[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12679-12680]
[FR Doc No: 2021-04467]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5698-022]

Triton Power Company; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 5698-022.
    c. Date Filed: December 31, 2020.
    d. Submitted By: Triton Power Company (Triton Power).
    e. Name of Project: Chateaugay High Falls Hydroelectric Project.
    f. Location: On the Chateaugay River in the Town of Chateaugay,
Franklin County, New York. The project does not occupy any federal
land.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Tim Carlsen, Chief Executive
Officer,

Hydroland, Inc., 403 Madison Ave. N #240, Bainbridge Island, WA 98110;
(844) 493-7612; [email protected]
    i. FERC Contact: Jeremy Feinberg at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Triton Power filed its request to use the Traditional Licensing
Process on December 31, 2020. Triton Power provided public notice of
its request on December 29, 2020. In a letter dated February 26, 2021,
the Director of the Division of Hydropower Licensing approved Triton
Power's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the New York State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Triton Power as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Triton Power filed a Pre-Application Document (PAD; including a
proposed process plan and schedule) with the Commission, pursuant to 18
CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed and/or printed on the
Commission's website (http://www.ferc.gov), using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field, to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY).
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 5698. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by December 31,
2023.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: February 26, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-04467 Filed 3-3-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35362-35363]
[FR Doc No: 2014-14447]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1189]

Canned Tuna Deviating From Identity Standard; Temporary Permit
for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) received
applications for temporary permits from Bumble Bee Foods, LLC; Chicken
of the Sea International; and StarKist Seafood Company (the
applicants). We are announcing that we have issued temporary permits to
the applicants to market test products (designated as ``canned tuna''
products) that deviate from the U.S. standard of identity for canned
tuna. The purpose of the temporary permits is to market test the
product throughout the United States and the Commonwealth of Puerto
Rico. The permits will allow the applicants to measure consumer
acceptance of the products and assess the commercial feasibility of the
products.

DATES: These permits are effective for 15 months, beginning on the date
each applicant introduces or causes the introduction of the test
products into interstate commerce, but not later than September 18,
2014.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We have issued a temporary permit to each of
the following applicants: Bumble Bee Foods, LLC; Chicken of the Sea
International; and StarKist Seafood Company. We are issuing these
temporary permits in accordance with 21 CFR 130.17, which addresses
temporary permits for interstate shipment of experimental packs of food
varying from the requirements of standards of identity issued under
section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341).
    These permits cover limited interstate marketing tests of products
identified as ``canned tuna.'' These test products deviate from the
U.S. standard of identity for canned tuna (21 CFR 161.190) in that they
are labeled without the statement ``Below Standard in Fill'' as
required in Sec.  161.190(c)(4) and 21 CFR 130.14(b). The test products
meet all the requirements of the standard with the exception of this
deviation.
    The purpose of these temporary permits is to market test the
product throughout the United States and the Commonwealth of Puerto
Rico. These permits will allow the applicants to measure customer
acceptance of the products and assess commercial feasibility of the
products.
    Table 1 lists the amount of product for distribution and the
manufacturers of the products for each of the applicants. The retail
cans for the products are of various sizes.

