63.5(d)(1)-(4)...................  Approval of Construction/    Yes.................
                                    Reconstruction.
63.5(e)..........................  Approval of Construction/    Yes.................
                                    Reconstruction.
63.5(f)(1)-(2)...................  Approval of Construction/    Yes.................
                                    Reconstruction.
63.6(a)..........................  Compliance for Standards     Yes.................
                                    and Maintenance.
63.6(b)(1)-(5)...................  Compliance Dates...........  Yes.................
63.6(b)(6).......................  ...........................  No..................  [Reserved].
63.6(b)(7).......................  Compliance Dates...........  Yes.................
63.6(c)(1)-(2)...................  Compliance Dates...........  Yes.................
63.6(c)(3)-(4)...................  ...........................  No..................  [Reserved].
63.6(c)(5).......................  Compliance Dates...........  Yes.................
63.6(d)..........................  ...........................  No..................  [Reserved].
63.6(e)(1)-(2)...................  Operation & Maintenance....  No..................  See Sec.   63.1348(d) for
                                                                                general duty requirement.
                                                                                Any reference to Sec.
                                                                                63.6(e)(1)(i) in other
                                                                                General Provisions or in
                                                                                this subpart is to be
                                                                                treated as a cross-
                                                                                reference to Sec.
                                                                                63.1348(d).
63.6(e)(3).......................  Startup, Shutdown            No..................  Your operations and
                                    Malfunction Plan.                                  maintenance plan must
                                                                                address periods of
                                                                                startup and shutdown. See
                                                                                Sec.   63.1347(a)(1).
63.6(f)(1).......................  Compliance with Emission     No..................  Compliance obligations
                                    Standards.                                         specified in subpart LLL.
63.6(f)(2)-(3)...................  Compliance with Emission     Yes.................
                                    Standards.
63.6(g)(1)-(3)...................  Alternative Standard.......  Yes.................
63.6(h)(1).......................  Opacity/VE Standards.......  No..................  Compliance obligations
                                                                                specified in subpart LLL.
63.6(h)(2).......................  Opacity/VE Standards.......  Yes.................
63.6(h)(3).......................  ...........................  No..................  [Reserved].
63.6(h)(4)-(h)(5)(i).............  Opacity/VE Standards.......  Yes.................
63.6(h)(5)(ii)-(iv)..............  Opacity/VE Standards.......  No..................  Test duration specified in
                                                                                subpart LLL.
63.6(h)(6).......................  Opacity/VE Standards.......  Yes.................
63.6(h)(7).......................  Opacity/VE Standards.......  Yes.................
63.6(i)(1)-(14)..................  Extension of Compliance....  Yes.................
63.6(i)(15)......................  ...........................  No..................  [Reserved].
63.6(i)(16)......................  Extension of Compliance....  Yes.................
63.6(j)..........................  Exemption from Compliance..  Yes.................
63.7(a)(1)-(3)...................  Performance Testing          Yes.................  Sec.   63.1349 has
                                    Requirements.                                      specific requirements.
63.7(b)..........................  Notification period........  Yes.................  Except for repeat
                                                                                performance test caused
                                                                                by an exceedance. See
                                                                                Sec.   63.1353(b)(6).
63.7(c)..........................  Quality Assurance/Test Plan  Yes.................
63.7(d)..........................  Testing Facilities.........  Yes.................
63.7(e)(1).......................  Conduct of Tests...........  No..................  See Sec.   63.1349(e). Any
                                                                                reference to 63.7(e)(1)
                                                                                in other General
                                                                                Provisions or in this
                                                                                subpart is to be treated
                                                                                as a cross-reference to
                                                                                Sec.   63.1349(e).
63.7(e)(2)-(4)...................  Conduct of tests...........  Yes.................
63.7(f)..........................  Alternative Test Method....  Yes.................
63.7(g)..........................  Data Analysis..............  Yes.................
63.7(h)..........................  Waiver of Tests............  Yes.................
63.8(a)(1).......................  Monitoring Requirements....  Yes.................
63.8(a)(2).......................  Monitoring.................  No..................  Sec.   63.1350 includes
                                                                                CEMS requirements.
63.8(a)(3).......................  ...........................  No..................  [Reserved].
63.8(a)(4).......................  Monitoring.................  No..................  Flares not applicable.
63.8(b)(1)-(3)...................  Conduct of Monitoring......  Yes.................
63.8(c)(1)-(8)...................  CMS Operation/Maintenance..  Yes.................  Temperature and activated
                                                                                carbon injection
                                                                                monitoring data reduction
                                                                                requirements given in
                                                                                subpart LLL.
63.8(d)..........................  Quality Control............  Yes, except for the
                                                                 reference to the
                                                                 SSM Plan in the
                                                                 last sentence.
63.8(e)..........................  Performance Evaluation for   Yes.................
                                    CMS.
63.8(f)(1)-(5)...................  Alternative Monitoring       Yes.................  Additional requirements in
                                    Method.                                            Sec.   63.1350(l).
63.8(f)(6).......................  Alternative to RATA Test...  Yes.................
63.8(g)..........................  Data Reduction.............  Yes.................

