[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61163-61166]
[FR Doc No: 2017-27855]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2017-N-6643]

Medical Devices; Hematology and Pathology Devices; Classification
of the Flow Cytometric Test System for Hematopoietic Neoplasms

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the flow cytometric test system for hematopoietic neoplasms into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for the flow cytometric test system for hematopoietic
neoplasms' classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective December 27, 2017. The classification
was applicable on June 29, 2017.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the flow cytometric test system
for hematopoietic neoplasms as class II (special controls), which we
have

determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On October 3, 2016, Beckman Coulter submitted a request for De Novo
classification of the ClearLLab Reagents (T1, T2, B1, B2, M). FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 29, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 864.7010. We have named
the generic type of device flow cytometric test system for
hematopoietic neoplasms, and it is identified as a device that consists
of reagents for immunophenotyping of human cells in relation to the
level of expression, antigen density, and distribution of specific
cellular markers. These reagents are used as an aid in the differential
diagnosis or monitoring of hematologically abnormal patients having or
suspected of having hematopoietic neoplasms. The results should be
interpreted by a pathologist or equivalent professional in conjunction
with other clinical and laboratory findings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Flow Cytometric Test for Hematopoietic Neoplasms Risks and
                           Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Incorrect test results (false negatives  General Controls and Special
 or false positives).                     Controls (1) and (2) (21 CFR
                                          864.7010(b)(1) and (2)).
Incorrect interpretation of device       General Controls and Special
 results by the end user.                 Controls (1), (2), and (3) (21
                                          CFR 864.7010(b)(1), (2), and
                                          (3)).
Patient harm from specimen(s)            General Controls and Special
 collection.                              Control (1) (21 CFR
                                          864.7010(b)(1)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to

premarket notification requirements under section 510(k) of the FD&C
Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in 21 CFR part 814,
subparts A through E, regarding premarket approval, have been approved
under OMB control number 0910-0231; the collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR parts
801 and 809, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for part 864 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  864.7010 to subpart H to read as follows:

Sec.  864.7010  Flow cytometric test system for hematopoietic
neoplasms.

    (a) Identification. A flow cytometric test for hematopoietic
neoplasms is a device that consists of reagents for immunophenotyping
of human cells in relation to the level of expression, antigen density,
and distribution of specific cellular markers. These reagents are used
as an aid in the differential diagnosis or monitoring of
hematologically abnormal patients having or suspected of having
hematopoietic neoplasms. The results should be interpreted by a
pathologist or equivalent professional in conjunction with other
clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include the following
information:
    (i) The indications for use must indicate the clinical
hematopoietic neoplasms for which the assay was designed and validated,
for example, chronic leukemia or lymphoma.
    (ii) A detailed device description including the following:
    (A) A detailed description of all test components, all required
reagents, and all instrumentation and equipment, including
illustrations or photographs of nonstandard equipment or methods.
    (B) Detailed documentation of the device software including, but
not limited to, standalone software applications and hardware-based
devices that incorporate software.
    (C) A detailed description of methodology and assay procedure.
    (D) A description of appropriate internal and external quality
control materials that are recommended or provided. The description
must identify those control elements that are incorporated into the
testing procedure, if applicable.
    (E) Detailed specifications for sample collection, processing, and
storage.
    (F) Detailed specification of the criteria for test results
interpretation and reporting including pre-established templates.
    (G) If applicable, based on the output of the results, a
description of the specific number of events to collect, result
outputs, and analytical sensitivity of the assay that will be reported.
    (iii) Information that demonstrates the performance characteristics
of the test, including:
    (A) Device performance data from either a method comparison study
comparing the specific lymphocyte cell markers to a predicate device or
data collected through a clinical study demonstrating clinical validity
using well-characterized clinical specimens. Samples must be
representative of the intended use population of the device including
hematologic neoplasms and the specific sample types for which the test
is indicated for use.
    (B) If applicable, device performance data from a clinical study
demonstrating clinical validity for parameters not established in a
predicate device of this generic type using well-characterized
prospectively obtained clinical specimens including all hematologic
neoplasms and the specific sample types for which the device is
indicated for use.
    (C) Device precision data using clinical samples to evaluate the
within-lot, between-lot, within-run, between run, site-to-site and
total variation using a minimum of three sites, of which at least two
sites must be external sites. Results shall be reported as the standard
deviation and percentage coefficient of variation for each level
tested.
    (D) Reproducibility data generated using a minimum of three lots of
reagents to evaluate mean fluorescence intensity and variability of the
recovery of the different markers and/or cell populations.
    (E) Data from specimen and reagent carryover testing performed
using well-established methods (e.g., CLSI H26-A2).
    (F) Specimen and prepared sample stability data established for
each specimen matrix in the anticoagulant combinations and storage/use
conditions that will be indicated.
    (G) A study testing anticoagulant equivalency in all claimed
specimen type/anticoagulant combinations using clinical specimens that
are representative of the intended use population of the device.
    (H) Analytic sensitivity data using a dilution panel created from
clinical samples.
    (I) Analytical specificity data, including interference and cross-
contamination.
    (J) Device stability data, including real-time stability of
reagents under various storage times and temperatures.
    (K) For devices that include polyclonal antibodies, Fluorescence
Minus One (FMO) studies to evaluate non-specific binding for all
polyclonal antibodies. Each FMO tube is compared to reagent reference
to demonstrate that no additional population appears when one marker is
absent. Pre-specified acceptance criteria must be provided and
followed.
    (L) For devices indicated for use as a semi-quantitative test,
linearity data using a dilution panel created from clinical samples.
    (M) For devices indicated for use as a semi-quantitative test,
clinically relevant analytical sensitivity data,

