[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46970-46976]
[FR Doc No: 2013-18623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]

Medical Device User Fee Rates for Fiscal Year 2014

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012,
which was signed by the President on July 9, 2012 (MDUFA III),
authorizes FDA to collect user fees for certain medical device
submissions and annual fees both for certain periodic reports and for
establishments subject to registration. The FY 2014 fee rates are
provided in this document. These fees apply from October 1, 2013,
through September 30, 2014. To avoid delay in the review of your
application, you should pay the fee before or at the time you submit
your application to FDA. The fee you must pay is the fee that is in
effect on the later of the date that your application is received by
FDA or the date your fee payment is recognized by the U.S. Treasury. If
you want to pay a reduced small business fee, you must qualify as a
small business before you make your submission to FDA; if you do not
qualify as a small business before you make your submission to FDA, you
will have to pay the higher standard fee. This document provides
information on how the fees for FY 2014 were determined, the payment
procedures you should follow, and how you may qualify for reduced small
business fees.

FOR FURTHER INFORMATION CONTACT: For information on Medical Device User
Fees: Visit FDA's Web site at http://www.fda.gov/mdufa.
    For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this document refers to these collectively as
``submissions'' or ``applications''); for periodic reporting on class
III devices; and for the registration of certain establishments. Under
statutorily defined conditions, a qualified applicant may receive a fee
waiver or may pay a lower small business fee. (See 21 U.S.C. 379j(d)
and (e).) Additionally, the Secretary of Health and Human Services (the
Secretary) may, at the Secretary's sole discretion, grant a fee waiver
or reduction if the Secretary finds that such waiver or reduction is in
the interest of public health. (See 21 U.S.C. 379j(f).)
    Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2013 through FY 2017; the
base fee for a premarket application received by FDA during FY 2014 is
$252,960. From this starting point, this document establishes FY 2014
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2013 through FY 2017; the base fee for an
establishment registration in FY 2014 is $3,200. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary under
section 510 of the FD&C Act (21 U.S.C. 360) because such establishment
is engaged in the manufacture, preparation, propagation, compounding,
or processing of a device is required to pay the annual fee for
establishment registration.

II. Revenue Amount for FY 2014

    The base revenue amount for FY 2014 is $112,580,497, as set forth
in the statute prior to the inflation adjustment. MDUFA directs FDA to
use the yearly revenue amount as a starting point to set the fee rates
for each fee type. The fee calculations for FY 2014 are described in
this document.

Inflation Adjustment

    MDUFA specifies that the $112,580,497 is to be further adjusted for
inflation increases for FY 2014 using two separate adjustments--one for
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all
personnel compensation and benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the first 3 of the 4 preceding
FYs, multiplied by .60, or 60 percent (see 21 U.S.C. 379j(c)(2)(C)).
The data on total PC&B paid and numbers of FTE paid, from which the
average cost per FTE can be derived, are published in FDA's
Justification of Estimates for Appropriations Committees.
    Table 1 summarizes that actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2014.
The 3-year average is 2.05 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,634,108,000     $1,761,655,000     $1,824,703,000  .................
Total FTE...........................             12,526             13,331             13,382  .................
PC&B per FTE........................           $130,457           $132,147           $136,355  .................
Percent change from previous year...              1.67%              1.30%              3.18%              2.05%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.05 percent multiplied by 60 percent, or
1.23 percent.
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2014 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 of the preceding 4 years of available
data multiplied by .40, or 40 percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 2 provides the summary data for the percent change in the
specified CPI for the Baltimore-Washington area. This data is published
by the Bureau of Labor Statistics and can be found on their Web site at
http://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked
``Washington-Baltimore All Items, November 1996 = 100--CUURA311SA0''
and then clicking on the ``Retrieve Data'' button.

               Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
                Year                         2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            142.218            146.975            150.212  .................
Annual percent change...............              1.72%              3.34%              2.20%              2.42%
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    The non-pay adjustment is 2.42 percent times 40 percent, or .968
percent.
    To complete the inflation adjustment, the payroll component (1.230
percent) is added to the non-pay component (0.968 percent), for a total
inflation adjustment of 2.198 percent (rounded), and then one is added,
making 1.02198. The base revenue amount for FY 2014 ($112,580,497) is
then multiplied by 1.02198, yielding an inflation adjusted amount of
$115,055,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2014

    Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A).) For FY 2014, the base fee
will be adjusted as specified in the FD&C Act for inflation (see 21
U.S.C. 379j(b) and (c)). Table 3 provides the last 3 years of fee
paying submission counts. These numbers are used to project the fee
paying submission that FDA will receive in FY 2014. The fee paying
submission counts are published in the Agency's MDUFA Financial Report
to Congress each year.

