[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11449-11454]
[FR Doc No: 2015-04379]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
2, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0014.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Investigational New Drug (IND) Regulations--21 CFR Part 312 (OMB
Control Number 0910-0014)--Extension

    FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in FDA regulations entitled ``Investigational
New Drug Application'' in part 312 (21 CFR part 312). Part 312
implements provisions of section 505(i) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) to issue regulations
under which the clinical investigation of the safety and effectiveness
of unapproved new drugs and biological products can be conducted.
    FDA is charged with implementing statutory requirements that drug
products marketed in the United States be shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the FD&C Act provides that a new drug
may not be introduced or delivered for introduction into interstate
commerce in the United States unless FDA has previously approved a new
drug application (NDA). FDA approves an NDA only if the sponsor of the
application first demonstrates that the drug is safe and effective for
the conditions prescribed, recommended, or suggested in the product's
labeling. Proof must consist, in part, of adequate and well-controlled
studies, including studies in humans, that are conducted by qualified
experts. The IND regulations establish reporting requirements that
include an initial application as well as amendments to that
application, reports on significant revisions of clinical investigation
plans, and information on a drug's safety or effectiveness. In
addition, the sponsor is required to give FDA an annual summary of the
previous year's clinical experience.
    Submissions are reviewed by medical officers and other Agency
scientific reviewers assigned responsibility for overseeing the
specific study. The IND regulations also contain recordkeeping
requirements that pertain to the responsibilities of sponsors and
investigators. The detail and complexity of these requirements are
dictated by the scientific procedures and human subject safeguards that
must be followed in the clinical tests of investigational new drugs.
    The IND information collection requirements provide the means by
which FDA can monitor the clinical investigation of the safety and
effectiveness of unapproved new drugs and biological products,
including the following: (1) Monitor the safety of ongoing clinical
investigations; (2) determine whether the clinical testing of a drug
should be authorized; (3) ensure production of reliable data on the
metabolism and pharmacological action of the drug in humans; (4) obtain
timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; and (8) obtain other
information pertinent to determining whether clinical testing should be
continued, and information related to the protection of human subjects.
Without the information provided by industry as required under the IND
regulations, FDA cannot authorize or monitor the clinical
investigations which must be conducted prior to authorizing the sale
and general use of new drugs. These reports enable FDA to monitor a
study's

progress, to assure subject safety, to assure that a study will be
conducted ethically, and to increase the likelihood that the sponsor
will conduct studies that will be useful in determining whether the
drug should be marketed and available for use in medical practice.
    There are two forms that are required under part 312:
    Form FDA-1571--``Investigational New Drug Application.'' A person
who intends to conduct a clinical investigation submits this form to
FDA. It includes the following information:
    (1) A cover sheet containing background information on the sponsor
and investigator;
    (2) A table of contents;
    (3) An introductory statement and general investigational plan;
    (4) An investigator's brochure describing the drug substance;
    (5) A protocol for each planned study;
    (6) Chemistry, manufacturing, and control information for each
investigation;
    (7) Pharmacology and toxicology information for each investigation;
and
    (8) Previous human experience with the investigational drug.
    Form FDA-1572--``Investigator Statement.'' Before permitting an
investigator to begin participation in an investigation, the sponsor
must obtain and record this form. It includes background information on
the investigator and the investigation, and a general outline of the
planned investigation and the study protocol.
    FDA is requesting OMB approval for the following reporting and
recordkeeping requirements in part 312.

I. Reporting Requirements

Section 312.2(e)--Requests for FDA advice on the applicability of part
312 to a planned clinical investigation.
Section 312.6--Labeling of an investigational new drug. Estimates for
the information collection in this requirement are included under Sec.
312.23(a)(7)(iv)(d).
Section 312.8--Charging for investigational drugs under an IND.
Section 312.10--Applications for waiver of requirements under part 312.
As indicated in Sec.  312.10(a), estimates for the information
collection in this requirement are included under Sec. Sec.  312.23 and
312.31. In addition, other waiver requests under Sec.  312.10 are
estimated in table 1.
Section 312.20(c)--Applications for investigations involving an
exception from informed consent under Sec.  50.24 (21 CFR 50.24).
Estimates for the information collection in this requirement are
included under Sec.  312.23.
Section 312.23--IND (content and format).
Section 312.23(a)(1)--Cover sheet FDA-1571.
Section 312.23(a)(2)--Table of Contents.
Section 312.23(a)(3)--Investigational plan for each planned study.
Section 312.23(a)(5)--Investigator's brochure.
Section 312.23(a)(6)--Protocols--Phase 1, 2, and 3.
Section 312.23(a)(7)--Chemistry, manufacturing, and control
information.
Section 312.23(a)(7)(iv)(a),(b),(c)--A description of the drug
substance, a list of all components, and any placebo used.
Section 312.23(a)(7)(iv)(d)--Labeling: Copies of labels and labeling to
be provided each investigator.
Section 312.23(a)(7)(iv)(e)--Environmental impact analysis regarding
drug manufacturing and use.
Section 312.23(a)(8)--Pharmacological and toxicology information.
Section 312.23(a)(9)--Previous human experience with the
investigational drug.
Section 312.23(a)(10)--Additional information.
Section 312.23(a)(11)--Relevant information.
Section 312.23(f)--Identification of exception from informed consent.
Section 312.30--Protocol amendments.
    Sec.  312.30(a)--New protocol
    Sec.  312.30(b)--Changes in protocol
    Sec.  312.30(c)--New investigator.
    Sec.  312.30(d)--Content and format.
    Sec.  312.30(e)--Frequency.
Section 312.31--Information amendments.
    Sec.  312.31(b)--Content and format.
    -- Chemistry, toxicology, or technical information.
Section 312.32--Safety reports.
    Sec.  312.32(c)(1)--Written reports to FDA and to investigators.
    Sec.  312.32(c)(2)--Telephone reports to FDA for fatal or life-
threatening experience.
    Sec.  312.32(c)(3)--Format or frequency.
    Sec.  312.32(d)--Followup submissions.
Section 312.33--Annual reports.
    Sec.  312.33(a)--Individual study information.
    Sec.  312.33(b)--Summary information.
    Sec.  312.33(b)(1)--Adverse experiences.
    Sec.  312.33(b)(2)--Safety report summary.
    Sec.  312.33(b)(3)--List of fatalities and causes of death.
    Sec.  312.33(b)(4)--List of discontinuing subjects.
    Sec.  312.33 (b)(5)--Drug action.
    Sec.  312.33 (b)(6)--Preclinical studies and findings.
    Sec.  312.33 (b)(7)--Significant changes.
    Sec.  312.33(c)--Next year general investigational plan.
    Sec.  312.33(d)--Brochure revision.
    Sec.  312.33(e)--Phase I protocol modifications.
    Sec.  312.33(f)--Foreign marketing developments.
Section 312.38(b) and (c)--Notification of withdrawal of an IND.
Section 312.41--Comment and advice on an IND. Estimates for the
information collection in this requirement are included under Sec.
312.23.
Section 312.42--Sponsor requests that a clinical hold be removed, and
submits a complete response to the issues identified in the clinical
hold order.
Section 312.44(c) and (d)--Opportunity for sponsor response to FDA when
IND is terminated.
Section 312.45(a) and (b)--Sponsor request for, or response to, an
inactive status determination of an IND.
Section 312.47--Meetings, including ``End-of-Phase 2'' meetings and
``Pre-NDA'' meetings.
Section 312.48--Dispute resolution. Estimates for the information
collection in this requirement are included under Sec.  312.47.
Section 312.53(c)--Investigator information. Investigator report (Form
FDA-1572) and narrative; Investigator's background information; Phase 1
outline of planned investigation and Phase 2 outline of study protocol.
Section 312.54(a) and (b)--Sponsor submissions concerning
investigations involving an exception from informed consent under Sec.
50.24.
    Sec.  312.55(b)--Sponsor reports to investigators on new
observations, especially adverse reactions and safe use. Only ``new
observations'' are estimated under this section; investigator brochures
are included under Sec.  312.23.
Section 312.56(b), (c), and (d)--Sponsor monitoring of all clinical
investigations, investigators, and drug safety; notification to FDA and
others.
Section 312.58(a)--Sponsor's submission of records to FDA on request.
Section 312.64--Investigator reports to the sponsor.
    Sec.  312.64(a)--Progress reports.
    Sec.  312.64(b)--Safety reports
    Sec.  312.64(c)--Final reports.
    Sec.  312.64(d)--Financial disclosure

