[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Notices]
[Pages 63553-63554]
[FR Doc No: 2015-26597]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0611; FRL-9935-93-ORD]

Board of Scientific Counselors Sustainable and Healthy
Communities Subcommittee; Notification of Public Teleconference Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public teleconference meeting and public comment.

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SUMMARY: The U.S. Environmental Protection Agency, Office of Research
and Development (ORD), hereby provides notice that the Board of
Scientific Counselors (BOSC) Sustainable and Healthy Communities (SHC)
Subcommittee will host a public teleconference meeting on Wednesday,
November 4, 2015, from 11:00 a.m. to 2:00 p.m., Eastern Time.
Deliberations will focus on a draft report summarizing the SHC
Subcommittee findings and recommendations from its September 2015
meeting. Documents from the September meeting are available for viewing
and downloading at http://www2.epa.gov/bosc/sustainable-and-healthy-communities-subcommittee-meeting-documents.
    There will be a public comment period from 11:45 a.m. to 12:00 p.m.
Eastern Time. Members of the public are encouraged to provide comments.
For additional information about registering to attend the meeting or
to provide public comment, please see the SUPPLEMENTARY INFORMATION
section below. Due to a limited number of telephone lines, attendance
will be on a first-come, first-served basis. Pre-registration is
required.

DATES: The BOSC SHC Subcommittee teleconference meeting on Wednesday,
November 4, 2015, will begin promptly at 11:00 a.m. The conference call
may adjourn early if all business is finished or may adjourn late if
additional time is needed. Preregistration for the teleconference
meeting closes at noon, Monday, November 2, 2015. The deadline to sign
up to speak during the public comment period, or to submit written
public comment, is also noon, Monday, November 2, 2015. All times noted
are Eastern Time.

ADDRESSES: Participation in the conference call will be by
teleconference only; meeting rooms will not be used. Members of the
public may obtain the call-in number and access code for the call from
Jace Cuj[eacute], the Designated Federal Officer (DFO), via any of the
contact methods listed in the FOR FURTHER INFORMATION CONTACT section
below.
    Submitting Comments: Submit your comments, identified by Docket ID
No. EPA-HQ-ORD-2015-0611, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0611.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0611.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Sustainable and Healthy Communities Subcommittee
Docket, Mail Code: 2822T, 1301 Constitution Ave. NW., Washington, DC
20004, Attention Docket ID No. EPA-HQ-ORD-2015-0611.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW., Washington, DC, Attention Docket ID No.
EPA-HQ-ORD-2015-0611. Note: this is not a mailing address. Deliveries
are only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2015-0611. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment. If the EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
information about the EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at www.regulations.gov or in hard copy at the Board of Scientific
Counselors (BOSC) Sustainable and Healthy Communities Subcommittee
Docket, EPA/DC, William Jefferson Clinton West Building, Room 3334,
1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone

number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO)
via mail at: Jace Cuj[eacute], Mail Code 8104R, Office of Science
Policy, Office of Research and Development, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
via phone/voice mail at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Charter of the BOSC states that the
advisory committee shall provide advice and recommendations on all
aspects (technical and management) of the ORD's research program. The
BOSC is federal advisory committee chartered under the Federal Advisory
Committee Act (FACA), 5 U.S.C., App. 2. Additional information about
the BOSC is available at: http://www2.epa.gov/bosc.
    This meeting is open to the public. Any member of the public
interested in receiving a draft agenda, joining the teleconference, or
making a presentation during the teleconference may contact Jace
Cuj[eacute], DFO, via any of the contact methods listed in the FOR
FURTHER INFORMATION CONTACT section above. Proposed agenda items for
the meeting include, but are not limited to, the following:
presentation and discussion of the subcommittee's draft responses to
the charge questions and approval of the final draft letter report
prior to its submission to the BOSC Executive Committee.
    Written Statements: Written comments for the public teleconference
must be received by noon Monday, November 2, 2015, Eastern Time, so
they can be distributed to the BOSC SHC Subcommittee prior to the
teleconference. Written comments should be sent to Jace Cuj[eacute] at
the address listed in the FOR FURTHER INFORMATION CONTACT section or
through regulations.gov, Docket ID No. EPA-HQ-ORD-2015-0611.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Jace Cuj[eacute] at<PHONE_NUMBER> or<EMAIL_ADDRESS>
To request accommodation of a disability, please contact Jace
Cuj[eacute], preferably at least ten days prior to the meeting, to give
the EPA as much time as possible to process your request.

    Dated: October 15, 2015.
Fred S. Hauchman,
Director, Office of Science Policy.
[FR Doc. 2015-26597 Filed 10-19-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49098-49100]
[FR Doc No: 2017-22994]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5657]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Measure Non-Microbial
Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients
With Suspected Sepsis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the device to detect and measure non-microbial analyte(s) in human
clinical specimens to aid in assessment of patients with suspected
sepsis 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 device to detect and measure non-
microbial analyte(s) in human clinical specimens to aid in assessment
of patients with suspected sepsis'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 October 24, 2017. The classification was
applicable on February 20, 2016.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the device to detect and measure
non-microbial analyte(s) in human clinical specimens to aid in
assessment of patients with suspected sepsis 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 to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). 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 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 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

