	We are sensitive to the appropriate treatment of data reported as detection limit values in the development of MACT floors and emissions limits. We believe that the statistical probability procedures applied in calculating the floor or an emissions limit inherently and reasonably account for emissions data variability including measurement imprecision when the database represents multiple tests from multiple emissions units for which all of the data are measured significantly above the method detection level. That is less true when the database includes emissions occurring below method detection capabilities regardless of how those data are reported.
      The EPA's guidance to respondents for reporting pollutant emissions used to support the data collection specified the criteria for determining test-specific method detection levels. Those criteria ensure that there is only about a 1 percent probability of an error in deciding that the pollutant measured at the method detection level is present when in fact it was absent. (Reference: ReMAP: PHASE 1, Precision of Manual Stack Emission Measurements; American Society of Mechanical Engineers, Research Committee on Industrial and Municipal Waste, February 2001.) Such a probability is also called a false positive or the alpha, Type I, error. This means specifically that for a normally distributed set of measurement data, 99 out of 100 single measurements will fall within +-2.54 x standard deviation of the true concentration. The anticipated range for the average of repeated measurements comes progressively closer to the true concentration. More precisely, the anticipated range varies inversely with the square root of the number of measurements. Thus, for a known standard deviation (SD) of anticipated single measurements, the anticipated range for 99 out of 100 future triplicate measurements will fall within +- 2.54 SD/√3 of the true concentration. This relationship translates to an expected measurement imprecision for an emissions value occurring at or near the method detection level of about 40 to 50 percent.
      By assuming a similar distribution of measurements across a range of values and increasing the mean value to a higher representative value (e.g., 3 times method detection level or 3xMDL), we can estimate measurement imprecision at other levels. For a measurement at 3xMDL, the estimated measurement imprecision for a three test run average value would be on the order 10 to 20 percent. This is about the same measurement imprecision as found for Methods 23 and 29 indicated in the ASME ReMAP study for the sample volumes prescribed in the final rule (e.g., 4 to 6 dscm) for multiple tests.
      Instead of the method detection limit, analytical laboratories often report a value above the method detection limit that represents the laboratory's perceived confidence in the quality of the value. This independently adjusted value is expressed differently by various laboratories and is called limit of quantitation (LOQ), practical quantitation limit (PQL), or reporting limit (RL). In many cases, the LOQ, PQL, or RL is simply a multiplication of the method detection limit. Commonly used multipliers range from 3 to 10. Because these values reflect individual laboratories' perceived confidence, and, therefore, could be viewed as arbitrary, we decline to adopt the LOQ, PQL, or RL in the database for calculating floor values because such approaches in our view would inappropriately inflate the MACT floor standards. Our alternative to those inconsistent approaches is discussed below.
      We recognize that an emissions limit based on a small subset of data or data from a single source may be significantly different than the actual method detection levels achieved by the best performing testing companies in practice. This fact, combined with the low levels of emissions measured from many of the best performing units, led us to develop a procedure intended to account for the contribution of measurement imprecision to data variability in establishing effective emissions limits. That procedure is for identifying a representative method detection level (RDL).
      For the total organic HAP emissions data, we applied the following procedure for determining an RDL for methods used in measuring organic HAPs. We determined method detection capabilities for Method 320 and Method 18 as appropriate for the various compounds (e.g., Method 320 for aldehydes, Method 18 for arenes). We believe that this approach is representative of procedures practiced by the better performing testing companies and laboratories using the reasonably applicable and sensitive analytical procedures. We determined for each of the organic HAPs the expected method detection level for the respective method based on internal experience and method capabilities reported by testing companies. With these reported values, we identified the resulting mean of the method detection levels as the representative detection level (RDL) because it is characteristic of accepted source emissions measurement performance. The following table summarizes those findings.
Pollutant
                                  Method used
                                      RDL
                               ppmv, as measured
                                      RDL
                                ppmv @7% O2 dry
Formaldehyde
                                  Method 320
                                                                           0.15
                                                                           0.23
Acetaldehyde
                                      "
                                                                           1.50
                                                                           2.34
Benzene
                          Method 18 (adsorbent tube)
                                                                           0.04
                                                                           0.08
Toluene
                                      "
                                                                           0.04
                                                                           0.08
Styrene
                                      "
                                                                           0.04
                                                                           0.08
Xylenes (m,p,o)
                                      "
                                                                           0.12
                                                                           0.24
Napthalene
                                      "
                                                                           0.03
                                                                           0.06

