[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Proposed Rules]
[Pages 69034-69039]
[FR Doc No: 2011-28724]

Vol. 76

Monday,

No. 215

November 7, 2011

Part V

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 866

Microbiology Devices; Classification of In Vitro Diagnostic Device for
Yersinia Species Detection and Draft Guidance for Industry and Food and
Drug Administration Staff; Class II Special Controls Guidance Document:
In Vitro Diagnostic Devices for Yersinia Species Detection;
Availability; Proposed Rule and Notice

Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-N-0729]

Microbiology Devices; Classification of In Vitro Diagnostic
Device for Yersinia Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify in vitro diagnostic devices for Yersinia species (spp.)
detection into class II (special controls), in accordance with the
recommendation of the Microbiology Devices Advisory Panel (the panel).
FDA is publishing in this document the recommendation(s) of the panel
regarding the classification of this device. After considering public
comments on the proposed classification, FDA will publish a final
regulation classifying this device.

DATES: Submit either electronic or written comments by February 6,
2012. See section IV of this document for the proposed effective date
of a final rule based on this proposed rule.

ADDRESSES: You may submit comments, identified with the FDA docket
number found in brackets in the heading of this document, by any of the
following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0729 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Request for Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5553, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Legal Authority

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (Pub.
L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public
Law 105-115), the Medical Device User Fee and Modernization Act (Pub.
L. 107-250), and the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval). Elsewhere in this issue of the Federal Register, FDA is
announcing the availability for comment of the draft guidance document
that FDA proposes to designate as a special control for this device. In
addition, the proposed rule would establish as a special control
limitations on the distribution of this device.
    Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies a
device after it: (1) Receives a recommendation from a device
classification panel (an FDA advisory committee); (2) publishes the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) publishes a final regulation
classifying the device type (see section 513(d) of the FD&C Act). FDA
has classified most preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the FD&C Act)
into class III without any FDA rulemaking process. Those devices remain
in class III and require premarket approval, unless and until: (1) FDA
reclassifies the device into class I or II; (2) FDA issues an order
classifying the device into class I or II in accordance with section
513(f)(2) of the FD&C Act, as amended by the FDAMA; or (3) FDA issues
an order finding the device to be substantially equivalent, under
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to previously offered devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application until FDA promulgates a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
    Consistent with the FD&C Act and the regulations, FDA consulted
with the panel, regarding the classification of this device.

B. Regulatory History of In Vitro Diagnostic Devices for Yersinia spp.
Detection

    After the enactment of the Medical Device Amendments of 1976, FDA
undertook to identify and classify all preamendments devices, in
accordance with section 513(b) of the FD&C Act. However, in vitro
diagnostic devices for Yersinia spp. detection were not identified and
classified in this initial effort. FDA subsequently identified several
preamendments devices for Yersinia spp. detection, including Yersinia
spp. antisera conjugated with a fluorescent dye (immunofluorescent
reagents) used to presumptively identify Yersinia-like organisms in
clinical specimens, antigens used to identify antibodies to Y. pestis
(Fraction 1) in serum, and bacteriophage used for differentiating Y.
pestis from other

Yersinia spp. based on susceptibility to lysis by the phage.
    Consistent with the FD&C Act and the regulations, FDA held a panel
meeting on March 7, 2002, regarding the classification of the
preamendments in vitro diagnostic devices for Yersinia spp. detection.
After the panel meeting FDA found one additional in vitro diagnostic
device for Yersinia spp. detection to be substantially equivalent to a
preamendment device within that type. The additional device has the
same intended use as its predicate device but makes use of newer
nucleic acid amplification technology (NAAT). While it exhibits
technological differences from the preamendments Yersinia spp.
detection devices, FDA has determined that it is as safe and effective
as, and does not raise different questions of safety and effectiveness
from its predicate (see section 513(i) of the FD&C Act).

II. Panel Recommendation

    At a public meeting held on March 7, 2002, the panel recommended
that in vitro diagnostic devices for Yersinia spp. detection (Ref. 1)
be classified into class II.

A. Identification

    FDA is proposing the following identification based on the panel's
recommendation and the available information. An in vitro diagnostic
device for Yersinia spp. detection is used to detect and differentiate
among Yersinia spp. and presumptively identify Y. pestis and other
Yersinia spp. from cultured isolates or clinical specimens as an aid in
the diagnosis of plague and other diseases caused by Yersinia spp. This
device may consist of Yersinia spp. antisera conjugated with a
fluorescent dye (immunofluorescent reagents) used to presumptively
identify Yersinia-like organisms in clinical specimens or bacteriophage
used for differentiating Y. pestis from other Yersinia spp. based on
susceptibility to lysis by the phage or antigens used to identify
antibodies to Y. pestis (Fraction 1) in serum. Diseases caused by
Yersinia infections include three different forms of plague (bubonic,
pneumonic, and septicemic), caused by Y. pestis, and gastrointestinal
infection, caused by Y. pseudotuberculosis and Y. enterocolitica.

