[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21222-21223]
[FR Doc No: 2017-09115]

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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: ER17-1512-000.
    Applicants: CinCap V, LLC.
    Description: Tariff Cancellation: Cancellation of MBR Tariff to be
effective 6/30/2017.
    Filed Date: 5/1/17.
    Accession Number: 20170501-5209.
    Comments Due: 5 p.m. ET 5/22/17.

    Docket Numbers: ER17-1513-000.
    Applicants: Duke Energy Commercial Enterprises, Inc.
    Description: Tariff Cancellation: Cancellation of MBR Tariff to be
effective 6/30/2017.
    Filed Date: 5/1/17.
    Accession Number: 20170501-5210.
    Comments Due: 5 p.m. ET 5/22/17.

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

    Docket Numbers: ES17-19-000.
    Applicants: ITC Great Plains, LLC.
    Description: Application of ITC Great Plains, LLC under Section 204
of the Federal Power Act and Part 34 of the Commission's Regulations.
    Filed Date: 4/27/17.
    Accession Number: 20170427-5557.
    Comments Due: 5 p.m. ET 5/18/17.

    Docket Numbers: ES17-20-000.
    Applicants: ITC Midwest LLC.
    Description: Application of ITC Midwest LLC under Section 204 of
the Federal Power Act and Part 34 of the Commission's Regulations.
    Filed Date: 4/27/17.
    Accession Number: 20170427-5567.
    Comments Due: 5 p.m. ET 5/18/17.

    Docket Numbers: ES17-21-000.
    Applicants: International Transmission Company.
    Description: Application of International Transmission Company
under Section 204 of the Federal Power Act and Part 34 of the
Commission's Regulations.
    Filed Date: 4/27/17.
    Accession Number: 20170427-5572.
    Comments Due: 5 p.m. ET 5/18/17.

    Docket Numbers: ES17-22-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Application of Michigan Electric Transmission Company,
LLC under Section 204 of the Federal Power Act and Part 34 of the
Commission's Regulations.
    Filed Date: 4/27/17.
    Accession Number: 20170427-5585.
    Comments Due: 5 p.m. ET 5/18/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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>.

    Dated: May 1, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-09115 Filed 5-4-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Notices]
[Pages 46974-46975]
[FR Doc No: 2017-21678]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-2577-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; York Haven
Power Company, LLC

    This is a supplemental notice in the above-referenced proceeding of
York Haven Power Company, 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 October 23, 2017.
    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: October 2, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-21678 Filed 10-6-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 27001-27002]
[DOCID:fr12my08-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0281]

Pilot Program to Evaluate Proposed Name Submissions; Concept
Paper; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comments.

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SUMMARY:  The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) of the Food and
Drug Administration (FDA) are announcing a public technical meeting in
preparation for a pilot program to enable pharmaceutical firms to
evaluate proposed propriety names and submit the data generated from
those evaluations to FDA for review. The purpose of the public
technical meeting is to discuss a concept paper that describes the
logistics of the pilot program, proposed recommendations for carrying
out a proprietary name review, and the way FDA intends to review
submissions made under the pilot program. FDA plans to formally issue
the concept paper by the end of fiscal year (FY) 2008 and expects to
begin enrollment in the pilot program in FY 2009.

DATES:  The public meeting will be held on June 5 and 6, 2008, from
8:30 a.m. to 5 p.m. each day. Register to make a presentation at the
meeting by May 23, 2008. See section III of this document for
information on how to attend or present at the meeting. Submit any
written or electronic comments regarding the concept paper and pilot
program by July 7, 2008.

ADDRESSES:  The public meeting will be held at the Crowne Plaza Hotel,
877 Georgia Ave., Silver Spring, MD 20910 (Metro: Silver Spring Station
on the Red Line). Submit written or electronic requests to make a
presentation at the meeting to Lana Pauls (see FOR FURTHER INFORMATION
CONTACT). A draft concept paper will be available soon.
    Comment Submissions: Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Lana Pauls, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796-
0518, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Institute of Medicine (IOM) in its 2006 report ``Preventing
Medication Errors'' noted that ``[i]n particular, drug names that look
or sound alike increase the risk of medication errors.'' FDA also has
determined that many of the medication errors reported to the agency
result from proprietary names that look or sound like the names of
other medical products. Reducing the potential for medication errors
due to proprietary name confusion is part of FDA's ongoing medical
product risk management effort. In 2003, FDA held two public meetings
that explored many of the issues involved in proprietary name review:
     The June 26, 2003, public meeting on ``Minimizing
Medication Errors--Methods for Evaluating Proprietary Names for Their
Confusion Potential,'' Docket No. 2002N-0201 (68 FR 32529, May 30,
2003). Information about the meeting is available at http://
www.fda.gov/cder/meeting/drugNaming.htm.
     The December 4, 2003, meeting of the Drug Safety and Risk
Management Advisory Committee (68 FR 65075, November 18, 2003).
Transcripts, presentations, and materials from the meeting are
available at http://www.fda.gov/ohrms/dockets/ac/
cder03.html#DrugSafetyRiskManagement.
    FDA reviews proprietary names from both promotional and safety
perspectives. The promotional review of proposed names considers
whether the name functions to overstate the efficacy, minimize the
risk, broaden the indication, make unsubstantiated superiority claims
for the product, or is overly fanciful. The safety review of a proposed
name is based on the findings of a Failure Modes and Effects Analysis
of the proprietary name, and is focused on the avoidance of medical
errors. FDA not only considers the potential for a name to be spelled
similarly and/or sound similar to a currently marketed product or one
that is in the approval pipeline, but also considers the potential for
the proposed name to inadvertently function as a source of error for
reasons other than look and sound-alike name confusion, for instance
whether the abbreviation for the drug would be similar to the
abbreviation of another drug product.
    Consideration also is given to the proposed product's
characteristics including its intended use, dosage form and strength,
and route of administration, because the product characteristics
provide a context for communication of the product name and ultimately
determine the use of the product in the usual clinical practice
setting. In addition, because product-name confusion can occur at any
point in the medication use process, FDA considers the potential for
confusion throughout the process, including product procurement,
prescribing and ordering, dispensing, administration, and monitoring
the impact of the medication.
    Currently, the data generated to access this information is
internal to FDA. However, there have been a number of calls for
industry to become involved in the name testing process including

