[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Notices]
[Page 41803]
[FR Doc No: 2011-17777]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0095]

Guidance for Industry and Food and Drug Administration Staff;
Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection and Differentiation of Influenza
Viruses; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection or
Detection and Differentiation of Influenza Viruses.'' FDA is issuing
this guidance to inform industry and Agency staff of its
recommendations for analytical and clinical performance studies to
support premarket submissions for in vitro diagnostic devices intended
for the detection or detection and differentiation of influenza
viruses.

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

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Establishing the Performance Characteristics of In
Vitro Diagnostic Devices for the Detection or Detection and
Differentiation of Influenza Viruses'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tamara Feldblyum, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5550, Silver Spring, MD 20993, 301-796-
6195.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document recommends studies that may be used to
establish the analytical and clinical performance of in vitro
diagnostic devices (IVDs) for the detection or detection and
differentiation of influenza viruses. The document addresses devices
that detect either influenza viral antigens or influenza viral genome
(protein or nucleic acid), including those for novel influenza viruses
in either human specimens or culture isolate. The guidance does not
address devices that detect serological response from the host to the
viral antigen, nor does it address establishing performance of non-
influenza components of multi-analyte or multiplex devices. This
guidance document identifies the classification regulations and product
codes for existing legally marketed influenza tests and supplements
other FDA documents that discuss the specific contents of premarket
submissions. The draft of the guidance was issued for comment for 90
days on February 15, 2008. A total of four sets of comments were
received. In response to comments, FDA made clarifying edits in several
sections, and also added a section on determining the assay cut-off and
equivocal zone. In addition, to address growing complexity of the
devices, new sections were added regarding labeling, instrumentation,
hardware and software, use of fresh and frozen specimens, nucleic acids
extraction methods, and recommendations to help monitor postmarket
device performance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection or
Detection and Differentiation of Influenza Viruses.'' It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
the document ``Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or Detection and Differentiation
of Influenza Viruses,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1638 to identify the guidance you are requesting.

IV. Paperwork Reduction Act

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR 809.10 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; and the
collections of information in 42 CFR part 493 have been approved under
OMB control number 0910-0598.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-17777 Filed 7-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Rules and Regulations]
[Page 71260]
[FR Doc No: 2011-29652]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-1042]

Drawbridge Operation Regulation; China Basin, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eleventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Third Street Drawbridge across China Basin, mile 0.0, at San Francisco,
CA. The deviation is necessary to allow the City of San Francisco to
inspect the bridge structure as required by the U.S. Department of
Transportation. This deviation allows the bridge to be secured in the
closed-to-navigation position during the deviation period.

DATES: This deviation is effective from 10 a.m. to 2 p.m. on November
16, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of the docket USCG-2011-1042 and are available
online by going to http://www.regulations.gov, inserting USCG-2011-1042
in the ``Keyword'' box and then clicking ``Search''. They are also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 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 rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION: The City of San Francisco requested a
temporary change to the operation of the Third Street Drawbridge, mile
0.0, over China Basin, at San Francisco, CA. The drawbridge navigation
span provides a vertical clearance of 3 feet above Mean High Water in
the closed-to-navigation position. As required by 33 CFR 117.149, the
draw shall open on signal if at least one hour notice is given to the
San Francisco Department of Public Works. Navigation on the waterway is
commercial and recreational.
    The Third Street Drawbridge will be secured in the closed-to-
navigation position from 10 a.m. to 2 p.m. on November 16, 2011, to
allow the City of San Francisco to inspect the bridge structure as
required by the U.S. Department of Transportation. This temporary
deviation has been coordinated with the waterway users. No objections
to the proposed temporary deviation were received.
    Vessels that can transit the bridge, while in the closed-to-
navigation position, may continue to do so at any time. In the event of
an emergency, the drawbridge can open upon one hour notice.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: November 3, 2011.
D.H. Sulouff,
Bridge Section Chief, Eleventh Coast Guard District.
[FR Doc. 2011-29652 Filed 11-16-11; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47651-47654]
[FR Doc No: 2018-20431]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84141; File No. SR-C2-2018-020]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
To Amend Its Rules Relating to Categories of Registration and
Respective Qualification Examinations Required for Trading Permit
Holders (``TPHs'') and Associated Persons That Engage in Trading
Activities on the Exchange