including limit of blank, limit of detection, and limit of
quantification.
    (iv) Identification of risk mitigation elements used by the device,
including a detailed description of all additional procedures, methods,
and practices incorporated into the instructions for use that mitigate
risks associated with testing the device.
    (2) The 21 CFR 809.10 compliant labeling must include the
following:
    (i) The intended use statement in the 21 CFR 809.10(a)(2) and
(b)(2) compliant labeling must include a statement that the results
should be interpreted by a pathologist or equivalent professional in
conjunction with other clinical and laboratory findings. The intended
use statement must also include information on what the device detects
and measures, whether the device is qualitative, semi-quantitative,
and/or quantitative, the clinical indications for which the device is
to be used, and the specific population(s) for which the device is
intended.
    (ii) A detailed description of the performance studies conducted to
comply with paragraph (b)(1)(iii) of this section and a summary of the
results.
    (3) As part of the risk management activities performed under 21
CFR 820.30 design controls, product labeling and instruction manuals
must include clear examples of all expected phenotypic patterns and
gating strategies using well-defined clinical samples representative of
both abnormal and normal cellular populations. These samples must be
selected based upon the indications described in paragraph (b)(1)(i) of
this section.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27855 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P


Kathy Kaufman/RTP/USEPA/US

05/15/2008 11:24 AM

To

Eileen Pritchard/DC/USEPA/US@EPA

cc

Tricia Crabtree/RTP/USEPA/US@EPA, "Joseph-J Dougherty" <EMAIL_ADDRESS>Lydia Wegman/RTP/USEPA/US@EPA, Mary Henigin/DC/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, "Alan Rush" <EMAIL_ADDRESS>Charlotte Bertrand/DC/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Brian Heninger/DC/USEPA/US@EPA

Subject

Pb RIA Chapters for OMB

Eileen:  By this email OAQPS is transmitting revised  Chapters 1 through 7 of the Pb NAAQS RIA, as well as  the Executive Summary, to OPEI for OMB review.   The most recent changes in response to OMB comments are highlighted or colored.

The chapters are attached below.

Thanks!

-- Kathy

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>


[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Notices]
[Page 4752]
[FR Doc No: 2020-01313]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10747; 34-88012; File No. 265-32]

SEC Small Business Capital Formation Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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SUMMARY: The Securities and Exchange Commission Small Business Capital
Formation Advisory Committee, established pursuant to Section 40 of the
Securities Exchange Act of 1934 as added by the SEC Small Business
Advocate Act of 2016, is providing notice that it will hold a public
meeting. The public is invited to submit written statements to the
Committee.

