[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]
[Page 58624-58625]
[DOCID:fr13no09-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER09-1729-000]

Conectiv Mid Merit, LLC; Notice of Filing

November 5, 2009.
    Take notice that, on November 4, 2009, Conectiv Mid Merit, LLC
filed an amendment to their application for market-based rate authority
filed on September 25, 2009 in the above-captioned docket, pursuant to
the Commissions' request. Such filing serves to reset the filing dates
in these proceedings.
    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 and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 25, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-27289 Filed 11-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78603-78605]
[FR Doc No: 2016-26933]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0743]

Medical Device Reporting for Manufacturers; Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Medical Device Reporting for
Manufacturers; Guidance for Industry and Food and Drug Administration
Staff.'' This guidance document is intended to assist medical device
manufacturers meet applicable reporting and recordkeeping requirements
for certain device-related adverse events and malfunctions.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-D-0743 for ``Medical Device Reporting for Manufacturers''.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Medical Device Reporting for Manufacturers'' to the Office of the
Center Director, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Isaac Chang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Medical device reporting under section 519(a) of the Federal Food
Drug, and Cosmetic Act (21 U.S.C. 360i(a)) provides a mechanism that
allows FDA and device manufacturers, user facilities, and importer of
medical devices to identify and monitor adverse events (deaths and
serious injuries) and certain malfunctions involving your medical
devices. The goal is to detect and correct problems in a timely manner.
This guidance updates FDA's policy and clarifies FDA's interpretations
of the regulatory requirements under part 803 (21 CFR part 803) and
includes a section on common reporting errors.
    The draft of this guidance was made available in the Federal
Register on July 9, 2013 (78 FR 41069), and the comment period closed
October 7, 2013. FDA reviewed and considered all public comments
received and revised the guidance as appropriate.
    This document supersedes the draft entitled, ``Medical Device
Reporting for Manufacturers; Guidance for Industry and Food and Drug
Administration Staff,'' dated July 9, 2013, and the previous guidance
on this topic, ``Medical Device Reporting for Manufacturers,'' issued
March 1997.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on medical device reporting. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Medical Device Reporting for
Manufacturers; Guidance for Industry and Food and Drug Administration
Staff'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1828 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809, regarding
labeling, have been approved under OMB control number 0910-0485; the
collections of information in part 803, regarding medical device
reporting, have been approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 806, regarding corrections
and removals, have been approved under OMB control number 0910-0359;
the collections of information in 21 CFR part 807, subpart E, regarding
premarket notification,

have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 812, regarding investigational device
exemptions, have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814, subparts A through E,
regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in 21 CFR part 820,
regarding quality system regulations, have been approved under OMB
control number 0910-0073; the collections of information regarding
MedWatch: The Food and Drug Administration Medical Products Reporting
Program have been approved under OMB control number 0910-0291; and the
collections of information regarding the Adverse Event Program for
Medical Devices (Medical Product Safety Network (MedSun)) have been
approved under OMB control number 0910-0471.

    Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26933 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10691-10692]
[FR Doc No: 2016-04348]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 19b-4(e) and Form 19b-4(e); SEC File No. 270-447, OMB
Control No. 3235-0504.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') is soliciting comments on the existing collection of
information provided for in Rule 19b-4(e) (17 CFR 240.19b-4(e)) under
the Securities Exchange Act of 1934 (15 U.S.C 78a et seq.) (the
``Act''). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 19b-4(e) permits a self-regulatory organization (``SRO'') to
list and trade a new derivative securities product without submitting a
proposed rule change pursuant to Section 19(b) of the Act (15 U.S.C.
78s(b)), so long as such product meets the criteria of Rule 19b-4(e)
under the Act. However, in order for the Commission to maintain an
accurate record of all new derivative securities products traded on the
SROs, Rule 19b-4(e) requires an SRO to file a summary form, Form 19b-
4(e), to notify the Commission when the SRO begins trading a new
derivative securities product that is not required to be submitted as a
proposed rule change to the Commission. Form 19b-4(e) should be
submitted within five business days after an SRO begins trading a new
derivative securities product that is not required to be submitted as a
proposed rule change. In addition, Rule 19b-4(e) requires an SRO to
maintain, on-site, a copy of Form 19b-4(e) for a prescribed period of
time.
    This collection of information is designed to allow the Commission
to maintain an accurate record of all new derivative securities
products traded on the SROs that are not deemed to be proposed rule
changes and to determine whether an SRO has properly availed itself of
the permission granted by Rule 19b-4(e). The Commission reviews SRO
compliance with Rule 19b-4(e) through its routine inspections of the
SROs.
    The respondents to the collection of information are SROs (as
defined by the Act), all of which are national securities exchanges. As
of January 2016, there are eighteen entities registered as national
securities exchanges with the Commission. The Commission receives an
average total of 2,088 responses per year, which corresponds to an
estimated annual response burden of 2,088 hours. At an average hourly
cost of $64, the aggregate related internal cost of compliance with
Rule 19b-4(e) is $133,632 (2,088 burden hours multiplied by $64/hour).

    Compliance with Rule 19b-4(e) is mandatory. Information received in
response to Rule 19b-4(e) shall not be kept confidential; the
information collected is public information.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: February 24, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-04348 Filed 2-29-16; 8:45 am]
 BILLING CODE 8011-01-P