[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Rules and Regulations]
[Pages 30900-30901]
[FR Doc No: 2023-10277]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0197]
RIN 1625-AA00

Safety Zone; Ohio River, Racine, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
on a 24-mile stretch of the Ohio River for paddle craft during the 1st
Annual Race on the OYO. The safety zone will extend 100 yards from any
participating vessel, as they transit from Racine, Ohio to Point
Pleasant, West Virginia. This action is necessary to provide for the
safety of life on these navigable waters during a paddle fest on June
17, 2023. This rulemaking prohibits persons and vessels from being in
the safety zone unless authorized by the Captain of the Port Ohio
Valley or a designated representative.

DATES: This rule is effective from 6:00 a.m. through 4:00 p.m. on June
17, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0197 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST1 Chelsea Zimmerman, Marine
Safety Unit Huntington, U.S. Coast Guard;<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because we must establish the safety zone by
June 17, 2023, and lack sufficient time to request public comments and
respond to these comments before the safety zone must be established.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Ohio Valley (COTP) has determined that
potential hazards associated with the 1st Annual Race on the OYO
starting June 17, 2023, will be a safety concern for anyone on the Ohio
River between Racine, Ohio, and Point Pleasant, WV. This rule is needed
to protect participants, vessels, and the marine environment in the
navigable waters within the moving safety zone for the duration of the
event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 6:00 a.m. through 4:00
p.m. on June 17, 2023. The safety zone will cover all navigable waters
within a 100-yard radius of participant vessels between Racine, Ohio,
and Point Pleasant, WV on the Ohio River. The duration of the safety
zone is intended to protect participants, vessels, and the marine
environment from potential hazards associated with river congestion.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on size, location,
duration, and time-of-day of the safety zone. Vessel traffic will be
authorized to transit around the safety zone, once authorized by the
Captain of the Port Ohio Valley or their designated representative.
Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone, and the rule would allow
vessels to seek permission to enter the zone, and safely pass
participating vessels.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting only 10 hours that will prohibit vessels from being
within 100 yards of any participating paddle craft. It is categorically
excluded from further review under paragraph L60(a) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0197 to read as follows:

Sec.  165.T08-0197   Safety Zone; Ohio River, Racine, OH.

    (a) Regulated area. The Coast Guard is establishing a temporary
moving safety zone on the Ohio River from Racine, OH to Point Pleasant,
WV, around participating vessels in the 1st Annual Race on the OYO. The
safety zone will extend 100-yards from any participant as they transit
from the launch point in Racine, OH, until their finish location in
Point Pleasant, WV.
    (b) Definitions. Designated representative means a Coast Guard
Patrol Commander (PATCOM), including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel and a Federal,
State, and local officer designated by or assisting the Captain of the
Port Ohio Valley (COTP) in the enforcement of the regulations in this
section.
    Participant means all persons and vessels registered with the event
sponsor as a participant in the race.
    (c) Regulations. The Coast Guard may patrol the event area under
the direction of a designated Coast Guard Patrol Commander. The Patrol
Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call
sign ``PATCOM.''
    (1) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state or local
law enforcement and sponsor provided vessels assigned or approved by
the Commander, Eighth Coast Guard District, to patrol the event.
    (2) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer and will be operated at a no wake speed in a
manner which will not endanger participants in the event or any other
craft.
    (3) No spectator shall anchor, block, loiter, or impede the through
transit of participants or official patrol vessels in the regulated
area during the effective dates and times, unless cleared for entry by
or through an official patrol vessel.
    (4) The Patrol Commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both
    (5) Any spectator vessel may anchor outside the regulated area
specified above, but may not anchor in, block, or loiter in a navigable
channel.
    (6) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (7) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM marine radio channel 16 or phone at 1-800-253-
7465. Those in the regulated area must comply with all lawful orders or
directions given to them by the COTP or the designated representative.
    (8) The COTP will provide notice of the regulated area through
advanced notice via local notice to mariners and broadcast notice to
mariners and by on-scene designated representatives.
    (d) Enforcement periods. This safety zone will be subject to
enforcement from 6:00 a.m. to 4:00 p.m. on June 17, 2023.

    Dated: May 4, 2023.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2023-10277 Filed 5-12-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Rules and Regulations]
[Page 57383-57384]
[DOCID:fr21se10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0325; Airspace Docket No. 10-AWP-2]

Modification of Class E Airspace; Willcox, AZ

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action will amend existing Class E airspace at Willcox,
AZ, to accommodate aircraft using a new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedures
(SIAPs) at Cochise County Airport. This will improve the safety and
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective date, 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On June, 14, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend controlled airspace at Willcox,
AZ (75 FR 33561). Interested parties were invited to participate in
this rulemaking

effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9U dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace extending upward from 700 feet
above the surface, at Cochise County Airport, to accommodate IFR
aircraft executing new RNAV (GPS) SIAPs at the airport. This action is
necessary for the safety and management of IFR operations.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in subtitle VII, part A,
subpart I, section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
additional controlled airspace at Cochise County Airport, Willcox, AZ.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Willcox, AZ [Modified]

Cochise County Airport, AZ
    (Lat. 32[deg]14'44'' N., long. 109[deg]53'41'' W.)

    That airspace extending upward from 700 feet above the surface
within 6.5-mile radius of the Cochise County Airport and within 5
miles each side of the 225[deg] bearing from the Cochise County
Airport extending from the 6.5-mile radius to 14.5 miles southwest
of the Cochise County Airport, and within 5.5 miles southeast and
4.5 miles northwest of the 055[deg] bearing from the Cochise County
Airport extending from the 6.5-mile radius to 14.5 miles northeast
of the Cochise County Airport; that airspace extending upward from
1,200 feet above the surface bounded on the north by lat.
32[deg]22'40'' N., long. 109[deg]25'00'' W.; to lat. 32[deg]14'30''
N., long. 109[deg]28'00'' W.; to lat. 32[deg]21'20'' N., long.
109[deg]58'00'' W.; to lat. 32[deg]30'00'' N., long. 109[deg]54'00''
W.; thence to point of beginning.