      The second step in the process is to calculate 3xRDL for the sum or total of the organic HAPs to compare with the emissions limit in the final rule. This step is similar to what we have used for other NESHAP including the proposed Portland Cement rule. As outlined above, we use the multiplication factor of 3 to reduce the imprecision of the analytical method until the imprecision in the field sampling reflects the relative method precision as estimated by the ASME ReMAP study. That study indicates that such relative imprecision remains a constant 10 to 20 percent over the range of the method. For assessing the calculated floor results relative to measurement method capabilities, if 3xRDL were less than the calculated floor or emissions limit (e.g., calculated from the upper predictive limit, UPL), we would conclude that measurement variability was adequately addressed with the initial floor calculation. The calculated floor or emissions limit would need no adjustment. If, on the other hand, the value equal to 3xRDL were greater than the UPL, we would conclude that the calculated floor or emissions limit did not account entirely for measurement variability. Where such was the case, we would substitute the value equal to 3xRDL for the calculated floor or emissions limit. This would result in an emissions limit where the method would produce measurement accuracy on the order of 10 to 20 percent similar to other EPA test methods and the results found in the ASME ReMAP study.
      We summed the RDLs adjusted for dilution and moisture as shown in the table above. We determined 3xRDL for the sum of the adjusted pollutants to be 11.2 ppmv @ 7 percent O2, dry. This value is greater than the final 9 ppmv @ 7 percent O2, dry, in the final rule. This result means that we would propose to adjust the total organic HAP limit to 12 ppmv @ 7 percent O2, dry.  At this level, we believe that currently available emissions testing procedures and technologies provide the measurement certainty sufficient for sources to demonstrate compliance at the levels of the revised emissions limit.


[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Page 41711]
[FR Doc No: 2023-13564]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97780; File No. SR-ICEEU-2023-010]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Designation of Longer Period for Commission Action on Proposed Rule
Change, as Modified by Amendment No. 1, Relating to Amendments to the
Clearing Rules

June 21, 2023.
    On April 21, 2023, ICE Clear Europe Limited filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change SR-ICEEU-2023-010 (``Proposed Rule Change'') pursuant to Section
19(b) of the Securities Exchange Act of 1934 (``Exchange Act'') \1\ and
Rule 19b-4 \2\ thereunder a proposed rule change regarding the
treatment of non-default losses.\3\ The Proposed Rule Change was
published for public comment in the Federal Register on May 10,
2023.\4\ The Commission has not received comments regarding the
proposal described in the Proposed Rule Change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Notice of Filing infra note 4, 88 FR 30187.
    \4\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Filing of Proposed Rule Change, as Modified by Amendment
No. 1, Relating to Amendments to the Clearing Rules, Exchange Act
Release No. 34-97429 (May 4, 2023); 88 FR 30187 (May 10, 2023) (SR-
ICEEU-2023-010) (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Exchange Act \5\ provides that, within 45
days of the publication of notice of the filing of a proposed rule
change, or within such longer period up to 90 days as the Commission
may designate if it finds such longer period to be appropriate and
publishes its reasons for so finding, or as to which the self-
regulatory organization consents, the Commission shall either approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether the proposed rule change
should be disapproved. The 45th day after publication of the Notice of
Filing is June 24, 2023. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

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

    In order to provide the Commission with sufficient time to consider
the Proposed Rule Change, the Commission finds that it is appropriate
to designate a longer period within which to take action on the
Proposed Rule Change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Exchange Act,\6\ designates August 8, 2023 as the date by which the
Commission shall either approve, disapprove, or institute proceedings
to determine whether to disapprove proposed rule change SR-ICEEU-2023-
010.
---------------------------------------------------------------------------

    \6\ Id.

