[Federal Register: October 15, 2008 (Volume 73, Number 200)]
[Notices]
[Page 61140-61143]
[DOCID:fr15oc08-106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Request for Nominations for Voting Members on Public Advisory
Panels or Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee, certain device panels of the
Medical Devices Advisory Committee, the National Mammography Quality
Assurance Advisory Committee, and the Technical Electronic Products
Radiation Safety Standards Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for current vacancies
and those that will or may occur through August 31, 2009.
    FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.

DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.

ADDRESSES: All nomination for membership should be sent electronically
to<EMAIL_ADDRESS>or by mail to Advisory Committee Oversight &
Management Staff (HF-4), 5600 Fishers Lane, rm. 15A-12, Rockville, MD
20857. Information about becoming a member on a FDA advisory committee
can also be obtained by visiting FDA's Web site at http://www.fda.gov/
oc/advisory/default.htm.

FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl., (MPN1), Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations of voting members for vacancies
listed as follows:

                                Table 1.
------------------------------------------------------------------------
                                         Current &
 Committee/Panel and Expertise Needed     Upcoming     Approximate Date
                                         Vacancies          Needed
------------------------------------------------------------------------
Dental Products Panel of the Medical              3  Immediately
 Devices Advisory Committee--dentists,
 engineers, and scientists who have
 expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering,
 and dental anatomy
------------------------------------------------------------------------
Medical Devices Dispute Resolution                1  Immediately
 Panel of the Medical Devices Advisory
 Committee--experts with broad, cross-
 cutting scientific, clinical,
 analytical, or mediation skills
                                                  1  October 1, 2008
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel of            3  November 1, 2008
 the Medical Devices Advisory
 Committee--otologists,
 neurotologists, audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices              3  January 1, 2009
 Panel of the Medical Devices Advisory
 Committee--transplant specialists,
 gastroenterologists, urologists, and
 nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices               2  September 1, 2009
 Panel of the Medical Devices Advisory
 Committee--surgeons (general,
 plastic, reconstructive, pediatric,
 thoracic, abdominal, pelvic, and
 endoscopic); dermatologists; experts
 in biomaterials, lasers, wound
 healing, and quality of life; and
 biostatisticians
------------------------------------------------------------------------
Hematology and Pathology Devices Panel            2  Immediately
 of the Medical Devices Advisory
 Committee--hematologists (benign and/
 or malignant hematology),
 hematopathologists (general and
 special hematology, coagulation and
 homeostasis, and hematological
 oncology), gynecologists with special
 interests in gynecological oncology,
 cytopathologists, and molecular
 pathologists with special interests
 in development of predictive and
 prognostic biomarkers
                                                  2  March 1, 2009
------------------------------------------------------------------------
Immunology Devices Panel of the                   1  Immediately
 Medical Devices Advisory Committee--
 persons with experience in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine
                                                  2  March 1, 2009
------------------------------------------------------------------------