DATES: The meeting will be held on Tuesday, February 4, 2020, from 9:30
a.m. to 3:30 p.m. (ET) and will be open to the public. Seating will be
on a first-come, first-served basis. Written statements should be
received on or before February 4, 2020.

ADDRESSES: The meeting will be held at the Commission's headquarters,
100 F Street NE, Washington, DC. The meeting will be webcast on the
Commission's website at www.sec.gov. Written statements may be
submitted by any of the following methods:

Electronic Statements

     Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an email message to<EMAIL_ADDRESS>Please
include File Number 265-32 on the subject line; or

Paper Statements

     Send paper statements to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-32. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method. The Commission will post all statements on the SEC's website at
www.sec.gov.
    Statements also will be available for website 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. (ET). All statements received will be posted without change;
we do not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Julie Z. Davis, Senior Special
Counsel, Office of the Advocate for Small Business Capital Formation,
at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public.
Persons needing special accommodations because of a disability should
notify the contact person listed in the section above entitled FOR
FURTHER INFORMATION CONTACT. The agenda for the meeting includes
matters relating to rules and regulations affecting small and emerging
companies under the federal securities laws.

    Dated: January 22, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-01313 Filed 1-24-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Page 28431]
[FR Doc No: 2014-11203]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0035]

Drawbridge Operation Regulations; St. Croix River, Stillwater, MN

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; cancellation.

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SUMMARY: The Coast Guard is canceling the scheduled temporary deviation
concerning the operating schedule for the Stillwater Highway Drawbridge
across the St. Croix River, mile 23.4, at Stillwater, Minnesota, during
the 2014 navigation season.

DATES: The temporary deviation published on April 14, 2014, in the
Federal Register (79 FR 20784) is cancelled as of May 15, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0035] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
cancellation, call or email Eric A. Washburn, Bridge Administrator,
Western Rivers, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

A. Basis and Purpose

    On April 14, 2014, we published a temporary deviation based on the
City of Stillwater, Minnesota's request entitled ``Notice of deviation
from drawbridge regulation; request for comments'' in the Federal
Register (79 FR 20784). The temporary deviation concerned performing a
functional review of drawspan operations during the navigation season
by allowing the bridge to be operated on an altered opening schedule
Monday through Friday (except Federal Holidays) for approximately 5
months. This deviation from the operating regulations was authorized
under 33 CFR 117.35.

B. Cancellation

    On April 16, 2014, a public meeting regarding this temporary
deviation based on a request by the City of Stillwater was held.
    After the public meeting, on April 23, 2014, the City of Stillwater
rescinded their request for the temporary deviation; therefore, the
Coast Guard is canceling the scheduled deviation.

    Dated: May 2, 2014.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2014-11203 Filed 5-15-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42122-42125]
[FR Doc No: 2013-16855]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30592; 812-14118]

Bridge Builder Trust and Olive Street Investment Advisers, LLC;
Notice of Application

July 9, 2013.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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SUMMARY OF APPLICATION: Applicants request an order that would permit
them to enter into and materially amend sub-advisory agreements without
shareholder approval and that would grant relief from certain
disclosure requirements.

APPLICANTS: Bridge Builder Trust (the ``Trust'') and Olive Street
Investment Advisers (the ``Adviser'') (collectively, ``Applicants'').

DATES: Filing Dates: The application was filed February 1, 2013, and
amended on June 18, 2013.

HEARING OR NOTIFICATION OF HEARING: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on August 5, 2013, and should be accompanied by proof of service
on the applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants:
The Trust: Joseph C. Neuberger, 2020 East Financial Way, Suite 100,
Glendora, CA 91741; The Adviser: James A. Tricarico, Olive Street
Investment Advisers, LLC, 12555 Manchester Road, St. Louis, MO 63131.