        Table 1--Amount, Manufacturer, and Location by Applicant
------------------------------------------------------------------------
                                   Amount of canned
            Applicant                  tuna for        Manufacturer and
                                     distribution          location
------------------------------------------------------------------------
Bumble Bee Foods, LLC, 9655       141,000,000 pounds  Asian Alliance, 8/
 Granite Ridge Dr., San Diego,     (lbs) (63,800,905   8 Moo 3, Rama 2
 CA 92123.                         kilograms (kgs)).   Rd., Bunbor,
                                                       Muang,
                                                       Samutsakorn
                                                       74000, Thailand.
                                                      Chicken of the Sea
                                                       Georgia Canning,
                                                       129 North
                                                       Commerce Dr.,
                                                       Lyons, GA 30436.
                                                      Bumble Bee
                                                       Seafoods, Inc.,
                                                       13100 Arctic
                                                       Circle, Santa Fe
                                                       Springs, CA
                                                       90670.
                                                      Chotiwat
                                                       Manufacturing
                                                       Co., 84/22 Moo 7,
                                                       Asia Highway Rd.
                                                       43, P.O.
                                                       Box 37, T.
                                                       Korhong, Hatyai
                                                       Songkhla,
                                                       Thailand 90110.
                                                      Gentuna (GTC/
                                                       Century), P.O.
                                                       Tambler, General
                                                       Santos City,
                                                       South Cotabato,
                                                       Philippines 9500.
                                                      I.S.A. Value Co.,
                                                       Ltd. (Narong),
                                                       101/6 Mu 6, Soi
                                                       Muangsakul Road,
                                                       Samaedam,
                                                       Bangkhutien,
                                                       Bangkok 10150,
                                                       Thailand.
                                                      Pataya Foods, 90/6
                                                       Tambol Tarsai,
                                                       Muang,
                                                       Samutprakarn,
                                                       Pataya, Thailand.
                                                      PT Aneka Tuna,
                                                       Jalan Raya
                                                       Surabaya-Malang
                                                       Km. 38, Gempol,
                                                       Pasuruan 67155
                                                       Jawa Timur.
                                                      R.S. Cannery Co.,
                                                       Ltd., 255/1
                                                       Industrial Soi 3,
                                                       Industrial
                                                       Estate,
                                                       Samutprakarn
                                                       10280, Thailand.

                                                      Tropical Canning
                                                       Thailand, Km. 19
                                                       Kanjanavanich
                                                       Rd., Thungyai,
                                                       Hatyai, Songkhla
                                                       90110, Thailand.
                                                      Unicord, 39/3 Moo
                                                       8, Sedtakit 1
                                                       Rd., Thasai,
                                                       Muang,
                                                       Samutsakorn
                                                       74000, Thailand.
Chicken of the Sea                77,500,000 lbs      Bumble Bee
 International, 9330 Scranton      (35,067,873 kgs).   Seafoods, Inc.,
 Rd., Suite 500, San Diego, CA                         13100 Arctic
 92121.                                                Circle, Santa Fe
                                                       Springs, CA
                                                       90670.
                                                      Century Canning,
                                                       Suite 1906,
                                                       Centerpoint
                                                       Bldg., Julia
                                                       Vargas Avenue
                                                       cor. Garnet St.,
                                                       Ortigas Ctr.,
                                                       Pasig City,
                                                       Manila,
                                                       Philippines 1605.
                                                      Chicken of the Sea
                                                       Georgia Canning,
                                                       129 North
                                                       Commerce Dr.,
                                                       Lyons, GA 30436.
                                                      MMP International,
                                                       19/8 Moo 6,
                                                       Tambol Nadee,
                                                       Muang District,
                                                       Samutsakorn
                                                       74000, Thailand.
                                                      PT Juifa
                                                       International
                                                       Foods, JL Lingkar
                                                       Timur No. 53,
                                                       Tegal Kamulyan
                                                       Cilacap 53211,
                                                       Jawa Tengah,
                                                       Indonesia.
                                                      Songkhla Canning,
                                                       333 Kanjanavanich
                                                       Rd., Tumbol
                                                       Pavong, Amphur
                                                       Muang, Songkhla
                                                       90100, Thailand.
                                                      Thai Union Frozen
                                                       Products PCL, 72/
                                                       1 Moo 7 Sethakit
                                                       1 Rd., Tambon
                                                       Tarsrai, Amphur
                                                       Muang,
                                                       Samutsakorn
                                                       74000, Thailand.
                                                      Thai Union
                                                       Manufacturing, 30/
                                                       2 Moo 8, Sethakit
                                                       1 Road, Tambon
                                                       Tarsrai, Amphur
                                                       Muang,
                                                       Samutsakorn
                                                       74000, Thailand.
                                                      Yueh Chyang Canned
                                                       Food Group, Nhut
                                                       Chinh Village,
                                                       Ben Luc District,
                                                       Long An Province,
                                                       Vietnam.
StarKist Seafood Company, 225     182,500,000 lbs     Galapesca S.A.,
 North Shore Dr., Pittsburgh, PA   (82,579,185 kgs).   Km. 12.5 Via A
 15212.                                                Duale, Guayaquil,
                                                       Ecuador.
                                                      StarKist Samoa
                                                       Co., 368 Atu'u
                                                       Rd., Pago Pago,
                                                       American Samoa
                                                       96799.
------------------------------------------------------------------------