63.9(a)..........................  Notification Requirements..  Yes.................
63.9(b)(1)-(5)...................  Initial Notifications......  Yes.................
63.9(c)..........................  Request for Compliance       Yes.................
                                    Extension.
63.9(d)..........................  New Source Notification for  Yes.................
                                    Special Compliance
                                    Requirements.
63.9(e)..........................  Notification of performance  Yes.................  Except for repeat
                                    test.                                              performance test caused
                                                                                by an exceedance. See
                                                                                Sec.   63.1353(b)(6).
63.9(f)..........................  Notification of VE/Opacity   Yes.................  Notification not required
                                    Test.                                              for VE/opacity test under
                                                                                Sec.   63.1350(e) and
                                                                                (j).
63.9(g)..........................  Additional CMS               Yes.................
                                    Notifications.
63.9(h)(1)-(3)...................  Notification of Compliance   Yes.................
                                    Status.
63.9(h)(4).......................  ...........................  No..................  [Reserved].
63.9(h)(5)-(6)...................  Notification of Compliance   Yes.................
                                    Status.
63.9(i)..........................  Adjustment of Deadlines....  Yes.................
63.9(j)..........................  Change in Previous           Yes.................
                                    Information.
63.10(a).........................  Recordkeeping/Reporting....  Yes.................
63.10(b)(1)......................  General Recordkeeping        Yes.................
                                    Requirements.
63.10(b)(2)(i)-(ii)..............  General Recordkeeping        No..................  See Sec.   63.1355(g) and
                                    Requirements.                                      (h).
63.10(b)(2)(iii).................  General Recordkeeping        Yes.................
                                    Requirements.
63.10(b)(2)(iv)-(v)..............  General Recordkeeping        No..................
                                    Requirements.
63.10(b)(2)(vi)-(ix).............  General Recordkeeping        Yes.................
                                    Requirements.
63.10(c)(1)......................  Additional CMS               Yes.................  PS-8A supersedes
                                    Recordkeeping.                                     requirements for THC
                                                                                CEMS.
63.10(c)(1)......................  Additional CMS               Yes.................  PS-8A supersedes
                                    Recordkeeping.                                     requirements for THC
                                                                                CEMS.
63.10(c)(2)-(4)..................  ...........................  No..................  [Reserved].
63.10(c)(5)-(8)..................  Additional CMS               Yes.................  PS-8A supersedes
                                    Recordkeeping.                                     requirements for THC
                                                                                CEMS.
63.10(c)(9)......................  ...........................  No..................  [Reserved].
63.10(c)(10)-(15)................  Additional CMS               Yes.................  PS-8A supersedes
                                    Recordkeeping.                                     requirements for THC
                                                                                CEMS.
63.10(d)(1)......................  General Reporting            Yes.................
                                    Requirements.
63.10(d)(2)......................  Performance Test Results...  Yes.................
63.10(d)(3)......................  Opacity or VE Observations.  Yes.................
63.10(d)(4)......................  Progress Reports...........  Yes.................
63.10(d)(5)......................  Startup, Shutdown,           No..................  See Sec.   63.1354(c) for
                                    Malfunction Reports.                               reporting requirements.
                                                                                Any reference to Sec.
                                                                                63.10(d)(5) in other
                                                                                General Provisions or in
                                                                                this subpart is to be
                                                                                treated as a cross-
                                                                                reference to Sec.
                                                                                63.1354(c).
63.10(e)(1)-(2)..................  Additional CMS Reports.....  Yes.................
63.10(e)(3)......................  Excess Emissions and CMS     Yes.................  Exceedances are defined in
                                    Performance Reports.                               subpart LLL.
63.10(e)(3)(vii) and (viii)......  Excess Emissions and CMS     No..................  Superseded by
                                    Performance Reports.                               63.1354(b)(10).
63.10(f).........................  Waiver for Recordkeeping/    Yes.................
                                    Reporting.
63.11(a)-(b).....................  Control Device Requirements  No..................  Flares not applicable.
63.12(a)-(c).....................  State Authority and          Yes.................
                                    Delegations.
63.13(a)-(c).....................  State/Regional Addresses...  Yes.................
63.14(a)-(b).....................  Incorporation by Reference.  Yes.................
63.15(a)-(b).....................  Availability of Information  Yes.................
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-16811 Filed 7-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 27, 2010 (Volume 75, Number 207)]
[Notices]
[Page 66083]
[DOCID:fr27oc10-55]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13723-000]

Iron Mask Hydro, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

October 20, 2010.
    On May 6, 2010, and supplemented on July 15, 2010, Iron Mask Hydro,
LLC filed an application for a preliminary permit, pursuant to section
4(f) of the Federal Power Act (FPA), proposing to study the feasibility
of the Iron Mask Pumped Storage Project to be located near the U.S.
Bureau of Reclamation's Canyon Ferry Lake in the vicinity of Townsend,
Montana, in Broadwater County, Montana. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project will consist of the following: (1) A 225-foot-
high, 1,795-foot-long upper dam made of either zoned earth and rockfill
or concrete-face earth and rockfill; (2) a 50-foot-high, 950-foot-long
earth-filled upper saddle dike A; (3) a 20-foot-high, 400-foot-long
earth-filled upper saddle dike B; (4) a 40-foot-high, 6,559-foot-long
lower embankment made of zoned earth or rockfill; (5) an upper
reservoir with a storage capacity of 4,888 acre-feet; (6) a lower
reservoir with a storage capacity of 4,888 acre-feet; (7) a 1,626-foot-
long, 12.9-foot-diameter unlined upper low-pressure tunnel; (8) a
4,809-foot-long, 12.9-foot-diameter unlined, concrete-lined, and steel-
lined pressure shaft; (9) a 200-foot-long, 12.9-foot-diameter concrete-
lined and steel-lined high pressure tunnel; (10) four 6.5-foot-diameter
steel-lined penstocks (length to be determined); (11) a 5,073-foot-
long, 15.5-foot-diameter concrete-lined or unlined tailrace; (12) a
260-foot-long, 65-foot-wide, 120-foot-high underground powerhouse
located at a depth of 1,000 feet; (13) one 150-megawatt (MW), one 100-
MW, and one 50-MW reversible pump-turbines totaling 300 MW of
generating capacity, with up to 100 MW of additional pumping capacity,
for a total of 400 MW pumping capacity; (14) an approximately 3,000-
footlong, 24-foot-high main access tunnel leading from the ground level
to the powerhouse; and (15) a new single-circuit 230-kilovolt, 4.9-
mile-long transmission line with a 150-foot right of way. Annual energy
production is estimated to be 919,800 megawatt-hours.
    Applicant Contact: Matthew Shapiro, CEO, Gridflex Energy, LLC, 1210
W. Franklin Street, Ste. 2, Boise, ID 83702; phone:<PHONE_NUMBER>.
    FERC Contact: Kelly Wolcott<PHONE_NUMBER>.
    The deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications has been extended 60 days from the issuance of
this notice to December 20, 2010. Entities that have already filed
comments, motions to intervene, competing applications, or notices of
intent to file competing applications do not need to re-file. Competing
applications and notices of intent must meet the requirements of 18 CFR
4.36. Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/
ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13723) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-27124 Filed 10-26-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70375-70377]
[FR Doc No: 2021-26740]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0595]

Medical Devices; Neurological Devices; Classification of the
Transcutaneous Electrical Nerve Stimulator for Attention Deficit
Hyperactivity Disorder

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the transcutaneous electrical nerve stimulator for
attention deficit hyperactivity disorder (ADHD) 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 transcutaneous electrical nerve stimulator for ADHD'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.

DATES: This order is effective December 10, 2021. The classification
was applicable on April 19, 2019.