FOR FURTHER INFORMATION CONTACT: Jennifer L. Sawin, Branch Chief, at
(202) 551-6724 (Division of Investment Management, Office of Investment
Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust, a Delaware statutory trust, is registered under the
Act as an open-end management investment company. The Trust is
organized as a series trust and currently consists of one series, which
will be advised by the Adviser.\1\ The Adviser is a limited liability
company organized under Missouri law. The Adviser is, and any future
Adviser will be, registered as an investment adviser under the
Investment Advisers Act of 1940 (``Advisers Act''). The Adviser will
serve as the investment adviser to the Funds pursuant to an investment
advisory agreement with the Trust or Fund (the ``Advisory
Agreement'').\2\ Each Advisory Agreement was approved or will be
approved by the Fund's board of trustees (the ``Board''), including a
majority of the trustees who are not ``interested persons,'' as defined
in section 2(a)(19) of the Act, of the Trust, the Fund, or the Adviser
(``Independent Trustees''), and by the Fund's shareholder(s) in the
manner required by sections 15(a) and 15(c) of the Act and rule 18f-2
under the Act. The terms of each Advisory Agreement will comply with
section 15(a) of the Act.
---------------------------------------------------------------------------

    \1\ Applicants request relief with respect to any existing and
any future series of the Trust or any other registered open-end
management company that: (a) Is advised by the Adviser or a person
controlling, controlled by, or under common control with the Adviser
or its successor (each, also an ``Adviser''); (b) uses the manager
of managers structure described in the application; and (c) complies
with the terms and conditions of the requested order (any such
series, a ``Fund'' and collectively, the ``Funds''). The only
existing registered open-end management investment company that
currently intends to rely on the requested order is named as an
Applicant, and the only series that currently intends to rely on the
requested order as a Fund is the Bridge Builder Bond Fund. For
purposes of the requested order, ``successor'' is limited to an
entity that results from a reorganization into another jurisdiction
or a change in the type of business organization. If the name of any
Fund contains the name of a Sub-Adviser (as defined below), that
name will be preceded by the name of the Adviser.
    \2\ ``Advisory Agreement'' includes advisory agreements with an
Adviser for the Bridge Builder Bond Fund and any future Funds.
---------------------------------------------------------------------------

    2. Under the terms of each Advisory Agreement, the Adviser will
provide the Funds with overall management services and will
continuously review, supervise and administer each Fund's investment
program, subject to the supervision of, and policies established by the
Board. For the investment management services it will provide to each
Fund the Adviser will receive the fee specified in the Advisory
Agreement from such Fund, based on the average daily net assets of the
Fund. The Advisory Agreement permits the Adviser, subject to the
approval of the Board, to delegate certain responsibilities to one or
more sub-advisers (``Sub-Advisers'') to provide investment advisory
services to the Funds. As of the date of the amended application, the
Adviser had not entered into sub-advisory agreements with any Sub-
Advisers (``Sub-Advisory Agreements''). Each Sub-Adviser will be an
investment adviser as defined in section 2(a)(20) of the Act and, if
required, registered with the Commission as an ``investment adviser''
under the Advisers Act. The Adviser evaluates, allocates assets to and
oversees the Sub-Advisers, and makes recommendations about their
hiring, termination and replacement to the Board, at all times subject
to the authority of the Board. The Adviser will compensate the Sub-
Advisers out of the advisory fee paid by a Fund to the Adviser under
the Advisory Agreement.
    3. Applicants request an order to permit the Adviser, subject to
Board approval, to select certain Sub-Advisers to manage all or a
portion of the assets of a Fund or Funds pursuant to a Sub-Advisory
Agreement and materially amend existing Sub-Advisory Agreements without
obtaining shareholder approval. The requested relief will not extend to
any Sub-Adviser that is an affiliated person, as defined in section
2(a)(3) of the Act, of the Trust, a Fund, or the Adviser, other than by
reason of serving as a sub-adviser to one or more of the Funds
(``Affiliated Sub-Adviser'').
    4. Applicants also request an order exempting the Funds from
certain disclosure provisions described below that may require the
Applicants to disclose fees paid by the Adviser or a Fund to each Sub-
Adviser. Applicants seek an order to permit a Fund to disclose (as both
a dollar amount and a percentage of the Fund's net assets): (a) The
aggregate fees paid to the Adviser and any Affiliated Sub-Adviser; and
(b) the aggregate fees paid to Sub-Advisers other than Affiliated Sub-
Advisers (collectively, ``Aggregate Fee Disclosure''). Any Fund that
employs an Affiliated Sub-Adviser will provide separate disclosure of
any fees paid to the Affiliated Sub-Adviser.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by a vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the Securities Exchange Act of 1934 (``1934 Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    6. Applicants assert that the shareholders expect the Adviser,
subject to the review and approval of the Board, to select the Sub-
Advisers who are best