    Issued in Seattle, Washington, on August 30, 2010.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2010-23394 Filed 9-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35065-35067]
[FR Doc No: 2017-15901]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-1620]

Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Cardiovascular Status Indicator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
adjunctive cardiovascular status indicator into class II (special
controls). The special controls that will apply to the device are
identified in this order and will be part of the codified language for
the adjunctive cardiovascular status indicator's classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective July 28, 2017. The classification was
applicable on December 21, 2016.

FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-
796-1235<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. The Agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) of the FD&C Act and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On May 24, 2016, Flashback Technologies submitted a request for
classification of the CipherOx CRI Tablet under section 513(f)(2) of
the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on December 21, 2016, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  870.2200.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an adjunctive
cardiovascular status indicator will need to comply with the special
controls named in this final order. A De Novo classification decreases
regulatory burdens. When FDA classifies a device type as class I or II
via the De Novo pathway, other manufacturers do not have to submit a De
Novo request or premarket approval application in order to market the
same type of device, unless the device has a new intended use or
technological characteristics that raise different questions of safety
or effectiveness. Instead, manufacturers can use the less burdensome
510(k) pathway, when necessary, to market their device, and the device
that was the subject of the original De Novo classification can serve
as a predicate device for additional 510(k)s from other manufacturers.
    The device is assigned the generic name adjunctive cardiovascular
status indicator, and it is identified as a prescription device based
on sensor technology for the measurement of a physical parameter(s).
This device is intended for adjunctive use with other physical vital
sign parameters and patient information and is not intended to
independently direct therapy.
    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--Adjunctive Cardiovascular Status Indicator Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
           Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Delayed or incorrect treatment due    Software verification, validation, and hazard analysis.
 to erroneous output as a result of   Non-clinical performance testing.
 software malfunction or algorithm    Clinical performance testing.
 error.                               Labeling.
Delayed or incorrect treatment due    Usability assessment.
 to user misinterpretation.           Labeling.
----------------------------------------------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
    Adjunctive cardiovascular status indicators are not safe for use
except under the supervision of a practitioner licensed by law to
direct the use of the device. As such, the device is a prescription
device and must satisfy prescription labeling requirements (see 21 CFR
801.109 Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA believes premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device type and, therefore, is planning to exempt
the device from the premarket notification requirements under section
510(m) of the FD&C Act. Once finalized, persons who intend to market
this device type need not submit a 510(k) premarket notification
containing information on the adjunctive cardiovascular status
indicator prior to marketing the device.

II. 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.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of

information found in other FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120, and the collections of information in 21 CFR part
801, regarding labeling have been approved under OMB control number
0910-0485.

List of Subjects in 21 CFR Part 870

    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
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

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

0
2. Add Sec.  870.2200 to subpart C to read as follows:

Sec.  870.2200  Adjunctive cardiovascular status indicator.

    (a) Identification. The adjunctive cardiovascular status indicator
is a prescription device based on sensor technology for the measurement
of a physical parameter(s). This device is intended for adjunctive use
with other physical vital sign parameters and patient information and
is not intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Software description, verification, and validation based on
comprehensive hazard analysis must be provided, including:
    (i) Full characterization of technical parameters of the software,
including any proprietary algorithm(s);
    (ii) Description of the expected impact of all applicable sensor
acquisition hardware characteristics on performance and any associated
hardware specifications;
    (iii) Specification of acceptable incoming sensor data quality
control measures; and
    (iv) Mitigation of impact of user error or failure of any subsystem
components (signal detection and analysis, data display, and storage)
on accuracy of patient reports.
    (2) Scientific justification for the validity of the status
indicator algorithm(s) must be provided. Verification of algorithm
calculations and validation testing of the algorithm using a data set
separate from the training data must demonstrate the validity of
modeling.
    (3) Usability assessment must be provided to demonstrate that risk
of misinterpretation of the status indicator is appropriately
mitigated.
    (4) Clinical data must be provided in support of the intended use
and include the following:
    (i) Output measure(s) must be compared to an acceptable reference
method to demonstrate that the output measure(s) represent(s) the
predictive measure(s) that the device provides in an accurate and
reproducible manner;
    (ii) The data set must be representative of the intended use
population for the device. Any selection criteria or limitations of the
samples must be fully described and justified;
    (iii) Agreement of the measure(s) with the reference measure(s)
must be assessed across the full measurement range; and
    (iv) Data must be provided within the clinical validation study or
using equivalent datasets to demonstrate the consistency of the output
and be representative of the range of data sources and data quality
likely to be encountered in the intended use population and relevant
use conditions in the intended use environment.
    (5) Labeling must include the following:
    (i) The type of sensor data used, including specification of
compatible sensors for data acquisition;
    (ii) A description of what the device measures and outputs to the
user;
    (iii) Warnings identifying sensor reading acquisition factors that
may impact measurement results;
    (iv) Guidance for interpretation of the measurements, including
warning(s) specifying adjunctive use of the measurements;
    (v) Key assumptions made in the calculation and determination of
measurements;
    (vi) The measurement performance of the device for all presented
parameters, with appropriate confidence intervals, and the supporting
evidence for this performance; and
    (vii) A detailed description of the patients studied in the
clinical validation (e.g., age, gender, race/ethnicity, clinical
stability) as well as procedural details of the clinical study.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15901 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P