    On March 4, 2015, B[middot]R[middot]A[middot]H[middot]M[middot]S
GmbH, part of Thermo Fisher Scientific, submitted a request for De Novo
classification of the B[middot]R[middot]A[middot]H[middot]M[middot]S
PCT sensitive KRYPTOR. 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 February 20, 2016, 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 866.3215. We have named
the generic type of device, device to detect and measure non-microbial
analyte(s) in human clinical specimens to aid in assessment of patients
with suspected sepsis, and it is identified as an in vitro device
intended for the detection and qualitative and/or quantitative
measurement of one or more non-microbial analytes in human clinical
specimens to aid in the

assessment of patients with suspected sepsis when used in conjunction
with clinical signs and symptoms and other clinical and laboratory
findings.
    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--Device To Detect and Measure Non-Microbial Analyte(s) in Human
   Clinical Specimens To Aid in Assessment of Patients With Suspected
                  Sepsis Risks and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Incorrect determination of               Special Controls (2), (3), and
 procalcitonin (PCT) value, including     (7) (21 CFR 866.3215(b)(2); 21
 false positives and false negatives,     CFR 866.3215(b)(3); and 21 CFR
 by the device can lead to improper       866.3215(b)(7)).
 patient management.
Incorrect interpretation of device       Special Controls (1), (4), (5),
 results by end user can lead to          (6), and (7) (21 CFR
 improper patient management.             866.3215(b)(1); 21 CFR
                                          866.3215(b)(4); 21 CFR
                                          866.3215(b)(5); 21 CFR
                                          866.3215(b)(6); and 21 CFR
                                          866.3215(b)(7)).
Manual calculation error of final        Special Control (7) (21 CFR
 results.                                 866.3215(b)(7)).
------------------------------------------------------------------------

    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, the collections of
information in part 820 have been approved under OMB control number
0910-0073, 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.  866.3215 to subpart D to read as follows:

Sec.  866.3215   Device to detect and measure non-microbial analyte(s)
in human clinical specimens to aid in assessment of patients with
suspected sepsis.

    (a) Identification. A device to detect and measure non-microbial
analyte(s) in human clinical specimens to aid in assessment of patients
with suspected sepsis is identified as an in vitro device intended for
the detection and qualitative and/or quantitative measurement of one or
more non-microbial analytes in human clinical specimens to aid in the
assessment of patients with suspected sepsis when used in conjunction
with clinical signs and symptoms and other clinical and laboratory
findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include the device's
detailed Indications for Use statement describing what the device
detects and measures, the results provided to the user, whether the
measure is qualitative and/or quantitative, the clinical indications
for which the test is to be used, and the specific population(s) for
which the device use is intended.
    (2) Premarket notification submissions must include detailed
documentation of the device description, including (as applicable), all
device components, software, ancillary reagents required but not
provided, explanation of the device principle and methodology, and for
molecular devices include detailed documentation of the primer/probe
sequence, design, and rationale for sequence selection.
    (3) Premarket notification submissions must include detailed
documentation of applicable analytical studies, such as, analytical
sensitivity (Limit of Detection, Limit of Blank, and Limit of
Quantitation), precision, reproducibility, analytical measuring range,
interference, cross-reactivity, and specimen stability.
    (4) Premarket notification submissions must include detailed
documentation of a prospective clinical study or, if appropriate,
results from an equivalent sample set. This detailed documentation must
include the following information:
    (i) Results must demonstrate adequate device performance relative
to a well-accepted comparator.
    (ii) Clinical sample results must demonstrate consistency of device
output throughout the device measuring range likely to be encountered
in the Intended Use population.
    (iii) Clinical study documentation must include the original study
protocol (including predefined statistical analysis plan), study report
documenting support for the Indications for Use(s), and results of all
statistical analyses.
    (5) Premarket notification submissions must include evaluation of
the level of the non-microbial analyte in asymptomatic patients with
demographic characteristics (e.g., age, racial, ethnic, and gender
distribution) similar to the Intended Use population.
    (6) As part of the risk management activities performed under 21
CFR 820.30 design controls, you must document an appropriate end user
device training program that will be

offered as part of your efforts to mitigate the risk of failure to
correctly operate the instrument.
    (7) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling, and a detailed explanation of the
interpretation of the limitations of the samples (e.g., collected on
day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10)
compliant labeling.

    Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22994 Filed 10-23-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Page 76342]
[FR Doc No: 2016-26444]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-184-000]

SociVolta Inc.; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
SociVolta Inc.'s application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is November 15, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 26, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-26444 Filed 11-1-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 191 (Thursday, October 2, 2014)]
[Rules and Regulations]
[Page 59431]
[FR Doc No: C1-2014-20893]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2014-0366; Special Conditions No. 25-564-SC]

Special Conditions: Embraer S.A.; Model EMB-550 Airplane; Flight
Envelope Protection: High Incidence Protection System

Correction

    In rule document 2014-20893 appearing on pages 52165 through 52169
in the issue of Wednesday, September 3, 2014, make the following
corrections:
    1. On page 52169, in the first column, the 27th line from the
bottom should read: ``In lieu of Sec.  25.107(c) and (g) we propose the
following requirements, with additional sections (c') and (g'):''
    2. On page 52169, in the first column, the 11th line from the
bottom should read: ``(c') In icing conditions with the ``takeoff ice''
accretion defined in part 25, appendix C, V2 may not be less than--''
    3. On page 52169, in the second column, the eighth line from the
top should read: ``(g') In icing conditions with the ``final takeoff
ice'' accretion defined in part 25, appendix C, VFTO, may
not be less than--''

[FR Doc. C1-2014-20893 Filed 10-1-14; 8:45 am]
BILLING CODE 1505-01-P