                                Table 3--3-Year Average of Fee Paying Submissions
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                Application type                  FY 2010 actual  FY 2011 actual  FY 2012 actual  3-Year average
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Full Fee Applications...........................              32              24              25              27
    Small Business..............................               8               7               6               7
Panel Track Supplement..........................              11               7              12              10
    Small Business..............................               2               1               0               1
180-Day Supplements.............................             103              92             145             113
    Small Business..............................              20              15              21              19
Real-Time Supplements...........................             146             145             196             162
    Small Business..............................              20              17              22              20
510(k)s.........................................           2,367           2,398           2,865           2,543
    Small Business..............................           1,032             938           1,086           1,019
30-Day Notice...................................             669             755             801             742
    Small Business..............................              78              67              60              68
513(g) Request for Classification Information...              56              40              46              47
    Small Business..............................              25              35              30              30
Annual Fee for Periodic Reporting...............             427             466             478             457
    Small Business..............................              78              78              39              65

Establishment Registration \1\ *................  ..............  ..............  ..............          22,500
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\1\ Estimate for establishment registration based on preliminary FY 2013 numbers because the criteria for this
  fee changed beginning in FY 2013.

    The information in Table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays both the estimated revenue using the FY 2014 base fees set in
statute and the estimated revenue adding the inflation adjustment to
the FY 2014 base fees. The increases to the base fees are needed in
order to collect the new revenue target of $115,055,000.

                           Table 4--Fees Needed To Achieve New FY 2014 Revenue Target
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                                                                                Adjusted FY
                Application type                   FY 2014 base      Estimated       2014 fees       Adjusted
                                                       fees           revenue     (standard fee)      revenue
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................        $252,960      $6,829,920        $258,520      $6,980,040
    Small Business..............................          63,240         442,680          64,630         452,410
Panel-Track Supplement..........................         189,720       1,897,200         193,890       1,938,900
    Small Business..............................          47,430          47,430          48,473          48,473
180-Day Supplements.............................          37,944       4,287,672          38,778       4,381,914
    Small Business..............................           9,486         180,234           9,695         184,205
Real-Time Supplements...........................          17,707       2,868,566          18,096       2,931,552
    Small Business..............................           4,427          88,536           4,524          90,480
510(k)s.........................................           5,059      12,865,546           5,170      13,147,310
    Small Business..............................           2,530       2,577,662           2,585       2,634,115
30-Day Notice...................................           4,047       3,003,141           4,136       3,068,912
    Small Business..............................           2,024         137,610           2,068         140,624
513(g) Request for Classification Information...           3,415         160,503           3,490         164,030
    Small Business..............................           1,707          51,224           1,745          52,350
Annual Fee for Periodic Reporting...............           8,854       4,046,095           9,048       4,134,936
    Small Business..............................           2,213         143,871           2,262         147,030
Establishment Registration......................           3,200      72,000,000           3,313      74,542,500
                                                 ---------------------------------------------------------------
    Total.......................................  ..............     111,627,891  ..............     115,039,781
----------------------------------------------------------------------------------------------------------------