suited to achieve the Fund's investment objectives. Applicants assert
that, from the perspective of the shareholder, the role of the Sub-
Advisers is substantially equivalent to that of the individual
portfolio managers employed by traditional investment company advisory
firms. Applicants state that requiring shareholder approval of each
Sub-Advisory Agreement would impose unnecessary delays and expenses on
the Funds and may preclude the Funds from acting promptly when the
Adviser and Board consider it appropriate to hire Sub-Advisers or amend
Sub-Advisory Agreements. Applicants note that the Advisory Agreements
and any Sub-Advisory Agreements with Affiliated Sub-Advisers will
remain subject to the shareholder approval requirements of section
15(a) of the Act and rule 18f-2 under the Act.
    7. If a new Sub-Adviser is retained in reliance on the requested
order, the applicable Fund will inform its shareholders of the hiring
of a new Sub-Adviser pursuant to the following procedures (``Modified
Notice and Access Procedures''): (a) Within 90 days after a new Sub-
Adviser is hired for the Fund, the Fund will send its shareholders
either a Multi-manager Notice or a Multi-manager Notice and Multi-
manager Information Statement; \3\ and (b) the Fund will make the
Multi-manager Information Statement available on the Web site
identified in the Multi-manager Notice no later than when the Multi-
manager Notice (or Multi-manager Notice and Multi-manager Information
Statement) is first sent to shareholders, and will maintain it on that
Web site for at least 90 days. Applicants assert that a proxy
solicitation to approve the appointment of new Sub-Advisers would
provide no more meaningful information to shareholders than the
proposed Multi-manager Information Statement. Moreover, as indicated
above, the applicable Board would comply with the requirements of
sections 15(a) and 15(c) of the Act before entering into or amending
Sub-Advisory Agreements.
---------------------------------------------------------------------------

    \3\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Exchange
Act, and specifically will, among other things: (a) Summarize the
relevant information regarding the new Sub-Adviser; (b) inform
shareholders that the Multi-manager Information Statement is
available on a Web site; (c) provide the Web site address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that Web site; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Fund.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the requested order to permit Aggregate Fee Disclosure.
Multi-manager Information Statements will be filed electronically
with the Commission via the EDGAR system.
---------------------------------------------------------------------------

    8. Applicants assert that the requested disclosure relief will
benefit shareholders of the Funds because it will improve the Adviser's
ability to negotiate the fees paid to Sub-Advisers. Applicants state
that the Adviser may be able to negotiate rates that are below a Sub-
Adviser's ``posted'' amounts if the Adviser is not required to disclose
the Sub-Advisers' fees to the public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the Act, or, in the case of a Fund
whose public shareholders purchase shares on the basis of a prospectus
containing the disclosure contemplated by condition 2 below, by the
sole initial shareholder before offering the Fund's shares to the
public.
    2. The prospectus for each Fund will disclose the existence,
substance, and effect of any order granted pursuant to the application.
Each Fund will hold itself out to the public as employing the manager
of managers structure described in the application. The prospectus will
prominently disclose that the Adviser has ultimate responsibility
(subject to oversight by the Board) to oversee the Sub-Advisers and
recommend their hiring, termination, and replacement.
    3. Funds will inform shareholders of the hiring of a new Sub-
Adviser (other than an Affiliated Sub-Adviser) within 90 days after the
hiring of that new Sub-Adviser pursuant to the Modified Notice and
Access Procedures.
    4. The Adviser will not enter into a Sub-Advisory Agreement with
any Affiliated Sub-Adviser without that agreement, including the
compensation to be paid thereunder, being approved by the shareholders
of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination and selection of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    6. When a Sub-Adviser change is proposed for a Fund with an
Affiliated Sub-Adviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders and does not involve a conflict of
interest from which the Adviser or the Affiliated Sub-Adviser derives
an inappropriate advantage.
    7. Independent legal counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then
existing Independent Trustees.
    8. Each Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per-Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any Sub-Adviser during
the applicable quarter.
    9. Whenever a Sub-Adviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    10. The Adviser will provide general management services to a Fund,
including overall supervisory responsibility for the general management
and investment of the Fund's assets and, subject to review and approval
of the Board, will (i) set a Fund's overall investment strategies; (ii)
evaluate, select and recommend Sub-Advisers to manage all or part of a
Fund's assets; (iii) when appropriate, allocate and reallocate a Fund's
assets among multiple Sub-Advisers; (iv) monitor and evaluate the
performance of Sub-Advisers; and (v) implement procedures reasonably
designed to ensure that the Sub-Advisers comply with a Fund's
investment objective, policies and restrictions.
    11. No trustee or officer of the Trust, or of a Fund, or director
or officer of the Adviser, will own directly or indirectly (other than
through a pooled investment vehicle that is not controlled by such
person) any interest in a Sub-Adviser, except for (i) ownership of
interests in the Adviser or any entity that controls, is controlled by,
or is under common control with the Adviser; or (ii) ownership of less
than 1% of the outstanding securities of any class of equity or debt of
a publicly traded company that is either a Sub-Adviser or an entity
that controls, is controlled by, or is under common control with a Sub-
Adviser.
    12. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.