FOR FURTHER INFORMATION CONTACT: Pamela Scott, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the transcutaneous electrical
nerve stimulator for ADHD 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, 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 (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    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 is required
to 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.
    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 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 July 30, 2018, NeuroSigma, Inc. submitted a request for De Novo
classification of the Monarch eTNS 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 April 19, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5898.\1\ We have named the generic type of device transcutaneous
electrical nerve stimulator for ADHD, and it is identified as a
prescription device that stimulates transcutaneously or percutaneously
through electrodes placed on the forehead.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    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--Transcutaneous Electrical Nerve Stimulator for ADHD Risks and
                           Mitigation Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction...........  Biocompatibility evaluation.
Injury or discomfort from           Electromagnetic compatibility
 electrical stimulation, including   testing; Electrical, mechanical,
 burns and nerve damage.             and thermal safety testing; Non-
                                     clinical performance testing;
                                     Software verification, validation,
                                     and hazard analysis; Shelf life
                                     testing; and Labeling.
Misuse that may result in device    Labeling.
 failure, user discomfort, or
 injury.
Skin irritation or infection from   Labeling.
 use on broken skin.
------------------------------------------------------------------------

    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, transcutaneous electrical nerve
stimulators for ADHD 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 and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met (referring
to 21 U.S.C. 352(f)(1)).

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 and guidance. 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. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; 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 882

    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 882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5898 to subpart F to read as follows:

Sec.  882.5898  Transcutaneous electrical nerve stimulator for
attention deficit hyperactivity disorder.

    (a) Identification. A transcutaneous electrical nerve stimulator
for attention deficit hyperactivity disorder (ADHD) is a prescription
device that stimulates transcutaneously or percutaneously through
electrodes placed on the forehead.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the electromagnetic
compatibility and electrical, mechanical, and thermal safety of the
device.
    (3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following must be performed:
    (i) Electrical performance testing must validate electrical output
and duration of stimulation;
    (ii) Battery performance testing must be performed; and
    (iii) Adhesive integrity testing of the electrodes must be
conducted.
    (4) The technical parameters of the device including waveform,
maximum output current and voltage, pulse duration, frequency, net
charge per pulse, maximum current density, maximum average current, and
maximum average power density must be fully characterized.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Shelf life testing of the electrodes must be performed to
demonstrate continued package integrity and component functionality
over the labeled shelf life.
    (7) Labeling must include the following:
    (i) A contraindication for patients with an implanted metallic or
electronic device in the head, a cardiac pacemaker, or an implanted or
wearable defibrillator;
    (ii) A warning that the device is only for use on clean, intact
skin;
    (iii) Information on how the device operates and the typical
sensations experienced during treatment;
    (iv) A detailed summary of the device technical parameters;
    (v) A shelf life for the electrodes;
    (vi) Instructions for use, including placement of the device on the
patient; and
    (vii) Cleaning instructions.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26740 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66335-66338]
[FR Doc No: 2020-22900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1359]

Sugars that Are Metabolized Differently Than Traditional Sugars

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is establishing a
docket and invites information about and comments on the nutrition
labeling of sugars that are metabolized differently than traditional
sugars. We are taking this action to inform our regulatory approach to
these distinctly metabolized sugars to promote the public health and
help consumers make informed dietary decisions.

DATES: Submit either electronic or written comments on the notice by
December 18, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,

untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 18, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1359 for ``Sugars that are Metabolized Differently than
Traditional Sugars.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Office of
Nutrition and Food Labeling, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In general, under section 403(q) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343(q)) (FD&C Act), a food is deemed misbranded
unless its label or labeling bears nutrition information for certain
nutrients. To implement section 403(q) of the FD&C Act, we have issued
regulations related to:
     The declaration of nutrients on food labeling, including
nutrients that are required or permitted to be declared and the format
for such declaration;
     Daily Values (DVs) for nutrients, which are used to
declare nutrient contents as percent DVs (%DVs) on the Nutrition Facts
label; and
     Exemptions for certain specified products.
    These regulations are at Sec.  101.9 (21 CFR 101.9). Additionally,
section 403(q)(2)(A) of the FD&C Act provides discretion to the
Secretary of Health and Human Services, and, by delegation, to FDA, to
determine whether providing nutrition information regarding a nutrient
will assist consumers in maintaining healthy dietary practices.
    In the Federal Register of May 27, 2016 (81 FR 33742), we issued a
final rule titled ``Food Labeling: Revision of the Nutrition and
Supplement Facts Labels'' (``Nutrition Facts final rule''). The
Nutrition Facts final rule revised the Nutrition Facts label to reflect
new scientific information by, among other things: (1) Requiring the
declaration of the gram amount of ``Added Sugars'' in a serving of a
product, establishing a Daily Reference Value (DRV), and requiring the
%DV declaration for ``Added Sugars'' and (2) changing ``Sugars'' to
``Total Sugars'' and requiring that ``Includes `X'g Added Sugars'' be
indented and declared directly below ``Total Sugars'' on the label. We
discussed our rationale for the required declaration of ``Added
Sugars'' in the preamble to both the Nutrition Facts final rule (81 FR
33742 at 33799 through 33801) and the proposed rule in the Federal
Register of March 3, 2014 (79 FR 11880 at 11902 through 11905), and
explained our establishment of a DRV of 10 percent of total energy
intake from ``Added Sugars'' and requirement of a %DV for ``Added
Sugars'' in the preamble to the supplemental proposed rule in the
Federal Register of July 27, 2015 (80 FR 44303 at 44307 through
44309).\1\
---------------------------------------------------------------------------

    \1\ We also recognize that with the requirement for the
mandatory declaration of added sugars on the label, there is an
interest in the use of nutrient content claims that convey to
consumers information about the amount of sugars or added sugars in
a product. In the Nutrition Facts final rule, we said that we plan
to revisit our nutrient content claims regulations as appropriate
and as time and resources permit (81 FR 33742 at 33751). We intend
to address nutrient content claims related to sugars and added
sugars at a later date.
---------------------------------------------------------------------------

    In the Nutrition Facts final rule, we confirmed that our definition
of ``Total Sugars'' remains the same as the previously existing
definition of ``Sugars'' at Sec.  101.9(c)(6)(ii)--