reports.
Section 312.66--Investigator reports to institutional review board
(IRB). Estimates for the information collection in this requirement are
included under Sec.  312.53.
Section 312.70--Investigator disqualification; opportunity to respond
to FDA.
Section 312.83--Sponsor submission of treatment protocol. Estimates for
this requirement are included under Sec.  312.320.
Section 312.85--Sponsors conducting phase 4 studies. Estimates for the
information collection in this requirement are included under Sec.
312.23, and under Sec. Sec.  314.50, 314.70, and 314.81 in OMB control
number 0910-0001.
Section 312.110(b)--Requests to export an investigational drug.
Section 312.120--Submissions related to foreign clinical studies not
conducted under an IND.
Section 312.130--Requests for disclosable information in an IND and
from investigations involving an exception from informed consent under
Sec.  50.24.
Sections 312.310(b); 312.305(b)--Submissions related to expanded access
and treatment of an individual patient.
Section 312.310(d)--Submissions related to emergency use of an
investigational new drug.
Sections 312.315(c); 312.305(b)--Submissions related to expanded access
and treatment of an intermediate-size patient population.
Section 312.320--Submissions related to a treatment IND or treatment
protocol.

II. Recordkeeping Requirements

Section 312.52(a)--Transfer of obligations to a contract research
organization.
Section 312.57--Sponsor recordkeeping on the investigational drug.
Section 312.59--Sponsor recordkeeping of disposition of unused supply
of drugs. Estimates for the information collection in this requirement
are included under Sec.  312.57.
Section 312.62(a)--Investigator recordkeeping of disposition of drugs.
Section 312.62(b)--Investigator recordkeeping of case histories of
individuals.
Section 312.120(d)--Recordkeeping requirements for submissions related
to foreign clinical studies not conducted under an IND. Estimates for
the information collection in this requirement are included under Sec.
312.57.
Section 312.160(a)(3)--Records pertaining to the shipment of drugs for
investigational use in laboratory research animals or in vitro tests.
Section 312.160(c)--Shipper records of alternative disposition of
unused drugs.

    In the Federal Register of November 5, 2014 (79 FR 65663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 24 comments, however, these
comments did not address the information collection.
    FDA estimates the burden of this collection of information as
follows:

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   800            1                800              24          19,200
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              56            1.25              70              48           3,360
 investigational drug...........
312.10, Requests to waive a                   50            1.76              88              24           2,112
 requirement in part 312........
312.23(a) through (f), IND                 1,689            1.57           2,648           1,600       4,236,800
 content and format (including
 Form FDA 1571).................
312.30(a) through (e), Protocol            3,739            5.77          21,588             284       6,130,992
 amendments.....................
312.31 (b), Information                    4,537            3.39          15,377             100       1,537,700
 amendments.....................
312.32(c) and (d), IND Safety                755           24.28          18,332              32         586,624
 reports........................
312.33(a) through (f), IND                 2,877            2.76           7,953             360       2,863,080
 Annual reports.................
312.38(b) and (c), Notifications             862            1.54           1,328              28          37,184
 of withdrawal of an IND........
312.42, Sponsor requests that a              158            1.30             205             284          58,220
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    12            1                 12              16             192
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                   260            1.73             451              12           5,412
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                  225            1.86             419             160          67,040
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports            1,444            8.38          12,087              80         966,960
 submitted to the sponsor,
 including Form FDA 1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure. (Third party
 disclosure)....................
312.54(a), Sponsor submissions                 7            5                 35              48           1,680
 to FDA concerning
 investigations involving an
 exception from informed consent
 under 21 CFR 50.24.............
312.54(b), Sponsor notifications               7            1                  7              48             336
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).
 (Includes third party
 disclosure)....................
312.55(a), Investigator                      590            3.50           2,067              48          99,216
 brochures submitted by the
 sponsor to each investigator.
 (Third party disclosure).......