    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-16855 Filed 7-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69501-69503]
[FR Doc No: 2013-27625]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70859; File No. SR-ISE-2013-54]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

November 13, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 1, 2013, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I,
II and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The ISE proposes to decrease its Options Regulatory Fee. The text
of the proposed rule change is available on the Exchange's Web site
(http://www.ise.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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 Exchange proposes to decrease its Options Regulatory Fee
(``ORF''). The Exchange has reevaluated the current amount of the ORF
in light of increased trading volumes year-to-date. In order to ensure
that revenue collected from the ORF, in combination with other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs, the Exchange is proposing to decrease the ORF from
$0.0042 per contract to $0.0039 per contract. The Exchange is also
proposing to remove language from its Schedule of Fees that indicates
that the ORF is effective starting on January 1, 2010 as this effective
date has passed.
    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of members' customer
options business, including performing routine surveillance and
investigations, as well as policy, rulemaking, interpretive and
enforcement activities. The Exchange believes that revenue generated
from the proposed ORF, when combined with all of the Exchange's other
regulatory fees and fines, will cover a material portion, but not all,
of the Exchange's regulatory costs. The Exchange notes that its
regulatory responsibilities with respect to member compliance with
options sales practice rules have been allocated to the Financial
Industry Regulatory Authority (``FINRA'') under a 17d-2 Agreement. The
ORF is not designed to cover the cost of options sales practice
regulation.
    The ORF is assessed by the Exchange to each member for all options
transactions in both Standard Options and Mini Options executed or
cleared by the member that are cleared by The Options Clearing
Corporation (``OCC'') in the customer range, i.e., transactions that
clear in the customer account of the member's clearing firm at OCC,
regardless of the exchange on which the transaction occurs. In other
words, ISE imposes the ORF on all customer-range transactions executed
by a member, even if the transactions do not take place on the
Exchange.\3\ The ORF also is charged for transactions that are not
executed by a member but are ultimately cleared by a member. In the
case where a non-member executes a transaction and a member clears the
transaction, the ORF will be assessed to the member who clears the
transaction. In the case where a member executes a transaction and
another member clears the transaction, the ORF will similarly be
assessed to the member who clears the transaction.
---------------------------------------------------------------------------

    \3\ Exchange rules require each member to submit trade
information in order to allow the Exchange to properly prioritize
and match orders and quotations and report resulting transactions to
the OCC. See ISE Rule 712. The Exchange represents that it has
surveillance in place to verify that members comply with the rule.
---------------------------------------------------------------------------