B. Classification Recommendation

    The panel recommended that in vitro diagnostic devices for Yersinia
spp. detection be classified into class II. The panel believed that
class II with special controls (guidance document and limitations on
the distribution) would provide reasonable assurance of the safety and
effectiveness of the device.

C. Summary of Reasons and Data To Support the Recommendation

    The panel considered information from the literature presented by
FDA (Refs. 2 to 7), information presented at the meeting by
representatives from the United States Army Medical Research Institute
for Infectious Diseases who shared the historical perspective on their
institution's use of devices for the detection of Y. pestis and their
personal experience using these devices, and the panel's personal
knowledge and experience.
    Evidence presented to the panel addressed how the preamendments
devices of this type work and some of their limitations. Bacteriophage
tests are used for differentiating Y. pestis from Y.
pseudotuberculosis. The test is performed at 20-25 [deg]C because the
bacteriophage can lyse Y. pseudotuberculosis at 37 [deg]C but not at
lower temperatures. Lysis at 22-25 [deg]C provides presumptive evidence
that a culture isolate is Y. pestis. The fluorescent antibody reagent
is a fluorescein-labeled antibody against Fraction 1 (F1) antigen that
is used to microscopically visualize specific binding with cultured
bacteria. A protein from the capsular envelope of Y. pestis is used to
microscopically visualize specific binding with cultured bacteria. The
test can be performed with culture growth or can be done on clinical
specimens that have gram-negative bacteria resembling Y. pestis. The
presence of F1 antigen is presumptive evidence of Y. pestis, which must
be confirmed with other testing. F1 antigen can be used to sensitize
sheep erythrocytes for hemagglutination testing to detect antibody
responses to F1 in human sera. Significant levels of human antibody to
this antigen can be retrospective confirmation of Y. pestis infection
or can be presumptive of Y. pestis infection when a single serum sample
is tested.
    The panel discussed considerations about use of these devices,
including the training, experience, and facilities necessary for safe
handling of test materials and specimens, and for appropriate test
execution and interpretation of test results. They also discussed the
desirability of coordination by public health Agencies, including the
Centers for Disease Control and Prevention, to ensure that appropriate
performance standards and use guidelines are developed for these tests
and to encourage that test results be reported to public health
authorities.
    The panel recommended that in vitro diagnostic devices for Yersinia
spp. detection should be classified into class II because they
concluded that special controls, in addition to general controls, would
provide reasonable assurance of the safety and effectiveness of the
device, and there is sufficient information to establish special
controls to provide such assurance.

D. Risks to Health

    Based on the panel's discussion and recommendations, and FDA's
experience with these devices, we believe the following are risks to
health associated with the use of the device type.
    Failure of in vitro diagnostic devices for Yersinia spp. detection
to perform as indicated or an error in interpretation of results may
lead to misdiagnosis and improper patient management or inaccurate
epidemiological information that may contribute to inappropriate public
health responses. FDA believes that this type of device presents risks
associated with a false-negative test result and a false-positive test
result, as explained in this document. In addition, there may be risks
to laboratory workers resulting from handling positive cultures and
control materials.
    A false-positive result may lead to a medical decision causing a
patient to undergo unnecessary or ineffective treatment, as well as
inaccurate epidemiological information on the presence of plague
disease in a community. A false-negative result may lead to delayed
recognition by the physician of the presence or progression of disease
and inaccurate epidemiological information to control and prevent
additional infections. A false-negative result could potentially delay
diagnosis and treatment of infection caused by Y. pestis or other
Yersinia spp.
    Additionally, exposure to organisms potentially present in test
specimens and those used as control materials poses a risk of infection
of Yersinia to laboratory workers.

