[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 830-831]
[FR Doc No: 2014-00023]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]

Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Blood Glucose Monitoring
Test Systems for Prescription Point-of-Care Use.'' This draft guidance
document describes studies and criteria FDA recommends for blood
glucose monitoring test systems (BGMSs) which are for prescription
point-of-care use. When finalized, FDA intends for this document to
guide manufacturers in conducting appropriate performance studies and
preparing premarket notifications for these device types. This draft
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 7, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Blood Glucose Monitoring Test Systems for
Prescription Point-of-Care Use '' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5654, Silver Spring, MD 20993-0002, 301-
796-6136.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document describes studies and criteria FDA
recommends for blood glucose monitoring test systems (BGMSs) which are
for prescription point-of-care use. When finalized, FDA intends for
this document to guide manufacturers in conducting appropriate
performance studies and preparing premarket notifications for these
device types. Portable blood glucose monitoring test systems (glucose
meters) that measure blood glucose concentrations are widely used in
hospitals as well as in a variety of other clinical settings including
both acute and chronic care facilities, general hospital wards and
intensive care units, physicians' offices, assisted living facilities
and nursing homes.
    Historically, FDA has not recommended different types of
information in premarket submissions (510(k)s) for blood glucose meters
used by medical professionals as compared to over-the-counter self-
monitoring devices intended for use by lay users. In recent years,
however, concerns have been raised including infection control issues
related to point-of-care glucose meters. According to the Centers for
Medicare and Medicaid Services (CMS) and the Centers for Disease
Control and Prevention (CDC), blood glucose monitoring devices can
transmit bloodborne pathogens if these devices are contaminated with
blood specimens and are shared between users without effective
cleaning, disinfecting and appropriate infection control measures.
Because BGMS devices, which are used in professional healthcare
settings, are more likely to be used on multiple patients, this type of
use requires certain design features and cleaning capability to prevent
the spread of blood-borne pathogens.
    In addition, concerns have been raised citing the inability of
currently cleared BGMS devices to perform effectively in professional
healthcare settings because the device's safety and effectiveness have
not been evaluated for some of the intended use populations. Patients
in these settings are often fundamentally different than lay users
using these devices at home. Patients in professional healthcare
settings can be acutely ill and medically fragile and are more likely
to present physiological and pathological factors

that could interfere with glucose measurements as compared to the lay
population. Errors in BGMS device accuracy can lead to incorrect
insulin dosing, which, when combined with other factors, can lead to
increased episodes of hypoglycemia. For hospitalized patients who may
be seriously ill, any inaccuracies in the meters would further increase
the risk to these patients. Previously, most blood glucose monitoring
devices, even those intended to be used by healthcare professionals,
were submitted to FDA with claims for OTC use. Thus, they were
evaluated for use in the lay population, and the specific issues that
occur in the professional healthcare setting were never addressed, the
performance of the devices was not evaluated in the intended use
population, and the scientific and clinical issues may not have been
adequately addressed for these uses. Therefore, where devices are
intended for use in professional healthcare settings, distinct
performance parameters are proposed as recommendations in the draft
guidance.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on Blood
Glucose Monitoring Test Systems for Prescription Point-of-Care Use . It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care
Use'', you may either send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1755 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in 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 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR 801 and 21 CFR 809.10 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00023 Filed 1-6-14; 8:45 am]
BILLING CODE 4160-01-P[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][NOTICES]


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81332-81335]
[FR Doc No: 2015-32685]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0242]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Positron
Emission Tomography Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in FDA's regulations on current good manufacturing practice
(CGMP) for positron emission tomography (PET) drugs.

DATES: Submit either electronic or written comments on the collection
of information by February 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0242 for ``Agency Information Collection Activities:
Proposed Collection; Comment Request; Current Good Manufacturing
Practice for Positron Emission Tomography Drugs.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520) Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Current Good Manufacturing Practice for Positron Emission Tomography
Drugs (OMB Control Number 0910-0667)--Extension

    Positron emission tomography is a medical imaging modality
involving the use of a unique type of radiopharmaceutical drug product.
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that
PET drug products meet the requirements of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) regarding safety, identity, strength,
quality, and purity. The CGMP requirements for PET drugs are issued
under the provisions of the Food and Drug Administration Modernization
Act of 1997 (the Modernization Act). These CGMP requirements are
designed to take into account the unique characteristics of PET drugs,
including their short half-lives and the fact that most PET drugs are
produced at locations that are very close to the patients to whom the
drugs are administered.
    The CGMP regulations are intended to ensure that approved PET drugs
meet the requirements of the FD&C Act as to safety, identity, strength,
quality, and purity. The regulations address the following matters:
Personnel and resources; quality assurance; facilities and equipment;
control of components, in-process materials, and finished products;
production and process controls; laboratory controls; acceptance
criteria; labeling and packaging controls; distribution controls;
complaint handling; and recordkeeping.
    The CGMP regulations establish several recordkeeping requirements
and a third-party disclosure requirement for the production of PET
drugs. In making our estimates of the time spent in complying with
these information collection requirements, we relied on communications
we have had with PET producers, visits by our staff to PET facilities,
and our familiarity with both PET and general pharmaceutical
manufacturing practices. The estimated annual recordkeeping and third-
party disclosure burden is based on there being approximately 129 PET
drug production facilities.
    As explained in this document, Table 1 provides an estimate of the
annual recordkeeping burdens and Table 2 provides an estimate of the
annual third-party disclosure burdens associated with this collection.

I. Investigational and Research PET Drugs

    Section 212.5(b)(2) provides that for investigational PET drugs
produced under an investigational new drug (IND) and research PET drugs
produced with approval of a Radioactive Drug Research Committee (RDRC),
the requirement under the FD&C Act to follow current good manufacturing
practice is met by complying with the regulations in part 212 or with
USP 32 Chapter 823. We believe that PET production facilities producing
drugs under INDs and RDRCs are currently substantially complying with
the recordkeeping requirements of USP 32 Chapter 823 (see section
121(b) of the Modernization Act), and accordingly, we do not estimate
any recordkeeping burden for this provision.