specifically, as the sum of all free mono- and disaccharides (such as
glucose, fructose, lactose, and sucrose). We defined ``Added Sugars,''
in part, as sugars that are either added during the processing of foods
or are packaged as such. We codified this definition in our regulations
at Sec.  101.9(c)(6)(iii).
    In determining which sugars should be included in the definition of
``Added Sugars'' in the Nutrition Facts final rule, we considered the
presence of added sugars as a component of dietary intake and whether
it was consistent with the concept of ``empty calories'' (81 FR 33742
at 33835). (The Scientific Report of the 2015 Dietary Guidelines
Advisory Committee noted that sugars that are added to foods either by
the consumer or by food manufacturers are referred to as ``empty
calories'' because they provide calories, but few or no nutrients. See
United States Department of Agriculture and HHS, Scientific Report of
the 2015 Dietary Guidelines Advisory Committee, 2015, Part D. ``Chapter
1: Food and Nutrient Intakes, and Health: Current Status and Trends,''
pg. 69, available at https://health.gov/dietaryguidelines/2015-scientific-report/pdfs/scientific-report-of-the-2015-dietary-guidelines-advisory-committee.pdf.) We noted, in the preamble to the
Nutrition Facts final rule, that it would be extremely difficult for
individuals consuming large amounts of empty calories from sugar-
sweetened foods and beverages to be able to consume enough other
components of a healthy dietary pattern (81 FR 33742 at 33807). In part
because of this, current dietary recommendations include limiting the
consumption of added sugars in the diet, which we explained in the
preamble to the supplemental proposed rule (80 FR 44303 at 44308).
    We are aware that some members of the food industry are looking for
ways to reformulate products to reduce the sugar content of foods while
still providing products that meet consumer preferences. The use of
sugars that provide fewer calories, that are not associated with dental
caries, and that result in a lower glycemic and insulinemic response
than other sugars could be one way for industry to provide products
that meet both current dietary recommendations and consumer
preferences.
    There are several sugars that are not metabolized by the body like
other substances that are traditionally known as sugars. The sugars
that many consumers are most familiar with (``traditional sugars''),
such as sucrose, are associated with an increased risk of dental
caries, have 4 calories per gram, and cause an increase in blood
glucose and insulin levels after consumption. Some sugars (e.g.,
allulose, D-tagatose, isomaltulose) do not have all of the same effects
in the body as traditional sugars. Because of that, we have received
multiple requests from industry to treat these sugars that are
metabolized differently than traditional sugars as distinct from
traditional sugars for purposes of nutrition labeling. For example,
some asked that we exempt certain sugars from inclusion as a
carbohydrate, sugar, or added sugar on the Nutrition Facts label for
foods and beverages (see, e.g., Citizen Petition Submitted by Tate &
Lyle Ingredients Americas LLC requesting that Allulose be Exempt From
Being Included As a Carbohydrate, Sugar, or Added Sugar in the
Nutrition Facts Label on Foods and Beverages, April 10, 2015, Docket
Number FDA-2015-P-1201); some asked that we use a lower general factor
for the caloric value of certain sugars (see, e.g., Citizen Petition
Submitted by The Food Lawyers Requesting the Use of a General Factor of
0.4 Calories Per Gram of Allulose on the Nutrition Facts Label, July
12, 2016, Docket Number FDA-2016-P-2030); and others asked that we
define ``Total Sugars'' as the sum of all free mono- and disaccharides
that contain at least one unit of glucose or fructose (see, e.g.,
Citizen Petition Submitted by Bonumose LLC for Consideration of D-
tagatose as Dietary Fiber, November 19, 2018, Docket Number FDA-2018-P-
4454).
    In the preamble to the Nutrition Facts final rule, we stated that
we needed additional time to fully consider certain information
provided about one of these sugars that is metabolized differently than
traditional sugars--specifically, allulose (81 FR 33742 at 33796).
Therefore, we did not reach a decision as to whether allulose should be
excluded from the declaration of ``Total Carbohydrate,'' ``Total
Sugars,'' or ``Added Sugars.'' We stated that allulose, as a
monosaccharide, must be included in the amount of the declaration of
``Total Carbohydrate,'' ``Total Sugars,'' and ``Added Sugars'' pending
any future rulemaking that would otherwise consider excluding allulose
from the declarations. We also noted that D-tagatose and isomaltulose
are chemically sugars. Because these sweeteners are chemically sugars,
and other substances are included or excluded from the definition of
``Total Sugars'' and ``Added Sugars'' based on whether they are a free
mono- or disaccharide rather than on their physiological effects,
including D-tagatose and isomaltulose in the declaration of added
sugars is consistent with how we have characterized other sugars. As
such, we did not exclude D-tagatose and isomaltulose from the ``Added
Sugars'' declaration in the Nutrition Facts final rule (81 FR 33742 at
33837).
    In the Federal Register of April 18, 2019 (84 FR 16272), we
announced the publication of a draft guidance that provided our view on
the declaration of allulose on Nutrition and Supplement Facts labels,
as well as on the caloric content of allulose. We announce our final
guidance elsewhere in this edition of the Federal Register. The
guidance states our intent to exercise enforcement discretion for the
exclusion of allulose from the amount of ``Total Sugars'' and ``Added
Sugars'' declared on the label and the use of a general factor of 0.4
calories per gram (kcal/g) for allulose when determining ``Calories''
on the Nutrition and Supplement Facts labels pending review of the
issues in a rulemaking.
    We are interested in learning more about the kinds of sugars that
are metabolized differently than traditional sugars and that are used
in foods, any distinct physiological effects in the body caused by
those sugars, and how we should treat those sugars for purposes of food
labeling.

II. Request for Comments and Information

    We invite comment, particularly scientific data and other evidence,
about the following topics:

A. General Information About Sugars That Are Metabolized Differently
Than Traditional Sugars

    1. We are aware of three sugars that are metabolized differently in
the body than traditional sugars: allulose, D-tagatose, and
isomaltulose. What other sugars are metabolized differently in the body
than traditional sugars? Please provide any studies that examine the
chemical properties or physiological effects of these other sugars.
    2. What research on consumer awareness or understanding of the
differences between sugars that are metabolized differently than
traditional sugars and traditional sugars is available? Please provide
any data or other information that supports your response.

B. Declaration of Total Sugars

    1. We could take one of various approaches to account for sugars
that are metabolized differently than traditional sugars in the
declaration of ``Total Sugars.'' For example, we could require them to
be declared within the

``Total Sugars'' declaration, we could exclude them from the ``Total
Sugars'' declaration, or we could adjust the gram amount of the ``Total
Sugars'' declaration based on their caloric contribution to the diet.
What considerations could inform our approach? Please explain your
reasoning, and provide data or other information that would support
these considerations and any recommended approach.
    2. In the guidance regarding allulose, we discuss factors that we
considered when determining whether a sugar should be excluded from the
declaration of ``Total Sugars,'' including pH of dental plaque after
consumption, caloric value, and glycemic and insulinemic response.
What, if any, other factors impact whether a sugar should be excluded
from the declaration of ``Total Sugars''? Please provide any data or
other information that supports your response.