E. Special Controls

    Based on the panel's discussion and recommendations, FDA believes
that, in addition to general controls, the proposed special controls
discussed in this document are adequate to address the risks to health.
    FDA believes that the draft guidance document entitled ``Class II
Special Controls Guidance Document: In Vitro Diagnostic Devices for
Yersinia spp. Detection'' and limitations on distribution of these
devices, set forth in the proposed classification regulation,

will address the risks identified previously in this document and
provide a reasonable assurance of safety and effectiveness of the
device. The class II special controls guidance document provides
information on how to meet premarket (510(k)) submission requirements
for the assays in sections that discuss performance studies and
labeling. The guidance document provides specific recommendations for
NAAT tests and tests using the technologies employed by the
preamendments devices. The performance studies section of the guidance
describes studies to demonstrate appropriate performance and control
against assays that may otherwise fail to perform to acceptable
standards. The labeling section of the guidance addresses factors such
as directions for use, quality control, and precautions for use and
interpretation. The special controls guidance recommendations will
allow the manufacturer to identify the causes of false-positive and
false-negative test results and appropriately label their device to
limit the occurrence of false positives and false negatives.
    In addition, FDA proposes as a special control that distribution of
these devices be limited to laboratories with experienced personnel who
have training in principles and use of microbiological culture
identification methods and infectious disease diagnostics, and with
appropriate biosafety equipment and containment. As noted, the panel
was concerned about improper use of these devices and recommended that
these devices be used only by personnel sufficiently skilled to
maximize their performance and to appropriately interpret and make use
of test results. FDA believes that this proposed distribution
limitation will appropriately help assure the safe and effective use of
these devices and that it is consistent with the intent of the panel in
its discussion of limitations on the use of the devices and on
monitoring of test results.

            Table 1--Risks to Health and Mitigation Measures
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            Identified risks                    Mitigation measures
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A false-negative test result may lead to  Device description--
 delay of therapy and progression of       recommended.
 disease and epidemiological failure to   Performance studies--
 promptly recognize disease in the         recommended.
 community.                               Labeling--recommended.
                                          Limited distribution--
                                           required.
A false-positive test result may lead to  Device description--
 unnecessary treatment and incorrect       recommended.
 epidemiological information that leads   Performance studies--
 to unnecessary prophylaxis and            recommended.
 management of others.                    Labeling--recommended.
                                          Limited distribution--
                                           required.
Biosafety and a risk of transmission of   Labeling--recommended.
 Yersinia infection to laboratory         Limited distribution--
 workers handling test specimens and       required.
 control materials.
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III. Proposed Classification

    FDA agrees with the panel's recommendation that in vitro diagnostic
devices for Yersinia spp. detection should be classified into class II
because special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device, and
there is sufficient information to establish special controls to
provide such assurance.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.

V. Environmental Impact

    The Agency has determined that under 21 CFR 25.34(b) this
classification 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.

VI. Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Orders 12866 and 13563 direct Agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule would create no new
burdens, the Agency proposes to certify that the final rule will not
have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

B. Need for Regulation

    In vitro diagnostic devices used to identify and differentiate
among Yersinia spp. are currently unclassified preamendment devices.
Heightened interest in biological warfare and bioterrorism has
generated interest in devices that would identify Y. pestis, the
pathogen responsible for plague and other diseases. FDA has identified
information for the safe and effective use of such devices and has
applied this information in its clearance of a device that identifies
Y. pestis. However, the lack of a formal device classification and
published guidance may deter additional firms from entering the market
for such devices. Devices are typically classified, and these
designations are published in the Federal Register.
    Market failure can occur when market participants lack important
information or when they possess incorrect information. Because this
device lacks a

formal classification and published data recommendations, potential
manufacturers may be unable to assess whether to enter this market.
Even manufacturers in possession of these standards that would
otherwise enter this market might interpret the absence of a formal
classification as FDA uncertainty about its premarket review
requirements or that FDA may be about to change these requirements,
making market entry seem riskier than it is. The market failure we
intend to address is one of imperfect information. Classifying this
device would provide valuable information to manufacturers about what
is needed to obtain FDA clearance. Manufacturers lacking this
information might choose not to enter the market for this device when a
well-informed manufacturer would. Moreover, the submission process may
be unclear to both manufacturers and FDA because the data requirements
are not clearly articulated.