    The ORF is collected indirectly from members through their clearing
firms by OCC on behalf of the Exchange. As a practical matter, it is
not feasible or reasonable for the Exchange (or any SRO) to identify
each executing member that submits an order on a trade-by-trade basis.
There are countless executing market participants, and each day such
participants can and often do drop their connection to one market
center and establish themselves as participants on another. It is
virtually impossible for any exchange to identify each executing
participant on a given trading day. Clearing members, however, are
distinguished from executing participants because they remain
identified to the Exchange regardless of the identity of the initiating
executing participant, their location, and the market center on which
they execute transactions. Therefore, the Exchange believes it is more
efficient for the operation of the Exchange and for the marketplace as
a whole to collect the ORF indirectly from members through their
clearing firms.
    The Exchange also believes that its broad regulatory
responsibilities with respect to a member's activities supports

applying the ORF to transactions cleared but not executed by a member.
The Exchange's regulatory responsibilities are the same regardless of
whether a member executes a transaction or clears a transaction
executed on its behalf. The Exchange regularly reviews all such
activities, including performing surveillance for position limit
violations, manipulation, front-running, contrary exercise advice
violations and insider trading.
    The Exchange further believes it is reasonable and appropriate for
the Exchange to charge the ORF for options transactions regardless of
the exchange on which the transactions occur. The Exchange has a
statutory obligation to enforce compliance by members and their
associated persons under the Act and the rules of the Exchange, and to
surveil for other manipulative conduct by market participants
(including non-members) trading on the Exchange. Many of the Exchange's
market surveillance programs require the Exchange to look at and
evaluate activity across all options markets, such as surveillance for
position limit violations, manipulation, front-running and contrary
exercise advice violations/expiring exercise declarations. The Exchange
cannot effectively surveil for such conduct without looking at and
evaluating activity across all options markets. Also, the Exchange and
the other options exchanges are required to populate a consolidated
options audit trail (``COATS'') system in order to surveil a member's
activities across markets.\4\
---------------------------------------------------------------------------

    \4\ COATS effectively enhances intermarket options surveillance
by enabling the options exchanges to promptly reconstruct the market
to effectively surveil certain rules.
---------------------------------------------------------------------------

    The Exchange believes that charging the ORF across markets will
avoid having members direct their trades to other markets in order to
avoid the fee and to thereby avoid paying for their fair share for
regulation. If the ORF did not apply to activity across markets then a
member would send their orders to the least cost, least regulated
exchange. Other exchanges do impose a similar fee on their member's
activity, including the activity of those members on the ISE.\5\
---------------------------------------------------------------------------

    \5\ See e.g. Securities Exchange Act Release Nos. 61133 (Dec. 9,
2009), 74 FR 66715 (December 16, 2009) (SR-Phlx-2009-100); 68711
(Jan. 23, 2013), 78 FR 6155 (Jan. 29, 2013) (SR-MIAX-2013-01)).
---------------------------------------------------------------------------

    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange expects to monitor its regulatory costs
and revenues at a minimum on an annual basis. If the Exchange
determines regulatory revenues exceed regulatory costs, the Exchange
will adjust the ORF by submitting a fee change filing to the
Commission. The Exchange will notify members of adjustments to the ORF
via circular.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Exchange Act \6\ in
general, and furthers the objectives of Section 6(b)(4) of the Exchange
Act \7\ in particular, in that it is an equitable allocation of
reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The Exchange believes that the
proposed fee is reasonable in that it would help the Exchange to ensure
that revenue collected from the ORF, in combination with other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs in light of increased trading volumes. The Exchange
has designed the ORF to generate revenues that, when combined with all
of the Exchange's other regulatory fees, will be less than or equal to
the Exchange's regulatory costs, which is consistent with the
Commission's view that regulatory fees be used for regulatory purposes
and not to support the Exchange's business.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes the ORF is equitable and not unfairly
discriminatory because it is objectively allocated to members in that
it is charged to all members on all their transactions that clear as
customer at the OCC. Moreover, the Exchange believes the ORF ensures
fairness by assessing fees to those members that require more Exchange
regulatory services based on the amount of customer options business
they conduct. Regulating customer trading activity is much more labor
intensive and requires greater expenditure of human and technical
resources than regulating non-customer trading activity, which tends to
be more automated and less labor-intensive. As a result, the costs
associated with administering the customer component of the Exchange's
overall regulatory program are materially higher than the costs
associated with administering the non-customer component of its
regulatory program (e.g., member proprietary transactions).