    Bumble Bee Foods, LLC; Chicken of the Sea International; and
StarKist Seafood Company will distribute the test products throughout
the United States and the Commonwealth of Puerto Rico. The information
panels on the labels of the test products must bear nutrition labeling
in accordance with 21 CFR 101.9. Each of the ingredients used in the
food must be declared on the labels of the test products as required by
the applicable sections of part 101. These permits are effective for 15
months, beginning on the date each applicant introduces or causes the
introduction of the test products into interstate commerce, but not
later than September 18, 2014.

    Dated: June 17, 2014.
Philip C. Spiller,
Acting Director, Office of Nutrition, Labeling and Dietary Supplements,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2014-14447 Filed 6-19-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 31007-31008]
[FR Doc No: 2020-10930]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88885; File No. SR-NSCC-2020-003]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Designation of Longer Period for Commission
Action on a Proposed Rule Change To Enhance National Securities
Clearing Corporation's Haircut-Based Volatility Charge Applicable to
Illiquid Securities and UITs and Make Certain Other Changes to
Procedure XV

May 15, 2020.
    On March 16, 2020, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-NSCC-2020-003 (``Proposed Rule
Change'') pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The Proposed Rule
Change was published for comment in the Federal Register on March 31,
2020.\3\ The Commission has received four comment letters on the
Proposed Rule Change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 88474 (March 25, 2020),
85 FR 17910 (March 31, 2020) (SR-NSCC-2020-003) (``Notice''). NSCC
also filed the proposal contained in the Proposed Rule Change as
advance notice SR-FICC-2020-802 (``Advance Notice'') with the
Commission pursuant to Section 806(e)(1) of the Dodd-Frank Wall
Street Reform and Consumer Protection Act entitled the Payment,
Clearing, and Settlement Supervision Act of 2010 (``Clearing
Supervision Act''). 12 U.S.C. 5465(e)(1); 17 CFR 240.19b-4(n)(1)(i).
Notice of filing of the Advance Notice was published for comment in
the Federal Register on April 15, 2020. Securities Exchange Act
Release No. 88615 (April 9, 2020), 85 FR 21037 (April 15, 2020) (SR-
NSCC-2020-802). The proposal contained in the Proposed Rule Change
and the Advance Notice shall not take effect until all regulatory
actions required with respect to the proposal are completed.
    \4\ Letter from Christopher R. Doubek, CEO, Alpine Securities
Corporation (April 21, 2020); Letter from John Busacca, Founder,
Securities Industry Professional Association (April 23, 2020);
Letter from Charles F. Lek, Lek Securities Corporation (April 30,
2020); Letter from James C. Snow, President/CCO, Wilson-Davis & Co.,
Inc., all available at https://www.sec.gov/comments/sr-nscc-2020-003/srnscc2020003.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the

proposed rule change, or institute proceedings to determine whether the
proposed rule change should be disapproved. The 45th day after
publication of the notice for the Proposed Rule Change is May 15, 2020.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the Proposed Rule Change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the Proposed Rule Change so that it has sufficient time to consider and
take action on the Proposed Rule Change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \6\ and for
the reasons stated above, the Commission designates June 29, 2020 as
the date by which the Commission shall either approve, disapprove, or
institute proceedings to determine whether to disapprove proposed rule
change SR-NSCC-2020-003.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-10930 Filed 5-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60865-60867]
[FR Doc No: 2017-27784]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2017-N-6568]

Medical Devices; Anesthesiology Devices; Classification of the
External Negative Pressure Airway Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