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

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

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-13564 Filed 6-26-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56827-56828]
[FR Doc No: 2012-22668]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2280-015]

FirstEnergy Generation Corporation, FirstEnergy Generation, LLC;
Notice of Application for Transfer of License, and Soliciting Comments
and Motions To Intervene

    On July 6, 2012, FirstEnergy Generation Corporation (transferor)
and FirstEnergy Generation, LLC (transferee) filed an application for
the transfer of license for the Kinzua Pumped Storage Project (FERC No.
2280), located on the Allegheny River in Warren County, Pennsylvania.
    Applicants seek Commission approval to transfer the license for the
Kinzua Pumped Storage Project from the transferor to the transferee.
    Applicants' Contact: Mr. Morgan E. Parke, Sr. Corporate Counsel,
FirstEnergy Service Company, 76 South Main Street, A-GO-15, Akron, OH
44308, Telephone<PHONE_NUMBER> and Mr. John A. Whittaker IV, Winston &
Strawn LLP, 1700 K Street NW., Washington, DC 20006-3817, Telephone
(202) 282-5766.
    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: October 1,
2012.

Comments and motions to intervene may be filed electronically via the
Internet. See 18 CFR 385.2001(a)(1) and the instructions on the
Commission's Web site under 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. If unable to
be filed electronically, documents may be paper-filed.
    To paper-file, an original plus seven copies should be mailed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426. More information about this
project 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-2280) in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3372.

    Dated: September 10, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-22668 Filed 9-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Proposed Rules]
[Pages 12865-12866]
[FR Doc No: 2021-03969]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0042; Airspace Docket No. 20-AEA-13]
RIN 2120-AA66

Proposed Amendment VOR Federal Airway V-487; Eastern New York and
Northern Vermont

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend VOR Federal airway V-487 in the
vicinity of Glens Falls, NY, and Burlington, VT. The proposed change
would substitute a radial from the Burlington, VT, VOR/DME (BTV), in
place of the current Glens Falls, NY, VOR/DME (GFL) radial, for
defining a navigation fix along the route. Additionally, this action
would remove segments of V-487 between Burlington, VT, and St Jean,
Canada. These changes are necessary due to the decommissioning of the
Glens Falls, NY, VOR/DME, and the decommissioning of the St Jean,
Canada VOR/DME (YJN).

DATES: Comments must be received on or before April 19, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527 or<PHONE_NUMBER>. You must identify FAA Docket No. FAA-
2021-0042; Airspace Docket No. 20-AEA-13 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Policy Group, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591; telephone:<PHONE_NUMBER>. The Order is also
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of FAA Order
7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes 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
the 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 would amend the VOR Federal airway V-487 to match
changes in navigation aid infrastructure.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0042; Airspace Docket No. 20-AEA-13 and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0042; Airspace Docket No. 20-AEA-13.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Eastern Service Center, Federal
Aviation Administration, Room 210, 1701 Columbia Ave., College Park, GA
30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this proposed rule. FAA Order 7400.11E
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend VOR
Federal airway V-487 in the vicinity of Glens Falls, NY, and
Burlington, VT. The proposed change would substitute a radial from the
Burlington, VT, VOR/DME, in place of the current Glens Falls, NY, VOR/
DME radial, for defining the ENSON, VT, navigation fix. Currently, the
ENSON, VT, navigation fix is defined by the intersection of the
Cambridge, NY, VOR/DME (CAM) 002[deg]

