Safety Zone; Sacramento New Year's Eve Fireworks, Sacramento River, Sacramento, CA

CourtCoast Guard
Citation86 FR 70377
Record Number2021-26792
Publication Date10 December 2021
70377
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.5898 to subpart F to read
as follows:
§ 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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2021–0866]
Safety Zone; Sacramento New Year’s
Eve Fireworks, Sacramento River,
Sacramento, CA
AGENCY
: Coast Guard, DHS.
ACTION
: Notification of enforcement of
regulation.
SUMMARY
: The Coast Guard will enforce
the three safety zones in the navigable
waters of the Sacramento River near
River Walk Park and the Tower Bridge
in Sacramento, CA in support of the
Sacramento New Year’s Eve Fireworks
in the Captain of the Port, San Francisco
area of responsibility on December 31,
2021. This action is necessary to protect
personnel, vessels, and the marine
environment from the dangers
associated with pyrotechnics. During
the enforcement periods noted below,
unauthorized persons or vessels are
prohibited from entering into, transiting
through, or anchoring in the safety zone,
unless authorized by the Patrol
Commander (PATCOM) or other federal,
state, or local law enforcement agencies
on scene to assist the Coast Guard in
enforcing the regulated area.
DATES
: The regulation in 33 CFR
165.1191, will be enforced for the
location in Table 1 to § 165.1191, Item
number 25, from 8:30 p.m. until 9:45
p.m. on December 31, 2021.
FOR FURTHER INFORMATION CONTACT
: If
you have questions about this
notification of enforcement, call or
email Lieutenant Anthony Solares,
Waterways Management, U.S. Coast
Guard Sector San Francisco; telephone
(415) 399–3585, email SFWaterways@
uscg.mil.
SUPPLEMENTARY INFORMATION
: The Coast
Guard will enforce the safety zones
established in 33 CFR 165.1191 Table 1,
Item number 25, for the Sacramento
New Year’s Eve Fireworks Display from
8:30 p.m. until 9:45 p.m. on December
31, 2021, or as announcement via
Broadcast Notice to Mariners. The safety
zone will extend to all three safety
zones established in 33 CFR 165.1191
Table 1, Item number 25. During the
period of enforcement, the three safety
zones for the Sacramento New Year’s
Eve Fireworks Display will encompass
the navigable waters, from surface to
bottom, around the fireworks firing sites
within three respective circles each with
a radius of 700 feet with the respective
circle centers in approximate positions:
Southern Firing Site at 38°3450.00N
121°3029.20W,
Northern Firing Site at 38°3502.07N
121°3039.73W, and
Near the Tower Bridge at 34°3449.43N
121°3029.19W (NAD83).
The safety zones will be enforced
from 8:30 p.m. until 9:45 p.m. on
December 31, 2021, or as announced via
Broadcast Notice to Mariners.
In addition to this notification in the
Federal Register, the Coast Guard plans
to provide notification of the safety zone
and its enforcement period via the Local
Notice to Mariners.
Under the provisions of 33 CFR
165.1191, unauthorized persons or
vessels are prohibited from entering
into, transiting through, or anchoring in
the safety zone during all applicable
effective dates and times, unless
authorized to do so by the PATCOM or
other Official Patrol defined as a federal,
state, or local law enforcement agency
on scene to assist the Coast Guard in
enforcing the regulated area.
Additionally, each person who receives
notice of a lawful order or direction
issued by the PATCOM or Official
Patrol shall obey the order or direction.
The PATCOM or Official Patrol may,
upon request, allow the transit of
commercial vessels through regulated
areas when it is safe to do so.
If the Captain of the Port determines
that the regulated area need not be
enforced for the full duration stated in
this notice, a Broadcast Notice to
Mariners may be used to grant general
permission to enter the regulated area.
Dated: December 6, 2021.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the
Port, San Francisco.
[FR Doc. 2021–26792 Filed 12–9–21; 8:45 am]
BILLING CODE 9110–04–P
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