September 14, 2018.
    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 September 7, 2018, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. 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\ 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

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'') proposes to
amend its rules relating to categories of registration and respective
qualification examinations required for Trading Permit Holders
(``TPHs'') and associated persons that engage in trading activities on
the Exchange.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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 Exchange 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 Exchange 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The SEC recently approved a proposed rule change to restructure the
FINRA representative-level qualification examination program.\3\ The
rule change, which will become effective on October 1, 2018,
restructures the examination program into a more efficient format
whereby all new representative-level applicants will be required to
take a general knowledge examination (the Securities Industry
Essentials Examination (``SIE'')) and a tailored, specialized knowledge
examination (a revised representative-level qualification examination)
for their particular registered role. Individuals are not required to
be associated with an Exchange or any other self-regulatory
organization (``SRO'') member to be eligible to take the SIE. However,
passing the SIE alone will not qualify an individual for registration
with the Exchange. To be eligible for registration, an individual must
also be associated with a firm, pass an appropriate qualification
examination for a representative or principal and satisfy the other
requirements relating to the registration process.
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    \3\ See Securities Exchange Act Release No. 81098 (July 7,
2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-
FINRA-2017-007).
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    The SIE would assess basic product knowledge; the structure and
function of the securities industry markets, regulatory agencies and
their functions; and regulated and prohibited practices. In particular,
the SIE will cover four major areas. The first, ``Knowledge of Capital
Markets,'' focuses on topics such as types of markets and offerings,
broker-dealers and depositories, and economic cycles. The second,
``Understanding Products and Their Risks,'' covers securities products
at a high level as well as associated investment risks. The third,
``Understanding Trading, Customer Accounts and Prohibited Activities,''
focuses on accounts, orders, settlement and prohibited activities. The
final area, ``Overview of the Regulatory Framework,'' encompasses
topics such as SROs, registration requirements and specified conduct
rules. It's anticipated that the SIE would include 75 scored questions
plus an additional 10 unscored pretest questions. The passing score
would be determined through methodologies compliant with testing
industry standards used to develop examinations and set passing
standards.
    The restructured program eliminates duplicative testing of general
securities knowledge on the current representative-level qualification
examinations by moving such content into the SIE. The SIE will test
fundamental securities related knowledge, including knowledge of basic
products, the structure and function of the securities industry, the
regulatory agencies and their functions and regulated and prohibited
practices, whereas the revised representative-level qualification
examinations will test knowledge relevant to day-to-day activities,
responsibilities and job functions of representatives. The SIE was
developed in consultation with a committee of industry representatives
and representatives of several other SROs. Each of the current
representative-level examinations covers general securities knowledge,
with the exception of the Research Analyst (Series 86 and 87)
examinations.
    The Exchange proposes to require that effective October 1, 2018,
new applicants seeking to register in a representative capacity with
the Exchange must pass the SIE before their registrations can become
effective. The Exchange proposes to make the requirement operative on
October 1, 2018 to coincide with the effective date of FINRA's
requirement.\4\
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    \4\ The Exchange notes that the Exchange's affiliate, Cboe
Exchange, Inc. (``Cboe Options'') is also submitting a similar rule
change to require the SIE for representative-level registrations. In
that rule filing, Cboe Options proposes to make clear in Rule 9.3
that persons required to register as a General Securities
Representative must also pass the SIE. The Exchange notes that
Chapter IX of Cboe Options Rules is incorporated by reference and as
such, the proposed requirement will similarly apply to the Exchange.
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    The Exchange notes that individuals who are registered as of
October 1, 2018 are eligible to maintain their registrations without
being subject to any additional requirements. Individuals who had been
registered within the past two years prior to October 1, 2018, would
also be eligible to maintain those registrations without being subject
to any additional requirements, provided they register within two years
from the date of their last registration. However, with respect to an
individual who is not registered on the effective date of the proposed
rule change but was registered within the past two years prior to the
effective date of the proposed rule change, the individual's SIE status
in the CRD system would be administratively terminated if such
individual does not register with the Exchange within four years from
the date of the individual's last registration. The Exchange also notes
that consistent with Interpretation and Policy .04 of Rule 3.4, the
Exchange will consider waivers of the SIE alone or the SIE and the
representative or principal-level examination(s) for TPHs who are
seeking registration in a representative- or principal-level
registration category.\5\
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    \5\ Pursuant to a Regulatory Services Agreement between FINRA
and the Exchange, FINRA provides the Exchange certain exam waiver
services in responding to exam waiver requests from Exchange TPHs.
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    Lastly, the Exchange proposes to adopt Interpretation and Policy
.08 of Rule 3.4 to provide individuals who are associated persons of
firms and who hold foreign registrations an alternative, more flexible,
process to obtain an Exchange representative-level registration.\6\ The
Exchange believes