IOM's 2006 report, IOM's 1999 report ``To Err is Human,''
Recommendation 238 from the HHS Advisory Committee on
Regulatory Reform's November 21, 2002 report, and, most recently, in
the Prescription Drug User Fee Act (PDUFA IV) performance goals.
    In Title I of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85), Congress reauthorized and expanded
the Prescription Drug User Fee program for FY 2008 through FY 2012
(PDUFA IV). As part of the performance goals and procedures set forth
in an enclosure to the letter from the Secretary of the Health and
Human Services referred to in section 101(c) of FDAAA, FDA agreed to
publish a concept paper on and implement a pilot program to enable
pharmaceutical firms participating in the pilot to evaluate proposed
proprietary names and submit the data generated from those evaluations
to FDA for review. This process is consistent with other areas of drug
review in which FDA evaluates data generated by firms rather than
producing such data independently. FDA intends the concept paper to
provide transparency to the FDA review processes, as well as to provide
a consistent, scientific approach to the review of proprietary names
data. FDA agreed to conduct a public meeting to discuss the content of
the concept paper, which will describe the logistics of the pilot
program, proposed recommendations for carrying out a proprietary name
review, and the way FDA intends to review submissions made under the
pilot program. FDA is developing the concept paper, which contains its
current thinking on the logistics of the pilot and name testing and
evaluation under the pilot. The concept paper will be available at the
Division of Dockets Management and on the Internet prior to the meeting
(see ADDRESSES). FDA welcomes written and electronic comments on the
draft concept paper before and after the public meeting (see section IV
of this document).

II. Scope of Public Meeting

    At the public meeting, FDA will present its current thinking on
proprietary name review testing and the proposed pilot program, and
will solicit feedback from industry, patient safety groups, academics,
health care professionals, other governmental agencies, and the public.
The meeting will include panel discussions and individual and/or joint
presentations. Some of the key questions that will be considered at the
meeting include, but are not limited to, the following:
    1. What are best practices in safety and promotional testing of
proprietary names? What are the limitations of current methods and how
may they be overcome?
    2. What combination of tests should be undertaken and what data
should be submitted by sponsors participating in the pilot? Discussion
of testing procedures should focus on advances in the field of name
testing since the 2003 public meetings (e.g., improvements in test
design, accuracy, and validation, as well as use of practitioner input
in the range of clinical settings in which drugs are procured,
prescribed, prepared/dispensed, administered, and monitored).
    3. How should testing be standardized to achieve valid, reliable
results across studies?
    4. What criteria should FDA consider in evaluating the testing done
and the data submitted?
    5. How should the pilot program be structured and evaluated?
    6. Are there any public health concerns raised by the pilot program
and how should they be addressed?
    Speakers who wish to present material in the public meeting must
register before the meeting (see section III of this document). Time
will be allowed for questions and answers after each panel discussion.
    Information gathered from the meeting and from comments submitted
to the docket will be used to develop the final concept paper. FDA
intends to publish the final concept paper by the end of FY 2008 and
expects to begin enrollment in the pilot in FY 2009.

III. Attendance and Registration

    There is no fee to attend the meeting, and attendees who do not
wish to make an oral presentation do not need to register. Seating will
be on a first-come, first-served basis.
    If you would like to make an oral presentation during the meeting,
you must register and provide an abstract of your presentation by close
of business on May 23, 2008. You must provide your name, title,
business affiliation (if applicable), address, telephone and fax
numbers, and e-mail address to Lana Pauls (see FOR FURTHER INFORMATION
CONTACT). You should identify the topic or section of the draft concept
paper you wish to address in your presentation, whether you wish to
address comments on day one or day two, and the approximate time
requested for your presentation. FDA has identified topics of special
interest in section II of this document and is posting a draft concept
paper and agenda on the Internet (see ADDRESSES). The Centers may
change the time allotted depending on the number of people requesting
to present. Individuals and organizations with common interests are
urged to consolidate or coordinate their presentations and to request
time for a joint presentation. Persons registered to make an oral
presentation should check in before the meeting. If you need special
accommodations because of disability, please contact Lana Pauls (see
FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding issues and
questions presented in the concept paper or at the meeting. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: May 6, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10513 Filed 5-9-08; 8:45 am]

BILLING CODE 4160-01-S