II. Batch Production and Control Records

    Sections 212.20(c) through (e), 212.50(a) through (c), and
212.80(c) set forth requirements for batch and production records as
well as written control records. We estimate that it would take
approximately 20 hours annually for each PET production facility to
prepare and maintain written production and control procedures and to
create and maintain master batch records for each PET drug produced. We
also estimate that there will be a total of approximately 221 PET drugs
produced, with a total recordkeeping burden of approximately 4,420
hours. We estimate that it would take a PET production facility an
average of 30 minutes to complete a batch record for each of
approximately 501 batches. Our estimated burden for completing batch
records is approximately 32,320 hours.

III. Equipment and Facilities Records

    Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain
requirements for records dealing with equipment and physical
facilities. We estimate that it would take approximately 1 hour to
establish and maintain these records for each piece of equipment in
each PET production facility. We estimate that the total burden for
establishing procedures for these records would be approximately 1,939
hours. We estimate that recording maintenance and cleaning information
would take approximately 5 minutes a day for each piece of equipment,
with a total recordkeeping burden of approximately 40,238 hours.

IV. Records of Components, Containers, and Closures

    Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements
on records regarding receiving and testing of components, containers,
and closures. We estimate that the annual burden for establishing these
records would be approximately 259 hours. We estimate that each
facility would receive approximately 36 shipments annually and would
spend approximately 10 minutes per shipment entering records. The
annual burden for maintaining these records would be approximately 773
hours.

V. Process Verification

    Section 212.50(f)(2) requires that any process verification
activities and results be recorded. Because process verification is
only required when results of the production of an entire batch are not
fully verified through finished-product testing, we believe that
process verification will be a very rare

occurrence, and we do not estimate any recordkeeping burden for
documenting process verification.

VI. Laboratory Testing Records

    Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b),
and 212.70(a), (b), and (d) set out requirements for documenting
laboratory testing and specifications referred to in laboratory
testing, including final release testing and stability testing. Each
PET drug production facility will need to establish procedures and
create forms for the different tests for each product they produce. We
estimate that it will take each facility an average of 1 hour to
establish procedures and create forms for one test. The estimated
annual burden for establishing procedures and creating forms for these
records is approximately 3,232 hours, and the annual burden for
recording laboratory test results is approximately 10,730 hours.

VII. Sterility Test Failure Notices

    Section 212.70(e) requires PET drug producers to notify all
receiving facilities if a batch fails sterility tests. We believe that
sterility test failures might occur in only 0.05 percent of the batches
of PET drugs produced each year. Therefore, we have estimated in Table
2 that each PET drug producer will need to provide approximately 0.25
sterility test failure notice per year to receiving facilities. The
notice would be provided using email or facsimile transmission and
should take no more than 1 hour.

VIII. Conditional Final Releases

    Section 212.70(f) requires PET drug producers to document any
conditional final releases of a product. We believe that conditional
final releases will be fairly uncommon, but for purposes of the PRA, we
estimated that each PET production facility would have one conditional
final release a year and would spend approximately 1 hour documenting
the release and notifying receiving facilities. The estimate of one
conditional final release per year per facility is an appropriate
average number because many facilities may have no conditional final
releases while others might have only a few.

IX. Out-of-Specification Investigations

    Sections 212.20(c) and 212.71(a) and (b) require PET drug producers
to establish procedures for investigating products that do not conform
to specifications and conduct these investigations as needed. We
estimate that it will take approximately 1 hour annually to record and
update these procedures for each PET production facility. We also
estimate, for purposes of the PRA, that 36 out-of-specification
investigations would be conducted at each facility each year and that
it would take approximately 1 hour to document the investigation, which
results in an annual burden of 4,654 hours.

X. Reprocessing Procedures

    Sections 212.20(c) and 212.71(d) require PET drug producers to
establish and document procedures for reprocessing PET drugs. We
estimate that it will take approximately 1 hour a year to document
these procedures for each PET production facility. We do not estimate a
separate burden for recording the actual reprocessing, both because we
believe it would be an uncommon event and because the recordkeeping
burden has been included in our estimate for batch production and
control records.

XI. Distribution Records

    Sections 212.20(c) and 212.90(a) require that written procedures
regarding distribution of PET drug products be established and
maintained. We estimate that it will take approximately 1 hour annually
to establish and maintain records of these procedures for each PET
production facility. Section 212.90(b) requires that distribution
records be maintained. We estimate that it will take approximately 15
minutes to create an actual distribution record for each batch of PET
drug products, with a total burden of approximately 16,160 hours for
all PET producers.

XII. Complaints

    Sections 212.20(c) and 212.100 require that PET drug producers
establish written procedures for dealing with complaints, as well as
document how each complaint is handled. We estimate that establishing
and maintaining written procedures for complaints will take
approximately 1 hour annually for each PET production facility and that
each facility will receive approximately one complaint a year and will
spend approximately 30 minutes recording how the complaint was dealt
with.

                                                    Table 1--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   No. of         No. of records      Total annual          Average  burden per
               21 CFR Section                  recordkeepers     per recordkeeper       records                recordkeeping              Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Batch Production and Control Records                       129               1.71                221  20.............................              4,420
 212.20(c), 212.20(e); 212.50(a), 212.50(b).
Batch Production and Control Records                       129                501             64,640  0.5 (30 mins.)                              32,320
 212.20(d) and (e); 212.50(c); 212.80(c).
Equipment and Facilities Records 212.20(c);                129                 15              1,939  1..............................              1,939
 212.30(b); 212.50(d), 212.60(f).
Equipment and Facilities Records 212.30(b),                129              3,758            484,800  0.083 (5 mins.)                             40,238
 212.50(d); 212.60(f).
Records of Components, Containers, and                     129                  2                259  1..............................                259
 Closures 212.20(c); 212.40(a), 212.40(b).
Records of Components, Containers, and                     129                 36              4,654  0.166 (10 mins.)                               773
 Closures 212.40(e).
Laboratory Testing Records 212.20(c);                      129                 25              3,232  1..............................              3,232
 212.60(a), 212.60(b), 212.61(a);
 212.70(a), 212.70(b), 212.70(d).
Laboratory Testing Records 212.60(g);                      129                501             64,640  0.166 (10 min.)                             10,730
 212.61(b); 212.70(d)(2), 212.70(d)(3).
Conditional Final Releases 212.70(f).......                129                  1                129  1..............................                129
Out-of-Specification Investigations                        129                 36              4,654  1..............................              4,654
 212.20(c); 212.71(a).
Reprocessing Procedures 212.71(b)..........                129                  1                129  1..............................                129