312.55(b), Sponsor reports to                590            3.50           2,067              48          99,216
 investigators on new
 observations, especially
 adverse reactions and safe use.
 (Third party disclosure).......
312.56(b),(c), and (d), Sponsor            3,584            6.52          23,355              80       1,868,400
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects.
 (Includes third party
 disclosure)....................
312.58(a), Sponsor's submissions              60            1                 60               8             480
 of clinical investigation
 records to FDA on request
 during FDA inspections.........
312.64, Investigator reports to            1,444            1              1,444              24          34,656
 the sponsor, including progress
 reports, safety reports, final
 reports, and financial
 disclosure reports. (Third
 party disclosure)..............
312.70, During the                             4            1                  4              40             160
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5),                     11           26.28             289              75          21,675
 Written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b), Submissions to FDA             1,414            8.63          12,198              32         390,336
 of ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Waiver requests                   35            2.34              82              24           1,968
 submitted to FDA related to the
 use of foreign clinical studies
 not conducted under an IND.....
312.130, Requests for                          3            1                  3               8              24
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b),                   228            1.76             401               8           3,208
 Submissions related to expanded
 access and treatment of an
 individual patient.............
312.310(d), Submissions related              410            2.19             899              16          14,384
 to emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                    44            7.07             311             120          37,320
 Submissions related to expanded
 access and treatment of an
 intermediate-size patient
 population.....................
312.320(b), Submissions related               12           12.67             152             300          45,600
 to a treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      19,134,039
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                       Table 2--Estimated Annual Recordkeeping Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for               335            1.50             503               2           1,006
 the transfer of obligations to
 a contract research
 organization...................
312.57, Sponsor recordkeeping              1,689            1              1,689             100         168,900
 showing the receipt, shipment,
 or other disposition of the
 investigational drug, and any
 financial interests............
312.62(a), Investigator                    1,444            1              1,444              40          57,760
 recordkeeping of the
 disposition of drugs...........
312.62(b), Investigator                    1,444            1              1,444              40          57,760
 recordkeeping of case histories
 of individuals.................
312.160(a)(3), Records                       547            1.40             782          * 0.50             391
 pertaining to the shipment of
 drugs for investigational use
 in laboratory research animals
 or in vitro tests..............
312.160(c), Shipper records of               547            1.40             782          * 0.50             391
 alternative disposition of
 unused drugs...................
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............         286,190
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* Thirty (30) minutes.

                          Table 3--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   217            1.18             255              24           6,120
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              20            1.50              30              48           1,440
 investigational drug...........
312.10, Requests to waive a                    2            1                  2              24              48
 requirement in part 312........
312.23(a) through (f), IND                   335            1.35             452           1,600         723,200
 content and format.............
312.30(a) through (e), Protocol              694            5.84           4,050             284       1,150,200
 amendments.....................
312.31(b), Information                        77            2.43             187             100          18,700
 amendments.....................
312.32(c) and (d), IND Safety                161            8.83           1,421              32          45,472
 reports........................
312.33(a) through (f), IND                   745            2.14           1,595             360         574,200
 Annual reports.................
312.38(b) and (c), Notifications             134            1.69             227              28           6,356
 of withdrawal of an IND........
312.42, Sponsor requests that a               67            1.30              87             284          24,708
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    34            1.15              39              16             624
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                    55            1.38              76              12             912
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                   88            1.75             154             160          24,640
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports              453            6.33           2,869              80         229,520
 submitted to the sponsor,
 including Form FDA-1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure.....................
312.54(a), Sponsor submissions                 1            1                  1              48              48
 to FDA concerning
 investigations involving an
 exception from informed consent
 under Sec.   50.24.............
312.54(b), Sponsor notifications               1            1                  1              48              48
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).....
312.55(a), Number of                         239            1.91             457              48          21,936
 investigator brochures
 submitted by the sponsor to
 each investigator..............
312.55(b), Number of sponsor                 243            4.95           1,203              48          57,744
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
312.56(b), (c), and (d), Sponsor             108            2.21             239              80          19,120
 notifications to FDA and others
 resulting from: (1) The
 sponsor's monitoring of all
 clinical investigations and
 determining that an
 investigator is not in
 compliance with the
 investigation agreements; (2)
 the sponsor's review and
 evaluation of the evidence
 relating to the safety and
 effectiveness of the
 investigational drug; and (3)
 the sponsor's determination
 that the investigational drug
 presents an unreasonable and
 significant risk to subjects...
312.58(a), Number of sponsor's                 7            1                  7               8              56
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
312.64, Number of investigator             2,728            3.82          10,411              24         249,864
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
312.70, During the                             5            1                  5              40             200
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5), Number              18            1                 18              75           1,350
 of written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........

312.120(b), Number of                        280            9.82           2,750              32          88,000
 submissions to FDA of
 ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Number of waiver                   7            2.29              16              24             384
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.130, Number of requests for              350            1.34             470               8           3,760
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b),                    78            1.08              84               8             672
 Number of submissions related
 to expanded access and
 treatment of an individual
 patient........................
312.310(d), Number of                         76            2.76             210              16           3,360
 submissions related to
 emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                     9            1                  9             120           1,080
 Number of submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population........
312.320(b), Number of                          1            1                  1             300             300
 submissions related to a
 treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,254,062
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                        Table 4--Estimated Annual Recordkeeping Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for                75            1.40             105               2             210
 the transfer of obligations to
 a contract research
 organization...................
312.57, Sponsor recordkeeping                335            2.70             904             100          90,400
 showing the receipt, shipment,
 or other disposition of the
 investigational drug, and any
 financial interests............
312.62(a), Investigator                      453            1                453              40          18,120
 recordkeeping of the
 disposition of drugs...........
312.62(b), Investigator                      453            1                453              40          18,120
 recordkeeping of case histories
 of individuals.................
312.160(a)(3), Records                       111            1.40             155          * 0.50              78
 pertaining to the shipment of
 drugs for investigational use
 in laboratory research animals
 or in vitro tests..............
312.160(c), Shipper records of               111            1.40             155          * 0.50              78
 alternative disposition of
 unused drugs...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         127,006
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* Thirty (30) minutes.

    Dated: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04379 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P


                 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET
                    Part II: Information Collection Detail

IMPORTANT:  A separate Part II must be completed for each Information Collection (IC) activity associated with the ICR.  If more than one Part II is required, create a separate Part II document for each IC.  For more information see OEI's ICR website at http://intranet.epa.gov/icrintra/.  There you will find information on completing this form (see OEI's ICRAS instructions under the Prepare an ICR tab) and information on how break your ICR into ICs (see OMB's ROCIS IC Q&A under the Download Guidance tab).
1. Title of Information Collection:  Federal Implementation Plans Under the Clean Air Act for Indian Reservations in ID, OR, and WA
2. Is this a common form?
  Yes
  No

(Select Yes to identify forms that EPA is willing to host for potential use by other Federal Agencies.)

