[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52815-52817]
[FR Doc No: 2015-21551]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75762; File No. 600-35]

Notice of Filing and Request for Comment on Chicago Mercantile
Exchange Inc.'s Request To Withdraw From Registration as a Clearing
Agency

August 26, 2015.

I. Introduction

    Pursuant to Section 19(a)(3) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ on August 3, 2015, Chicago Mercantile Exchange
Inc. (``CME'') filed with the Securities and Exchange Commission
(``Commission'') a written request (the ``Written Request'') to
withdraw from registration as a clearing agency under Section 17A

of the Exchange Act.\2\ The Commission is publishing this notice to
solicit comments from interested persons concerning CME's request.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(a)(3).
    \2\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

II. Description

    The statements in this Item II concerning the background of CME's
request for withdrawal from registration and its reasons for making the
request have been submitted by CME in its Written Request. CME is
registered as a derivatives clearing organization (``DCO'') with the
Commodity Futures Trading Commission (``CFTC'') and offers clearing
services for futures and swap products. Pursuant to Section 17A(l) of
the Exchange Act,\3\ CME became deemed registered as a clearing agency
solely for the purpose of clearing security-based swaps (``SBS''). To
date, CME has never cleared SBS, has decided that it will not clear
SBS, and has filed a rule change with the Commission (File Number SR-
CME-2014-49) reflecting CME's decision not to clear SBS.\4\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78q-1(l).
    \4\ See Securities Exchange Act Release No. 73615 (Nov. 17,
2014), 79 FR 69545 (Nov. 21, 2014) (SR-CME-2014-49). The only
exception is with respect to a set of very limited circumstances
where single-name CDS contracts are created following the occurrence
of a restructuring credit event in respect of a reference entity
that is a component of an iTraxx Europe index CDS contract (``iTraxx
Contract''). According to the standard terms of the iTraxx Contract,
upon the occurrence of a restructuring credit event with respect to
a reference entity that is a component of an iTraxx Contract, such
reference entity will be ``spun out'' and maintained as a separate
single-name CDS contract (a ``Restructuring European Single Name CDS
Contract'') until settlement. If neither of the counterparties
elects to trigger settlement, the positions in the Restructuring
European Single Name CDS Contract will be maintained at CME until
maturity of the index or the occurrence of a subsequent credit event
for the same reference entity. CME stated that the clearing of
Restructuring European Single Name CDS Contracts would be a
necessary byproduct of clearing iTraxx Contracts, which commenced on
February 2, 2015. CME has filed a rule change that will not permit
market participants to increase, close out, or otherwise affect the
size of a position in a Restructuring European Single Name CDS
Contract, unless such increase, close-out, or change in size of a
position in a Restructuring European single Name CDS Contract is due
to (i) the occurrence of a credit event (where the Restructuring
European Single Name CDS Contract needs to be settled and ceases to
exist), (ii) a default management process (where a member defaults
on its obligation to CME and CME needs to hedge and auction off the
member's portfolio in order to determine the loss amount, or to
transfer the defaulting member's customer positions to another
clearing member), (iii) close-out of a defaulting customer's
positions, or (iv) withdrawal from clearing membership by an
existing clearing member, all in accordance with the existing CME
rules. According to such rule change, CME may impose an increase or
decrease in the position of a Restructuring European Single Name CDS
contract only through its default management process under
applicable CME rules. See Securities Exchange Act Release No. 34-
74055 (Jan. 14, 2015), 80 FR 2991 (Jan. 21, 2014) (SR-CME-2015-001).
---------------------------------------------------------------------------