Reprocessing Procedures 212.20(c);                         129                  1                129  1..............................                129
 212.71(d).
Reprocessing Procedures 212.20(c);                         129                  1                129  1..............................                129
 212.90(a).
Distribution Records 212.90(b).............                129                501             64,640  0.25 (15 mins.)                             16,160
Complaints 212.20(c); 212.100(a)...........                129                  1                129  1..............................                129
Complaints 212.100(b), 212.100(c)..........                129                  1                129  0.5 (30 mins.)                                  65
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  .................  .................  .................  ...............................            115,435
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                Table 2--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of         Annual frequency      Total annual          Hours per
                   21 CFR section                         respondents        of disclosure        disclosures         disclosure          Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sterility Test Failure Notices 212.70(e)............                129                0.25                  32                   1                  32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    Dated: December 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32685 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P


                                                                  July 11, 2014

                        Western Power Issues Roundtable
                            Friday, August 1, 2014
                          Offices of Skadden Arps LLP
                             700 14[th] St., N.W.
                              Washington DC 20005
                       Room 11-AB; 9 a.m.  -  3:00 p.m.

The Western Power Trading Forum (WPTF) will conduct once again a roundtable on Western Power Issues for the benefit of the trade group members and invited industry guests. The roundtable format has proven highly successful in airing what otherwise are complex issues in a collegial fashion that allow participants to ask questions and engage in meaningful dialogue. This session will have three broad topics:
   * CAISO's Fifteen Minute Market: As Planned or Unintended Consequences?
   * EPA's Proposed Carbon Rules -- Fragmenting Electricity Markets?
   * Electricity/Gas Coordination in the West

Our roundtable format has been well received and the attendees tell me they learn more in a few hours than they ever thought possible.  The agenda for the August 1 meeting found on page 3, below, will encourage lively discussions.  A lunch will be hosted by WPTF, and a reception will be held immediately following the roundtable hosted by Skadden Arps and WPTF.   I look forward to seeing you there.

Sincerely,

Gary B. Ackerman
Executive Director
                             Invited Participants
 * designates confirmed participant or observer
Industry Guests

*Jeb Stenhouse, EPA
*Professor Ben Hobbs, Johns Hopkins
*Scott Harvey, FTI Consulting
*Brad Bouillon, CAISO
*Brad Cooper, CAISO
*Ellen Wolfe, Resero Consulting
*Clare Breidenich, WPTF

FERC Staff

*Arnie Quinn
*Steve Rodgers

WPTF Member Participants

*John Estes, Skadden Arps
*Harry Singh, Goldman Sachs
*Peter Colussy, Xcel Energy
*Bruce Bleiweis, DC Energy
*Sarah Novasel, Calpine
*Brian Theaker, NRG
*Michael Evans, Shell
*Laura Beane, Iberdrola
*Dede Hapner, PG&E
*Mel Christopher, PG&E
*Mason Emnett, NextEra
*Adam Raphaely, Noble Americas
*Randy Cullison, Tenaska
*Steve Huhman, Morgan Stanley
*Ron Moulton, WAPA
*Steve Eckert, Brookfield
*Michael MacDougall, Powerex
*John Fulkerson, PGE
*Paul Borkovich, SoCalGas
*Chris Bursaw, Capital Power
*Greg Wetstone, Terra-Gen
*Andre Templeman, for LS Power
*David Francis, EDF Trading
*Mary Lynch, Exelon/Constellation
*Braydon Boulanger, TransAlta
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Partial List of Invited Observers

*Jamie Simler, FERC
*Scott Miller, FERC
*Len Tao, FERC
*Sandra Waldstein, FERC
*Terence Burke, FERC
*Patricia Schaub, FERC
*Jette Gebhart, FERC
*Robin Lunt, FERC
*Heidi Werntz, FERC
*Elizabeth Arnold, FERC
*Christina Hayes, FERC
*John Shepherd, Skadden Arps
*Joel Newton, NextEra
*Andrew Sharer, NRG
*Taylor Roye, NRG
*Joe Cavicchi, Capital Power
*Joanna Perry, Capital Power
*Mark Bryfogle, Consultant
*Mihai Cosman, Exelon
*Mike McElhany, WAPA
*Susan Pope, FTI Consulting
*Melissa Mitchell, EPSA
*Andrew Ulmer, CAISO
*Terri Moreland, CAISO
*Julia Berg, Deloitte Services LP
*Jay Carriere, Berkshire Hathaway

                                      AGENDA
Unless noted otherwise, speakers will be allotted five minutes for their remarks to help frame the issue, and there will be facilitated discussion for each panel's balance of time.

9:00 a.m. Opening Remarks (Meeting in Room 11-AB)

9:15 a.m. First Panel: Fifteen Minute Market: As Planned or Unintended Consequences?
Last May the CAISO inaugurated a new Fifteen Minute Market (FMM) to comply with FERC Order 764 on sub-hourly scheduling.  The early results have elicited a swarm of comments from market participants that the FFM prices are too unpredictable and yield counter-intuitive results.  Many importers are eschewing the FMM.   Did the introduction of a new market between the day-ahead and real-time transactions impart too much complexity and unintended consequences.  The panelists will be: Ellen Wolfe, Resero ... Laura Beane, Iberdrola ... Mike MacDougall, Powerex ... Brad Cooper, CAISO.

