[Federal Register Volume 83, Number 198 (Friday, October 12, 2018)]
[Notices]
[Pages 51750-51752]
[FR Doc No: 2018-22209]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84380; File No. SR-NYSENAT-2018-22]

Self-Regulatory Organizations; NYSE National, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its
Schedule of Fees

October 5, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on September 28, 2018, NYSE National, Inc. (``Exchange'' or
``NYSE National'') 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 self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Schedule of Fees and Rebates to
(1) revise the requirements to qualify for the Adding Tier 2 credits;
(2) adopt a new Adding Tier 3 that would set forth fees for displayed
and non-displayed orders that add liquidity to the Exchange; and (3)
eliminate waiver of the volume requirements for the current Taking
Tier. The Exchange proposes to implement the rule change on October 1,
2018. The proposed rule change is available on the Exchange's website
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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Schedule of Fees and Rebates to
(1) revise the requirements to qualify for the Adding Tier 2 credits;
(2) adopt a new Adding Tier 3 that would set forth fees for displayed
and non-displayed orders that add liquidity to the Exchange; and (3)
eliminate waiver of the volume requirements for the current Taking
Tier.
    The Exchange proposes to implement the rule change on October 1,
2018.
Adding Tier 2 Requirements
    Currently, under Adding Tier 2, the Exchange offers the following
fees for transactions in stocks with a per share price of $1.00 or more
when adding liquidity to the Exchange if the ETP Holder quotes at least
5% of the NBBO \4\ in 1,000 or more symbols on an average daily basis,
calculated monthly:
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    \4\ To satisfy the 5% requirement, ETP Holders must maintain a
bid or an offer at the NBB or the NBO for at least 5% of the trading
day in round lots in a security for that security to count toward
the tier requirement. The terms ``NBB,'' ``NBO,'' ``NBBO,'' and
``BBO'' are defined in NYSE National Rule 1.1.
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     $0.0005 per share for adding displayed orders;
     $0.0005 per share for orders that set a new Exchange BBO;
\5\
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    \5\ The term ``BBO'' is defined in Rule 1.1 to mean the best bid
or offer that is a Protected Quotation on the Exchange. The term
``BB'' means the best bid that is a Protected Quotation on the
Exchange and the term ``BO'' means the best offer that is a
Protected Quotation on the Exchange.
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     $0.0007 per share for adding non-displayed orders; and
     $0.0005 per share for adding MPL orders.
    The Exchange proposes to revise the requirements for the Adding
Tier 2 fees and provide alternative requirements to qualify for the
fees.
    First, in addition to requiring ETP Holders to quote at least 5% of
the NBBO in 1,000 or more symbols on an average daily basis, calculated
monthly, the Exchange proposes that ETP Holders also execute 0.25% or
more Adding average daily volume (``ADV'') as a percentage of U.S.
consolidated ADV (``CADV'').
    Second, the Exchange proposes that ETP Holders can alternatively
qualify for the above Adding Tier 2 fees when adding liquidity to the
Exchange if the ETP Holder quotes at least 5% of the NBBO in 2,500 or
more symbols on an average daily basis, calculated monthly and execute
0.10% or more Adding ADV as a percentage of U.S. CADV. The proposed 5%
requirement would be the same as the current 5% requirement described
in footnote **.
    For example, in a given month of 20 trading days, if an ETP Holder
quotes at least 5% of the NBBO in 3,000 securities each day for the
first 10 days and quotes at least 5% of the NBBO in 2,400 securities
each day for the last 10 days, the ETP Holder would have 2,700
securities on an average daily basis that meet the 5% NBBO requirement
for the billing month. If that same ETP holder executes 10.5 million
shares Adding ADV in that same month where U.S. CADV is 7 billion
shares, or 0.15% as a percentage of U.S. CADV, the qualifications for
Adding Tier 2 would be met.
Proposed Adding Tier 3
    The Exchange proposes a new Adding Tier 3 for displayed and non-
displayed orders in securities priced at or above $1.00. Current Adding
Tier 3 would be re-named ``Adding Tier 4.''
    Under proposed Adding Tier 3, the Exchange would offer the
following fees for transactions in stocks with a per share price of
$1.00 or more when adding liquidity to the Exchange if the ETP Holder
quotes at least 5% of the NBBO \6\ in 2000 or more symbols on an
average daily basis, calculated monthly, and executes 0.10% or more
Adding ADV as a percentage of U.S. CADV:
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    \6\ See note 5, supra.
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     $0.0009 per share for adding displayed orders;
     $0.0009 per share for orders that set a new Exchange BBO;
     $0.0011 per share for adding non-displayed orders; and
     $0.0005 per share for MPL orders.
    For example, in a given month of 20 trading days, if an ETP Holder
quotes at least 5% of the NBBO in 2,400 securities each day for the
first 10 days and quotes at least 5% of the NBBO in 2,000 securities
each day for the last 10 days, the ETP Holder would have 2,200
securities on an average daily basis that meet the 5% NBBO requirement
for the billing month. If that same ETP holder executes 10.5 million
shares Adding ADV in that same month where U.S. CADV was 7 billion
shares, or 0.15% as a percentage of U.S. CADV, that ETP holder would
meet the qualifications for Adding Tier 3.
Elimination of Volume Requirement Waiver
    As reflected in footnote * of the Schedule of Fees and Rebates, the
volume requirements for the current Taking Tier is waived. The Exchange

