[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Page 56359]
[FR Doc No: 2018-24675]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3408-EM]; [Docket ID FEMA-2018-0001]

Commonwealth of the Northern Mariana Islands; Emergency and
Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the Commonwealth of the Northern Mariana Islands (FEMA-
3408-EM), dated October 23, 2018, and related determinations.

DATES: The declaration was issued October 23, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 23, 2018, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the
Commonwealth of the Northern Mariana Islands resulting from Typhoon
Yutu beginning on October 24, 2018, and continuing, are of
sufficient severity and magnitude to warrant an emergency
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (``the Stafford
Act''). Therefore, I declare that such an emergency exists in the
Commonwealth of the Northern Mariana Islands.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Benigno
Bern Ruiz, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the Commonwealth of the Northern Mariana
Islands have been designated as adversely affected by this declared
emergency:

The municipalities of Rota, Saipan, Tinian, and the Northern Islands
for emergency protective measures (Category B), limited to direct
Federal assistance, under the Public Assistance program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA) are
to be used for reporting and drawing funds: 97.030, Community Disaster
Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033,
Disaster Legal Services; 97.034, Disaster Unemployment Assistance
(DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster
Housing Assistance to Individuals and Households In Presidentially
Declared Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and Households;
97.050, Presidentially Declared Disaster Assistance to Individuals and
Households--Other Needs; 97.036, Disaster Grants--Public Assistance
(Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-24675 Filed 11-9-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Rules and Regulations]
[Pages 13551-13553]
[FR Doc No: 2017-04941]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-1142]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the High Throughput Genomic Sequence
Analyzer for Clinical Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the high
throughput genomic sequence analyzer for clinical use 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 classification of the high throughput genomic sequence analyzer
for clinical use device. 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 March 14, 2017. The classification was
applicable on November 19, 2013.

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_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) of the FD&C Act.
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. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on September 13, 2013, classifying the Illumina MiSeqDx Platform into
class III, because it was not substantially equivalent to a device that
was introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II.
    On September 23, 2013, FDA received from Illumina, Inc., a request
for classification of the Illumina MiSeqDx Platform submitted 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) of the FD&C Act. 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 November 19, 2013, 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 862.2265.
    Following the effective date of this final classification order,
any firm intending to market a high throughput genomic sequence
analyzer for clinical use 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 PMA 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 pathway of 510(k), 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 high throughput genomic
sequence analyzer for clinical use, and it is identified as an
analytical instrument system intended to generate, measure and sort
signals in order to analyze nucleic acid sequences in a clinical
sample. The device may include a signal reader unit; reagent handling,
dedicated instrument control, and other hardware components; raw data
storage mechanisms; data acquisition software; and software to process
detected signals.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks:

   Table 1--High Throughput Genomic Sequence Analyzer for Clinical Use
                      Risks and Mitigation Measures
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         Identified risks to health              Required mitigations
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Inaccurate test results due to               Special Control (1) (21 CFR
 unavailability of necessary components of    862.2265(b)(1)).
 the instrument system.
Inaccurate results due to unknown            Special Control (2) (21 CFR
 performance of the instrument system.        862.2265(b)(2)).
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    FDA believes that the special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness. The special controls for a
high throughput genomic sequence analyzer for clinical use include a
detailed outline of analytical performance information that must be
generated for the instrument system (i.e., platform and all associated
software). This includes analytical validation using well characterized
samples (i.e., well characterized or reference materials) to
demonstrate the system's capabilities and to identify limitations.
    The validation testing, as required by the special controls, only
establishes the instrument's general capabilities and does not
establish the instrument's capabilities or suitability with respect to
any specific claims. Instruments indicated for a specific diagnostic
test, including those that make claims for a specific test, (e.g.,
hematology panel; oncology panel) require additional independent
validation and are not high throughput genomic sequence analyzers for
clinical use under 21 CFR 862.2265.
    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 high throughput genomic sequence analyzer
for clinical use prior to marketing the device.

II. Analysis of Environmental Impact

    We have 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 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 862

    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
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 is revised to read as follows:

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

0
2. Add Sec.  862.2265 to subpart C to read as follows:

Sec.  862.2265  High throughput genomic sequence analyzer for clinical
use.

    (a) Identification. A high throughput genomic sequence analyzer for
clinical use is an analytical instrument system intended to generate,
measure and sort signals in order to analyze nucleic acid sequences in
a clinical sample. The device may include a signal reader unit; reagent
handling, dedicated instrument control, and other hardware components;
raw data storage mechanisms; data acquisition software; and software to
process detected signals.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling for the instrument system must reference legally
marketed pre-analytical and analytical reagents to be used with the
instrument system and include or reference legally marketed analytical
software that includes sequence alignment and variant calling
functions, to be used with the instrument system.
    (2) The labeling for the instrument system must include a
description of the following information:
    (i) The specimen type(s) validated as an appropriate source of
nucleic acid for this instrument.
    (ii) The type(s) of nucleic acids (e.g., germline DNA, tumor DNA)
validated with this instrument.
    (iii) The type(s) of sequence variations (e.g. single nucleotide
variants, insertions, deletions) validated with this instrument.
    (iv) The type(s) of sequencing (e.g., targeted sequencing)
validated with this instrument.
    (v) The appropriate read depth for the sensitivity claimed and
validation information supporting those claims.
    (vi) The nucleic acid extraction method(s) validated for use with
the instrument system.
    (vii) Limitations must specify the types of sequence variations
that the instrument cannot detect with the claimed accuracy and
precision (e.g., insertions or deletions larger than a certain size,
translocations).
    (viii) Performance characteristics of the instrument system must
include:
    (A) Reproducibility data generated using multiple instruments and
multiple operators, and at multiple sites. Samples tested must include
all claimed specimen types, nucleic acid types, sequence variation
types, and types of sequencing. Variants queried shall be located in
varying sequence context (e.g., different chromosomes, GC-rich
regions). Device results shall be compared to reference sequence data
with high confidence.
    (B) Accuracy data for all claimed specimen types and nucleic acid
types generated by testing a panel of well characterized samples to
query all claimed sequence variation types, types of sequencing, and
sequences located in varying sequence context (e.g., different
chromosomes, GC-rich regions). The well-characterized sample panel
shall include samples from at least two sources that have highly
confident sequence based on well-validated sequencing methods. At least
one

reference source shall have sequence generated independently of the
manufacturer with respect to technology and analysis. Percent agreement
and percent disagreement with the reference sequences must be described
for all regions queried by the instrument.
    (C) If applicable, data describing endogenous or exogenous
substances that may interfere with the instrument system.
    (D) If applicable, data demonstrating the ability of the system to
consistently generate an accurate result for a given sample across
different indexing primer combinations.
    (ix) The upper and lower limit of input nucleic acid that will
achieve the claimed accuracy and reproducibility. Data supporting such
claims must also be summarized.

    Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04941 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P