10:30 a.m. Second Panel: EPA's Proposed Carbon Rules -- Fragmenting Electricity Markets?
U.S. EPA's proposed carbon rule for existing electric generators provides significant flexibility to individual states in how they meet their emission targets. We are already seeing the impact of California's carbon regulations on electricity markets throughout the West; the possibility of multiple states imposing different carbon regulations creates even more uncertainty and complexity for companies that transact in multiple markets. The panelists for this session will be: Clare Breidenich, WPTF ... Jeb Stenhouse, U.S. EPA ... Peter Colussy, Xcel.

--------------------------------------------------------------------------------
12:00 p.m.: Hosted Lunch
--------------------------------------------------------------------------------
	Keynote Speaker: John Estes III: Update on Power Industry Trends

1:00 p.m. Third Panel: Electricity/Gas Coordination in the West

Scheduling practices for natural gas rest upon the timelines employed by different balancing authorities and gas pipelines.  Under normal operating conditions the coordination is seamless.  However, extremely cold days have caused disruptions in the natural gas pipeline system, and ensuing power plant curtailments. The promise of greater dependence on renewable energy also leads to greater dependence on natural-gas generation for swing capacity in order to maintain grid reliability.  How are the grid operators in the West handling these issues?  Panelists will be: Mel Christopher, PG&E  ... Brad Bouillon, CAISO  ... Paul Borkovich, SoCalGas.

2:30 p.m. Participants: The Most Important Thing I Learned Today and Adjourn

3:00 p.m. Reception hosted by WPTF (In Room 11-311)


[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34926-34927]
[FR Doc No: 2015-14977]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4224-DR; Docket ID FEMA-2015-0002]

Guam; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Territory of Guam (FEMA-4224-DR), dated June 5, 2015,
and related determinations.

DATES: Effective June 5, 2015.

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 June 5, 2015, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the
Territory of Guam resulting from Typhoon Dolphin during the period
of May 13-16, 2015, is of sufficient severity and magnitude to
warrant a major disaster 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 a major
disaster exists in the Territory of Guam.
    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 disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance and Hazard
Mitigation throughout the Territory. Consistent with the requirement
that Federal assistance be supplemental, any Federal funds provided
under the Stafford Act for Hazard Mitigation will be limited to 75
percent of the total eligible costs. Federal funds provided under
the Stafford Act for Public Assistance also will be limited to 75
percent of the total eligible costs, with the exception of projects
that meet the eligibility criteria for a higher Federal cost-sharing
percentage under the Public Assistance Alternative Procedures Pilot
Program for Debris Removal implemented pursuant to section 428 of
the Stafford Act.
    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, under
Executive Order 12148, as amended, Rosalyn L. Cole, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas have been designated as adversely affected by
this major disaster:

    The Territory of Guam for Public Assistance.

    All areas within the Territory of Guam are eligible for
assistance under the Hazard Mitigation Grant 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-14977 Filed 6-17-15; 8:45 am]
BILLING CODE 9111-23-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0097; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Section 110(a)(1) 8-Hour Ozone Maintenance Plan and 2002
Base-Year Inventory for the Wayne County Area

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania.  The Pennsylvania
Department of Environmental Protection (PADEP) submitted a SIP revision
consisting of a maintenance plan that provides for continued attainment
of the 8-hour ozone national ambient air quality standard (NAAQS) for at
least 10 years after the April 30, 2004 designations, as well as, a 2002
base-year inventory for the Wayne County Area.  EPA is approving the
maintenance plan and the 2002 base-year inventory for the Wayne County
Area as revisions to the Pennsylvania SIP in accordance with the
requirements of the Clean Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2008-0097.  All documents in the docket are listed
in the www.regulations.gov website.  Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute.  Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form.  Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies of the State
submittal are available at the Pennsylvania Department of Environment
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT:  Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On April 14, 2008 (73 FR 20002), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania.  The NPR proposed
approval of Pennsylvania’s SIP revision that establishes a maintenance
plan for the Wayne County Area that provides for continued attainment of
the 8-hour ozone NAAQS for at least 10 years after designation, and a
2002 base- year emissions inventory.  The formal SIP revisions were
submitted by PADEP on December 17, 2007.  Other specific requirements of
Pennsylvania’s SIP revision and the rationales for EPA’s proposed
actions are explained in the NPR and will not be restated here.  No
public comments were received on the NPR.

II.  Final Action

EPA is approving the maintenance plan and the 2002 base-year inventory
for the Wayne County Area, submitted on December 17, 2007, as revisions
to the Pennsylvania SIP.  EPA is approving the maintenance plan and 2002
base-year inventory for the Wayne County Area because it meets the
requirements of section 110(a)(1) of the CAA.

III.  Statutory and Executive Order Reviews

A.   General Requirements

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

  is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this action and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  A major rule cannot
take effect until 60 days after it is published in the Federal Register.
 This action is not a “major rule” as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [Insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action approving the maintenance plan and the 2002 base-year
inventory for the Wayne County Area may not be challenged later in
proceedings to enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

__May 28, 2008_______
_________/s/________________

Dated:                            				William T. Wisniewski, Acting
                           							Regional Administrator,

                                  					Region III.

  SEQ CHAPTER \h \r 1 40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for part 52 continues to read as follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart NN–Pennsylvania

2.  In ( 52.2020, the table in paragraph (e)(1) is amended by adding an
entry for the 8-Hour Ozone Maintenance Plan and 2002 Base-Year Inventory
for Wayne County at the end of the table to read as follows:

( 52.2020  	Identification of plan.