radial, and the Glens Falls, NY, VOR/DME 032[deg] radial.
    This change is necessary because the Glens Falls VOR/DME has been
decommissioned and is no longer in service. As amended, the ENSON fix
would be defined by the intersection of the Burlington, VT, 187[deg]
(T)/202[deg] (M), and the Cambridge, NY 002[deg] radials. This change
would not affect navigation along that portion of the route.
    Additionally, the FAA proposes to remove the segment of V-487 that
extends between the Burlington, VT, VOR/DME, and the St Jean, Canada
VOR/DME due to the decommissioning of the St Jean VOR/DME. As amended,
V-487 would extend between LaGuardia, NY, and Burlington, VT.
    Note: when new radials are specified in a proposed airway route
description, both True and Magnetic degrees are stated in the NPRM.
Otherwise, only True degrees are included in the description.
    Domestic VOR Federal airways are published in paragraph 6010(a) of
FAA Order 7400.11E, dated July, 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airway listed in this document would be subsequently published
in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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 that this proposed 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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 part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 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 FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways

* * * * *

V-487 [Amended]

    From LaGuardia, NY; Bridgeport, CT; INT Bridgeport 343[deg] and
Cambridge, NY, 189[deg] radials; Cambridge; INT Burlington, VT,
187[deg]T/202[deg]M and Cambridge 002[deg] radials; Burlington.
* * * * *

    Issued in Washington, DC, on February 22, 2021.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-03969 Filed 3-4-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52647-52649]
[FR Doc No: 2017-24585]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5881]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Automated Indirect Immunofluorescence Microscope
and Software-Assisted System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the automated indirect immunofluorescence microscope and software-
assisted system 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 automated indirect
immunofluorescence microscope and software-assisted system's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective November 14, 2017. The classification
was applicable on April 9, 2015.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the automated indirect
immunofluorescence microscope and software-assisted system as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation, in part
by reducing regulatory burdens by placing the device into a lower
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA 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.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining
``substantial equivalence''). Instead, sponsors can use the less-
burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on November 14, 2014, finding
the NOVA View[supreg] Automated Fluorescence Microscope not
substantially equivalent to a predicate not subject to PMA. Thus, the
device remained in class III in accordance with section 513(f)(1) of
the FD&C Act when we issued the order.
    On December 11, 2014, Inova Diagnostics, Inc. submitted a request
for De Novo classification of the NOVA

View[supreg] Automated Fluorescence Microscope. 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 general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 9, 2015, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.4750. We have named
the generic type of device automated indirect immunofluorescence
microscope and software-assisted system, and it is identified as a
device that acquires, analyzes, stores, and displays digital images of
indirect immunofluorescent slides. It is intended to be used as an aid
in the determination of antibody status in clinical samples. The device
may include a fluorescence microscope with light source, a motorized
microscope stage, dedicated instrument controls, a camera, a computer,
a sample processor, or other hardware components. The software may
include fluorescent signal acquisition and processing software, data
storage and transferring mechanisms, or assay specific algorithms to
suggest results. A trained operator must confirm results generated with
the device.
    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--Automated Indirect Immunofluorescence Microscope and Software-
              Assisted System Risks and Mitigation Measures
------------------------------------------------------------------------
       Identified risks            Mitigation measures/21 CFR section
------------------------------------------------------------------------
Inaccurate test results that   Special controls (1), (2), and (3) (21
 provide false positive or      CFR 866.4750(b)(1); 21 CFR
 false negative results.        866.4750(b)(2); and 21 CFR
                                866.4750(b)(3)).
Failure to correctly           Special controls (1), (2)(i), (2)(ii)(A),
 interpret test results can     (2)(ii)(B), (2)(iii), and (3) (21 CFR
 lead to false positive or      866.4750(b)(1); 21 CFR
 false negative results.        866.4750(b)(2)(i); 21 CFR
                                866.4750(b)(2)(ii)(A); 21 CFR
                                866.4750(b)(2)(ii)(B); 21 CFR
                                866.4750(b)(2)(iii); and 21 CFR
                                866.4750(b)(3)).
------------------------------------------------------------------------

    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. In order 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.

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
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 parts 801 and 809, regarding labeling have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.4750 to subpart E to read as follows:

Sec.  866.4750   Automated indirect immunofluorescence microscope and
software-assisted system.