3. Obligation to respond (check one):
       Voluntary
       Required to obtain or retain benefits
        Mandatory

Note: Only one selection may be made.  If multiple categories apply, you must create additional ICs to account for the burden associated with each category.
4. Frequency of reporting (only to be completed if there are reporting requirements, check all that apply):

  Hourly
  Daily
  Weekly
  Monthly
  Yearly
    Every Decade
    Quarterly
    Semi-Annually
  Biennially
  Once
  Occasionally
5.  CFR Citation(s) for the information collection under review (if applicable):

Title  Rule for non-Title V operating permits  Part  40  Section  49.139
Title              Part              Section
Title              Part              Section
Title              Part              Section
6. Information Collection Instruments/Forms (if applicable) :

Form Name:  Permit application
Form Number:  7630-9
URL (required if electronic) :  http://yosemite.epa.gov/R10/tribal.nsf/programs/farr-nontitleV
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Form Name:
Form Number:
URL (required if electronic) :
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Form Name:
Form Number:
URL (required if electronic) :
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Attach additional sheets if necessary.

Note: Instruments/Forms must be submitted/uploaded as a separate attachment.

7.  Federal Enterprise Architecture Business Reference Model:

Line of Business (check one) :                                                                         Subfunction (check one) :
  Environmental Management
  Environmental Monitoring and Forecasting
  Environmental Remediation
  Pollution Prevention and Control
  Health
  Illness Prevention
  Immunization Management
  Public Health Monitoring
  Health Care Services
  Consumer Health and Safety
  Natural Resources
  Water Resource Management
  Conservation, Marine and Land Management
  Recreational Resource Management and Tourism
  Agricultural Innovation and Services
Note: Most EPA ICRs will be aligned with the Environmental Management FEA Line of Business.  Other likely categories are also listed.  For a full listing of the FEA Business Reference Model categories and definitions, see: http://www.whitehouse.gov/omb/egov/documents/FY07_Ref_Model_Mapping_QuickGuide.pdf.
8. Privacy Act System of Records (if applicable) :

Title:
Federal Register Citation:    Volume                Page Number                Publication Date
9. Respondents

Total Number:  35
Small Entity Number:  7
Percentage of responses collected electronically:  0

Affected Public (check one) :

  Individuals or Households
  Private Sector (if private sector, check all that apply)
                  Business or other for-profit
                  Not-for-profit institutions
                  Farms
  State, Local, or Tribal Governments
  Federal Government

Note:  Only one selection may be made.  If multiple categories apply, you must create additional ICs to account for the burden associated with each category.  Selecting multiple subcategories within "Private Sector" will not affect then number of ICs required.
10. Frequency: How often on average will each respondent respond to the Information Collection?

Calculated Annual Frequency:  1
   (responses per respondent per year)

Calculated Annual Number of Responses:  35
  Year

  Hour
  Business hour
  Day
  Business Day
  Week
  Month
  Decade
  Quarter
  Half-year

Number of Respondents 1  per

11. Hour and Cost Burden: Enter the hours and cost (per response) broken out by reporting, record keeping, and third party disclosure:

                              Hours per Response
                           Total Annual Hour Burden
                               Cost per Response
                           Total Annual Cost Burden
Reporting
                                      20
                                      700

Recordkeeping
                                      30
                                     1050

Third Party Disclosure

Total
                                      50
                                     1750

IMPORTANT: "Cost per Response" and "Total Annual Cost Burden" should include Capital/Startup and O&M costs only.

12. Annual Responses and Burden Change

                                Total Requested
                       Program Change due to New Statute
                    Program Change due to Agency Discretion
                  Change due to Adjustment in Agency Estimate
                      Change due to Violation of the PRA
                              Currently Approved
Annual Responses
                                      35

                                       5

                                      30
Annual Hour Burden
                                     1750

                                     -750

                                     2500
Annual Cost Burden
                                       0

                                       0

                                       0


[Federal Register: December 5, 2005 (Volume 70, Number 232)]
[Notices]
[Page 72492-72493]
[DOCID:fr05de05-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52834; File No. SR-Phlx-2005-63]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change Relating to the Prohibition of
Trade Shredding

November 25, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, as amended, (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on October 25, 2005, the Philadelphia Stock Exchange,
Inc. (``Phlx'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(l).
    \2\ 17 CFR 240. 19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 707, Conduct Inconsistent with
Just and Equitable Principles of Trade, to prohibit members, member
organizations and persons associated with or employed by a member or
member organization from unbundling orders for execution for the
primary purpose of maximizing a monetary or like payment to the member,
member organization, or person associated with or employed by a member
or member organization.
    The text of the proposed rule change appears below. Additions are
in italics.
* * * * *

Rule 707 Conduct Inconsistent With Just and Equitable Principles of
Trade

    A member, member organization, or person associated with or
employed by a member or member organization shall not engage in conduct
inconsistent with just and equitable principles of trade.
    Commentary:
    .01 No Change
    .02 Without limiting the generality of Rule 707, it is conduct
inconsistent with just and equitable principles of trade for any
member, member organization, or person associated with or employed by a
member or member organization to engage in conduct that has the intent
or effect of unbundling equity securities orders for execution for the
primary purpose of maximizing a monetary or in-kind amount received by
the member, member organization, or person associated with or employed
by a member or member organization as a result of the execution of such
equity securities orders. For purposes of this section, ``monetary or
in-kind amounts'' shall be defined to include commissions, gratuities,
payments for or rebate of fees resulting from the entry of such equity
securities orders, or any similar payments of value to the member,
member organization, or person associated with or employed by a member
or member organization.
* * * * *

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 Phlx 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 these statements may be examined at the places specified in
Item IV below. The Phlx has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to prohibit ``trade
shredding'' which is the practice of unbundling customer orders for
equity securities into multiple smaller orders for the primary purpose
of maximizing payments to the member or member organization, and
thereby possibly disadvantaging the customer by, for example, charging
excessive fees or commissions, or failing to obtain best execution of
an equity security order. Such payments may create a conflict of
interest between the customer and the member or member organization.
For example, as a result of the manner in which market data revenues
are calculated, market centers can derive a greater share of market
data revenue by increasing the number of trades that they report to the
consolidated tape. At the same time, some markets have adopted a
practice of sharing these increased revenues with market participants,
including non-members, who send in equity securities orders. Thus, the
Commission has expressed concern that an incentive exists for market
participants receiving rebates to engage in distortive behavior, such
as trade shredding, as a means to increase their share of market data
revenues. Other economic arrangements between members or member
organizations and their customers may create similar incentives to
engage in similarly distortive behavior.
    The Commission has requested that all U.S. self-regulatory
organizations implement rule changes to inhibit the practice of trade
shredding. The Phlx does not rebate revenues from tape reporting to
members or non-members. Thus, there is no incentive in this area for
Phlx order providers to engage in trade shredding on orders sent to the
Exchange. However, a member or member organization may engage in
conduct that has an impact similar to trade shredding, in that it
unbundles a customer's order for the primary purpose of maximizing
payments to the member or member organization at the customer's expense
and to the customer's detriment.
    In response to the Commission's request, the Exchange proposes to
amend Rule 707 by adding Commentary .02 which prohibits all such
practices. Specifically, the new Commentary to Rule 707 would prohibit
any member, member organization, or person associated with or employed
by a member or member organization from unbundling orders for execution
for the primary purpose of maximizing a monetary or like payment of a
type described in the rule.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\3\ in general, and furthers the objectives of Section 6(b)(5) of
the Act,\4\ in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of, a
free and open market and a national market system, and in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change will impose no
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received comments on this
proposal.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Phlx-2005-63 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.
    All submissions should refer to File Number SR-Phlx-2005-63. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal offices of Phlx. 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-Phlx-2005-63 and should be submitted on or before December 27, 2005.
---------------------------------------------------------------------------