* 	* 	* 	* 	*

(e) * * *

(1)* * *

Name of non-regulatory SIP revision	Applicable geographic area	State
submittal date	EPA approval date	Additional explanation

*            *             *            *            *            *
     *

8-Hour Ozone Maintenance Plan and 2002 Base-Year Inventory	Wayne County
12/17/2007	[Insert Federal Register] publication date] [Insert page
number where the document begins]

*	*	*	*	*

 PAGE

 PAGE   6

 PAGE  7


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Rules and Regulations]
[Pages 38916-38919]
[FR Doc No: 2022-13844]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0025; Airspace Docket No. 21-ACE-2]
RIN 2120-AA66

Amendment of Multiple Air Traffic Service (ATS) Routes and
Establishment of Area Navigation (RNAV) Routes in the Vicinity of
Liberal, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Jet Routes J-19, J-20, J-52, J-98, J-134,
and J-231, RNAV route Q-176, and VHF Omnidirectional Range (VOR)
Federal airways V-210, V-234, V-350, and V-507; and establishes RNAV
routes T-418 and T-431. The FAA is taking this action due to the
planned decommissioning of the VOR portion of the Liberal, KS (LBL),
VOR/Tactical Air Navigation (VORTAC) navigational aid (NAVAID). The
Liberal VOR is being decommissioned in support of the FAA's VOR Minimum
Operational Network (MON) program.

DATES: Effective date 0901 UTC, September 8, 2022. 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 JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, 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 Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Policy Directorate, 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 modifies the route structure as necessary to preserve
the safe and efficient flow of air traffic within the National Airspace
System.

History

    The FAA published a notice of proposed rulemaking (NPRM) for Docket
No. FAA-2022-0025 in the Federal Register (87 FR 5747; February 2,
2022), amending Jet Routes J-19, J-20, J-52, J-98, J-134, and J-231,
RNAV route Q-176, and VOR Federal airways V-210, V-234, V-304, V-350,
and V-507; and establishing RNAV routes T-418 and T-431. The proposed
amendment and establishment actions were due to the planned
decommissioning of the VOR portion of the Liberal, KS, VORTAC NAVAID.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. No comments were
received.
    Jet Routes are published in paragraph 2004, RNAV Q-routes are
published in paragraph 2006, VOR Federal airways are published in
paragraph 6010(a), and United States RNAV T-routes are published in
paragraph 6011 of FAA Order JO 7400.11F, dated August 10, 2021, and
effective September 15, 2021, which is incorporated by reference in 14
CFR 71.1. The ATS routes listed in this

document will be published subsequently in FAA Order JO 7400.11.

Differences From the NPRM

    In the NPRM, the FAA proposed to amend V-304 by removing the airway
segment overlying the Liberal VORTAC between the Borger, TX, VORTAC and
the Lamar, CO, VOR/Distance Measuring Equipment (VOR/DME) NAVAIDs.
Subsequent to the NPRM, the FAA published a rule for Docket No. FAA-
2021-0821 in the Federal Register (87 FR 26985; May 6, 2022) removing
V-304 in its entirety. The V-304 airway removal was effective July 14,
2022, and consequently removed from this docket.
    Also, the NPRM proposed to establish T-431 between two new
waypoints (WPs); the KENTO, NM, WP and the RREDD, KS, WP. However, the
RREDD WP name had been reserved for use elsewhere within the NAS prior
to being used for T-431 and required the WP name to be changed. As a
result, the proposed T-431 route point named RREDD, KS, WP is being
renamed the KNSAS, KS, WP. The latitude/longitude coordinates of the
KNSAS WP remain the same as those used for the RREDD WP in the proposed
T-431 route description, therefore this WP name change does not affect
the proposed charted alignment of T-431. The RREDD, KS, WP name listed
in the proposed T-431 description is changed to the KNSAS, KS, WP in
this action.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending Jet Routes J-19, J-
20, J-52, J-98, J-134, and J-231, RNAV route Q-176, and VOR Federal
airways V-210, V-234, V-350, and V-507; and establishing RNAV routes T-
418 and T-431. These amendment and establishment actions are due to the
planned decommissioning of the VOR portion of the Liberal, KS, VORTAC.
The ATS route actions are described below.
    J-19: J-19 extends between the Phoenix, AZ, VORTAC and the
Northbrook, IL, VOR/DME. The route segment between the Phoenix, AZ,
VORTAC and the Zuni, NM, VORTAC is removed as it overlaps J-244, which
remains. The route segment between the Zuni, NM, VORTAC and the Fort
Union, NM, VORTAC is removed since J-244 provides a shorter, more
efficient routing between the two NAVAIDs. The route segment between
the Fort Union, NM, VORTAC and the Wichita, KS, VORTAC is removed due
to the planned Liberal VOR decommissioning. Finally, the route segment
between the Wichita, KS, VORTAC and the St. Louis, MO, VORTAC is
removed as it overlaps J-134 completely and J-110 between the Butler,
MO, VORTAC and St. Louis, MO, VORTAC. Collectively, the route segments
between the Phoenix, AZ, VORTAC and the St. Louis, MO, VORTAC are
removed. The unaffected portions of the existing route remain as
charted.
    J-20: J-20 extends between the Seattle, WA, VORTAC and the
Montgomery, AL, VORTAC. The route segment overlying the Liberal VORTAC
between the Lamar, CO, VOR/DME and the Will Rogers, OK, VORTAC is
removed. The unaffected portions of the existing route remain as
charted.
    J-52: J-52 extends between the Vancouver, BC, Canada VOR/DME and
the Vulcan, AL, VORTAC; and between the intersection of the Columbia,
SC, VORTAC 042[deg] and Flat Rock, VA, VORTAC 212[deg] radials (TUBAS
fix) and the Richmond, VA, VORTAC. The portion within Canada is
excluded. The route segment overlying the Liberal VORTAC between the
Lamar, CO, VOR/DME and the Ardmore, OK, VORTAC is removed. The
unaffected portions of the existing route remain as charted.
    J-98: J-98 extends between the Liberal, KS, VORTAC and the
Farmington, MO, VORTAC. The route segment overlying the Liberal VORTAC
between the Liberal, KS, VORTAC and the Mitbee, OK, VORTAC is removed.
The unaffected portions of the existing route remain as charted.
    J-134: J-134 extends between the Los Angeles, CA, VORTAC and the
Falmouth, KY, VOR/DME. The route segment overlying the Liberal VORTAC
between the Cimarron, NM, VORTAC and the Wichita, KS, VORTAC is
removed. The unaffected portions of the existing route remain as
charted.
    J-231: J-231 extends between the Twentynine Palms, CA, VORTAC and
the Liberal, KS, VORTAC. The route segment overlying the Liberal VORTAC
between the Anton Chico, NM, VORTAC and Liberal, KS, VORTAC is removed.
The unaffected portions of the existing route remain as charted.
    Q-176: Q-176 extends between the Cimarron, NM, VORTAC and the
OTTTO, VA, WP. The Liberal, KS, VORTAC and the Wichita, KS, VORTAC
route points are replaced with the TOTOE, KS, WP and the WRIGL, KS, WP,
respectively. The two new WPs are established in the immediate vicinity
of the NAVAIDs they replace. Additionally, the GBEES, IN, route point
is changed from ``FIX'' to ``WP'' to match the FAA's aeronautical
database information and charted depiction. The unaffected portions of
the existing route remain as charted.
    V-210: V-210 extends between the Los Angeles, CA, VORTAC and the
Okmulgee, OK, VOR/DME; between the Brickyard, IN, VORTAC and the
Rosewood, OH, VORTAC; and between the Revloc, PA, VOR/DME and the
Yardley, PA, VOR/DME. The airway segment overlying the Liberal VORTAC
between the Lamar, CO, VOR/DME and the Will Rogers, OK, VORTAC is
removed. The unaffected portions of the existing airway remain as
charted.
    V-234: V-234 extends between the St. Johns, AZ, VORTAC and the
Centralia, IL, VORTAC. The airspace at and above 8,000 feet MSL between
the Vichy, MO, VOR/DME and the intersection of the Vichy, MO, VOR/DME
091[deg] and St. Louis, MO, VORTAC 171[deg] radials is excluded when
the Meramec Military Operations Area (MOA) is activated by NOTAM. The
airway segment overlying the Liberal VORTAC between the Dalhart, TX,
VORTAC and the Hutchinson, KS, VOR/DME is removed. Additionally, the
Meramec MOA no longer exists; therefore, the exclusion language in the
airway description is also removed. The unaffected portions of the
existing airway remain as charted.
    V-350: V-350 extends between the Liberal, KS, VORTAC and the
Chanute, KS, VORTAC. The airspace at and above 6,000 feet MSL from 8 NM
to 54 NM west of the Chanute VOR is excluded when the Eureka High MOA
is activated. The airway segment overlying the Liberal VORTAC between
the Liberal, KS, VORTAC and the Wichita, KS, VORTAC is removed. The
unaffected portions of the existing airway remain as charted.
    V-507: V-507 extends between the Ardmore, OK, VORTAC and the Garden
City, KS, VORTAC. The airway segment overlying the Liberal VORTAC
between the Mitbee, OK, VORTAC and the Garden City, KS, VORTAC is
removed. The unaffected portions of the existing airway remain as
charted.
    T-418: T-418 is a new RNAV route extending between the Lamar, CO,
VOR/DME and the Mitbee, OK, VORTAC. This T-route mitigates the removal
of the V-210 airway segment between the Lamar, CO, VOR/DME and Liberal,
KS,