C. Background

    Y. pestis, the causative agent of plague, is associated with over
100 million deaths worldwide during three historical pandemics. Rodents
and other mammals have historically served as reservoirs of plague,
while fleas feeding on these animals are vectors that can transmit the
disease to humans. Improved urban sanitary conditions, including
improved rodent control, has dramatically reduced the incidence of
plague, while availability of antibiotics has dramatically lowered the
mortality rate.
    Plague has been endemic in the continental United States since at
least 1900. The United States averaged 18 cases of plague per year in
the 1980s and 9 cases per year since 1990. In 2006, a total of 13 human
plague cases were reported among residents of four states. This is the
largest number of cases reported in a single year in the United States
since 1994. Two of the 13 cases were fatal.
    Those infected with plague are likely to survive if they are
treated with antibiotics soon after the symptoms appear. Treatment
generally consists of taking antibiotics for at least 7 days. Without
treatment, mortality is 60 percent for bubonic plague and 100 percent
for pneumonic and septicemic plague. The primary public health issue
associated with plague, however, would be its potential use in warfare
or in an act of terrorism, where hundreds or thousands of individuals
could be infected. Effective treatment would require rapid diagnosis,
the timely administration of antibiotics, and public health measures to
minimize the risk of further infection.
    In the event of a potential massive plague outbreak, one would want
to be able to test for Y. pestis quickly and accurately. Rapid
identification of Y. pestis and diagnosis of plague would improve the
ability to treat infected individuals and minimize the chances of
infecting others. Reducing the likelihood of false-negative testing
results would minimize the possibility that infected individuals would
be left untreated and that the disease would go undetected by public
health officials. Reducing the likelihood of false-positive testing
results would minimize potential costs associated with unnecessary
therapy and unnecessary infection control measures.
    The Microbiology Devices Panel met March 7, 2002, to recommend a
classification for in vitro diagnostic products for the identification
of Yersinia spp. The panel recommended that the devices be classified
as class II, without exemption from premarket notification
requirements, and that special controls include testing guidelines,
performance characteristics, and restrictions on distribution. FDA
generally concurs with these recommendations.
    In vitro diagnostic devices for Yersinia spp. detection are
preamendment, unclassified devices. As such, manufacturers of new
devices for Yersinia spp. detection may market these devices through
premarket notification procedures and are not required to submit
premarket approval applications. In 2007, a manufacturer obtained FDA
clearance for a device to detect Y. pestis through the 510(k) premarket
notification procedures. Throughout the process, FDA advised the
applicant on the studies that would establish the performance
characteristics of the device, device labeling, and distribution
restrictions to demonstrate substantial equivalence to a preamendment
device. This data submission was consistent with the recommendations of
the 2002 panel. Absent this rulemaking effort, FDA would continue to
regulate this device in this fashion.

D. Description of the Proposed Rule

    Through this proposal, FDA intends to follow the recommendations of
the 2002 Microbiology Devices Panel. This proposed rule would place
devices used for the in vitro identification of Yersinia spp. into
class II (special controls). General controls alone would be inadequate
for safe and effective use, and the class III premarket application
process would be unnecessary. The proposed special controls are
consistent with the principle of applying the appropriate regulatory
control necessary to provide reasonable assurance of safety and
effectiveness. The application of this intermediate level of regulatory
oversight and these specific special controls would be consistent with
FDA's treatment of other devices with similar risk profiles. Reagents
for detection of specific novel influenza A viruses, for example, are
class II devices.
    In addition to the general controls, FDA would require special
controls in the form of a guidance document that would include
recommendations for the types of information that should be included in
premarket submissions and restrictions on device distribution. The
guidance document would include a section on performance
characteristics, describing studies to demonstrate appropriate device
performance, and a section on labeling that would include device
intended use, instructions for use of the device, precautions, and the
interpretation and reporting of test results. The special controls
would also include the restricted distribution of these devices. Under
these special controls, the device would be limited to laboratories
with experienced personnel who have training in principles and use of
microbiological culture identification methods and infectious disease
diagnostics, and with appropriate biosafety equipment and containment.
These specific special controls are needed because of the public health
issues associated with Y. pestis infection.
    Erroneous test results when testing for Y. pestis can result in
serious public health consequences. Individuals infected with Y. pestis
are unlikely to survive if they are not treated in a timely manner. In
the case of a potential massive outbreak of Y. pestis, such as might
occur with the use of the pathogen as an instrument of bioterrorism,
the potential consequences could be substantial. False negatives or
otherwise mishandled test results could not only delay the treatment of
infected individuals, but also could prevent public health officials
from taking steps to prevent the transmission of plague to others.
False positives could lead to unnecessary use of antibiotics and
patient isolation, and would have serious economic and public health
consequences if the reporting of these results were to contribute to a
public health panic.
    FDA intends to address risks to public health not adequately
controlled by general controls through special controls. The device
description section of the special controls guidance

document would explain to manufacturers the need to include in the
premarket submission information on the nature of the device and its
proper use. The section on performance studies would recommend the
types of information and data manufacturers need to collect in order to
establish the performance of their device, clarifying regulatory
requirements. The special control on labeling would provide users with
information on the device's intended use, directions for use,
interpretation of results, and potential precautions. The control on
distribution would ensure that those using this device would have the
training and equipment needed to perform the test safely and
effectively, and that test results would be appropriately reported to
the public health authorities.