C. Declaration of Added Sugars

    1. We could take one of various approaches to account for sugars
that are metabolized differently than traditional sugars in the
declaration of ``Added Sugars.'' For example, we could require them to
be declared within the ``Added Sugars'' declaration, we could exclude
them from the ``Added Sugars'' declaration, or we could adjust the gram
amount of the ``Added Sugars'' or the %DV declaration based on their
caloric contribution to the diet. What considerations could inform our
approach? Please explain your reasoning, and provide data or other
information that would support these considerations and any recommended
approach.
    2. In the guidance regarding allulose, we discuss factors that we
considered when determining whether a sugar should be excluded from the
declaration of ``Added Sugars,'' including caloric value and glycemic
and insulinemic response. What other factors, if any, impact whether a
sugar should be excluded from the declaration of ``Added Sugars''?
Please provide any data or other information that supports your
response.
    3. We might adjust the %DV for ``Added Sugars'' for the U.S.
population 4 years of age and older based on the caloric contribution
of the sugar. For example:

    Assume a product contains 5 g of sucrose and 10 g of another sugar
with a caloric value of 2 kcal/g per serving.

Step 1. Calculate the Total Caloric Contribution of Sugars (amount of
sucrose (g/serving) x caloric value (kcal/g)) + (amount of other sugar
(g/serving) x caloric value (kcal/g))
    a. Sucrose: 5 g/serving x 4 kcal/g (caloric value of sucrose) = 20
kcal/serving
    b. Other sugar: 10 g/serving x 2 kcal/g (caloric value of other
sugar) = 20 kcal/serving
    c. Total Caloric Contribution = 20 kcal/serving (sucrose) + 20
kcal/serving (other sugar) = 40 kcal/serving
Step 2. Calculate Total Amount of Sugars Adjusted for the Total Caloric
Contribution (Total Caloric Contribution of Sugars (kcal/serving) / 4
kcal/g))
    Amount of Sugars Adjusted for Caloric Contribution = 40 kcal/
serving / 4 kcal/g = 10 g-equivalent/serving
Step 3. Calculate %DV for Added Sugars (Amount of Sugars Adjusted for
Caloric Contribution (g-equivalent) / 50 g/day (DV for Added Sugars for
the general U.S. population 4 years of age and older) x 100))
    %DV = (10 g-equivalent / 50 g/day) x 100 = 20%

    What considerations are there with respect to adjusting the %DV
declaration based on the caloric contribution of the sugar?

D. Label Declarations

    1. We currently require the disclosure of sugar alcohols and sugars
that are metabolized differently than traditional sugars in the
ingredient statement in accordance with Sec.  101.4(a), but also allow
for the voluntary declaration of sugar alcohols on the Nutrition Facts
label (Sec.  101.9(c)(6)(iv)). Please provide any data or other
information that we could consider when determining whether we should
allow for the voluntary declaration on the Nutrition Facts label of
sugars that are metabolized differently than traditional sugars.
    2. Sugar alcohols fall into a separate category of labeling and are
excluded from the ``Total Sugars'' and ``Added Sugars'' declarations.
Please provide any data or other information that we could consider
when determining whether sugars that are metabolized differently than
traditional sugars should be combined with sugar alcohols into one
declaration within the Nutrition Facts label.
    3. If sugars that are metabolized differently than traditional
sugars are excluded from the ``Total Sugars'' and ``Added Sugars''
declarations and are combined with sugar alcohols in a separate
labeling category within the Nutrition Facts label, what names would be
scientifically appropriate for such a category? Please provide any data
or other information that supports your recommendation.

    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22900 Filed 10-16-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74776-74777]
[FR Doc No: 2015-30296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Psychopharmacologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

Date and Time:
     The meeting will be held on February 3, 2016, from 8 a.m. to 5
p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the

appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: During the morning session, the committee will discuss
cognitive dysfunction in major depressive disorder (MDD). This is an
evolving concept and experts in the field have not yet reached
consensus as to whether cognitive dysfunction in MDD is a distinct
entity. The committee will consider the clinical presentation of
cognitive dysfunction in MDD, as well as methods for assessing this
condition.
    During the afternoon session, the committee will discuss new drug
application 204447/supplemental new drug application 006, for the
effectiveness of vortioxetine for the treatment of cognitive
dysfunction in MDD, submitted by Takeda Development Center Americas,
Inc.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
January 20, 2016. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before January 11, 2016. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by January 12, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Kalyani Bhatt at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30296 Filed 11-27-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4227-4230]
[FR Doc No: 2023-01270]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96694; File No. SR-LCH SA-2023-001]

Self-Regulatory Organizations; LCH SA; Notice of Filing of
Proposed Rule Change Relating to the Liquidity Risk Model Framework

January 18, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 4, 2023, Banque Centrale de Compensation, which conducts
business under the name LCH SA (``LCH SA''), filed with the Securities
and Exchange Commission (``Commission'') the proposed rule change
(``Proposed

Rule Change'') described in Items I, II and III below, which Items have
been primarily prepared by LCH SA. 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. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    LCH SA is proposing to amend its Liquidity Risk Model framework
(the ``Framework''), which describes the framework by which the LCH SA
Collateral and Liquidity Risk Management (``CaLRM'') team assures that
LCH SA has enough cash available to meet any financial obligations,
both expected and unexpected, that may arise over the liquidation
period for each of the clearing services that LCH SA offers.\3\ The
Framework is part of LCH SA's Risk Management Procedures (the
``Procedures'') and it is consistent with LCH group liquidity risk
policy to which LCH SA shall comply.
---------------------------------------------------------------------------

    \3\ LCH SA, a subsidiary of LCH Group, manages its liquidity
risk pursuant to, among other policies and procedures, the Group
Liquidity Risk Policy and the Group Liquidity Plan applicable to
each entity within LCH Group. In addition to its CDSClear service,
LCH SA provides clearing services in connection with cash equities
and derivatives listed for trading on Euronext (EquityClear),
commodity derivatives listed for trading on Euronext
(CommodityClear), and tri-party Repo transactions (RepoClear).
---------------------------------------------------------------------------

    The text of the Proposed Rule Change is in Exhibit 5 [sic].\4\
---------------------------------------------------------------------------

    \4\ Capitalized terms used but not defined herein shall have the
meaning specified in the CDS Clearing Rule Book or the Clearing
Supplement, as applicable.
---------------------------------------------------------------------------