    \5\ 5 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\5\
Jonathan G. Katz,
Secretary.
[FR Doc. E5-6826 Filed 12-2-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Notices]
[Pages 66442-66445]
[FR Doc No: 2014-26461]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73512; File No. SR-NYSEArca-2014-107]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To
Reflect Changes to the Means of Achieving the Investment Objective
Applicable to the Guggenheim Enhanced Short Duration ETF

November 3, 2014.
    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 21, 2014, 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 and II
below, which Items have been prepared by the self-regulatory
organization. On October 29, 2014, the Exchange filed Amendment No. 1
to the proposal.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change, as modified by Amendment No. 1
thereto, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(1).
    \3\ 17 CFR 240.19b-4.
    \4\ Amendment No. 1 clarified the last sentence in footnote 6 of
the proposed rule change filing and footnote 7 of the Exchange's
Exhibit 1 by replacing the sentence with the following: ``The asset-
back securities in which the Fund may invest include collateralized
debt obligations, as described in the Prior Release.''
---------------------------------------------------------------------------

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

    The Exchange proposes to submit a rule change to reflect changes to
the means of achieving the investment objective applicable to the
Guggenheim Enhanced Short Duration ETF (the ``Fund''). The shares of
the Fund are currently listed and traded on the Exchange under NYSE
Arca Equities Rule 8.600. 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
    The Commission has approved listing and trading on the Exchange of
shares (``Shares'') of the Guggenheim Enhanced Short Duration ETF, a
series of Claymore Exchange-Traded Fund Trust (the ``Trust''),\5\ under
NYSE Arca

Equities Rule 8.600, which governs the listing and trading of Managed
Fund Shares. The Shares of the Fund are currently listed and traded on
the Exchange under NYSE Arca Equities Rule 8.600.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 64550 (May 26,
2011), 76 FR 32005 (June 2, 2011) (SR-NYSEArca-2011-11) (order
approving listing and trading on the Exchange of the Guggenheim
Enhanced Core Bond ETF and Guggenheim Enhanced Ultra-Short Bond ETF)
(``Prior Order''). See also Securities Exchange Act Release No.
64224 (April 7, 2011), 76 FR 20401 (April 12, 2011) (SR-NYSEArca-
2011-11) (``Prior Notice,'' and together with the Prior Order, the
``Prior Release''). The name of the Guggenheim Enhanced Ultra-Short
Bond ETF was changed to the Guggenheim Enhanced Short Duration Bond
ETF in a supplement to the Registration Statement (as defined below)
effective December 5, 2011, and was further changed to Guggenheim
Enhanced Short Duration ETF in a supplement to the Registration
Statement (as defined below) effective September 27, 2013
(``September 27, 2013 Amendment''). The Fund and the Shares are
currently in compliance with the listing standards and other rules
of the Exchange and the requirements set forth in the Prior Release.
---------------------------------------------------------------------------

    The Shares are offered by the Trust, a statutory trust organized
under the laws of the State of Delaware and registered with the
Commission as an open-end management investment company.\6\ The
investment advisor to the Fund is Guggenheim Funds Investment Advisors,
LLC (the ``Adviser'').\7\
---------------------------------------------------------------------------

    \6\ The Trust is registered under the Investment Company Act of
1940 (15 U.S.C. 80a-1) (``1940 Act''). On September 27, 2013, the
Trust filed with the Commission an amendment to its registration
statement on Form N-1A under the Securities Act of 1933 (15 U.S.C.
77a) (``Securities Act''), and under the 1940 Act relating to the
Fund (File Nos. 333-134551 and 811-21906) (``Registration
Statement''). The description of the operation of the Trust and the
Fund herein is based, in part, on the Registration Statement. In
addition, the Commission has issued an order granting certain
exemptive relief to the Trust under the 1940 Act. See Investment
Company Act Release No. 29271, May 18, 2010 (File No. 812-13534)
(``Exemptive Order'').
    \7\ The Fund's investment advisor was previously named Claymore
Advisors, LLC. On September 10, 2010, Claymore Advisors, LLC changed
its name to Guggenheim Funds Investment Advisors, LLC.
---------------------------------------------------------------------------

    In this proposed rule change, the Exchange proposes to reflect
changes to the description of the measures the Adviser will utilize to
implement the Fund's investment objective, as described below.
    First, the Prior Release stated that the Fund may invest up to 10%
of its assets in mortgage-backed securities (``MBS'') or in other
asset-backed securities (``ABS'')\8\; this limitation does not apply to
securities issued or guaranteed by federal agencies and/or U.S.
government sponsored instrumentalities, such as the Government National
Mortgage Administration (``GNMA''), the Federal Housing Administration
(``FHA''), the Federal National Mortgage Association (``FNMA''), and
the Federal Home Loan Mortgage Corporation (``FHLMC''). Going forward,
the Fund proposes to have this limit apply to such privately issued
MBS; however, the Fund may invest up to 50% of its assets in ABS \9\
that are not mortgage-related. This 50% limitation would not apply to
securities issued or guaranteed by federal agencies and/or U.S.
government sponsored instrumentalities, such as the GNMA, FHA, FNMA,
and FHLMC. In addition, such holdings would be subject to the
respective limitations on the Fund's investments in illiquid assets and
high yield securities, as described below.
---------------------------------------------------------------------------

