Center for
Tobacco Products are announcing the following conference entitled
``Scientific Conference: Opioid and Nicotine Use, Dependence, and
Recovery--Influences of Sex and Gender.'' The purpose of the conference
is to discuss the biological (sex) and sociological (gender) influences
on misuse, abuse, and cessation of opioids and tobacco. Researchers,
educators, and clinicians may benefit from attending this
multidisciplinary review and update on opioid and tobacco.

DATES: The two-day conference will be held on September 27, 2018 (8:30
a.m.-4:00 p.m.) and September 28, 2018 (8:30 a.m.-4:00 p.m.). See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The conference will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503-A), Silver Spring, MD 20993. Entrance for the conference
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Gwendolyn Jones, Food and Drug
Administration, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver
Spring, MD 20993, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is responsible for protecting the public health by assuring the
safety and efficacy of FDA-regulated products. This conference will
provide the Agency with further insight into the devastating public
health crises caused by pervasive opioid and tobacco use. Drug overdose
deaths and opioid-involved deaths continue to increase in the United
States. Many of the drug overdose deaths (more than 6 out of 10)
involve an opioid. Since 1999, the number of overdose deaths involving
opioids (including prescription opioids and heroin) quadrupled. Drug
overdose deaths and opioid-involved deaths continue to increase in the
United States. Of the 63,632 drug overdose deaths in 2016, 66.4 percent
(42,249) involved opioids, with increases across age groups, racial/
ethnic groups, urbanization levels, and multiple states. Combustible
cigarettes have been identified as the dominant cause of tobacco-
related disease and are responsible for more than 20 million premature
deaths since the first Surgeon General's report in 1964. Together,
opioid and tobacco use are the leading causes of preventable disease
and death in the United States, and women are increasingly affected.
Sex and gender differences may influence susceptibility to substance
abuse, which could have implications for optimal prevention and
treatment. Gender influencers also impact public health from a familial
and environmental perspective. Researchers, educators, and clinicians
must be able to recognize and consider both sex and gender differences
to identify and treat women most at risk.

II. Topics for Discussion at the Conference

    The conference will include presentations and panel discussions by
experts in the field of opioid and tobacco research, professional
education, and clinical care on the biological (sex) and sociological
(gender) influences on misuse, abuse, and cessation of opioids and
tobacco. Each panel discussion will have a Q&A session to respond to
questions from in-person attendees.

III. Participating in the Conference

    Registration: To register for the Scientific Conference: Opioid and
Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender,
please visit the following website: https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308.
    Registration is free and in-person seating is limited. The
conference will also be available for viewing via webcast. Persons
interested in attending or viewing this conference must register online
by September 24, 2018, 5:00 p.m. Eastern Time. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If you need special
accommodations due to a disability, please email Gwendolyn Jones at
[email protected] (See FOR FURTHER INFORMATION CONTACT) no
later than September 24, 2018.
    Streaming Webcast of the public meeting: This public meeting will
also be webcast and can only be viewed if registered. To register,
please go to

https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308. Registrants will receive confirmation and information
about accessing the webcast when they have been accepted. FDA has
verified the website addresses in this document, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.

    Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15096 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P