proposes to eliminate the waiver for the Taking Tier. To effect this
change, the Exchange would delete ``Taking Tier'' from footnote *.
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that ETP
Holders would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\8\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its members, issuers and
other persons using its facilities and does not unfairly discriminate
between customers, issuers, brokers or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) & (5).
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Adding Tier 2 Requirements
    The Exchange believes that requiring ETP Holders to execute 0.25%
or more Adding average daily volume as a percentage of U.S. CADV in
addition to quoting at least 5% of the NBBO in 1,000 or more symbols on
an average daily basis, calculated monthly, in order to qualify for the
Adding Tier 2 fees is reasonable, equitable and not unfairly
discriminatory because it would encourage additional liquidity on the
Exchange and because members and member organizations benefit from the
greater amounts of liquidity that will be present on the Exchange. The
Exchange believes the proposed changes are equitable and not unfairly
discriminatory because it would continue to encourage member
organizations to send orders, thereby contributing to robust levels of
liquidity, which benefits all market participants. The proposed changes
will encourage the submission of additional liquidity to a national
securities exchange, thereby promoting price discovery and transparency
and enhancing order execution opportunities for member organizations
from the substantial amounts of liquidity that are present on the
Exchange. Moreover, the proposed changes are equitable and not unfairly
discriminatory because they would apply equally to all qualifying
member organizations that add liquidity to the Exchange and quote at
the NBBO. The Exchange notes that ETP Holders will now have two ways to
meet the requirements to qualify for Adding Tier 2, one of which is
described below.
    Similarly, the Exchange believes that providing an alternative way
for ETP Holders to qualify for the Adding Tier 2 rates when adding
liquidity to the Exchange if the ETP Holder quotes at least 5% of the
NBBO in 2,500 or more symbols on an average daily basis, calculated
monthly and 0.10% or more Adding ADV as a percentage of U.S. CADV is
reasonable, equitable and not unfairly discriminatory because the
proposed change would also encourage the submission of additional
liquidity to a national securities exchange, thereby contributing to
robust levels of liquidity, which benefits all market participants. The
requirement for a higher number of symbols quoting at least 5% of the
NBBO will encourage ETP Holders to quote at the NBBO, which contributes
to price discovery and benefits all market participants. Once again,
the proposed change is equitable and not unfairly discriminatory
because the alternate qualification method would apply equally to all
similarly situated ETP Holders that add liquidity to the Exchange and
quote at the NBBO.
Proposed Adding Tier 3
    The Exchange believes that the proposed Adding Tier 3 fees for ETP
Holder with at least 5% of the NBBO in 2000 or more symbols on an
average daily basis, calculated monthly, and 0.10% or more Adding ADV
as a percentage of U.S. CADV are reasonable because the proposed tiers
would further contribute to incentivizing ETP Holders to provide
increased displayed liquidity on the Exchange, benefiting all ETP
Holders. In addition, the Exchange believes that the proposed Adding
Tier 3 fees are equitable and not unfairly discriminatory as all
similarly situated market participants who add liquidity to the
Exchange and quote at the NBBO will be subject to the same fees on an
equal and non-discriminatory basis.
Elimination of Volume Requirement Waiver
    The Exchange believes it is reasonable to eliminate waiver of the
Taking Tier volume requirements because the waiver [sic] will encourage
additional liquidity on the Exchange and because members and member
organizations benefit from the greater amounts of liquidity that will
be present on the Exchange. The proposed elimination of the waiver is
not unfairly discriminatory because it will apply equally to all
similarly situated ETP Holders that add liquidity to the Exchange. The
Exchange notes that the requirement, 50,000 Adding ADV, is much smaller
when compared with the Adding ADV requirements for Adding Tier 2,
Adding Tier 3, and Adding Tier 4.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\9\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
changes would encourage the submission of additional liquidity to a
public exchange, thereby promoting price discovery and transparency and
enhancing order execution opportunities for ETP Holders. The Exchange
believes that this could promote competition between the Exchange and
other execution venues, including those that currently offer similar
order types and comparable transaction pricing, by encouraging
additional orders to be sent to the Exchange for execution.
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    \9\ 15 U.S.C. 78f(b)(8).
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    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of ETP Holders or competing order execution venues to maintain
their competitive standing in the financial markets.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
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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 protected]. Please include
File Number SR-NYSENAT-2018-22 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSENAT-2018-22. 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 website (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 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. 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. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSENAT-2018-22 and should
be submitted on or before November 2, 2018.
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    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-22209 Filed 10-11-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 22, 2009 (Volume 74, Number 182)]
[Notices]
[Page 48263-48264]
[DOCID:fr22se09-79]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2009-0318, FRL-8959-8]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Land Disposal Restrictions `No-Migration' Variances,
EPA ICR Number 1353.09, OMB Control Number 2050-0062