    \8\ As stated in the Prior Release, the Fund may invest in MBS
or other asset-backed securities issued or guaranteed by private
issuers. The MBS in which the Fund may invest may also include
residential mortgage-backed securities, collateralized mortgage
obligations and commercial mortgage-backed securities. The asset-
backed securities in which the Fund may invest include
collateralized debt obligations, as described in the Prior Release.
    \9\ ABS are bonds backed by pools of loans or other receivables.
ABS are securitized by a wide variety of assets and are generally
broken into 3 categories: consumer, commercial, and corporate. The
consumer category includes credit card, auto loan, student loan, and
timeshare loan ABS. The commercial category includes trade
receivables, equipment leases, oil receivables, film receivables,
rental cars, aircraft securitizations, ship and container
securitizations, whole business securitizations, and diversified
payment right securitizations. Corporate ABS include cash flow
collateralized loan obligations, collateralized by both middle
market and broadly syndicated bank loans. ABS are issued through
special purpose vehicles that are bankruptcy remote from the issuer
of the collateral. The credit quality of an ABS tranche depends on
the performance of the underlying assets and the structure. To
protect ABS investors from the possibility that some borrowers could
miss payments or even default on their loans, ABS include various
forms of credit enhancement.
---------------------------------------------------------------------------

    The Adviser represents that this change to the Fund's investment
limitations would allow the Adviser to better achieve the Fund's
investment objective to seek maximum current income, consistent with
preservation of capital and daily liquidity. Moreover, the Fund's
increased investment in ABS that are not mortgage-related will continue
to adhere to the Fund's investment strategy of investing in short
duration fixed income securities.\10\
---------------------------------------------------------------------------

    \10\ The Fund will target floating rate, shorter maturity,
shorter spread duration and other amortizing securities. These
securities' maturity and spread duration are consistent with the
Fund's investment objective.
---------------------------------------------------------------------------

    Because the Fund may invest no more than 10% of its net assets in
high yield securities (``junk bonds''), which are debt securities that
are rated below investment grade by nationally recognized statistical
rating organizations (``NRSROs''), or are unrated securities that the
Adviser believes are of comparable quality, the preponderance of the
Fund's investments in ABS will be in investment grade instruments. Due
to the quality of ABS in which the Fund will invest, the Adviser does
not expect that the Fund's additional investments in ABS that are not
mortgage-related will expose the Fund to additional liquidity risk.
    Second, the Prior Release stated that the Fund may invest up to an
aggregate amount of 15% of its net assets in: (1) Illiquid securities;
and (2) Rule 144A securities. Going forward, the Fund proposes that the
Fund may hold up to an aggregate amount of 15% of its net assets in
illiquid assets (calculated at the time of investment),\11\ including
Rule 144A securities deemed illiquid by the Adviser, consistent with
Commission guidance.\12\ The Exchange notes that the Commission has
approved proposals that have included similar representations relating
to issues of Managed Fund Shares proposed to be listed and traded on
the Exchange.\13\ The Adviser represents that the Adviser and the
Trust's Board of Trustees will continue to evaluate each Rule 144A
security based on the Fund's valuation procedures to oversee liquidity
and valuation concerns. With respect to investment in illiquid assets,
if changes in the values of the Fund's assets cause the Fund's holdings
of illiquid assets to exceed the 15% limitation (as if liquid assets
have become illiquid), the Fund will take such actions as it deems
appropriate and practicable to attempt to reduce its holdings of
illiquid assets.
---------------------------------------------------------------------------

    \11\ In reaching liquidity decisions, the Adviser may consider
the following factors: the frequency of trades and quotes for the
security; the number of dealers wishing to purchase or sell the
security and the number of other potential purchasers; dealer
undertakings to make a market in the security; and the nature of the
security and the nature of the marketplace trades (e.g., the time
needed to dispose of the security, the method of soliciting offers,
and the mechanics of transfer).
    \12\ The Commission has stated that long-standing Commission
guidelines have required open-end funds to hold no more than 15% of
their net assets in illiquid securities and other illiquid assets.
See Investment Company Act Release No. 28193 (March 11, 2008), 73 FR
14618 (March 18, 2008), footnote 34. See also, Investment Company
Act Release No. 5847 (October 21, 1969), 35 FR 19989 (December 31,
1970) (Statement Regarding ``Restricted Securities''); Investment
Company Act Release No. 18612 (March 12, 1992), 57 FR 9828 (March
20, 1992) (Revisions of Guidelines to Form N-1A). A fund's portfolio
security is illiquid if it cannot be disposed of in the ordinary
course of business within seven days at approximately the value
ascribed to it by the fund. See Investment Company Act Release No.
14983 (March 12, 1986), 51 FR 9773 (March 21, 1986) (adopting
amendments to Rule 2a-7 under the 1940 Act); Investment Company Act
Release No. 17452 (April 23, 1990), 55 FR 17933 (April 30, 1990)
(adopting Rule 144A under the Securities Act).
    \13\ See, e.g., Securities Exchange Act Release No. 70282
(August 29, 2013), 78 FR 54700 (September 5, 2013) (order approving
listing and trading on the exchange of First Trust Inflation Managed
Fund).
---------------------------------------------------------------------------

    Third, the Prior Release stated that the Fund primarily will invest
in U.S. dollar-denominated investment grade debt securities rated Baa
or higher by Moody's Investors Service, Inc. (``Moody's''), or
equivalently rated by Standard & Poor's Rating Group (``S&P'') or Fitch
Investor Services (``Fitch''), or, if unrated, determined by the
Adviser to be of comparable quality.
    Going forward, the Exchange proposes to change the representation
that the Fund primarily will invest in U.S. dollar-denominated
investment grade debt securities rated Baa or higher, as described
above, to a representation that

the Fund primarily will invest in U.S. dollar-denominated investment
grade debt securities rated Baa3 or higher by Moody's,\14\ or
equivalently rated by S&P, Fitch, or by any other NRSRO, or, if
unrated, determined by the Adviser to be of comparable quality. By
being permitted to invest in U.S. dollar-denominated investment grade
debt securities rated Baa3 or higher, as described above, the Fund will
be able to invest in a broader range of investment grade debt
securities, which will assist the Fund in meeting its investment
objective. In addition, by being permitted to consider ratings issued
by all NRSROs, which are registered with the Commission, the Fund will
be able to assess a broader range of available information regarding
the characteristics and quality of securities that it may consider for
investment.
---------------------------------------------------------------------------

    \14\ Baa3 is the lowest tier within the Baa rating.
---------------------------------------------------------------------------