Microbiology Devices Panel of the                 4  Immediately
 Medical Devices Advisory Committee--
 infectious disease clinicians, e.g.,
 pulmonary disease specialists,
 sexually transmitted disease
 specialists, pediatric infectious
 disease specialists, experts in
 tropical medicine and emerging
 infectious diseases, biofilm
 development; mycologists; clinical
 microbiologists and virologists;
 clinical virology and microbiology
 laboratory directors with expertise
 in clinical diagnosis and in vitro
 diagnostic assays, e.g.,
 hepatologists; molecular biologists
------------------------------------------------------------------------
Molecular and Clinical Genetics                   3  Immediately
 Devices Panel of the Medical Devices
 Advisory Committee--experts in human
 genetics and in the clinical
 management of patients with genetic
 disorders, e.g., pediatricians,
 obstetricians, neonatologists;
 individuals with training in inborn
 errors of metabolism, biochemical and/
 or molecular genetics, population
 genetics, epidemiology and related
 statistical training, and clinical
 molecular genetics testing (e.g.,
 genotyping, array CGH, etc.);
 individuals with experience in
 genetics counseling, medical ethics
 are also desired, and individuals
 with experience in ancillary fields
 of study will be considered
------------------------------------------------------------------------
Neurological Devices Panel of the                 2  Immediately
 Medical Devices Advisory Committee--
 neurosurgeons (cerebrovascular and
 pediatric), neurologists (stroke,
 pediatric, pain management, and
 movement disorders), interventional
 neuroradiologists, psychiatrists, and
 biostatisticians
                                                  2  December 1, 2008
------------------------------------------------------------------------
Obstetrics and Gynecology Devices                 3  Immediately
 Panel of the Medical Devices Advisory
 Committee--experts in perinatology,
 embryology, reproductive
 endocrinology, pediatric gynecology,
 gynecological oncology, operative
 hysteroscopy, pelviscopy,
 electrosurgery, laser surgery,
 assisted reproductive technologies,
 contraception, postoperative
 adhesions, and cervical cancer and
 colposcopy; biostatisticians and
 engineers with experience in
 obstetrics/gynecology devices;
 urogynecologists; experts in breast
 care; experts in gynecology in the
 older patient; experts in diagnostic
 (optical) spectroscopy; experts in
 midwifery; labor and delivery nursing
                                                  1  February 1, 2009
------------------------------------------------------------------------
Ophthalmic Devices Panel of the                   3  November 1, 2008
 Medical Devices Advisory Committee--
 ophthalmologists specializing in
 cataract and refractive surgery and
 vitreo-retinal surgery, in addition
 to vision scientists, optometrists,
 and biostatisticians practiced in
 ophthalmic clinical trials
------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices            3  Immediately
 Panel of the Medical Devices Advisory
 Committee--orthopedic surgeons
 (joint, spine, trauma, and
 pediatric); rheumatologists;
 engineers (biomedical, biomaterials,
 and biomechanical); experts in
 rehabilitation medicine, sports
 medicine, and connective tissue
 engineering; and biostatisticians
                                                  2  September 1, 2009
------------------------------------------------------------------------
Radiological Devices Panel of the                 2  February 1, 2009
 Medical Devices Advisory Committee--
 physicians with experience in general
 radiology, mammography, ultrasound,
 magnetic resonance, computed
 tomography, other radiological
 subspecialties and radiation
 oncology; scientists with experience
 in diagnostic devices, radiation
 physics, statistical analysis,
 digital imaging and image analysis
------------------------------------------------------------------------
National Mammography Quality Assurance            1  Immediately
 Advisory Committee--physicians,
 practitioners, or other health
 professionals whose clinical
 practice, research specialization, or
 professional expertise include a
 significant focus on mammography
                                                  3  February 1, 2009
------------------------------------------------------------------------
Device Good Manufacturing Practice                7  Immediately
 Advisory Committee--vacancies include
 three government representatives, two
 public representatives, and two
 health professionals
------------------------------------------------------------------------
Technical Electronic Product Radiation           15  Immediately
 Safety Standards Committee--vacancies
 include five government
 representatives, five industry
 representatives, and five general
 public representatives
------------------------------------------------------------------------

II. Functions

A. Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions of the Federal Food, Drug, and
Cosmetic Act (the act) for device advisory panels. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, performs the following duties: (1) Advises the
Commissioner of Food and Drugs (the Commissioner) regarding recommended
classification or reclassification of devices into one of three
regulatory categories, (2) advises on any possible risks to health
associated with the use of devices, (3) advises on formulation of
product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the act, (7) advises on the necessity to ban
a device, and (8) responds to requests from the agency to review and
make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to

the Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and agency guidance and policies. The panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or agency decisions or actions.