    The PMA and establishment registration fees were increased over the
base by the inflation adjustment (2.198%) as determined earlier in this
document. An additional $43 (rounded to the nearest whole dollar) was
added to the establishment registration fee in order to collect the
shortfall in revenue that resulted. This was done because the statute
directs that, after the inflation adjustment is made, the base
establishment registration fee amounts shall be further adjusted, as
necessary, for total fee collections to achieve the total revenue
amount specified after inflation adjustment (see 21 U.S.C. 379j(c)(3)).
Without this additional adjustment to the establishment registration
fee, the total collections would fall almost $1 million below the total
specified revenue after adjustment for inflation.
    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $258,520 for FY 2014. The fees set by reference
to the standard fee for a premarket application are:
     For a panel-track supplement, 75 percent of the standard
fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For a 30-day notice, 1.6 percent of the standard fee;
     For a 510(k) premarket notification, 2 percent of the
standard fee;
     For a 513(g) request for classification information, 1.35
percent of the standard fee; and
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee.
    For all submissions other than a 510(k) premarket notification, a
30-day notice, and a 513(g) request for classification information, the
small business fee is 25 percent of the standard (full) fee for the
submission. (See 21 U.S.C. 379j(d)(2)(C).) For a 510(k) premarket
notification submission, a 30-day notice, and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission. (See 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C).)
    The annual fee for establishment registration, after adjustment, is
set at $3,313 for FY 2014. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 5 sets out the FY 2014 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2014
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                                                  Standard fee (as a percent of
                                                the standard fee for a premarket      FY 2014      FY 2014 Small
                                                          application)             Standard fee    Business fee
----------------------------------------------------------------------------------------------------------------
Application Fee Type:

    Premarket application (a PMA submitted      Base Fee Adjusted as Specified          $258,520         $64,630
     under section 515(c)(1) of the FD&C Act     in the Statute.
     (21 U.S.C. 360e(c)(1)), a PDP submitted
     under section 515(f) of the FD&C Act (21
     U.S.C. 360e(f)), or a BLA submitted under
     section 351 of the Public Health Service
     Act (the PHS Act) (42 U.S.C. 262)).
    Premarket report (submitted under section   100%............................         258,520          64,630
     515(c)(2) of the FD&C Act).
    Efficacy supplement (to an approved BLA     100%............................         258,520          64,630
     under section 351 of the PHS Act).
    Panel-track supplement....................  75%.............................         193,890          48,473
    180-day supplement........................  15%.............................          38,778           9,695
    Real-time supplement......................  7%..............................          18,096           4,524
    510(k) premarket notification submission..  2%..............................           5,170           2,585
    30-day notice.............................  1.6%............................           4,136           2,068
    513(g) (21 U.S.C. 360c(g)) request for      1.35%...........................           3,490           1,745
     classification information.
Annual Fee Type:                                ................................  ..............  ..............
    Annual fee for periodic reporting on a      3.5%............................           9,048           2,262
     class III device.
    Annual establishment registration fee (to   Base Fee Adjusted as Specified             3,313           3,313
     be paid by the establishment engaged in     in the Statute.
     the manufacture, preparation,
     propagation, compounding, or processing
     of a device, as defined by 21 U.S.C.
     379i(13)).
----------------------------------------------------------------------------------------------------------------

IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees

    If your business has gross receipts or sales of no more than $100
million for the most recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. If you want to pay
the small business fee rate for a submission, or you want to receive a
waiver of the fee for your first premarket application or premarket
report, you should submit the materials showing you qualify as a small
business 60 days before you send your submission to FDA. If you make a
submission before FDA finds that you qualify as a small business, you
must pay the standard (full) fee for that submission.
    If your business qualified as a small business for FY 2013, your
status as a small business will expire at the close of business on
September 30, 2013. You must re-qualify for FY 2014 in order to pay
small business fees during FY 2014.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2014, you must submit the following to FDA:
    1. A completed FY 2014 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2014 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. This form is
not available separate from the guidance document.
    2. A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2013,
except:
    If you submit your FY 2014 MDUFA Small Business Qualification
before April 15, 2014, and you have not yet filed your return for 2013,
you may use tax year 2012.
    If you submit your FY 2014 MDUFA Small Business Qualification on or
after April 15, 2014, and have not yet filed your 2013 return because
you obtained an extension, you may submit your most recent return filed
prior to the extension.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The applicant must also submit a
statement signed by the head of the applicant's firm or by its chief
financial officer that the applicant has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the applicant has no affiliates.
    If you are a foreign business, and wish to qualify as a small
business for FY 2014, you must submit the following:
    1. A completed FY 2014 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2014 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/mdufa. This form is not available separate from the
guidance document.
    2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing

Authority of the country in which the firm is headquartered. This
certification must show the amount of gross receipts or sales for the
most recent tax year, in both U.S. dollars and the local currency of
the country, the exchange rate used in converting the local currency to
U.S. dollars, and the dates of the gross receipts or sales collected.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2013 or later), or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The applicant must also
submit a statement signed by the head of the applicant's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the applicant has no affiliates.