A. Background

    CME. CME states in the Written Request that it is registered with
the CFTC as a designated contract market. CME, which is also registered
with the CFTC as a DCO, operates CME Clearing. CME Clearing is one of
the world's leading central counterparty clearing providers and acts as
the guarantor of every transaction that happens in CME's markets. CME
Clearing offers clearing and settlement services for exchange-traded
contracts as well as for over-the-counter derivatives transactions. CME
Clearing also limits accumulation of losses or debt with twice daily
mark-to-market settlement, and is responsible for settling trading
accounts, clearing trades, collecting and maintaining performance bond
funds, regulating delivery, and reporting trading data.
    Clearing Agency Exemption. On March 23, 2009, the Commission
granted CME a temporary conditional exemption from the requirement to
register as a clearing agency under Section 17A of the Exchange Act
solely to perform the functions of a clearing agency for ``Cleared
CDS.'' \5\
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 34-59578 (Mar. 13,
2009), 74 FR 11781 (Mar. 19, 2009). The exemption was subsequently
extended. See Securities Exchange Act Release No. 34-61164 (Dec. 14,
2009), 74 FR 67258, (Dec. 18, 2009), Securities Exchange Act Release
No. 34-61803 (Mar. 30, 2010), 75 FR 17181, (Apr. 5, 2010), and
Securities Exchange Act Release No. 34-63388 (Nov. 29, 2010), 75 FR
75522 (Dec. 3, 2010).
---------------------------------------------------------------------------

    Dodd-Frank Act. Section 763(b) of the Dodd-Frank Wall Street Reform
and Consumer Protection Act of 2010 (``Dodd-Frank Act'') \6\ added
Section 17A(l) to the Exchange Act,\7\ which provides, in relevant
part, that a DCO registered with the CFTC that is required to register
under Section 17A is deemed to be registered under Section 17A solely
for the purpose of clearing SBS to the extent that, before the date of
enactment of Section 17A(l), the DCO cleared swaps pursuant to an
exemption from registration as a clearing agency. Pursuant to Section
17A(l), CME became a registered clearing agency solely for the purpose
of clearing SBS.\8\
---------------------------------------------------------------------------

    \6\ The Dodd-Frank Wall Street Reform and Consumer Protection
Act, Public Law 111-203, 124 Stat. 1376 (2010).
    \7\ 15 U.S.C. 78q-1(l).
    \8\ See Securities Exchange Act Release No. 69284 (Apr. 3,
2013), 78 FR 21046, 21047, n. 20 (Apr. 9, 2013).
---------------------------------------------------------------------------

    CME states in the Written Request that although it originally
anticipated that it would begin clearing SBS, it has not, in fact,
cleared SBS since the effective date of the Dodd-Frank Act, and does
not engage in any clearing agency activity for SBS or any other
security. On November 17, 2014, CME filed a rule change with the
Commission reflecting its decision not to clear SBS and remove any
provisions in its rulebook applicable to SBS.\9\
---------------------------------------------------------------------------

    \9\ See supra note 4.
---------------------------------------------------------------------------

    As a registered clearing agency, CME is required to comply with the
requirements of the Exchange Act and the rules and regulations
thereunder applicable to registered clearing agencies. These
requirements include the obligation to file proposed rule changes
pursuant to Section 19(b) of the Exchange Act.\10\ CME, as a DCO,
generally implements rule changes by self-certifying that the new rule
complies with the Commodity Exchange Act and the CFTC's regulations.
For purpose of the Commodity Exchange Act and regulations thereunder,
this self-certification process allows new rules and rule amendments to
become effective ten business days after the date on which the CFTC
receives the certification. CME notes that, while some proposed rule
changes may become effective upon filing pursuant to Section
19(b)(3)(A) of the Exchange Act,\11\ and Rule 19b-4(f) thereunder,\12\
others are required to go through a notice-and-comment period, pursuant
to Section 19(b)(2),\13\ before the Commission takes action on the
proposed rule change. CME states that this process can significantly
delay the date that the rule change becomes fully effective. CME claims
that, despite the absence of SBS clearing activity by CME, these
overlapping but divergent rule review processes have in fact resulted
in significant difficulties for CME.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b).
    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
    \13\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

B. Withdrawal of CME Pursuant to Section 19(a)(3) of the Exchange Act

    Following the effectiveness of the proposed rule change (SR-CME-
2014-49) regarding CME's decision not to clear SBS, CME has been filing
proposed rule changes pursuant to Section 19(b)(3)(A) of the Exchange
Act \14\ and Rule 19b-4(f)(4)(ii) \15\ thereunder, rendering those
changes immediately effective. Nonetheless, CME states in the Written
Request that given the absence of any actual or potential securities
clearing activity by CME, with the exception of the limited clearing
activities CME may need to provide in connection with