B. National Mammography Quality Assurance Advisory Committee

    The functions of the committee are to advise FDA on the following
topics: (1) Developing appropriate quality standards and regulations
for mammography facilities; (2) developing appropriate standards and
regulations for bodies accrediting mammography facilities under this
program; (3) developing regulations with respect to sanctions; (4)
developing procedures for monitoring compliance with standards; (5)
establishing a mechanism to investigate consumer complaints; (6)
reporting new developments concerning breast imaging, which should be
considered in the oversight of mammography facilities; (7) determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
(8) determining whether there will exist a sufficient number of medical
physicists after October 1, 1999, and (9) determining the costs and
benefits of compliance with these requirements.

C. Device Good Manufacturing Practice Advisory Committee

    The functions of the committee are to review proposed regulations
regarding good manufacturing practices governing the methods used in,
and the facilities and controls used for, manufacture, packaging,
storage, installation, and servicing of devices, and to make
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines developed to assist the medical
device industry in meeting the good manufacturing practice
requirements, and provides advice with regard to any petition submitted
by a manufacturer for an exemption or variance from good manufacturing
practice regulations.
    Section 520 of the act (21 U.S.C. 360(j)), as amended, provides
that the Device Good Manufacturing Practice Advisory Committee shall be
composed of nine members as follows: (1) Three of the members shall be
appointed from persons who are officers or employees of any Federal,
State, or local government; (2) two shall be representatives of the
interests of the device manufacturing industry; (3) two shall be
representatives of the interests of physicians and other health
professionals; and (4) two shall be representatives of the interests of
the general public. The agency will publish a separate notice
announcing the vacancies of two representatives of interests of the
device manufacturing industry.

D. Technical Electronic Product Radiation Safety Standards Committee

    The function of the committee is to provide advice and consultation
on the technical feasibility, reasonableness, and practicability of
performance standards for electronic products to control the emission
of radiation from such products. The committee may recommend electronic
product radiation safety standards for consideration.
    Section 534(f) of the act (21 U.S.C. 360kk(f)), as amended by the
Safe Medical Devices Act of 1990, provides that the Technical
Electronic Product Radiation Safety Standards Committee include five
members from governmental agencies, including State or Federal
Governments, five members from the affected industries, and five
members from the general public, of which at least one shall be a
representative of organized labor.

III. Qualifications

A. Panels of the Medical Devices Advisory Committee

    Persons nominated for membership on the panels should have
adequately diversified experience appropriate to the work of the panel
in such fields as clinical and administrative medicine, engineering,
biological and physical sciences, statistics, and other related
professions. The nature of specialized training and experience
necessary to qualify the nominee as an expert suitable for appointment
may include experience in medical practice, teaching, and/or research
relevant to the field of activity of the panel. The particular needs at
this time for each panel are listed in section I of this document. The
term of office is up to 4 years, depending on the appointment date.

B. National Mammography Quality Assurance Advisory Committee

    Persons nominated for membership should be physicians,
practitioners, and other health professionals, whose clinical practice,
research specialization, or professional expertise include a
significant focus on mammography and individuals identified with
consumer interests. Prior experience on Federal public advisory
committees in the same or similar subject areas will also be considered
relevant professional expertise.
    The particular needs at this time for this committee are listed in
section I of this document. The term of office is up to 4 years,
depending on the appointment date.

C. Device Good Manufacturing Practice Advisory Committee

    Persons nominated for membership as a health professional or
officer or employee of any Federal, State, or local government should
have knowledge of or expertise in any one or more of the following
areas: Quality assurance concerning the design, manufacture, and use of
medical devices. To be eligible for selection as a representative of
the general public, nominees should possess appropriate qualifications
to understand and contribute to the committee's work. The particular
needs at this time for this committee are listed in section I of this
document. The term of office is up to 4 years, depending on the
appointment date.

D. Technical Electronic Product Radiation Safety Standards Committee

    Persons nominated should be technically qualified by training and
experience in one or more fields of science or engineering applicable
to electronic product radiation safety. The particular needs at this
time for this committee are listed in section I of this document. The
term of office is up to 4 years, depending on the appointment date.