E. Costs and Benefits of the Proposed Regulation

    This proposed rule would not create any additional burdens or
directly result in significant benefits. Both current practice and this
proposed rule are applications of the recommendations of the 2002
Microbiology Devices Advisory Panel. The requirements associated with
class II and the chosen special controls do not change the requirements
FDA imposes on manufactures. Indirectly, however, the classification of
this device and publication of the special controls would benefit both
manufacturers and FDA. Manufacturers would benefit from published
regulatory requirements in that they would know the burdens associated
with entering this market before starting the premarket notification
process, and they would submit premarket notification submissions
containing the appropriate information. Improved knowledge of the
submission requirements would reduce the need for consultation with FDA
during the clearance process to facilitate FDA review and accelerate
product availability. Classification of this device and publication of
the requirements would also reduce FDA resources consumed in these
consultations and improve premarket review consistency.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule would impose no new
burdens, the Agency proposes to certify that this proposed rule would
not have a significant economic impact on a substantial number of small
entities.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain state requirements ``different from or
in addition to'' certain federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, Inc. 552 U.S. 312 (2008). The special controls established
by this proposed rule, if finalized, would create ``requirements'' to
restrict the distribution of these devices and to address each
identified risk to health presented by these specific medical devices
under 21 U.S.C. 360(k), even though product sponsors may have
flexibility in how they meet those requirements Cf. Papike v.
Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required. FDA also concludes that the special controls guidance
document identified by this rule refers to previously approved
collections of information found in FDA regulations. Elsewhere in this
issue of the Federal Register, FDA is publishing a notice announcing
the availability of a guidance entitled ``Class II Special Controls
Guidance Document: In Vitro Diagnostic Devices for Yersinia spp.
Detection.'' The notice contains an analysis of the paperwork burden
for the guidance.

IX. Request for 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.

X. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.)

1. Transcript of the FDA Microbiology Devices Panel meeting, March
7, 2002 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=348).
2. Bibel, D.J. and T.H. Chen, ``Diagnosis of Plague: An Analysis of
the Yersin-Kitasato Controversy,'' vol. 40, pp. 633-651,
Bacteriological Reviews, 1976.
3. Cavanaugh, DC and S.F. Quan, ``Rapid Identification of
Pasteurella pestis Using Specific Bacteriophage Lyophilized on
Strips of Filter Paper; a Preliminary Report,'' vol. 23, pp. 619-
620, American Journal of Clinical Pathology, 1953.
4. Chen, T.H. and K.F. Meyer, ``An Evaluation of Pasteurella pestis
Fraction-1-Specific Antibody for the Confirmation of Plague
Infections,'' vol. 34, pp. 911-918, Bulletin of the World Health
Organization, 1966.
5. Marshall, J.D., Jr., J.A. Mangiafico, and D.C. Cavanaugh,
``Comparison of the Reliability and Sensitivity of Three Serological
Procedures in Detecting Antibody to Yersinia pestis (Pasteurella
pestis),'' vol. 24, pp. 202-204, Applied Microbiology, 1972.
6. Perry, R.D. and J.D. Fetherston, ``Yersinia pestis--Etiologic
Agent of Plague,'' vol. 10, pp. 35-66, Clinical Microbiology
Reviews, 1997.
7. Rust J.H., Jr., S. Berman, W.H. Habig, et al., ``Stable Reagent
for the Detection of Antibody to the Specific Fraction 1 Antigen to
Yersinia pestis,'' vol. 23, pp. 721-724, Applied Microbiology, 1972.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    1. The authority citation for 21 CFR part 866 continues to read as
follows:

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

    2. Section 866.3945 is added to subpart D to read as follows:

Sec.  866.3945  In vitro diagnostic device for Yersinia spp. detection.