    The implementation of the Proposed Rule Change will be contingent
upon LCH SA's receipt of all necessary regulatory approvals, including
the approval by the Commission of the Proposed Rule Change described
herein.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, LCH SA included statements
concerning the purpose of and basis for the Proposed Rule Change and
discussed any comments it received on the Proposed Rule Change. The
text of these statements may be examined at the places specified in
Item IV below. LCH SA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The Framework is one of several well-developed policies and
procedures that LCH SA maintains to manage its liquidity risk, i.e.,
the risk that LCH SA will not have enough cash available, in extreme
but plausible circumstances, to settle margin payments or delivery
obligations when they become due, in particular upon the default of a
clearing member. Such policies and procedures include, among others:
    (i) the Group Liquidity Risk Policy which ensures that each CCP of
the LCH group has enough liquid resources on hand to meet all the
expected and unexpected financial obligations that arise during the
course of the day. The policy lays out how a CCP will measure whether
there is enough available liquid resources;
    (ii) the LCH SA Liquidity Plan that sets out the principles and
procedures for liquidity management within LCH SA. Its main objectives
are to:
     Ensure the liquidity adequacy of LCH SA at all times in
accordance with policies set by the appropriate governance authority
monitored and reported by Risk Management;
     Ensure that liquidity management and resources are aligned
with LCH SA operational requirements to meet payment obligations as
they fall due under Business as Usual and stressed liquidity
conditions;
     Ensure effective liquidity risk identification and
escalation within Collateral and Liquidity Management (``CaLM'')
service and other relevant departments with LCH SA.
    (iii) the Group Financial Resource Adequacy Plan which details the
standards by which financial resources should be assessed against
member exposures. This includes Variation Margins, Initial Margins,
Margin Add-Ons for liquidity risk, concentration risk, wrong way risk
where appropriate, as well as the sizing and re-sizing of the default
funds across the LCH Group CCPs;
    (iv) the Group Collateral Risk Policy; which sets out the standards
for the management of collateral risk across the LCH Group CCPs and
ensures that CCPs must have a robust mechanism in place to process and
control the collateral posted by members;
    (v) the Group Investment Risk Policy which sets out the standards
for the management of investment risk across the LCH Group CCPs;
    (vi) the LCH SA Collateral Control Framework which describes the
actions undertaken by the CaLRM team to implement the collateral limits
laid out in the Group Collateral Risk Policy and to ensure that the
prices integrated on a daily basis by margin team are accurate and
fairly priced.
    In brief, the Framework: (i) identifies LCH SA's sources of
liquidity and corresponding liquidity risks; (ii) identifies LCH SA's
liquidity requirements with respect to its members and its
interoperable central counterparty (``CCP''); \5\ (iii) describes the
metrics and limits that LCH SA monitors; and (iv) describes the
scenarios under which these metrics are computed.
---------------------------------------------------------------------------

    \5\ LCH SA has an interoperability agreement with Cassa di
Compensazione e Garanzia (``CC&G''), an Italian CCP, pursuant to
which LCH SA's clearing members and CC&G's clearing members are able
to benefit from common clearing services without having to join the
other CCP. Each CCP is a clearing member of the other one with a
particular status when accessing the clearing system of the other
counterparty.
---------------------------------------------------------------------------

    (i) Default Fund reduction and intraday injection of liquidity in
the settlement platform to be considered in operational target.\6\
---------------------------------------------------------------------------

    \6\ The Operational target represents the amount of liquidity to
be held to satisfy the liquidity needs related to the operational
management of the CCP in a stressed environment that does not lead
to a member's default.
---------------------------------------------------------------------------

    As per a recommendation from LCH SA's independent risk model
validation department,\7\ LCH SA is proposing to amend the Framework in
order to address more accurately its liquidity requirements in the
event of a Default Fund (``DF'') scheduled reduction \8\ or an
extraordinary intraday liquidity injection \9\ in the settlement
platform.
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    \7\ Only proposed changes described in (i) are due to model
validation recommendation.
    \8\ Every first business day of the month the CCP recalibrate
its DF amounts according to its internal procedures. If the amounts
recalibrated are lower than the amounts in force resources will be
returned to members accordingly within the 4th business day of the
month. Moreover only global reduction in DF amounts are considered
in the calculation of operational target. Increases in DF would
augment the available liquidity and reduce the Operational target
and therefore are not considered.
    \9\ When volumes in the settlement platform are particularly
high the treasury department may need to inject additional liquidity
during the day to ensure the smooth function of the settlement
flows.
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    Before any DF change there exists a latency between the final
approval of the new DF total amount and the settlement of the new
contributions. To properly reflect the decrease of the DF in the
calculation of the operational target until the settlement of the
contributions the new proposed framework will include the following
enhancements.
     The DF recomputed is compared to the DF actually paid and
in the account of LCH SA.
     The amount that will reported will be the following.
    [cir] only global drain of liquidity will be considered and added
to the operational target because they

represent a scheduled liquidity outflow that needs to be covered by
adequate liquidity resources by the CCP,
    [cir] Eventual negative amounts will be reported in the operational
target for all the days from the beginning of the month till settlement
date.
    Moreover, according to the current internal fails monitoring
operating mode, a threshold of 1 bln Euro is set to request a formal
approval by the LCH SA Chief Risk Officer and the Head of LCH SA CaLM
or their delegates, before allowing the LCH SA Operations team to
inject extraordinary liquidity intraday in the settlement platform.
    The current liquidity framework does not take into consideration
eventual extraordinary liquidity injection in the settlement system in
the calculation of the operational target. The revised liquidity
framework, while maintaining consistency with the current procedure,
will require a rerun of the operational target anytime a significant
amount (bigger or equal than 1 bln Euro) of liquidity is injected
intraday. Eventual intraday injection will be subtracted from the
liquidity resources available that are compared against the operational
target to ensure that LCH SA has adequate liquidity to satisfy the
needs related to the operational management of the CCP.
    (ii) Committed credit line.
    LCH SA is proposing clarifications to the Framework to reflect the
final closure of one committed credit line that took place the December
15th 2021. The committee credit line with Kas bank has been replaced by
a multi-currency overdraft facility of [euro]10 million with an
International bank. In addition the CCP put in place a secured
committed intraday credit line with Norges Bank to cover the non-Euro
VM payments for the Euronext Oslo listed derivatives activity. The
amount of the Norges bank credit line is flexible and is determined on
a daily basis based on the collateral deposited with Euroclear Bank.
    Finally, in accordance with what is defined in the SA liquidity
Plan, it has been reported in the Framework the list of options that
LCH SA has to address in a default situation any liquidity shortfall in
a currency different from EUR. These are:

 The non EUR cash deposited as collateral
 The sale of the non EUR securities of the defaulting member
 Repo transactions
    [cir] Bilateral Repo transactions (Non Euro cash taker and Non Euro
collateral giver)
    [cir] Cross-currency Bilateral Repo (Non Euro cash taker and Euro
collateral giver)
    [cir] Cross-currency Triparty Repo (Non Euro cash taker and Euro
collateral giver)
 The use of the multicurrency overdraft facility with an
International Bank
 Use of the FX spot market transactions
 ECB weekly tender in USD (last resort). Given its banking
status, LCH SA has access to the ECB Open market operations in USD.
 Replace LCH SA's liabilities in non EUR by EUR as per clearing
rulebook