IV. Nomination Procedures

    Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations will
include complete curriculum vitae of each nominee, current business
address and telephone number. Nominations will specify the advisory
panel(s) or advisory committee(s) for which the nominee is recommended.
Nominations will include confirmation that the nominee is aware of the
nomination, is willing to serve as a member of the advisory committee
if selected, and appears to have no conflict of interest that would
preclude membership. Potential candidates will be required to provide
detailed information concerning such matters as financial holdings,
employment, and research grants and/or contracts to permit evaluation
of possible sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: October 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24358 Filed 10-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Page 20683]
[FR Doc No: 2021-08124]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL21-67-000]

Kentucky Municipal Energy Agency; Notice of Request for Partial
Waiver

    Take notice that on April 8, 2021, pursuant to section 292.402 of
the Federal Energy Regulatory Commission's (Commission) regulations, 18
CFR 292.402, Kentucky Municipal Energy Agency (KYMEA), on behalf of
itself and its authorizing member municipal electric utilities,\1\
submitted a request for partial waiver of certain obligations imposed
on KYMEA and its authorizing Members through the Commission's
regulations \2\ implementing Section 210 of the Public Utility
Regulatory Policies Act of 1978, as amended (PURPA),\3\ as more fully
explained in the request.
---------------------------------------------------------------------------

    \1\ The authorizing Members are: Barbourville Utility Commission
of the City of Barbourville, Kentucky; City of Bardwell, Kentucky;
Cities Utilities Commission of the City of Corbin, Kentucky;
Electric and Water Plant Board of the City of Frankfort, Kentucky;
City of Falmouth, Kentucky; City of Madisonville, Kentucky; City of
Paris, Kentucky; and City of Providence, Kentucky.
    \2\ 18 CFR 292.303(a) and .303(b).
    \3\ 16 U.S.C. 824a-3.
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern time on April 30, 2021.

    Dated: April 13, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-08124 Filed 4-20-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48433-48435]
[FR Doc No: 2018-20766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3344]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Reporting and Recordkeeping for Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 collection of information
associated with adverse event reporting and recordkeeping for dietary
supplements as required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (DSNDCPA).

DATES: Submit either electronic or written comments on the collection
of information by November 26, 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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 26, 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-2018-N-3344 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act.'' 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: Domini Bean, 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.

Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act

OMB Control Number 0910-0635--Extension

    The DSNDCPA (Pub. L. 109-462) amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) with respect to serious adverse event reporting
and recordkeeping for dietary supplements and non-prescription drugs
marketed without an approved application. Section 761(b)(1) of the FD&C
Act (21 U.S.C. 379aa-1) requires the manufacturer, packer, or
distributor whose name appears on the label of a dietary supplement
marketed in the United States to submit to us all serious adverse event
reports associated with the use of a dietary supplement, accompanied by
a copy of the product label. The manufacturer, packer, or distributor
of a dietary supplement is required by the DSNDCPA to use the MedWatch
form (Form FDA 3500A) when submitting a serious adverse event report to
FDA. In addition, section 761(c)(2) of the FD&C Act requires the
submitter of the serious adverse event report (referred to in the
statute as the ``responsible person'') to submit to FDA a followup
report of any related new medical information the responsible person
receives within 1 year of the initial report.
    Section 761(e)(1) of the FD&C Act requires that responsible persons
maintain records related to the dietary supplement adverse event
reports they receive, whether or not the adverse event is serious, for
a period of 6 years.
    As required by the DSNDCPA, we issued guidance to describe the
minimum data elements for serious adverse event reports for dietary
supplements. The guidance entitled ``Guidance for Industry: Questions
and Answers Regarding Adverse Event Reporting and Recordkeeping for
Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act'' is available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. It discusses how,
when, and where to submit serious adverse event reports for dietary
supplements and followup reports. The guidance also provides our
recommendation on records maintenance and access for serious and non-
serious adverse event reports and related documents.
    The guidance recommends that the responsible person document their
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and between the responsible person and any other
person(s) who provided information about the adverse event; (2) the
responsible person's serious adverse event report to us with
attachments; (3) any new information about the adverse event received
by the responsible person; and (4) any reports to us of new information
related to the serious adverse event report.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        21 U.S.C. section            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--serious             230              12           2,760               2           5,520
 adverse event reports for
 dietary supplements............
21 U.S.C. 379aa-1(c)(2)--                     58              12             696               1             696
 followup reports of new medical
 information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,216
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
annual decrease of 219 hours for reporting. We attribute this
adjustment to a decrease in the number of reports we received over the
last few years.
    This estimate is based on our experience with similar adverse event
reporting programs and the number of serious adverse event reports and
followup reports received in the past 3 years. All dietary supplement
manufacturers, packers, or distributors are subject to serious adverse
event mandatory reporting.
    In the past 3 years, we received an average of 2,760 initial
serious adverse event reports. We also estimated an average number of
firms filing reports to be 230. Finally, we estimate that it will take
respondents an average of 2 hours per report to collect information
about a serious adverse event associated with a dietary supplement and
report the information to us on Form FDA 3500A. Thus, the estimated
burden associated with submitting initial dietary supplement serious
adverse event reports is 5,520 hours (2,760 responses x 2 hours) as
shown in row 1 of table 1.
    If a respondent that has submitted a serious adverse event report
receives new information related to the serious adverse event within 1
year of submitting the initial report, the respondent must provide the
new information to us in a followup report. We estimate that around 25
percent of serious adverse event reports related to dietary supplements
will have a followup report submitted, resulting in approximately 696
followup reports submitted annually. Dividing the annual number of
reports among the 230 firms reporting results in approximately 12
reports for 58 respondents. We estimate that each followup report will
require an hour to assemble and submit, including the time needed to
copy and attach the initial serious adverse event report as recommended
in the guidance. Thus, the estimated burden for followup reports of new
information is 696 hours (696 responses x 1 hour) as shown in row 2 of
table 1.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              21 U.S.C. section                  Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(e)(1))--dietary supplement           1,815              72         130,680  0.5 (30 minutes)..........................          65,340
 adverse events records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an
annual increase of 2,440 hours for recordkeeping. We attribute this
adjustment to an increase in the number of reports we received over the
last few years.
    All dietary supplement manufacturers, packers, or distributors are
subject to serious adverse event recordkeeping. We estimate that there
are 1,815 such respondents. Estimating that each recordkeeper will keep
approximately 72 records per year results in an annual burden of
130,680 records. Estimating that assembling and filing these records,
including any necessary photocopying, will take approximately 30
minutes, or 0.5 hour, per record, results in an annual burden of 65,340
hours (130,680 records x 0.5 hour).
    Once the documents pertaining to an adverse event report have been
assembled and filed in accordance with the safety reporting portal, we
expect the records retention burden to be minimal, as we believe most
establishments would normally keep this kind of record for at least
several years after receiving the report, as a matter of usual and
customary business practice.

    Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20766 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Page 63755]
[FR Doc No: 2016-22260]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-497-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on August 29, 2016, Columbia Gas Transmission, LLC
(Columbia), 5151 San Felipe, Suite 2500, Houston, Texas 77056, filed in
Docket No. CP16-497-000, a prior notice request pursuant to sections
157.205, 157.213, and 157.216 of the Commission's regulations under the
Natural Gas Act (NGA). Columbia seeks authorization to: (i) Convert a
storage well in Wayne County, Ohio from injection/withdrawal status to
observation status and abandon its associated pipeline and
appurtenances, and (ii) plug and abandon two storage wells, and their
associated appurtenances, located in Ashland, and Vinton Counties,
Ohio, respectively. Columbia proposes to perform these activities under
its blanket certificate issued in Docket No. CP83-76-000, all as more
fully set forth in the application which is on file with the Commission
and open to public inspection.
    The filing may be viewed on the web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
William A. Sala, Jr., Senior Counsel, Columbia Gas Transmission, LLC,
5151 San Felipe, Suite 2500, Houston, Texas 77056, or by calling (713)
386-3743 (telephone), or<PHONE_NUMBER> (fax<EMAIL_ADDRESS>    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: September 8, 2016.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-22260 Filed 9-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 249 (Friday, December 28, 2012)]
[Notices]
[Pages 76476-76477]
[FR Doc No: 2012-31143]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER13-251-001.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits tariff filing
per 35: Compliance Filing for APS Service Agreement No. 327-City of
Asuza to be effective 1/1/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5090.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-357-001.
    Applicants: Cirrus Wind 1, LLC.
    Description: Substitute MBR Tariff to be effective 12/6/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5025.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-428-001.
    Applicants: Pennsylvania Electric Company, PJM Interconnection,
L.L.C.
    Description: Penelec submits revised PJM SA No. 3440 to reflect
effective date of 12/14/2012 to be effective 12/14/2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5070.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-542-001.
    Applicants: Louisville Gas and Electric Company.
    Description: Louisville Gas and Electric Company submits tariff
filing per 35.17(b): Errata Attach M Rev to be effective 12/12/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5109.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-571-000.
    Applicants: Sierra Pacific Power Company.
    Description: Rate Schedule No. 64. Engineering Procurement
Construction Agmt-Mt Wheeler to be effective 12/17/2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5001.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-573-000.
    Applicants: CMS Energy Resource Management Company.
    Description: CMS ERM Company--MBR to be effective 12/19/2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5055.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-574-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Notice of Termination of Service Agreement No. 1742 to
be effective 12/31/2012 under ER13-574 Filing Type: 260.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5071.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-575-000.
    Applicants: Idaho Power Company.
    Description: AMPS, Associated Mountain Power System to be effective
12/21/2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5072.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-576-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Joint OATT Attachment K Phase One to be effective 1/
31/2013.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5141.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-577-000.
    Applicants: PacifiCorp.
    Description: BPA et al Malin Construction/Operation and O&M Trust
Agreements to be effective 9/22/2010.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5150.
    Comments Due: 5 p.m. ET 1/8/13.

    Docket Numbers: ER13-578-000.
    Applicants: Genesee Power Station Limited Partnership.
    Description: Genesee Power Station--MBR to be effective 12/19/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5000.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-579-000.
    Applicants: Grayling Generation Station Limited Partnership.
    Description: Grayling Generating Station--MBR to be effective 12/
20/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5012.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-580-000.
    Applicants: Dearborn Industrial Generation, L.L.C.
    Description: Dearborn Industrial Gen--MBR to be effective 12/20/
2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5020.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-581-000.
    Applicants: CMS Generation Michigan Power, LLC.
    Description: CMS Generation Michigan Power--MBR to be effective 12/
20/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5023.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-582-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Joint OATT Attachment K Phase Two to be effective 3/
31/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5024.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-583-000.
    Applicants: PJM Interconnection, L.L.C.