that there is sufficient overlap between the SIE and these foreign
qualification requirements to permit them to act as exemptions to the
SIE. As such the Exchange proposes to provide that individuals who are
in good standing as representatives with the Financial Conduct
Authority in the United Kingdom or with a Canadian stock exchange or
securities regulator would be exempt from the requirement to pass the
SIE, and thus would be required only to pass a specialized knowledge
examination to register with the Exchange as a representative. The
proposed approach would provide individuals with a United Kingdom or
Canadian qualification more flexibility to obtain an Exchange
representative-level registration. The Exchange notes that FINRA has
adopted a similar rule.\7\
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    \6\ As previously noted, Cboe Options is submitting a similar
rule change which includes the proposed language in Rule 3.4.08.
Cboe Options also proposes to include such language in a new
Interpretation and Policy .02 of Cboe Options Rule 9.3 to make clear
that such requirement also applies to representative-level
registrations required for persons who do business with the public.
Chapter IX of Cboe Options Rules is incorporated by reference and as
such, the proposed requirement will similarly apply to the Exchange.
    \7\ See Securities Exchange Act Release No. 81098 (July 7,
2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-
FINRA-2017-007).
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\8\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \9\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ Id.
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    The Exchange believes that the proposed rule change will improve
the efficiency of the Exchange's examination requirements, without
compromising the qualification standards, by eliminating duplicative
testing of general securities knowledge on examinations. FINRA has
indicated that the SIE was developed in an effort to adopt an
examination that would assess basic product knowledge; the structure
and function of the securities industry markets, regulatory agencies
and their functions; and regulated and prohibited practices. The
Exchange also notes that the introduction of the SIE and expansion of
the pool of individuals who are eligible to take the SIE, has the
potential of enhancing the pool of prospective securities industry
professionals by introducing them to securities laws, rules and
regulations and appropriate conduct before they join the industry in a
registered capacity. Lastly, the Exchange notes adopting the SIE
requirement is consistent with the requirement recently adopted by
FINRA.\11\
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    \11\ See Securities Exchange Act Release No. 81098 (July 7,
2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-
FINRA-2017-007).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change, which harmonizes its rules with recent rule
changes adopted by FINRA and which is being filed in conjunction with
similar filings by the other national securities exchanges, will reduce
the regulatory burden placed on market participants engaged in trading
activities across different markets. The Exchange believes that the
harmonization of these registration requirements across the various
markets will reduce burdens on competition by removing impediments to
participation in the national market system and promoting competition
among participants across the multiple national securities exchanges.

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

    The Exchange neither solicited nor received written comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days from the date of filing. However, Rule
19b-4(f)(6)(iii) \13\ permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative on
October 1, 2018 to coincide with the effective date of FINRA's proposed
rule change on which the proposal is based.\14\ The waiver of the
operative delay would make the Exchange's qualification requirements
consistent with those of FINRA. Therefore, the Commission believes that
the waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest and hereby waives the
30-day operative delay and designates the proposal operative on October
1, 2018.\15\
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    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ See supra note 3.
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the 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.

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-C2-2018-020 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-C2-2018-020. 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. 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-C2-2018-020 and should be submitted on
or before October 11, 2018.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-20431 Filed 9-19-18; 8:45 am]
 BILLING CODE 8011-01-P