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

DATES: This order is effective December 26, 2017. The classification
was applicable on December 23, 2015.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the external negative pressure
airway aid as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device

(see 21 U.S.C. 360c(f)(1)). We refer to these devices as
``postamendments devices'' because they were not in commercial
distribution prior to the date of enactment of the Medical Device
Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On August 18, 2014, Sommetrics submitted a request for De Novo
classification of the cNEP Airway Management System. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 23, 2015, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 868.5105. We have named
the generic type of device external negative pressure airway aid, and
it is identified as a prescription device that applies negative
pressure to a patient's neck to aid in providing a patent airway during
procedures requiring anesthesia.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--External Negative Pressure Airway Aid Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risks                   Mitigation measures
------------------------------------------------------------------------
Impaired blood flow........................  Clinical performance
                                              testing.
Failure of device or negative pressure       Non-clinical performance
 mechanism.                                   testing.
Adverse tissue reaction....................  Biocompatibility.
Dislodging of plaque, leading to possible    Labeling.
 stroke.
Inadequate collar fit......................  Labeling.
Use error..................................  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, external negative pressure airway
aids are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 868

    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
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 is revised to read as follows:

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

0
2. Add Sec.  868.5105 to subpart F to read as follows:

Sec.  868.5105   External negative pressure airway aid.

    (a) Identification. An external negative pressure airway aid is a
prescription device that applies negative pressure to a patient's neck
to aid in providing a patent airway during procedures requiring
anesthesia.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must document any adverse events
observed during clinical use, including impaired blood flow, and
demonstrate that the device performs as intended under anticipated
conditions.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated patient positions, does
not fail during use, and does not lose negative pressure capability.
The following testing should be performed:
    (i) Ability of the device to maintain a seal during various patient
positions;
    (ii) Device leakage testing to demonstrate the device maintains
vacuum;
    (iii) Drop testing to ensure the device does not incur functional
damage after dropping the device; and
    (iv) Functional testing after high and low storage temperature.
    (3) All patient contacting components must be demonstrated to be
biocompatible.
    (4) Labeling must include:
    (i) A summary of clinical testing results, including any adverse
events and evidence that effectiveness has been achieved.
    (ii) Technical specifications of the device, including collar
sizes, maximum duration of use, operating temperature, and storage
temperature range.
    (iii) Technical specifications of the vacuum source, including
maximum vacuum level and operational vacuum level.
    (iv) Instructions for use that includes how to place the device,
determination of size, verification of suction, reference to training
materials, and information on troubleshooting the device if it does not
attach properly.
    (v) A warning to screen patients for carotid artery disease due to
the probable risk of the device to dislodge arterial plaques in the
carotid artery.
    (vi) A warning to exclude patients with anatomical abnormalities.
    (vii) A warning not to use the device during medical procedures
involving medications that contain propofol.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27784 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 18, 2008 (Volume 73, Number 182)]
[Notices]
[Page 54186-54188]
[DOCID:fr18se08-90]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58513; File No. SR-CBOE-2008-92]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Hybrid Electronic Quoting Fee

September 11, 2008.
    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 August 29, 2008, the Chicago Board Options Exchange,
Incorporated ( ``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I, II and III below, which Items have been prepared
by the CBOE. The Commission is publishing this notice to solicit

comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    CBOE is proposing to amend its Hybrid Electronic Quoting Fee. The
text of the proposed rule change is available on the Exchange's Web
site (http://www.cboe.org/Legal), 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, CBOE 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 CBOE 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 purpose of this proposed rule change is to amend CBOE's Hybrid
Electronic Quoting Fee (``Quoting Fee''), which is applicable to all
Market-Makers, DPMs, and e-DPMs (collectively ``liquidity providers'')
in order to promote and encourage more efficient quoting.
    Under the current Quoting Fee, CBOE assesses all liquidity
providers who are submitting electronic quotations to CBOE in Hybrid
option classes a monthly amount of $450 per membership utilized.\3\
CBOE also assesses or credits fees on liquidity providers that vary
depending on: (i) the quality of the liquidity provider's quotation (a
quotation is a bid and an offer); and (ii) the value of the underlying
security and CBOE's bid in the option series. The Quoting Fee provides
that a liquidity provider's total credits cannot exceed the total
debits assessed. If the total credits were to exceed the total debits,
the Quoting Fee assessed to that liquidity provider would be $450.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 34-56927 (12/7/07),
72 FR 70912 (12/13/07), granting immediate effectiveness to SR-CBOE-
2007-145.
---------------------------------------------------------------------------