Restructuring European Single Name CDS Contracts,\16\ CME believes that
clearing agency registration is unwarranted and unnecessary. CME
therefore submits its request for withdrawal of its clearing agency
registration pursuant to Section 19(a)(3) of the Exchange Act \17\ and
respectfully requests that the Commission grant CME's request.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(4)(ii).
    \16\ CME recognized that, as noted in SR-CME-2014-49, CME could
be required to clear SBS in limited circumstances relating to its
clearing services of certain iTraxx Europe index untranched CDS
contracts. See supra note 4. CME has submitted a request to the
Division of Trading and Markets for no-action relief to address the
clearing of such SBS contracts.
    \17\ 15 U.S.C. 78s(a)(3).
---------------------------------------------------------------------------

    CME further states that if an affiliate of CME seeks to clear SBS
or another securities product, such affiliate would do so after
registering with the Commission pursuant to the process set forth in
Commission Rule 17Ab2-1.\18\ CME represents in the Written Request that
it will not seek to engage in securities clearing activity in reliance
on any ``deemed registered'' status pursuant to Section 17A(l) of the
Exchange Act.\19\
---------------------------------------------------------------------------

    \18\ 17 CFR 240.17Ab2-1.
    \19\ 15 U.S.C. 78q-1(1).
---------------------------------------------------------------------------

    Additionally, CME states that because CME never conducted any
clearing activity for SBS, it has no known or anticipated claims
associated with its clearing agency registration. Furthermore, CME
represents in the Written Request that it will maintain all documents,
books, and records, including correspondence, memoranda, papers,
notices, accounts and other records (collectively ``records'') made or
received by it in connection with proposed rule changes filed with the
Commission or in connection with its index CDS clearance and settlement
services as required to be maintained under Rule 17a-1(a) and (b).\20\
In the Written Request, CME further represents that it will produce
such records and furnish such information at the request of any
representative of the Commission, and will maintain such records for a
period of 5 years from the effective date of the withdrawal of CME's
registration as a clearing agency.
---------------------------------------------------------------------------

    \20\ 17 CFR 240.17a-1(a) and (b).
---------------------------------------------------------------------------

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the requested
withdrawal is consistent with the Exchange 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/other.shtml), or
     Send an email to<EMAIL_ADDRESS>Please include
File No. 600-35 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 600-35. 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/other.shtml).
Comments are also 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.
    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 600-35 and should be
submitted on or before September 22, 2015.

    By the Commission.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-21551 Filed 8-31-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Page 28156]
[FR Doc No: 2017-12898]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold a closed meeting on Thursday, June 22,
2017 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matters at the closed meeting.
    Chairman Clayton, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed; please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 15, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-12898 Filed 6-16-17; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Notices]
[Page 10196]
[DOCID:fr07mr07-74]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-182-000]

Honeoye Storage Corporation; Notice Of Proposed Change In FERC
Gas Tariff

February 27, 2007.
    Take notice that on February 23, 2007, Honeoye Storage Corporation
(Honeoye) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume 1A, the following tariff sheets, to be effective April
1, 2007.

Second Revised Sheet No. 3
First Revised Sheet No. 5
First Revised Sheet No. 6
Third Revised Sheet No. 22
First Revised Sheet No. 69
First Revised Sheet No. 74
Second Revised Sheet No. 77
Second Revised Sheet No. 98
Second Revised Sheet No. 99
Original Sheet No. 99A
First Revised Sheet No. 100
Second Revised Sheet No. 106
First Revised Sheet No. 124
Second Revised Sheet No. 130

    Honeoye states that copies of the filing are being mailed to
Honeoye's jurisdictional customers and interested state regulatory
agencies.
    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 and 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    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<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3970 Filed 3-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14811-14813]
[FR Doc No: 2012-6040]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0022]

Draft Guidance for Industry on Direct-to-Consumer Television
Advertisements--the Food and Drug Administration Amendments Act of 2007
Direct-to-Consumer Television Ad Pre-Dissemination Review Program;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Direct-to-
Consumer Television Advertisements--FDAAA DTC Television Ad Pre-
Dissemination Review Program.'' This draft guidance is intended to
assist sponsors of human prescription drug products, including
biological drug products, who are subject to the pre-dissemination
review of television advertisements (TV ads) provision of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre-
dissemination review'' is used throughout the guidance to refer to
review under the FD&C Act, which is entitled ``Prereview of Television
Advertisements.'') The draft guidance describes which TV ads FDA
intends to make subject to this provision, explains how FDA will notify
sponsors that an ad is subject to review under this provision, and
describes the general and center-specific procedures sponsors should
follow to submit their TV ads to FDA for pre-dissemination review in
compliance with the FD&C Act. These proposed TV ads will be subject to
a 45-calendar day review clock by FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 14, 2012. Submit written comments on the proposed
collection of information by May 14, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs:
Marci Kiester, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3368, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding prescription human biological products: Stephen Ripley,
Center for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike,

suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Direct-to-Consumer Television Advertisements--FDAAA DTC
Television Ad Pre-Dissemination Review Program.'' The Food and Drug
Administration Amendments Act of 2007 (FDAAA) added new section 503B to
the FD&C Act, which gives FDA the authority to ``* * * require the
submission of any television advertisement for a drug * * * not later
than 45 days before dissemination of the television advertisement.'' In
conducting a review of a TV ad under this section, FDA may make
recommendations with respect to information included in the label of
the drug on:
     Changes that are necessary to protect the consumer good
and well-being, or that are consistent with prescribing information for
the product under review; and
     Statements for inclusion in the advertisement to address
the specific efficacy of the drug as it relates to specific population
groups, including elderly populations, children, and racial and ethnic
minorities, if appropriate and if such information exists. (21 U.S.C.
353b(b)(1) and (b)(2)).
    FDA is issuing this guidance to communicate the categories of TV
ads it generally intends to require sponsors to submit under this
provision, to explain how it will notify sponsors that FDA is requiring
review under section 503B of the FD&C Act for ads for a particular drug
or group of drugs, and to provide sponsors with recommendations for the
information they need to properly submit these ads to the Agency for
pre-dissemination review.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on which TV ads
it intends to require be submitted under section 503B of the FD&C Act
and on the submission process for these ads. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, 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.
    FDA estimates the burden of this collection of information as
follows:
    Based on the number of TV ads produced annually by sponsors of
human prescription drug and biological products, we estimate that we
will receive approximately 80 ads per year for pre-dissemination review
from approximately 30 sponsors for the Center for Drug Evaluation and
Research (CDER) and 2 ads from 2 sponsors for CBER. FDA professionals
familiar with TV ads and the recommendations in the draft guidance
estimate that it should take a sponsor approximately 25 hours to
prepare and send the pre-dissemination review package and
documentation. This burden estimate includes all of the information
specified for CDER and CBER in the draft guidance section entitled
``Contents of a Complete Pre-Dissemination Review Package'' and in the
Appendix entitled ``Center-Specific Submission Procedures.''
    FDA cannot provide final comments on the acceptability of a TV ad
without reviewing a final recorded version in its entirety. However,
some sponsors may wish to receive comments from the Agency before
producing a final recorded version. Once the final recorded version is
produced, it should be submitted to the Agency for pre-dissemination
review. In this document, we have included in the table 1 burden
estimate for section 503B of the FD&C Act the time necessary to prepare
the final ad for submission.
    If FDA receives an incomplete submission package from a sponsor, we
will inform that sponsor and request a submission package that contains
the missing materials. We estimate that we will request a package
containing missing materials a total of 6 times from 6 different
sponsors annually, and that it will take each sponsor 5 hours to
prepare the resubmission with the missing materials. This resubmission
with missing materials is included in table 1 of this document.
    There is a 45-day review clock for TV ads submitted under section
503B. Under this review clock, FDA must notify the sponsor if the
Agency is not able to provide comments within a 45-day timeframe. When
a sponsor is notified by FDA that the Agency is not able to provide
comments, the sponsor should inform FDA whether it will disseminate the
TV ad without waiting for FDA comments, or wait for the Agency's
comments before disseminating the ad. We anticipate that we will be
able to review and comment on all TV ads submitted to the Agency within
the 45-day review clock timeframe, but for the purposes of this
collection of information, we are estimating that the Agency will be
unable to provide comments within the 45-day timeframe to one sponsor
for one TV ad per year. We estimate that the time needed for a sponsor
to prepare a letter informing FDA of its decision to disseminate or not
to disseminate the TV ad will be 1 hour.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. In the draft guidance, the
Agency has noted that sponsors subject to the section 503B pre-
dissemination review provision may revise their TV ads after receiving
comments from the Agency but before disseminating the ads, and may wish
to request additional comments under the voluntary submission process
delineated in Sec.  202.1(j)(4) (21 CFR 202.1(j)(4)). The collections
of information in Sec.  202.1(j)(4) have been approved under OMB
control number 0910-0686. For pre-dissemination review packages for
biological drug products under the purview of CBER, the Agency is
requesting a copy of the most current version of Form FDA 2253 to