V. Procedures for Paying Application Fees

    If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2013, through September 30,
2014, you must pay the fee in effect for FY 2014. The later of the date
that the application is received in the reviewing center's document
room or the date the U.S. Treasury recognizes the payment determines
whether the fee rates for FY 2013 or FY 2014 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
    FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: In no case should the
check for the fee be submitted to FDA with the application.)

A. Step One--Secure a Payment Identification Number (PIN) and Medical
Device User Fee Cover Sheet From FDA Before Submitting Either the
Application or the Payment

    Log on to the MDUFA Web site at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and click on
``MDUFA FORMS'' at the left side of the page, and then under the MDUFA
Forms heading, click on the link ``Create MDUFA User Fee Cover Sheet.''
Complete the Medical Device User Fee cover sheet. Be sure you choose
the correct application submission date range. (Two choices will be
offered until October 1, 2013. One choice is for applications and fees
that will be received on or before September 30, 2013, which are
subject to FY 2013 fee rates. A second choice is for applications and
fees received on or after October 1, 2013, which are subject to FY 2014
fee rates.) After completing data entry, print a copy of the Medical
Device User Fee cover sheet and note the unique PIN located in the
upper right-hand corner of the printed cover sheet.

B. Step Two--Electronically Transmit a Copy of the Printed Cover Sheet
With the PIN to FDA's Office of Financial Management

    Once you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Because electronic transmission is
possible, applicants are required to set up a user account and use
passwords to assure data security in the creation and electronic
submission of cover sheets.

C. Step Three--Submit Payment for the Completed Medical Device User Fee
Cover Sheet as Described in This Section, Depending on the Method You
Will Use To Make Payment

    1. If paying with a paper check:
     All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. (FDA's tax
identification number is 53-0196965, should your accounting department
need this information.)
     Please write your application's unique PIN, from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet, on your check.
     Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 956733, St. Louis, MO
63195-6733. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
    If you prefer to send a check by a courier (such as FedEx, DHL,
United Parcel Service (UPS), etc.), the courier may deliver the check
to: U.S. Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza,
St. Louis, MO 63101. (Note: This address is for courier delivery only.
Contact the U.S. Bank at<PHONE_NUMBER> if you have any questions
concerning courier delivery.)
    FDA records the official application receipt date as the later of
the following: (1) The date the application was received by FDA or (2)
the date the U.S. Treasury recognizes the payment. It is helpful if the
fee arrives at the bank at least 1 day before the application arrives
at FDA.
    2. If paying with credit card or electronic check (Automated
Clearing House (ACH)):
    FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment system, for online electronic
payment. You may make a payment via electronic check or credit card
after submitting your cover sheet. To pay online, select the ``Pay
Now'' button. Credit card transactions for cover sheets are limited to
$49,999.99.
    3. If paying with a wire transfer:
     Please include your application's unique PIN, from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet, in your wire transfer. Without the PIN your payment may not be
applied to your cover sheet and review of your application may be
delayed.
     The originating financial institution may charge a wire
transfer fee. Please ask your financial institution about the fee and
add it to your payment to ensure that your cover sheet is fully paid.
    Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD 20850.

D. Step Four--Submit Your Application to FDA With a Copy of the
Completed Medical Device User Fee Cover Sheet

    Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to one of the following addresses:
    1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and

Radiological Health, Document Mail Center, Bldg. 66, Rm. 0609, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002.
    2. Biologic applications should be sent to: Food and Drug
Administration, Center for Biologics Evaluation and Research, Document
Control Center (HFM-99), Suite 200N, 1401 Rockville Pike, Rockville, MD
20852-1448.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    As of FY 2011, you are no longer able to create a cover sheet and
obtain a PIN to pay the MDUFA Annual Fee for Periodic Reporting.
Instead, you will be invoiced at the end of the quarter in which your
PMA Periodic Report is due. Invoices will be sent based on the details
included on your PMA file; you are responsible to ensure your billing
information is kept up-to-date (you can update your contact for the PMA
by submitting an amendment).
    1. If paying with a paper check:
    All paper checks must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. (FDA's tax identification
number is 53-0196965, should your accounting department need this
information.)
     Please write your invoice number on the check.
     Mail the paper check and a copy of invoice to: Food and
Drug Administration, P.O. Box 956733, St. Louis, MO 63195-6733.