    Fourth, the Prior Release stated that the Fund will invest at least
80% of its net assets in fixed income securities. Going forward, the
Fund proposes that it will invest at least 80% of its net assets in
fixed income securities, and in exchange-traded funds (``ETFs'') and
closed-end funds that invest substantially all of their assets in fixed
income securities.\15\ All such ETFs and closed-end funds would be
listed on a U.S. national securities exchange. The Adviser represents
that, by allowing the Fund to invest in ETFs and closed-end funds that
invest substantially all of their assets in fixed-income securities and
have such investments count towards the Fund's 80% threshold (thus
allowing the Fund to invest in excess of 20% of its assets in such ETFs
and closed-end funds), the Fund may be able to realize its investment
objective in a more diversified and efficient manner than is currently
available under the Fund's current 20% limitation on non-fixed income
securities investments. Possible increased investments in such ETFs and
closed-end funds would give the Fund access to a diverse set of fixed-
income securities in an efficient fashion, with the liquidity and
transparency of a U.S. exchange-traded security.
---------------------------------------------------------------------------

    \15\ For purposes of this filing, ETFs include Investment
Company Units (as described in NYSE Arca Equities Rule 5.2(j)(3));
Portfolio Depositary Receipts (as described in NYSE Arca Equities
Rule 8.100); and Managed Fund Shares (as described in NYSE Arca
Equities Rule 8.600). The Fund will invest in the securities of ETFs
registered under the 1940 Act consistent with the requirements of
Section 12(d)(1) of the 1940 Act, or any rule, regulation or order
of the Commission or interpretation thereof.
---------------------------------------------------------------------------

    The Exchange notes that the Prior Release stated that the Fund is
considered non-diversified under the 1940 Act and can invest a greater
portion of assets in securities of individual issuers than a
diversified fund.\16\ In the September 27, 2013 Amendment, the Trust
amended this representation to state that the Fund is considered a
diversified fund. This change was made because, in view of the Fund's
investments, the Fund has been operating in a manner consistent with a
diversified fund for three years and, pursuant to Commission guidance,
the Fund has amended its disclosure in that regard. The revised
representation in the September 27, 2013 Amendment reflects this fact.
---------------------------------------------------------------------------

    \16\ The diversification standard is set forth in Section
5(b)(1) of the 1940 Act (15 U.S.C. 80a-5(b)(1)). The Fund intends to
maintain the level of diversification necessary to qualify as a
regulated investment company (``RIC'') under Subchapter M of the
Internal Revenue Code of 1986, as amended (26 U.S.C. 851).
---------------------------------------------------------------------------

    The Adviser represents that there is no change to the Fund's
investment objective. The Fund will continue to comply with all initial
and continued listing requirements under NYSE Arca Equities Rule 8.600.
    Except for the changes noted above, all other facts presented and
representations made in the Prior Release remain unchanged.
    All terms referenced but not defined herein are defined in the
Prior Release.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \17\ 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.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will continue to be listed and traded on the Exchange pursuant
to the initial and continued listing criteria in NYSE Arca Equities
Rule 8.600. The Adviser represents that increasing the Fund's
flexibility to invest in ABS that are not mortgage-related would allow
the Adviser to better achieve the Fund's investment objective to seek
maximum current income, consistent with preservation of capital and
daily liquidity. Moreover, the Fund's increased investment in ABS that
are not mortgage-related will continue to adhere to the Fund's
investment strategy of investing in short duration fixed income
securities. In addition, such holdings would be subject to the
limitation of the Fund's investments in illiquid assets, as described
above. Because the Fund may invest no more than 10% of its net assets
in junk bonds, which are debt securities that are rated below
investment grade by nationally recognized statistical rating
organizations, or are unrated securities that the Adviser believes are
of comparable quality, the preponderance of the Fund's investments in
ABS will be in investment grade instruments. With respect to the 15%
limitation on investments in illiquid assets, including Rule 144A
securities deemed illiquid by the Adviser, consistent with Commission
guidance, the Exchange notes that the Commission has approved proposals
that have included similar representations relating to issues of
Managed Fund Shares proposed to be listed and traded on the
Exchange.\18\ The Adviser represents that the Adviser and the Trust's
Board of Trustees will continue to evaluate each Rule 144A security
based on the Fund's valuation procedures to oversee liquidity and
valuation concerns.
---------------------------------------------------------------------------

    \18\ See note 12, supra [sic].
---------------------------------------------------------------------------

    With respect to the representation above that the Fund primarily
will invest in U.S. dollar-denominated investment grade debt securities
rated Baa3 or higher (instead of Baa or higher) by Moody's, or
equivalently rated by S&P, Fitch, or by any other NRSRO, or, if
unrated, determined by the Adviser to be of comparable quality, by
being permitted to invest in U.S. dollar-denominated investment grade
debt securities rated Baa3 or higher, as described above, the Fund will
be able to invest in a broader range of investment grade debt
securities, which will assist the Fund in meeting its investment
objective. In addition, with respect to the Fund utilizing ratings of
any NRSRO, rather than only enumerated NRSROs, in connection with its
fixed income investments, by being permitted to consider ratings issued
by all NRSROs, which are registered with the Commission, the Fund will
be able to assess a broader range of available information regarding
the characteristics and quality of securities that it may consider for
investment.
    With respect to the proposal for the Fund to invest at least 80% of
its net assets in fixed income securities, and in ETFs and closed-end
funds that invest substantially all of their assets in fixed income
securities, the Exchange notes that all such ETFs and closed-end funds
would be listed on a U.S. national

securities exchange. The Adviser represents that, by allowing the Fund
to invest in ETFs and closed-end funds that invest substantially all of
their assets in fixed-income securities and have such investments count
towards the Fund's 80% threshold, the Fund may be able to realize its
investment objective in a more diversified and efficient manner than is
currently available under the Fund's current 20% limitation on non-
fixed income securities investments. Possible increased investments in
such ETFs and closed-end funds would give the Fund access to a diverse
set of fixed-income securities in an efficient fashion, with the
liquidity and transparency of a U.S. exchange-traded security.
    With respect to the Fund's operation as a diversified Fund, this
change was made because, in view of the Fund's investments, the Fund
has been operating in a manner consistent with a diversified fund for
three years and, pursuant to Commission guidance, the Fund has amended
its disclosure in that regard. The revised representation in the
September 27, 2013 Amendment reflects this fact.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Adviser represents that there is no change to the Fund's
investment objective. The Fund will continue to comply with all initial
and continued listing requirements under NYSE Arca Equities Rule 8.600.
The Adviser represents that the purpose of the proposed changes is to
provide additional flexibility to the Adviser to meet the Fund's
investment objective, as discussed above.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that the Fund will continue to comply with all
initial and continued listing requirements under NYSE Arca Equities
Rule 8.600. The Adviser represents that the purpose of the proposed
changes is to provide additional flexibility to the Adviser to meet the
Fund's investment objective, as discussed above. The Adviser represents
that there is no change to the Fund's investment objective. Except for
the changes noted above, all other facts presented and representations
made in the Prior Release remain unchanged.