accompany the TV ad submission package. This collection of information
for Form FDA 2253 has been approved under OMB control number 0910-0001.
    Therefore, we estimate the annual reporting burden as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
       Type of submission           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Advertisements prepared in                    32            2.56              82              25           2,050
 accordance with section 503B of
 the FD&C Act...................
Resubmissions of incomplete                    6               1               6               5              30
 submission packages............
45-Day review clock decision                   1               1               1               1               1
 letter.........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,581
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6040 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 172 (Thursday, September 7, 2017)]
[Notices]
[Pages 42340-42341]
[FR Doc No: 2017-18996]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-487-000]

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

    Take notice that on August 22, 2017, Columbia Gas Transmission, LLC
(Columbia), 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700,
filed in Docket No. CP17-487-000 and pursuant to sections 157.205 and
157.208 of the Commission's regulations, a prior notice under its
blanket certificate issued in Docket No. CP83-76-000 requesting
authorization to install facilities and appurtenances and to make other
modifications (Crawford Counterstorage Project) at its existing
Crawford Compressor Station, located in Fairfield County, Ohio. The
project will increase the compression available for counterstorage at
its existing Crawford Storage Field, located in Hocking and Fairfield
Counties, Ohio, all as more fully set forth in the application, which
is on file with the Commission and open to public inspection. The
filing may also 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>.

    Columbia proposes to install one (1) Cat 3520/Ariel high-speed
reciprocating compressor unit, rated at 1,480 horsepower. Additionally,
Columbia proposes to designate as standby units two (2) existing
Waukesha reciprocating compressor units, rated at 250 hp each (Units 2
and 3), which are currently utilized for counterstorage compression.
The project will also involve the construction of a new compressor
building, new dehydration system, new gas cooler, new separators and
scrubbers, new control room building, and new station piping. The
project will result in an increase in counterstorage compression of 980
hp. The certificated physical parameters of the Crawford Storage Field
will remain unchanged by the proposed modifications. The estimated cost
of the project is approximately $20 million.
    Any questions regarding this application should be directed to
Robert D. Jackson, Manager, Certificates & Regulatory Administration,
Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 700,
Houston, Texas 77002-2700, at<PHONE_NUMBER> or FAX<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    Any person 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. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file 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 commenter's 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 commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, 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 original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time October 31, 2017.

    Dated: August 31, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-18996 Filed 9-6-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Page 61687]
[FR Doc No: 2011-25624]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX11-2-000]

City of College Station, TX; Notice of Filing

    Take notice that on September 27, 2011, pursuant to sections 210,
211, and 212 of the Federal Power Act, 16 USC 824i, 824j, and 824k,
Part 36 of the Federal Energy Regulatory Commission's (Commission)
Regulations, 18CFR 36.1, the City of College Station, TX filed an
application requesting that the Commission direct (1) Entergy Texas,
Inc. (ETI) to provide an interconnection located between ETI's College
Station Junction and College Station's Switch Station to be used only
during declared emergencies; and (2) direct ETI, in event of such
declared emergencies, to provide transmission service for power flows
within the transmission grid administered by the independent service
operator, the Electric Reliability Council of Texas, Inc., certified by
the Public Utility Commission of Texas to perform the functions set
forth in Section 39.151(a) of the Texas Public Utility Regulatory Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 pm Eastern Time on October 27, 2011.

    Dated: September 28, 2011
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-25624 Filed 10-4-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25278-25280]
[FR Doc No: 2022-09065]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0067]

Providing Submissions in Electronic Format--Postmarketing Safety
Reports; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports.'' This
guidance provides general information pertaining to electronic
submission of postmarketing safety reports (individual case safety
reports (ICSRs), attachments to ICSRs (ICSR attachments), and other
postmarketing safety reports) for certain human drugs, biological
products, and combination products. This guidance finalizes the revised
draft guidance entitled ``Providing Submissions in Electronic Format--
Postmarketing Safety Reports,'' issued in June 2014.