    (iii) Updated figure of maximum limit of liquidity injected in the
settlement system to ease settlement.
    In the section of the Framework that describes how the settlement
of physical securities is made and how such activity impact the
liquidity of the CCP, LCH SA is updating the maximum level of liquidity
to be injected daily in the settlement system to ease settlement flow.
    In particular, the CCP have defined for each Central Securities
Depository (CSD) in which settlement takes place an amount of liquidity
that is injected everyday to ease the settlement flow and such
liquidity consumption is monitored by Operation team during the
settlement cycle that occurs throughout the day.
    The updated figures have been defined as a function of the actual
settlement activity observed by Operations team to optimize the
management of the CCP liquidity.
    Moreover, in the same section of the Framework, it is described the
mechanism of auto-collateralization which is a feature of T2S that
enables to obtain the liquidity necessary to the finalization of
transactions by pledging the security underlying the transaction at the
Central Bank to get cash. It has been clarified that LCH SA
successfully managed to test the transfer to its 3G pool (central bank
liquidity) of securities coming from settlement for Italy, Spain and
Germany transactions.
2. Statutory Basis
    LCH SA has determined that the Proposed Rule Change is consistent
with the requirements of section 17A of the Act \10\ and regulations
thereunder applicable to it. section 17A(b)(3)(F) of the Act requires,
inter alia, that the rules of a clearing agency ``assure the
safeguarding of securities and funds that are in its custody or control
or for which it is responsible.'' \11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
    \11\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    LCH SA believes that the Proposed Rule Change is consistent with
the requirements of section 17A of the Act and regulations thereunder
applicable to it, including Commission Rule 17Ad-22(e). In particular,
section 17A(b)(3)(F) of the Act requires, inter alia, that the rules of
a clearing agency be designed to ``promote the prompt and accurate
clearance and settlement of derivatives agreements, contracts, and
transactions''. The proposed changes in the Operational target
described above under Item 3(1)(i) enhance the ability of LCH SA to
manage its liquidity during the daily services it provides by properly
anticipating potential scheduled needs (Default Fund reductions) as
well as ensuring that the liquidity available is always sufficient to
continue the clearing and settlement operations also in the event of
extraordinary intraday liquidity injection in the settlement systems.
The new proposed rule will further strengthen the robustness of the
liquidity management of the Clearing Agency thus contributing to the
prompt and accurate clearance and settlement of securities
transactions. The proposed changes described above also provide the
details about the means the Clearing Agency has to deal with liquidity
shortfalls in non Euros that may arise during a default situation. By
being allowed to leverage on different options the Clearing Agency has
the ability to address such liquidity shortfalls without impacting its
services and therefore promoting the accurate clearance and settlement
of securities transactions. Finally, the proposed changes described
under item (1) (iii) represent mainly an update of the figures of the
liquidity amounts used for easing settlement in the different CSD that
LCH SA uses. This update is the result of a periodic review performed
by the LCH SA Operation team to optimize the liquidity management of
the clearing house. By ensuring that the liquidity injected is
proportional to the settlement activity the clearing house is promoting
the prompt and accurate settlement of securities.
    As discussed above, LCH SA is proposing to amend the Framework to
address specifically LCH SA's liquidity requirements in the event of
Default Fund reduction or extraordinary intraday injection of liquidity
in the settlement platforms. The proposed amendments will assist LCH SA
in defining more accurately its liquidity requirements by assuring that
LCH SA will maintain appropriate levels of liquidity. Specifically, the
amended Framework will anticipate the effect of

scheduled reductions to the Default Fund amount or recalculate the
liquidity indicators whenever significant extraordinary liquidity is
injected intraday in the settlement systems.
    The policies and procedures set out in the amended Framework,
therefore, are designed to enhance LCH SA's ability to measure,
monitor, and manage the liquidity risk that may arise in connection
with its activities as a covered clearing agency. As such the
amendments to the Framework regarding LCH SA's liquidity requirements
are consistent with the requirements of Regulation 17dA-22(e)(7)(i)
\12\ requiring that a covered clearing agency's policies and procedures
be reasonably designed to ensure that it maintains sufficient liquid
resources in all relevant currencies to effect same-day and, where
appropriate, intraday and multiday settlement of payment obligations
with a high degree of confidence under a wide range of potential stress
scenarios that includes the default of the participant family that
would generate the largest aggregate payment obligation for it in
extreme but plausible market conditions and also with Regulation 17dA-
22(e)(7)(ii) \13\ requiring a covered clearing agency to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to ensure that it holds qualifying liquid resources
sufficient to meet the minimum liquidity resource requirement in each
relevant currency for which the covered clearing agency has payment
obligations owed to clearing members.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17Ad-22(e)(7)(i).
    \13\ 17 CFR 240.17Ad-22(e)(7)(ii).
---------------------------------------------------------------------------

B. Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.\14\ LCH SA does
not believe the Proposed Rule Change would have any impact, or impose
any burden, on competition. The Proposed Rule Change does not address
any competitive issue or have any impact on the competition among
central counterparties. LCH SA operates an open access model, and the
Proposed Rule Change will have no effect on this model.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

C. Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed rule change have not been
solicited or received. LCH SA will notify the Commission of any written
comments received by LCH SA.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-LCH SA-2023-001 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-LCH SA-2023-001. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of LCH SA and on LCH SA's website
at: https://www.lch.com/resources/rulebooks/proposed-rule-changes. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-LCH SA-2023-001 and should
be submitted on or before February 14, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-01270 Filed 1-23-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 26, 2007 (Volume 72, Number 17)]
[Notices]
[Page 3825]
[DOCID:fr26ja07-87]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2696-000]

Town of Stuyvesant, NY, Albany Engineering Corporation; Notice
Establishing Revised Schedule for Filing License Application

January 17, 2007.
    On August 2, 2005, the Commission issued a Notice of Intent to File
an Application for a New License for the Stuyvesant Falls Hydroelectric
Project.\1\ The notice established January 31, 2007, as the date for
filing the new license application and competing applications. On
December 19, 2006, the Town of Stuyvesant and Albany Engineering
Corporation, co-licensees for the project, requested an extension of
time until January 31, 2009, to file an application. The licensees
state that they have been unable to acquire the property rights
necessary to access the project site, which they are pursuing in
eminent domain proceedings. Thus, they have been unable to complete
studies needed to prepare an adequate application. The licensees
estimate that inspection and repairs will take between 12 and 18 months
to complete after ownership of the project property is conveyed.
Approximately one year is reportedly needed to conduct the studies. At
least one of the studies, the Instream Flow Incremental Methodology
study, requires the project to be in operating condition to be
conducted. By letter filed October 26, 2006, the U.S. Fish and Wildlife
Service supports extending the deadline.
---------------------------------------------------------------------------