    (a) Identification. An in vitro diagnostic device for Yersinia spp.

detection is a device that is used to detect and differentiate among
Yersinia spp. and presumptively identify Y. pestis and other Yersinia
spp. from cultured isolates or clinical specimens as an aid in the
diagnosis of plague and other diseases caused by Yersinia spp. Diseases
caused by Yersinia infections include three different forms of plague
(bubonic, pneumonic, and septicemic), caused by Y. pestis, and
gastrointestinal infection, caused by Y. pseudotuberculosis and Y.
enterocolitica. This device may consist of Yersinia spp. antisera
conjugated with a fluorescent dye (immunofluorescent reagents) used to
presumptively identify Yersinia-like organisms in clinical specimens or
bacteriophage used for differentiating Y. pestis from other Yersinia
spp. based on susceptibility to lysis by the phage; or antigens used to
identify antibodies to Y. pestis (Fraction 1) in serum.
    (b) Classification. Class II (special controls). The special
controls are:
    (1) ``Class II Special Controls Guidance Document: In Vitro
Diagnostic Devices for Yersinia spp. Detection; Guidance for Industry
and Food and Drug Administration Staff.'' See Sec.  878.1(e) for
availability information of this guidance document; and
    (2) Distribution is limited to laboratories with experienced
personnel who have training in principles and use of microbiological
culture identification methods and infectious disease diagnostics, and
with appropriate biosafety equipment and containment.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28724 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2224]
[DOCID:fr13ja06-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD05-13-000]

Joint Boards on Security; Constrained Economic Dispatch; Notice
Announcing Joint Board Meetings

January 6, 2006.
    On September 30, 2005, the Commission issued an order convening
regional joint boards \1\ pursuant to section 1298 of the Energy Policy
Act of 2005,\2\ which added section 223 to the Federal Power Act
(FPA).\3\ FPA section 223 requires the Commission to convene joint
boards on a regional basis pursuant to FPA section 209 ``to study the
issue of security constrained economic dispatch for the various market
regions,'' ``to consider issues relevant to what constitutes `security
constrained economic dispatch' and how such a mode of operating * * *
affects or enhances the reliability and affordability of service,'' and
``to make recommendations to the Commission.'' Initial joint board
meetings were held in November 2005.\4\
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    \1\ Joint Boards on Security Constrained Economic Dispatch, 112
FERC ] 61,353 (2005) (September 30 Order).
    \2\ Public Law No. 109-58, Sec.  1298, 119 Stat. 594, 986
(2005).
    \3\ 16 U.S.C. 824 et seq. (2000).
    \4\ Notices concerning the initial joint board meetings were
issued on October 14, 21 and 27, 2005, and on November 9, 16 and 18,
in accordance with the September 30 Order.
---------------------------------------------------------------------------

    Take notice that further joint board meetings will be held at the
Hyatt Regency on Capitol Hill, 400 New Jersey Avenue, NW., in
Washington DC. The schedule for the meetings is:
    South region--Sunday, February 12, 2006--9:30 a.m. to 12 p.m.
    PJM/MISO region--Sunday, February 12, 2006--12:30 p.m. to 3 p.m.
    West region Monday, February 13, 2006--9:45 a.m. to 12:15 p.m.
    Northeast region--Monday, February 13, 2006--9:45 a.m. to 12:15
p.m.
    These meeting are open to the public. Additional details regarding
these meetings, if any, will be announced in supplemental notices in
this docket and posted on the Commission's Web site at http://www.ferc.gov
.

    Take further notice that Commissioner Samuel J. Ervin, IV of North
Carolina is now serving as Vice Chair of the Joint Board for the South
region.
    A free webcast of the meetings announced above is available through
http://www.ferc.gov Anyone with Internet access who desires to view this event can do so by navigating to http://www.ferc.gov.'s Calendar of

Events and locating this event in the Calendar. The event will contain
a link to its webcast. The Capitol Connection provides technical
support for the webcasts. It also offers access to this event via
television in the DC area and via phone bridge for a fee. If you have
any questions, visit http://www.CapitolConnection.org or contact

Danelle Perkowski or David Reininger at<PHONE_NUMBER>.
    Transcripts of the meeting will be immediately available for a fee
from Ace Reporting Company<PHONE_NUMBER> or 1-800-336-6646). They will
be available for free on the Commission's eLibrary system seven
calendar days after FERC receives the transcript.
    For more information about the meeting, please contact Sarah
McKinley at<PHONE_NUMBER> or<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-288 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 106 (Monday, June 3, 2019)]
[Proposed Rules]
[Pages 25506-25508]
[FR Doc No: 2019-11258]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0648]
RIN 1625-AA11