VORTAC and the removal of the V-507 airway segment between the Liberal,
KS, VORTAC and Mitbee, OK, VORTAC. Additionally, this new T-route
provides RNAV routing capability from the Lamar, CO, area,
southeastward to the Gage, OK, area.
    T-431: T-431 is a new RNAV route extending between two new WPs
being established; the KENTO, NM, WP and the KNSAS, KS, WP. This T-
route provides non-radar routing from northeastern New Mexico eastward
to the Liberal, KS, VORTAC area to address frequent radar outages and
support the general aviation community in the area, as well as RNAV
routing between the Liberal, KS, VORTAC area and the Mankato, KS,
VORTAC area. Additionally, this new T-route provides RNAV routing
capability from northeastern New Mexico northeastward to the Mankato,
KS, area.
    All NAVAID radials listed in the ATS route descriptions below are
unchanged and stated in True degrees.
    FAA Order JO 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 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 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

    The FAA has determined that this action of amending Jet Routes J-
19, J-20, J-52, J-98, J-134, and J-231, RNAV route Q-176, and VOR
Federal airways V-210, V-234, V-350, and V-507; and establishing RNAV
routes T-418 and T-431, due to the planned decommissioning of the
Liberal, KS, VOR NAVAID, qualifies for categorical exclusion under the
National Environmental Policy Act (42 U.S.C. 4321 et seq.) and its
implementing regulations at 40 CFR part 1500, and in accordance with
FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points). As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. The FAA has determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    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(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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 2004 Jet Routes.

* * * * *

J-19 [Amended]

    From St. Louis, MO; Roberts, IL; to Northbrook, IL.

J-20 [Amended]

    From Seattle, WA; Yakima, WA; Pendleton, OR; Donnelly, ID;
Pocatello, ID; Rock Springs, WY; Falcon, CO; Hugo, CO; to Lamar, CO.
From Will Rogers, OK; Belcher, LA; Magnolia, MS; Meridian, MS; to
Montgomery, AL.
* * * * *

J-52 [Amended]

    From Vancouver, BC, Canada; Spokane, WA; Salmon, ID; Dubois, ID;
Rock Springs, WY; Falcon, CO; Hugo, CO; to Lamar, CO. From Ardmore,
OK; Texarkana, AR; Sidon, MS; Bigbee, MS; to Vulcan, AL. From INT
Columbia, SC, 042[deg] and Flat Rock, VA, 212[deg] radials; Raleigh-
Durham, NC; to Richmond, VA. The portion within Canada is excluded.
* * * * *

J-98 [Amended]

    From Mitbee, OK; Will Rogers, OK; Tulsa, OK; Springfield, MO; to
Farmington, MO.
* * * * *

J-134 [Amended]

    From Los Angeles, CA; Seal Beach, CA; Thermal, CA; Parker, CA;
Drake, AZ; Gallup, NM; to Cimarron, NM. From Wichita, KS; Butler,
MO; St Louis, MO; to Falmouth, KY.
* * * * *