    \1\ Pursuant to special legislation (sections 315(b) and (d) of
Pub. L. 108-137), the project's original license, which had been
surrendered, was reinstated and transferred to Stuyvesant Falls
Hydro Corporation and the Town of Stuyvesant Falls, New York, on
December 30, 2003. 105 FERC ] 62,231 (2003). On December 20, 2006,
the Commission approved the transfer of the license to the Town of
Stuyvesant Falls and Albany Engineering Corporation. 117 FERC ]
62,254 (2006). Noting that the original license had been surrendered
prior to the statutory deadline for filing notices of intent to
relicense the project, and would be reinstated after the statutory
deadline for filing relicensing applications, the order reinstating
the license stated that the Commission would issue a special
relicensing schedule, which was set forth in the August 2, 2005
notice.
---------------------------------------------------------------------------

    While the basis for licensees' request for additional time to file
their relicensing application appears reasonable, their requested two-
year extension of the filing deadline may not ultimately be required
and therefore may unduly delay the relicensing proceeding. Therefore, a
one-year extension of the deadline for filing applications (to January
31, 2008) is granted. In order to keep the Commission apprised of the
licensees' progress the licensees must file quarterly progress reports
on steps taken to successfully complete the eminent domain proceeding,
conduct necessary studies, and file a licensee application (a report is
due three-months following the issuance of this notice and every three
months thereafter until the licensee's application is filed).

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1136 Filed 1-25-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Notices]
[Pages 52995-52996]
[FR Doc No: 2020-18887]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0572; FRL-10012-81-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Chemical-Specific Rules Under the Toxic
Substances Control Act Section 8(a), Certain Nanoscale Materials
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Chemical-Specific Rules under the
Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through August 31,
2020. Public comments were previously requested via the Federal
Register on January 28, 2020 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before September 28,
2020.

ADDRESSES: Submit your comments to EPA, referencing Docket ID Number
EPA-HQ-OPPT-2010-0572 online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460. EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Alwood, Chemical Control Division, Office of Pollution Prevention and
Toxics, 7405M, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>For general information contact: The TSCA-
Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This information collection request (ICR) covers
reporting and

recordkeeping requirements for persons who manufacture or process
chemical substances as nanoscale materials. Under the Toxic Substances
Control Act (TSCA) section 8(a), EPA requires reporting and
recordkeeping for certain chemical substances as nanoscale materials.
EPA requires that persons who manufacture or process these nanoscale
materials notify EPA of certain information which includes production
volume, methods of manufacture and processing, exposure and release
information, and available health and safety information. The reporting
of these activities will provide EPA with an opportunity to evaluate
the information and consider appropriate action under TSCA to reduce
any risk to human health or the environment. The information will also
inform EPA's assessments of new chemical nanoscale materials submitted
to EPA under TSCA section 5.
    EPA's Office of Pollution Prevention and Toxics (OPPT), other EPA
Offices and/or other Federal agencies will generally be the primary
groups for which information will be collected. However, to the extent
that reported information is not considered to be confidential business
information (CBI), environmental groups, environmental justice
advocates, state and local government entities and other members of the
public will have access to this information for their own use.
    Form Numbers: 9600-07.
    Respondents/affected Entities: Entities potentially affected by
this ICR are nanomaterial manufacturers and nanomaterial processors.
    Respondent's obligation to respond: Mandatory (40 CFR 704).
    Estimated number of respondents: 285 per year.
    Frequency of response: On occasion.
    Total estimated burden: 40,089 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $3,067,546 (per year), includes $0 annualized
capital or operation and maintenance costs.
    Changes in the estimates: There is a decrease of 106,766 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease reflects EPA's expectation of decreased
submissions. In the previous ICR period, the rule required an initial
one-time reporting on current nanomaterials, while the reporting
covered in this period only requires the reporting of new
nanomaterials. Furthermore, burden estimates assume that the same
manufacturers will report each year and, therefore, will have already
undertaken rule familiarization in the previous ICR period. This change
is an adjustment to the estimates.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-18887 Filed 8-26-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Page 78227]
[FR Doc No: 2015-31542]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0659; FRL-9939-98-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Generic Clearance for Citizen Science and
Crowdsourcing Projects (New)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Generic Clearance for Citizen
Science and Crowdsourcing Projects (New)'' (EPA ICR No. 2521.01, OMB
Control No. 2080--NEW) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act (44
U.S.C. 3501 et seq.). This is a request for approval of a new
collection. Public comments were previously requested via the Federal
Register (80 FR 59148) on October 1, 2015 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before January 15,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
ORD-2015-0659 to (1) EPA online using www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Jay Benforado, IOAA-ORD, Mail Code
8101R, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
565-2494; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: EPA relies on scientific information. Citizen science and
crowdsourcing techniques will allow the Agency to collect qualitative
and quantitative data that might help inform scientific research,
assessments, or environmental screening; validate environmental models
or tools; or enhance the quantity and quality of data collected across
the country's diverse communities and ecosystems to support the
Agency's mission. Information gathered under this generic clearance
will be used by the Agency to support the activities listed above and
might provide unprecedented avenues for conducting breakthrough
research. Collections under this generic ICR will be from participants
who actively seek to participate on their own initiative through an
open and transparent process (the Agency does not select participants
or require participation); the collections will be low-burden for
participants; collections will be low-cost for both the participants
and the Federal Government; and data will be available to support the
scientific research (including assessments, environmental screening,
tools, models, etc.) of the Agency, states, tribal or local entities
where data collection occurs. EPA may, by virtue of collaborating with
non-federal entities, sponsor the collection of this type of
information in connection with citizen science projects. When
applicable, all such collections will accord with Agency policies and
regulations related to human subjects research and will follow the
established approval paths through EPA's Human Subjects Research Review
Official. Finally, personally identifiable information (PII) will only
be collected when necessary and in accordance with applicable federal
procedures and policies. If a new collection is not within the
parameters of this generic ICR, the Agency will submit a separate ICR
to OMB for approval.
    Form Numbers: None.
    Respondents/affected entities: Individuals.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 42,500 (total).
    Frequency of response: The frequency of responses will range from
once to on occasion.
    Total estimated burden: 389,083 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $12,893,959 (per year), includes $525,000
annualized capital for operation & maintenance costs.
    Changes in the Estimates: This is a new information collection.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-31542 Filed 12-15-15; 8:45 am]
BILLING CODE 6560-50-P