Revision for Regulated Navigation Area; Savannah River, GA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to amend the regulated navigation
area (RNA) on the Savannah River located between Fort Jackson, GA
(32[deg]04.93 N, 081[deg]02.19 W) and the Savannah River Channel
Entrance Sea Buoy. This document proposes to remove inapplicable and/or
outdated definitions, processes and requirements in the RNA following a
change in capability, infrastructure and layout of the Southern
Liquefied Natural Gas (LNG) facility on the Savannah River. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before August 2, 2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0648 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LT Joseph Palmquist, Coast Guard;
telephone<PHONE_NUMBER> ext. 221, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
GT Gross tons
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
RNA Regulated Navigation Area
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    On September 10, 2007, the Coast Guard published a final rule
titled ``Regulated Navigation Area: Savannah River, Savannah, GA'' at
33 CFR 165.756. (72 FR 51555). That rule established a RNA around the
Southern LNG facility on the Savannah River at Elba Island. Since
publishing the previous rule, there have been changes both to the
facility layout and to the types of vessels that make calls to the
facility. United States Coast Guard Marine Safety Unit Savannah, GA
held a public meeting to solicit public input on suggested changes to
this RNA. The public input we received is described in the Public
Participation and Request for Comments section of this NPRM. Therefore,
the U.S. Coast Guard proposes revision of and amendments to the RNA to
account for these changes and to ensure the safety and security of the
marine environment during LNG tankship operations. The Coast Guard
proposes this rulemaking under authority in 46 U.S.C. 70041 (previously
33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The Commander of the Seventh Coast Guard District proposes to amend
the Southern LNG facility RNA (33 CFR 165.756) as follows. The proposed
rule removes the definitions of ``Fire Wire'', ``Made-up'', and ``Make-
up'' because these terms do not align with the updated Oil Companies
International Maine Forum (OCIMF) guidance. Additionally, the proposed
rule removes requirements for LNG tankships moored inside the LNG
facility slip because the facility layout and capabilities changed,
rendering the requirements unnecessary. LNG tankships no longer moor
outside Southern LNG facility slip; they only moor inside the facility
slip.
    The current regulation prohibits vessels 1600 gross tons (GT) or
greater from overtaking within 1000 yards of the LNG facility slip when
a LNG tankship is present within the slip. This proposed rule would
instead not allow these vessels to meet nor overtake within the area
adjacent to either side of the Southern LNG facility slip when an LNG
tankship is present within the slip. The purpose of changing the
language to ``adjacent to either side of the LNG facility'' rather than
an exact distance is due to the changes of the facility layout,
including the facility no longer having the capabilities or
infrastructure to moor an LNG tankship outside of the Southern LNG
facility slip.
    This proposed rule removes the requirements for an LNG tankship
that is moored outside of the Southern LNG facility slip. Since
publishing the previous rule, there have been changes both to the
facility infrastructure and to the types of vessels that make calls to
the facility. The LNG tankships visiting

Southern LNG are only moored inside the LNG facility slip, not outside
the LNG facility slip. The slip outside of the LNG facility no longer
has the capability to moor LNG tankships. The change to Southern LNG
facility infrastructure capacity has made these requirements
unnecessary.
    Finally, the proposed changes remove various requirements for
vessels within the RNA. Vessels 1600 GT or greater will no longer be
required to have two towing vessels when passing a LNG tankship moored
outside of the LNG facility slip. Having two tugs is not required due
to the change in capability, infrastructure and layout of the Southern
LNG facility. Specifically, two tugs would not be required based on
transiting vessel's proximity to LNG tankships moored inside the
Southern LNG facility slip. Additionally, because transiting vessels
can communicate and safely transit each other using VHF communications
the Coast Guard has proposed removing various bridge watch requirements
for vessels moored at the Southern LNG facility.
    These proposed changes are necessary to ensure the safety of
persons and property within the RNA during LNG tankship operations and
transfers after changes in the facility layout. The changes to the
regulatory text we are proposing appear at the end of this document.