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The proposed rule change is not designed to address any
competitive issues. Rather, the proposed rule change is designed to
help the Exchange to adequately fund its regulatory activities while
seeking to ensure that total regulatory revenues do not exceed total
regulatory costs.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\9\ because it establishes a due, fee, or other charge
imposed by ISE.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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-ISE-2013-54 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2013-54. 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-ISE-2013-54 and should be
submitted on or before December 10, 2013.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27625 Filed 11-18-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]
[Page 51822-51823]
[DOCID:fr05se08-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive

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 October
6, 2008.

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 e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0363. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension

    With passage of the Animal Drug Availability Act, Congress enacted
legislation establishing a new class of restricted feed use drugs
called Veterinary Feed Directive (VFD) drugs. The VFD class of drugs
may be distributed without involving State pharmacy laws. Although
controls on the distribution and use of VFD drugs are similar to
controls for prescription drugs regulated under section 503(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f)), the
implementing VFD regulation under section 558.6 (21 CFR 558.6) is
tailored to the unique circumstances relating to the distribution of
medicated feeds. The content of the VFD is spelled out in the
regulation. All distributors of medicated feed containing VFD drugs
must notify FDA of their intent to distribute, and the distribution
records of all medicated feeds containing VFD must be maintained. The
VFD regulation ensures the protection of the public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost-effectively as possible.
    In the Federal Register of June 5, 2008 (73 FR 32029), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(a)(3)                15,000                    25            375,000                .25             93,750
 through
 (a)(5)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i)                300                     1                300                .25                 75
 through
 (d)(1)(iii)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv                 20                     1                 20                .25                  5
 )
----------------------------------------------------------------------------------------------------------------
558.6(d)(2)                 1,000                     5              5,000                .25              1,250
----------------------------------------------------------------------------------------------------------------
514..1(b)(9)                    1                     1                  1               3.00                  3
----------------------------------------------------------------------------------------------------------------
Total                      16,321  ....................  .................  .................             95,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual
21 CFR Section    Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(1)               112,500                    10          1,125,000              .0167             18,788
 through
 (c)(4)
----------------------------------------------------------------------------------------------------------------
558.6(e)(1)                 5,000                    75            375,000              .0167              6,263
 through
 (e)(4)
----------------------------------------------------------------------------------------------------------------
Total                     117,500  ....................  .................  .................             25,051
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20579 Filed 9-4-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10352-10353]
[FR Doc No: 2023-03385]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening
the comment period for the notice entitled ``Product-Specific
Guidances; Draft and Revised Draft Guidances for Industry,'' published
in the Federal Register of November 18, 2022. The Agency is taking this
action to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on
November 18, 2022 at 87 FR 69278. Either electronic or written comments
must be submitted by April 18, 2023.

ADDRESSES: You may submit comments on any guidance 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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 the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 18, 2022 (87 FR 69278), FDA
published a notice with a 60-day comment period to request comment on
the guidances for industry entitled, ``Product-Specific Guidances;
Draft and Revised Draft Guidances for Industry.'' The Agency has
received a request for a 60-day extension of the comment period for the
notice. FDA has considered the request and is reopening the comment
period for the notice until April 18, 2023. The Agency believes that an
additional 60 days will allow adequate time for interested persons to
submit comments.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at 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: February 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03385 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Notices]
[Page 20519]
[DOCID:fr25ap07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL04-49-003]

Entergy Services, Inc.; Notice of Filing

April 18, 2007.
    Take notice that on April 16, 2007, Entergy Services Inc., acting
as agent for Entergy Louisiana, LLC filed a refund report, pursuant to
the Commission's February 28, 2007 Order.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 7, 2007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-7799 Filed 4-24-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Notices]
[Page 61275]
[DOCID:fr21oc05-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG05-100-000]

Ontelaunee Power Operating Company, LLC; Notice of Filing

October 14, 2005.
    Take notice that on October 7, 2005, Ontelaunee Power Operating
Company, LLC filed with the Commission a notice of non-material change
in facts regarding its upstream ownership, pursuant to part 365 of the
Commission's regulations.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 21, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5809 Filed 10-20-05; 8:45 am]

BILLING CODE 6717-01-P