J-231 [Amended]

    From Twentynine Palms, CA; INT Twentynine Palms 075[deg] and
Drake, AZ, 262[deg] radials; Drake; INT Drake 111[deg] and St.
Johns, AZ, 268[deg] radials; St. Johns; to Anton Chico, NM.
* * * * *

2006 United States Area Navigation Routes.

* * * * *

Q-176 Cimarron, NM (CIM) to OTTTO, VA [Amended]
Cimarron, NM (CIM)                              VORTAC                         (Lat. 36[deg]29'29.03'' N, long. 104[deg]52'19.20'' W)
KENTO, NM                                       WP                             (Lat. 36[deg]44'19.10'' N, long. 103[deg]05'57.13'' W)
TOTOE, KS                                       WP                             (Lat. 37[deg]02'40.21'' N, long. 100[deg]58'16.87'' W)
WRIGL, KS                                       WP                             (Lat. 37[deg]44'42.79'' N, long. 097[deg]35'02.52'' W)
Butler, MO (BUM)                                VORTAC                         (Lat. 38[deg]16'19.49'' N, long. 094[deg]29'17.74'' W)
St Louis, MO (STL)                              VORTAC                         (Lat. 38[deg]51'38.48'' N, long. 090[deg]28'56.52'' W)
GBEES, IN                                       WP                             (Lat. 38[deg]41'54.72'' N, long. 085[deg]10'13.03'' W)
BICKS, KY                                       WP                             (Lat. 38[deg]38'29.92'' N, long. 084[deg]25'20.82'' W)
Henderson,                                      WV (HNN) DME                   (Lat. 38[deg]45'14.85'' N, long. 082[deg]01'34.20'' W)
OTTTO, VA                                       WP                             (Lat. 38[deg]51'15.81'' N, long. 078[deg]12'20.01'' W)

* * * * *

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-210 [Amended]

    From Los Angeles, CA; INT Los Angeles 083[deg] and Pomona, CA,
240[deg] radials; Pomona; INT Daggett, CA, 229[deg] and Hector, CA,
263[deg] radials; Hector; Goffs, CA; 13 miles, 23 miles 71 MSL, 85
MSL Peach Springs, AZ; Grand Canyon, AZ; Tuba City, AZ; 10 miles 90
MSL, 91 miles 105 MSL Rattlesnake, NM; Alamosa, CO; INT Alamosa
074[deg] and Lamar, CO, 250[deg] radials; 40 miles, 51 miles 65 MSL
to Lamar. From Will Rogers, OK; INT Will Rogers 113[deg] and
Okmulgee, OK, 238[deg] radials; to Okmulgee. From Brickyard, IN;
Muncie, IN; to Rosewood, OH. From Revloc, PA; INT Revloc 096[deg]
and Harrisburg, PA, 285[deg] radials; Harrisburg; Lancaster, PA; INT
Lancaster 095[deg] and Yardley, PA, 255[deg] radials; to Yardley.
* * * * *

V-234 [Amended]

    From St. Johns, AZ; INT St. Johns 085[deg] and Albuquerque, NM,
229[deg] radials; Albuquerque; INT Albuquerque 103[deg] and Anton
Chico, NM, 249[deg] radials; Anton Chico; to Dalhart, TX. From
Hutchinson, KS; Emporia, KS; Butler, MO; Vichy, MO; INT Vichy
091[deg] and Centralia, IL, 253[deg] radials; to Centralia.
* * * * *

V-350 [Amended]

    From Wichita, KS; to Chanute, KS. The airspace at and above
6,000 feet MSL from 8 NM to 54 NM west of Chanute VOR is excluded
during the time that the Eureka High MOA is activated.
* * * * *

V-507 [Amended]

    From Ardmore, OK; Will Rogers, OK; INT Will Rogers 284[deg] and
Mitbee, OK, 152[deg] radials; to Mitbee.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-418 Lamar, CO (LAA) to Mitbee, OK (MMB) [New]
Lamar, CO (LAA)                                 VOR/DME                        (Lat. 38[deg]11'49.53'' N, long. 102[deg]41'15.12'' W)
TOTOE, KS                                       WP                             (Lat. 37[deg]02'40.21'' N, long. 100[deg]58'16.87'' W)
Mitbee, OK (MMB)                                VORTAC                         (Lat. 36[deg]20'37.44'' N, long. 099[deg]52'48.44'' W)

                                                                      * * * * * * *
T-431 Kento, NM to KNSAS, KS [New]
KENTO, NM                                       WP                             (Lat. 36[deg]44'19.10'' N, long. 103[deg]05'57.13'' W)
TOTOE, KS                                       WP                             (Lat. 37[deg]02'40.21'' N, long. 100[deg]58'16.87'' W)
MOZEE, KS                                       WP                             (Lat. 38[deg]50'51.20'' N, long. 099[deg]16'35.85'' W)
KNSAS, KS                                       WP                             (Lat. 39[deg]48'22.62'' N, long. 098[deg]15'36.62'' W)

    Issued in Washington, DC, on June 23, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-13844 Filed 6-29-22; 8:45 am]
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[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]
[Page 16331-16333]
[DOCID:fr01ap10-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0249; Airspace Docket No. 10-ASO-22]

Establishment of Class E Airspace; Panama City, Tyndall AFB, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; request for comments.