    (a) Identification. An automated indirect immunofluorescence
microscope and software-assisted system is a device that acquires,
analyzes, stores, and displays digital images of indirect
immunofluorescent slides. It is intended to be used as an aid in the
determination of antibody status in clinical samples. The device may
include a fluorescence microscope with light source, a motorized
microscope stage, dedicated instrument controls, a camera, a computer,
a sample processor, or other hardware components. The software may
include fluorescent signal acquisition and processing software, data
storage and transferring mechanisms, or assay specific algorithms to
suggest results. A trained operator must confirm results generated with
the device.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling for the device must reference legally marketed
assays intended for use with the device.
    (2) Premarket notification submissions must include the following
information:
    (i) A detailed description of the device that includes:
    (A) A detailed description of instrumentation and equipment, and
illustrations or photographs of non-standard equipment or methods, if
applicable;
    (B) Detailed documentation of the software, including, but not
limited to, stand-alone software applications and hardware-based
devices that incorporate software, if applicable;
    (C) A detailed description of appropriate internal and external

quality controls that are recommended or provided. The description must
identify those control elements that are incorporated into the
recommended testing procedures;
    (D) Detailed description and specifications for sample preparation,
processing, and storage, if applicable;
    (E) Methodology and protocols for detecting fluorescence and
visualizing results; and
    (F) Detailed specification of the criteria for test results
interpretation and reporting.
    (ii) Data demonstrating the performance characteristics of the
device, which must include:
    (A) A comparison study of the results obtained with the
conventional manual method (i.e., reference standard), the device, and
the reading of the digital image without aid of the software, using the
same set of patient samples for each. The study must use a legally
marketed assay intended for use with the device. Patient samples must
be from the assay-specific intended use population and differential
diagnosis population. Samples must also cover the assay measuring
range, if applicable;
    (B) Device clinical performance established by comparing device
results at multiple U.S. sites to the clinical diagnostic standard used
in the United States, using patient samples from the assay-specific
intended use population and the differential diagnosis population. For
all samples, the diagnostic clinical criteria and the demographic
information must be collected and provided. Clinical validation must be
based on the determination of clinical sensitivity and clinical
specificity using the test results (e.g., antibody status based on
fluorescence to include pattern and titer, if applicable) compared to
the clinical diagnosis of the subject from whom the clinical sample was
obtained. The data must be summarized in tabular format comparing the
result generated by automated, manual, and digital only interpretation
to the disease status;
    (C) Device precision/reproducibility data generated from within-
run, between-run, between-day, between-lot, between-operator, between-
instruments, between-site, and total precision for multiple
nonconsecutive days (as applicable) using multiple operators, multiple
instruments and at multiple sites. A well-characterized panel of
patient samples or pools from the associated assay specific intended
use population must be used;
    (D) Device linearity data generated from patient samples covering
the assay measuring range, if applicable;
    (E) Device analytical sensitivity data, including limit of blank,
limit of detection, and limit of quantitation, if applicable;
    (F) Device assay specific cutoff, if applicable;
    (G) Device analytical specificity data, including interference by
endogenous and exogenous substances, if applicable;
    (H) Device instrument carryover data, if applicable;
    (I) Device stability data including real-time stability under
various storage times and temperatures, if applicable; and
    (J) Information on traceability to a reference material and
description of value assignment of calibrators and controls, if
applicable.
    (iii) Identification of risk mitigation elements used by the
device, including description of all additional procedures, methods,
and practices, incorporated into the directions for use that mitigate
risks associated with testing.
    (3) Your 21 CFR 809.10 compliant labeling must include:
    (i) A warning statement that reads ``The device is for use by a
trained operator in a clinical laboratory setting'';
    (ii) A warning statement that reads ``All software-aided results
must be confirmed by the trained operator'';
    (iii) A warning statement that reads ``This device is only for use
with reagents that are indicated for use with the device''; and
    (iv) A description of the protocol and performance studies
performed in accordance with paragraph (b)(2)(ii) of this section and a
summary of the results, if applicable.

    Dated: November 7, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24585 Filed 11-13-17; 8:45 am]
 BILLING CODE 4164-01-P