    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.15: Notice of Cancellation-First Revised SA Nos. 3156 & 3157 in Dkt
No. ER12-835-000 to be effective 12/5/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5086.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-584-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii: First Revised Service Agreement No. 3279; Queue No.
X1-046 to be effective 12/3/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5094.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-585-000.
    Applicants: New England Power Pool Participants Committee, ISO New
England Inc.
    Description: New England Power Pool Participants Committee submits
tariff filing per 35.13(a)(2)(iii: Rev to FCM Rules Rel to Cap Supply
Obl Bil and Rec Auc 1 of 2 to be effective 4/1/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5095.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER13-585-001.
    Applicants: New England Power Pool Participants Committee, ISO New
England Inc.
    Description: New England Power Pool Participants Committee submits
tariff filing per 35.17(b): Rev. to FCM Rules Rel to Cap Sup Obl Bil
and Rec Auc 2 of 2 to be effective 4/19/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5105.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER12-1932-003.
    Applicants: Franklin County Wind, LLC.
    Description: Franklin County Wind, LLC submits tariff filing per
35: FCW Market Based Rate Tariff--Compliance Filing to be effective 8/
1/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5064.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER12-1933-004.
    Applicants: Interstate Power and Light Company.
    Description: Interstate Power and Light Company submits tariff
filing per 35: IPL Market Based Rate Tariff--Compliance Filing to be
effective 8/1/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5065.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER12-1934-003.
    Applicants: Wisconsin Power and Light Company.
    Description: Wisconsin Power and Light Company submits tariff
filing per 35: WPL Market Based Rate Tariff--Compliance Filing to be
effective 8/1/2012.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5067.
    Comments Due: 5 p.m. ET 1/9/13.

    Docket Numbers: ER12-2302-001.
    Applicants: Midwest Independent Transmission System.
    Description: 12-18-12 SSR Compliance Filing to be effective 9/24/
2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5147.
    Comments Due: 5 p.m. ET 1/8/13.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES13-11-000.
    Applicants: Monongahela Power Company.
    Description: Application for Authorization under Section 204(a) of
the Federal Power Act to Issue Securities and Assume $73.5 Million
Promissory Note of FirstEnergy Service Company on behalf of Monongahela
Power Company.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5175.
    Comments Due: 5 p.m. ET 1/8/13.

    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: December 19, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-31143 Filed 12-27-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62590-62591]
[FR Doc No: 2015-26324]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76124; File No. SR-NYSEArca-2015-91]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change, as Modified by
Amendment No. 1, Amending the Exchange's Fee Schedule To Eliminate the
Sponsor Fee In Connection With Listing a New Derivative Securities
Product on the Exchange

October 9, 2015.
    Pursuant to Section 19(b)(1)\1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 5, 2015, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') 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 self-regulatory
organization. On October 8, 2015, the Exchange filed Amendment No. 1 to
the proposed rule change.\4\ The Commission is publishing this notice
to solicit comments on the proposed rule change, as modified by
Amendment No. 1, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ In Amendment No. 1, the Exchange represented that,
notwithstanding the elimination of the Sponsor Fee (as defined
herein), the Exchange will continue to be able to fund its
regulatory obligations.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the Exchange's Schedule of Fees and
Charges (``Fee Schedule'') to eliminate the $20,000 one-time
consultation fee when a first time sponsor, managing owner, general
partner or equivalent is listing a new Derivative Securities Product on
the Exchange. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of 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
    Currently, the Exchange's Schedule of Fees and Charges
(``Schedule'') provides that, where a first time sponsor, managing
owner, general partner or equivalent (``Sponsor'') lists a new
Derivative Securities Product \5\ on the Exchange, the Sponsor is
charged a one-time consulting charge of $20,000 (the ``Sponsor Fee'').
The Exchange originally implemented the Sponsor Fee in 2009 to
adequately compensate the Exchange for additional legal and business
resources to properly advise new Sponsors through the listing
process.\6\
---------------------------------------------------------------------------

    \5\ For the purposes of the Schedule, the term ``Derivative
Securities Products'' includes securities described in NYSE Arca
Equities Rules 5.2(j)(3) (Investment Company Units); 8.100
(Portfolio Depositary Receipts); 8.200 (Trust Issued Receipts);
8.201 (Commodity-Based Trust Shares); 8.202 (Currency Trust Shares);
8.203 (Commodity Index Trust Shares); 8.204 (Commodity Futures Trust
Shares); 8.300 (Partnership Units); 8.500 (Trust Units); 8.600
(Managed Fund Shares), and 8.700 (Managed Trust Securities).
    \6\ See Securities Exchange Act Release No. 60184 (June 29,
2009), 74 FR 32209 (July 7, 2009) (SR-NYSEArca-2009-52) (notice of
filing of proposed rule change to amend the schedule of fees and
changes for Exchange services).
---------------------------------------------------------------------------