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on January 31, 2010. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before November 23, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2009-0318, by one of the following methods:
     http://www.regulations.gov; Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket (2822T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: 1301 Constitution Ave., NW, Room 3334,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2009-0318. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Peggy Vyas, Office of Resource
Conservation and Recovery (mailcode 5303P), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-RCRA-2009-0318, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the RCRA Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for RCRA Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public

comments, access the index listing of the contents of the docket, and
to access those documents in the public docket that are available
electronically. Once in the system, select ``search,'' then key in the
docket ID number identified in this document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
business or other for-profit.
    Title: Land Disposal Restrictions `No-Migration' Variances.
    ICR numbers: EPA ICR No. 1353.09, OMB Control No. 2050-0062.
    ICR status: This ICR is currently scheduled to expire on January
31, 2010. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: To receive a variance from the hazardous waste land
disposal prohibitions, owner/operators of hazardous waste storage or
disposal facilities may petition the Environmental Protection Agency to
allow land disposal of a specific restricted waste at a specific site.
The EPA Regional Offices will review the petitions and determine if
they successfully demonstrate ``no migration.'' The applicant must
demonstrate that hazardous wastes can be managed safely in a particular
land disposal unit, so that ``no migration'' of any hazardous
constituents occurs from the unit for as long as the waste remains
hazardous. If EPA grants the variance, the waste is no longer
prohibited from land disposal in that particular unit. If the owner/
operator fails to make this demonstration, or chooses not to petition
for the variance, best demonstrated available technology (BDAT)
requirements of 40 CFR 268.40 must be met before the hazardous wastes
are placed in a land disposal unit. This ICR will be merged with ICR
No. 1442.19, the Land Disposal Restrictions ICR, when it is renewed
next year.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 3,168
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 1.
    Frequency of response: once.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 3,168 hours.
    Estimated total annual costs: $0. This includes an estimated burden
cost of $0 and an estimated cost of $0 for capital investment or
maintenance and operational costs.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 11, 2009.
Matt Hale,
Director, Office of Resource Conservation and Recovery.
[FR Doc. E9-22804 Filed 9-21-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Notices]
[Page 57472]
[DOCID:fr21se10-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0456]