DATES: The announcement of the guidance is published in the Federal
Register on April 28, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2001-D-0067 for ``Providing Submissions in Electronic Format--
Postmarketing Safety Reports.'' Received comments 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    For information concerning human drug products: Suranjan De, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002,
240-402-0498.
    For information concerning human biological products: Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Providing Submissions in Electronic Format--Postmarketing
Safety Reports.'' This guidance provides general information pertaining
to electronic submission of postmarketing safety reports (ICSRs, ICSR
attachments, and other postmarketing safety reports) under the
following provisions:
     21 CFR 314.80 and 314.98 (regarding products with approved
new drug applications (NDAs) and abbreviated new drug applications
(ANDAs), respectively, including combination products or drug
constituent parts with approved NDAs or ANDAs)
     21 CFR 600.80 (regarding products with approved biologics
license applications (BLAs), including combination products or
biological product constituent parts with approved BLAs)
     21 CFR part 4, subpart B (requiring additional reports for
combination products with approved NDAs, ANDAs, or BLAs)
     21 CFR 310.305 (regarding prescription drug products
marketed for human use without approved NDAs or ANDAs, including
prescription drug products that are compounded by facilities registered
as outsourcing facilities under section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 353b))
     21 CFR 329.100 and section 760 of the FD&C Act (21 U.S.C.
379aa) (regarding nonprescription drug products marketed for human use
without approved NDAs or ANDAs)
    This guidance does not apply to the following: Vaccines, human
cells, tissues, and cellular tissue-based products regulated under
section 361 of the Public Health Service Act (42 U.S.C. 264), whole
blood or blood components, combination products with a drug or
biological product constituent part marketed under a device
application, or lot distribution reports.
    On June 10, 2014, FDA published a final rule (79 FR 33072) to amend
its postmarketing safety reporting regulations for human drug and
biological products to require that persons subject to mandatory
reporting requirements submit safety reports in an electronic format
that the Agency can process, review, and archive. Elsewhere in the June
10, 2014, Federal Register (79 FR 33220), FDA announced the
availability of a revised draft guidance entitled ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports,'' which
revised and replaced the draft guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Postmarketing
Individual Case Safety Reports,'' issued on June 12, 2008 (73 FR
33436). The guidance announced in this current notice finalizes the
June 10, 2014, revised draft guidance of the same title. The Agency
considered comments on the draft guidance while finalizing the
guidance. Generally, we revised the draft guidance to update and
clarify topics, such as: (1) Options for transmitting reports in
electronic format; (2) the notification that submitters will receive
when FDA has received the electronic postmarketing safety report; (3)
requesting temporary waivers from the electronic submission
requirement; and (4) information on the receipt date of electronic
submissions in the case of submission failure.
    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 ``Providing Submissions in Electronic
Format--Postmarketing Safety Reports.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 pertaining to postmarketing reporting
of adverse drug experiences, including periodic and followup reports,
have been approved under OMB control number 0910-0001. The collections
of information in 21 CFR part 207 pertaining to registration of
producers of drugs and listing of drugs in commercial distribution have
been approved under OMB control number 0910-0045. The collections of
information in 21 CFR parts 310, 314, and 600 pertaining to
postmarketing reporting of adverse drug experiences for drugs subject
to an NDA have been approved under OMB control number 0910-0291
(MedWatch Forms FDA 3500, 3500A, and 3500B). The collections of
information in 21 CFR parts 310 and 314 pertaining to: (1)
Postmarketing reporting of adverse drug experiences for drugs without
approved

NDAs and the collections of information and (2) the submissions
required by section 760 of the FD&C Act for nonprescription human drug
products marketed without an approved application have been approved
under OMB control number 0910-0230. The collections of information in
21 CFR part 600 for biological drug products have been approved under
OMB control number 0910-0308. The collections of information pertaining
to the electronic submission of adverse event reports in 21 CFR parts
310, 314, and 329 have been approved under OMB control number 0910-
0645. The collections of information pertaining to submissions required
for outsourcing facilities under section 503B of the FD&C Act have been
approved under OMB control number 0910-0800. The collections of
information in 21 CFR part 4 pertaining to postmarketing safety
information sharing by constituent part applicants for combination
products have been approved under OMB control number 0910-0834.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09065 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P