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

SUMMARY: This action establishes Class E airspace at Panama City, FL,
to accommodate Standard Instrument Approach Procedures (SIAPs) at
Tyndall AFB. This action enhances the safety and airspace management of
Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, June 3, 2010. Comments for inclusion in the
Rules Docket must be received on or before May 17, 2010. The Director
of the Federal Register approves this incorporation by reference action
under Title 1, Code of Federal Regulations, part 51, subject to the
annual revision of FAA Order 7400.9 and publication of conforming
amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2010-0249; Airspace Docket No. 10-ASO-22, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 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 Avenue, College Park, Georgia 30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. Unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period, the
regulation will become effective on the date specified above. After the
close of the comment period, the FAA will publish a document in the
Federal Register indicating that no adverse or negative comments were
received and confirming the effective date. If the FAA receives, within
the comment period, an adverse or negative comment, or written notice
of intent to submit such a comment, a document withdrawing the direct
final rule will be published in the Federal Register, and a notice of
proposed rulemaking may be published with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. An electronic copy of this document
may be downloaded from and comments may be submitted and reviewed at
http://www.regulations.gov. Recently published rulemaking documents can
also be accessed through the FAA's Web page at http://www.faa.gov/
airports_airtraffic/air_traffic/publications/airspace_amendments.
Communications should identify both docket numbers and be submitted in
triplicate to the address specified under the caption ADDRESSES above
or through the Web site. All communications received on or before the
closing date for comments will be considered, and this rule may be
amended or withdrawn in light of the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's idea and suggestions is extremely helpful in evaluating
the effectiveness of this action and determining whether additional
rulemaking action would be needed. All comments submitted will be
available, both before and after the closing date for comments, in the
Rules Docket for examination by interested persons. Those wishing the
FAA to acknowledge receipt of their comments submitted in response to
this rule must submit a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-0249;
Airspace Docket No. 10-ASO-22.'' The postcard will be date stamped and
returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace at Panama City, FL, to provide
controlled airspace extending upward from 700 feet above the surface of
the earth to support the SIAPs developed for Tyndall AFB.
    Designations for Class E airspace areas extending upward from 700
feet or more above the surface of the Earth are published in FAA Order
7400.9T, signed August 27, 2009, and effective September 15, 2009,
which is incorporated by reference in 14 CFR part 71.1. The Class E
designations listed in this document will be published subsequently in
the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this direct final rule does not have federalism
implications under Executive Order 13132.
    The FAA has determined that this 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 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 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 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
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 Class E airspace at Panama City, FL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of 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 CLASS 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(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 Federal Aviation
Administration Order 7400.9T, Airspace Designations and Reporting
Points, signed August 27, 2009, effective September 15, 2009, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO FL E5 Panama City, Tyndall AFB, FL [New]

Tyndall AFB
    (Lat. 30[deg]04'12'' N., long. 85[deg]34'34'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Tyndall AFB.

    Issued in College Park, Georgia, on March 18, 2010.
Michael Vermuth,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-6827 Filed 3-31-10; 8:45 am]
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6417-6419]
[FR Doc No: 2022-02358]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2021-N-0913]

Medical Devices; Cardiovascular Devices; Classification of the
Photoplethysmograph Analysis Software for Over-the-Counter Use

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the photoplethysmograph analysis software for over-the-
counter use 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 photoplethysmograph analysis software
for over-the-counter use'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.

DATES: This order is effective February 4, 2022. The classification was
applicable on September 11, 2018.

FOR FURTHER INFORMATION CONTACT: Jennifer Kozen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2272, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the photoplethysmograph analysis
software for over-the-counter use 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 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 (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 device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    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. 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
section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device
sponsors do not have to submit a De Novo request or premarket approval
application to market a substantially equivalent device (see section
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.

II. De Novo Classification

    On August 9, 2018, FDA received Apple Inc.'s request for De Novo
classification of the Irregular Rhythm Notification Feature. 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 the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on September 11, 2018, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.2790.\1\ We have named the generic type of device
photoplethysmograph analysis software for over-the-counter use, and it
is identified as a device that analyzes photoplethysmograph data and
provides information for identifying irregular heart rhythms. This
device is not intended to provide a diagnosis.
---------------------------------------------------------------------------

    \1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    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--Photoplethysmograph Analysis Software for Over-the-Counter Use
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Poor quality incoming                    Clinical performance testing,
 photoplethysmograph (PPG) signal         Human factors testing, and
 resulting in failure to detect           Labeling.
 irregular heart rhythms.
Misinterpretation and/or over-reliance   Human factors testing, and
 on device output, leading to:            Labeling.
     Failure to seek treatment
     despite acute symptoms (e.g.,
     fluttering sensation in the chest,
     lightheadedness, and irregular
     pulse).
     Discontinuing or modifying
     treatment for chronic heart
     condition.
False negative resulting in failure to   Clinical performance testing;
 detect irregular heart rhythms and       Software verification,
 delay of further evaluation or           validation, and hazard
 treatment.                               analysis; Non-clinical
                                          performance testing; and
                                          Labeling.
False positive resulting in additional   Clinical performance testing;
 unnecessary medical procedures.          Software verification,
                                          validation, and hazard
                                          analysis; Non-clinical
                                          performance testing; and
                                          Labeling.
------------------------------------------------------------------------

    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. 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 and guidance. 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. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; 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 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; 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.  870.2790 to subpart C to read as follows:

Sec.  870.2790  Photoplethysmograph analysis software for over-the-
counter use.

    (a) Identification. A photoplethysmograph analysis software device
for over-the-counter use analyzes photoplethysmograph data and provides
information for identifying irregular heart rhythms. This device is not
intended to provide a diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must demonstrate the performance
characteristics of the detection algorithm under anticipated conditions
of use.
    (2) Software verification, validation, and hazard analysis must be
performed. Documentation must include a characterization of the
technical specifications of the software, including the detection
algorithm and its inputs and outputs.
    (3) Non-clinical performance testing must demonstrate the ability
of the device to detect adequate photoplethysmograph signal quality.
    (4) Human factors and usability testing must demonstrate the
following:
    (i) The user can correctly use the device based solely on reading
the device labeling; and
    (ii) The user can correctly interpret the device output and
understand when to seek medical care.
    (5) Labeling must include:
    (i) Hardware platform and operating system requirements;
    (ii) Situations in which the device may not operate at an expected
performance level;
    (iii) A summary of the clinical performance testing conducted with
the device;
    (iv) A description of what the device measures and outputs to the
user; and
    (v) Guidance on interpretation of any results.

    Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02358 Filed 2-3-22; 8:45 am]
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