    CBOE now proposes to amend the Quoting Fee and establish a cap of
$50,000 on the amount a liquidity provider's total credits can exceed
the total debits assessed. If the liquidity provider is a member
organization utilizing more than one membership, the $50,000 cap is
applied per member organization. CBOE believes that establishing a cap
of $50,000 will serve as an incentive to liquidity providers to submit
competitive quotations, and that the Quoting Fee will continue to
promote and encourage more efficient quoting and help to reduce quote
traffic.
    Additionally, CBOE proposes to make a technical change to Section
17 and delete the reference to ``Hybrid 2.0,'' which CBOE recently
deleted from its rules.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 34-58153 (7/14/08),
73 FR 41386 (7/18/08), granting immediate effectiveness to SR-CBOE-
2008-67.
---------------------------------------------------------------------------

    The Exchange intends to implement this revised Quoting Fee
effective September 1, 2008.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Securities Exchange Act of 1934 (``Act'') \5\, in
general, and furthers the objectives of Section 6(b)(4) \6\ of the Act
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among CBOE
members. In particular, CBOE believes the establishment of a $50,000
cap on the amount a liquidity provider's total credits can exceed the
total debits assessed is an equitable allocation of reasonable dues and
fees in that it will serve as an incentive to liquidity providers to
submit competitive quotations. CBOE also believes that the Quoting Fee
will continue to promote and encourage more efficient quoting and help
to reduce quote traffic.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and subparagraph (f)(2) of Rule 19b-4 \8\
thereunder. At any time within 60 days of the filing of such proposed
rule change, the Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2008-92 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-CBOE-2008-92. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m.

Copies of such filing also will be available for inspection and copying
at the principal office of the CBOE. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2008-92 and should be submitted on
or before October 9, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-21759 Filed 9-17-08; 8:45 am]

BILLING CODE 8010-01-P


TABLE 1 AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NEW SOURCE PERFORMANCE STANDARD ( NSPS) SUBPART SSS  MAGNETIC TAPE COATING REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/ Year ( D) EPA Hours/

Year ( E= C* D)

( E)

INITIAL PERFORMANCE TESTS New Plant 24 1 24 3 72 REPEAT PERFORMANCE TEST New Plant 24 0.2 4.8 3 14.4 REPORT REVIEW New Plant Notification of Construction 2 1 2 3 6 Notification of Anticipated Startup 0.5 1 0.5 3 1.5 Notification of Actual Startup 0.5 1 0.5 3 1.5 Notification of Initial Test 0.5 1.2 0.6 3 1.8 Review Test Results 8 1.2 9.6 3 28.8 Excess Emission Report 8 4 32 2.7 86.4 Report of No Excess Emissions 2 2 4 11.5 46 TOTAL ANNUAL HOURS 258.4 ANNUAL TRAVEL EXPENSES ( 1 person x 1.2 plants/ year x 3 d/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 1.2 plant/ yr) = $ 480.00 SALARY BURDEN ( per year)

1 person x 273 h/ yr x $ 35.89/ h = $ 9,273.98 TOTAL ANNUAL BURDEN $ 9,753.98 Assumptions Number of new plants ( per year) 1 Rate of failed performance tests 20%

Time required to participate with performance test ( hours per plant) 24 Time require to review construction notification ( hours) 2 Time required to review startup and initial test notifications ( hours) 0.5 Time required to review performance test results ( hours) 8 EPA labor rate ( GS 10 Step 1 + 110% overhead) $ 35.89 Percentage of new plant visits 10%

Round trip airfare to visit plant $ 250