IV. Regulatory Analyses

    We developed this proposed amendment to the Southern LNG facility
RNA at 33 CFR 165.756 after considering numerous statutes and Executive
orders related to rulemaking. Below we summarize our analyses based on
a number of these statutes and Executive orders and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This proposed amendment
and revision has not been designated a ``significant regulatory
action,'' under Executive Order 12866. Accordingly, the NPRM has not
been reviewed by the Office of Management and Budget (OMB), and
pursuant to OMB guidance it is exempt from the requirements of
Executive Order 13771.
    The economic impact of this proposed rule amendment is not
significant, as the amendment does not impact the area or effective
period of the current rule, but rather updates definitions and
processes based on changes both to the facility layout and to the types
of vessels that make calls to the LNG facility.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
RNA may be small entities, for the reasons stated in section IV.A
above, this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01 and Commandant Instruction M16475.1D, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary
determination that this action is one of a category of actions that do
not individually or cumulatively have a significant effect on the human
environment. This proposed rule involves a RNA when an LNG tankship in
excess of heel is transiting the area or moored at the LNG facility.
Normally such actions are categorically excluded from further review
under paragraph L60(b) of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 01. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. A public meeting was held on July 25, 2018 to determine whether
proposed amendments or revisions to the current RNA were necessary.
Members of the public, representatives from relevant marine industry,
and members of the Coast Guard were in attendance. One comment was
received regarding the notice of the public meeting, which was not
germane to the substance of the proposed changes. A summary of comments
received during the public meeting is available in the docket.
    One participant proposed removing reference in the regulation to
LNG tankships being moored outside of the Southern LNG facility slip as
the facility no longer has this capability because the dock has been
decommissioned. The Coast Guard agrees and in response to this comment
proposes removal of any reference to LNG tankships being moored outside
of the Southern LNG facility slip. The reference ``inside'' and
``outside'' the LNG facility remains described in various sections to
avoid confusion as to what infrastructure is being referenced with the
proposed rule. The proposed rule will only reference LNG tankships
moored inside Southern LNG facility slip. This reference accurately
describes where LNG tankship moor at Southern LNG.
    One participant proposed modifying the 1,000-yard area requirement
in which vessels 1,600 gross tons or greater may pass by the slip by
removing the 1,000-yard requirement and inserting ``adjacent to the
slip.'' The Savannah Pilots indicated their concurrence with this
proposal. The Coast Guard agrees and in response proposes to remove the
aforementioned 1,000-yard requirement and replace the language
``adjacent to the slip.''
    One participant suggested that maintaining a bridge watch on the
LNG vessel was unnecessary. The representative from Shell Shipping and
Maritime indicated that nowhere else is a bridge watch maintained on an
LNG vessel, and recommended eliminating the requirement. The
representative from the Savannah Maritime Association requested
information on how to communicate with passing vessels and the use of
VHF communications. The Coast Guard agrees with the recommendation, and
proposes to eliminate the requirement for a bridge watch.
    One participant requested an estimated number of times the RNA
would be enacted in a year. The representative from Kinder Morgan
estimated 36 vessels per year would import LNG to the Southern LNG
facility.
    One participant suggested definitions of different types of
vessels, such as barges and tankships, should be added to the current
regulation. The representative from Kinder Morgan suggested that barges
are not tankships and as such should not be included in the regulation.
The Coast Guard agrees, and does not propose to include any such
definitions at this time.
    Several comments received considered the use of the RNA by barges
and the need for inclusion. The Coast Guard does not believe reference
to barges in the current regulation is required at this time.
    The Coast Guard will consider all comments and material received
during the comment period to this proposal. Your comment can help shape
the outcome of this rulemaking. If you submit a comment, please include
the docket number for this rulemaking, indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit https://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and160.5; Department of Homeland Security Delegation No. 0170.1.

0
 2. Amend Sec.  165.756 by:
0
a. Removing in paragraph (b), the definitions for ``Fire Wire'',
``Made-up'', and ``Make-up'';
0
b. Removing paragraphs (d)(2), (d)(4), (d)(5) and (d)(6); redesignate
paragraph (d)(3) as paragraph (d)(2);
0
 c. Removing in newly designated paragraphs (d)(2)(i) and (ii), the
words ``as directed by the LNG vessel bridge watch required in
paragraph (d)(5) of this section.'' and
0
 d. Adding new paragraph (d)(3) to read as follows:

Sec.  165.756   Regulated Navigation Area; Savannah River, Georgia.

* * * * *
    (d) * * *
    (3) Requirements for other vessels while within the RNA. (i)
Vessels 1,600 gross tons or greater shall at a minimum, transit at bare
steerageway when within an area 1,000 yards on either side of the LNG
facility slip to minimize potential wake or surge damage to the LNG
facility and vessel(s) within the slip.
    (ii) Vessels 1,600 gross tons or greater shall not meet nor
overtake within the area adjacent to either side of the LNG facility
slip when an LNG tankship is present within the slip.
    (iii) Except for vessels involved in those operations noted in
paragraph (c) of this section entitled Applicability, no vessel shall
enter the LNG facility slip at any time without the permission of the
Captain of the Port.
* * * * *

    Dated: May 24, 2019.
P.J. Brown,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2019-11258 Filed 5-31-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: January 25, 2010 (Volume 75, Number 15)]
[Notices]
[Page 3948]
[DOCID:fr25ja10-88]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, January
28, 2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
January 28, 2010 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; adjudicatory
matters; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: January 21, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-1456 Filed 1-21-10; 4:15 pm]
BILLING CODE 8011-01-P