Clinical Investigator Training Course

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA), Office of Critical
Path Programs, in cosponsorship with the Clinical Trials Transformation
Initiative (CTTI), is announcing a 3-day training course for health
care professionals responsible for, or involved in, the conduct and/or
design of clinical trials (clinical investigators). This course is
intended to assist clinical investigators in understanding what
preclinical and clinical information is needed to support the
investigational use of medical products, as well as the scientific,
regulatory, and ethical considerations involved in the conduct of
clinical trials.

DATES:  The training course will be held on November 8 and 9, 2010,
from 8 a.m. to 5 p.m. and on November 10, 2010, from 8 a.m. to 3 p.m.

ADDRESSES:  The training course will be held at the National Labor
College, 10000 New Hampshire Ave., Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Nancy Masiello, Office of Critical
Path Programs, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4166, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration: Register by November 1, 2010, at the registration/
information Web site at https://www.trialstransformation.org/fda-
clinical-investigator-training-course/. Registration materials, payment
procedures, accommodation information, and a detailed description of
the course can be found at the registration/information Web site. The
registration fee is $350 per person. The fee includes course materials
and onsite lunch. Early registration is recommended because seating is
limited. There will be no onsite registration. Persons attending the
course are advised that FDA is not responsible for providing access to
electrical outlets. If you need special accommodations due to a
disability, please contact Nancy Masiello at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical
role in the development of medical products. They bear the
responsibility for ensuring the safe and ethical treatment of study
subjects and for acquiring adequate and reliable data to support
regulatory decisions. This course is intended to assist clinical
investigators in understanding what preclinical and clinical
information is needed to support the investigational use of medical
products, as well as the scientific, regulatory, and ethical
considerations involved in the conduct of clinical trials.
    The training course is designed to provide clinical investigators
with an overview of the following topics:
     The essential toxicological, pharmacological, and
manufacturing data to support investigational use in humans;
     Fundamental issues in the design and conduct of clinical
trials;
     Statistical and analytic considerations in the
interpretation of trial data;
     Appropriate safety evaluation during studies;
     The ethical considerations and regulatory requirements for
clinical trials; and
     Application and compliance issues.
    In addition, the course should:
     Foster a cadre of clinical investigators with knowledge,
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and
FDA;
     Enhance investigators' understanding of FDA's role in
experimental medicine; and
     Improve the quality of data while enhancing subject
protection in the performance of clinical trials.
    On November 8, 2010, the course will address the role of FDA in
clinical studies, regulatory considerations for clinical trials, and
review of the material generally appearing in an ``investigator's
brochure,'' i.e., the preclinical information (toxicology, animal
studies, and chemistry/manufacturing information) that supports initial
clinical trials in humans. Presentations will also discuss the role of
clinical pharmacology in early clinical studies and how this
information is used in the design of subsequent studies. On November 9,
2010, the course will include discussions of scientific, statistical,
ethical, and regulatory aspects of clinical studies. On November 10,
2010, the course will include discussions of safety assessment in
clinical trials, including hepatic and cardiovascular safety,
approaches to special populations (e.g., pregnant women and
pediatrics), and breakout sessions to discuss how to put together an
application, including related compliance issues.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23493 Filed 9-20-10; 8:45 am]
BILLING CODE 4160-01-S