    The Exchange proposes to amend the Fee Schedule to eliminate the
Sponsor Fee. The Exchange has determined to eliminate the Sponsor Fee
to permit the Exchange to better compete for listings of Derivative
Securities Products with other exchanges that do not impose a fee
similar to the Sponsor Fee. Elimination of the Sponsor Fee would
benefit Sponsors by providing a cost savings and by permitting them to
select their listing venue for a new Derivative Securities Product
based on level of service and without consideration of

whether a consulting fee would be charged.
    Listing Fees and Annual Fees applicable to Derivatives Securities
Products would remain unchanged.
2. Statutory Basis
    NYSE Arca believes that the proposal is consistent with Section
6(b) \7\ of the Act, in general, and Section 6(b)(4) \8\ of the Act in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its issuers and other
persons using its facilities. In addition, the Exchange believes the
proposal is consistent with the requirement under Section 6(b)(5) \9\
that an exchange have rules that are designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to, and perfect the
mechanism of a free and open market and, in general, to protect
investors and the public interest. The proposed elimination of the
Sponsor Fee is equitable and does not unfairly discriminate between
issuers because it would apply uniformly to all Sponsors. The Exchange
believes elimination of the Sponsor Fee is reasonable in that it
constitutes a reduction in fees for Sponsors. Notwithstanding the
elimination of the Sponsor Fee, the Exchange will continue to be able
to fund its regulatory obligations.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The Exchange believes the
proposed rule change would promote competition because it will permit
the Exchange to better compete with other exchanges that do not charge
a fee similar to the Sponsor Fee.

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 foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, 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-NYSEArca-2015-91 on the subject line.

Paper comments

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

All submissions should refer to File Number SR-NYSEArca-2015-91. 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 Number SR-NYSEArca-2015-91 and should
be submitted on or before November 6, 2015.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-26324 Filed 10-15-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57796-57797]
[FR Doc No: 2011-23829]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0100]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 of the Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated April 29, 2011, the Brownsville & Rio Grande
International Railroad (BRG) has

petitioned the Federal Railroad Administration (FRA) for a modification
to its waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR parts 232 and 215. FRA
assigned the petition Docket Number FRA-2010-0100.
    BRG seeks a modification to its waiver of compliance with certain
requirements of 49 CFR part 232, Brake System Safety Standards for
Freight and Other Non-Passenger Trains and Equipment; End-of-Train
Devices and 49 CFR part 215, Railroad Freight Car Safety Standards.
Presently, BRG's relief permits trains transferred by Union Pacific
Railroad (UP) (under Waiver Petition Docket Number FRA-2007-28340 from
the U.S./Mexico border interchange with the Kansas City Southern De
Mexico Railway (KCSM) at Brownsville, Texas) to move from BRG's
interchange point with UP at Milepost (MP) 4.48 to the BRG inspection
point between MP 8.0 and MP 9.0, where required FRA inspections are
performed. Occasionally, trains destined for interchange to BRG are
delayed at UP's Olmito Yard by additional Federal agency inspection
activities. BRG petitions for a modification to its present relief to
allow the railroad to pick up trains at Olmito Yard (in lieu of the
interchange point at MP 4.48). On those occasions, BRG would continue
to perform the required FRA inspections between MP 8.0 and MP 9.0 in
accordance with its present relief under FRA-2010-0100.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at http://www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Ave., 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 October 31, 2011 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 comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78), or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on September 13, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2011-23829 Filed 9-15-11; 8:45 am]
BILLING CODE 4910-06-P