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 purposes of the Act. The proposed changes to the
Fund's means of achieving the investment objective will permit the Fund
to adjust its portfolio to allow the Fund to continue to meet its
investment objectives in the most efficient manner possible and will
enhance competition among issues of Managed Fund Shares that invest in
fixed income securities.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(a) By order approve or disapprove such proposed rule change; or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an Email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-107 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2014-107. 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 the filing also will 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-2014-107 and should
be submitted on or before November 28, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-26461 Filed 11-6-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55099-55100]
[FR Doc No: 2023-17320]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-146, OMB Control No. 3235-0134]

Proposed Collection; Comment Request; Extension: Rule 15c1-7

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

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (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 15c1-7 (17 CFR 240.15c1-
7) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.)
(``Exchange Act''). The Commission plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 15c1-7 states that any act of a broker-dealer designed to
effect securities transactions with or for a customer account over
which the broker-dealer (directly or through an agent or employee) has
discretion will be considered a fraudulent, manipulative, or deceptive
practice under the federal securities laws, unless a record is made of
the transaction immediately by the broker-dealer. The record must
include (a) the name of the customer, (b) the name, amount, and price
of the security, and (c) the date and time when such transaction took
place.
    The Commission estimates that 350 respondents collect information
related to approximately 400,000 transactions annually under Rule 15c1-
7 and that each respondent would spend approximately 5 minutes on the
collection of information for each transaction, for a total time burden
of approximately 33,333 hours per year (approximately 95.2 hours per
respondent).
    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
estimates of the burden of the proposed 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 by
October 13, 2023.
    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: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John

Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: August 8, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-17320 Filed 8-11-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 17, 2009 (Volume 74, Number 50)]
[Notices]
[Page 11366-11367]
[DOCID:fr17mr09-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

March 10, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP96-312-188.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Company submits notice of the
termination of a Negotiated Rate Arrangement.
    Filed Date: 03/02/2009.
    Accession Number: 20090309-0168.
    Comment Date: 5 p.m. Eastern Time on Monday, March 16, 2009.

    Docket Numbers: RP99-176-185.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with a negotiated rate exhibit to an existing recourse
rate Storage Rate Schedule NSS Agreement with JP Morgan Ventures Energy
Corp etc.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0038.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-186.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with negotiated rate exhibit to an existing negotiated
Storage Rate Schedule NSS Agreement etc with Oneok Energy Services
Company, LP.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0039.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-187
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with negotiated rate exhibit to an existing discount
Transportation Rate Schedule FTS Agreement.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0040.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-188.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with negotiated rate exhibit to an existing discounted
Storage Rate Schedule NSS Agreement.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0041.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-189.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits a
new Transportation Rate Schedule FTS Agreement et al. Filed Date: 03/
05/2009.
    Accession Number: 20090306-0042.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-190.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with negotiated rate exhibit to an existing recourse rate
Storage Rate Schedule NSS Agreement.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0043.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP99-176-191.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
an amendment with a negotiated rate exhibit to an existing recourse
rate Transportation Rate Schedule FTS Agreement with Black Hills
Utility Holdings, Inc etc.
    Filed Date: 03/05/2009.
    Accession Number: 20090306-0036.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 17, 2009.

    Docket Numbers: RP04-274-017.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits its FERC
Gas Tariff, Second Revised Volume 1 the tariff sheets, the tariff
sheets listed on Appendix A effective dates indicated.
    Filed Date: 03/02/2009.
    Accession Number: 20090306-0107.
    Comment Date: 5 p.m. Eastern Time on Monday, March 16, 2009.

    Docket Numbers: RP08-257-004.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: Saltville Gas Storage Company LLC submits their refund
report pursuant to Sections 154.501 and 154.502 of the Commission's
regulations.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0140.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Docket Numbers: RP08-484-002.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Co submits Sixth Revised Sheet
318 et al to FERC Gas Tariff, First Revised Volume 1, to be effective
2/1/09.
    Filed Date: 02/27/2009.
    Accession Number: 20090304-0153.
    Comment Date: 5 p.m. Eastern Time on Friday, March 13, 2009.

    Docket Numbers: RP06-540-007.
    Applicants: High Island Offshore System, L.L.C.
    Description: Second annual report of non-routine expenditures
pursuant to its O&M Agreement for calendar year 2008 of High Island
Offshore System, L.L.C..
    Filed Date: 03/02/2009.
    Accession Number: 20090302-5186.
    Comment Date: 5 p.m. Eastern Time on Monday, March 16, 2009.

    Docket Numbers: RP09-435-000.
    Applicants: Chandeleur Pipe Line Company.
    Description: Chandeleur Pipe Line Company submits Petition For
Approval of Settlement requesting Commission approval of an Offer of
Settlement and Stipulation and Agreement etc.

    Filed Date: 03/04/2009.
    Accession Number: 20090305-0081.
    Comment Date: 5 p.m. Eastern Time on Monday, March 16, 2009.

    Docket Numbers: RP09-437-000.
    Applicants: Young Gas Storage Company, Ltd.
    Description: Young Gas Storage Company, LTD submits Eighth Revised
Sheet No 96 et al to FERC Gas Tariff, Original Volume No 1.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0163.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Docket Numbers: RP09-438-000.
    Applicants: Wyoming Interstate Company, Ltd.
    Description: Wyoming Interstate Company, Ltd submits Eighth Revised
Sheet No 72 et al to FERC Gas Tariff, Second Revised Volume No 2.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0164.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Docket Numbers: RP09-439-000.
    Applicants: Cheyenne Plains Gas Pipeline Company LLC.
    Description: Cheyenne Plains Gas Company, LLC submits First Revised
Sheet No 244 et al to FERC Gas Tariff, Original Volume No 1.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0165.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Docket Numbers: RP09-440-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Co submits Fifth Revised Sheet
No. 330B et al to FERC Gas Tariff, First Revised Volume No. 1, to be
effective 5/1/09.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0166.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Docket Numbers: RP09-441-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Fee Collection Report by Transcontinental Gas
Pipeline: Petitions for issuance of declaratory order.
    Filed Date: 03/06/2009.
    Accession Number: 20090309-0142.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 18, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-5685 Filed 3-16-09; 8:45 am]

BILLING CODE 6717-01-P