(Please note that this address is for payments of application and
annual report fees only and is not to be used for payment of annual
establishment registration fees.)

    If you prefer to send a check by a courier (such as FedEx, DHL,
UPS, etc.), the courier may deliver the check to: U.S. Bank, Attn:
Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. Contact the U.S. Bank
at<PHONE_NUMBER> if you have any questions concerning courier delivery.)
    2. If paying with a wire transfer:
     Please include your invoice number in your wire transfer.
Without the invoice number, your payment may not be applied and you may
be referred to collections.
     The originating financial institution may charge a wire
transfer fee. Please ask your financial institution about the fee and
add it to your payment to ensure that your invoice is fully paid.
    Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD 20850.

VII. Procedures for Paying Annual Establishment Fees

    In order to pay the annual establishment fee, firms must access the
Device Facility User Fee (DFUF) Web site at https://fdasfinapp8.fda.gov/OA_HTML/fdaCAcdLogin.jsp. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
You will create a DFUF order and you will be issued a PIN once you
place your order. After payment has been processed, you will be issued
a payment confirmation number (PCN). You will not be able to register
your establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2014 until it has completed the steps below to
register and pay any applicable fee. (See 21 U.S.C. 379j(g)(2).)
    Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.

A. Step One--Submit a DFUF Order With a PIN From FDA Before Registering
or Submitting Payment

    To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2014 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. Once you are satisfied that the data on the order are
accurate, electronically transmit that data to FDA according to
instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.

B. Step Two--Pay for Your DFUF Order

    Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
    1. If paying by credit card or electronic check (ACH):
    The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
    2. If paying with a paper check:
    If you prefer not to pay online, you may pay by a check, in U.S.
dollars and drawn on a U.S. bank, mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. (Note: This
address is different from the address for payments of application and
annual report fees and is to be used only for payment of annual
establishment registration fees.)
    If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only; do not send mail to this
address.)
    Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. A copy of your printed order should
also be mailed along with your check. FDA's tax identification number
is 53-0196965.
    3. If paying with a wire transfer:
    Wire transfers may also be used to pay annual establishment fees.
To send a wire transfer, please read and comply with the following
information:
    Include your order's unique PIN, from the upper right-hand corner
of your completed DFUF order, in your wire transfer. Without the PIN
your payment may not be applied to your facility and your registration
will be delayed.
    The originating financial institution may charge a wire transfer
fee. Please ask your financial institution about the fee and add it to
your payment to ensure that your order is fully paid. Use the following
account information when sending a wire transfer: New York Federal
Reserve Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD 20850.

C. Step Three--Complete the Information Online To Update Your
Establishment's Annual Registration for FY 2014, or To Register a New
Establishment for FY 2014

    Go to the Center for Devices and Radiological Health's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left of the page. This
opens up a new

page with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
link (Access Electronic Registration) at the bottom of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account if your
establishment did not create an account in FY 2013. Manufacturers of
licensed biologics should register in the BER system at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
    Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. Once you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
<EMAIL_ADDRESS>or call<PHONE_NUMBER> for assistance. (Note: this
email address and this telephone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.) Problems with BERS should be directed to
<EMAIL_ADDRESS>or call<PHONE_NUMBER>.

D. Step Four--Enter Your DFUF Order PIN and PCN

    After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18623 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Page 72517]
[FR Doc No: 2023-23195]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4727-DR; Docket ID FEMA-2023-0001]

Mississippi; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4727-DR), dated August 12, 2023, and
related determinations.

DATES: This amendment was issued September 21, 2023.

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: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 12, 2023.
    Madison County for Public Assistance.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-23195 Filed 10-19-23; 8:45 am]
BILLING CODE 9111-23-P


January 23-24, 2007 Meeting on Hearing Protector Labeling

EPA Headquarters, Washington, DC

Rule Making Schemes: Two number system

Method Comparison

Method

	A	B

Within Lab

	X

	Between Lab

X

Cost

	X

	Speed

	X

	Realism

X

Rank Order

X

Explanation

	X

	De-rate

X

Dual Number	X	X

Device’s inherent performance	X

	International Issues	X

	X

International testing is more complicated due to country specific
requirements.

	Standards are one consideration

	Measurement methods is the area of most debate international

	International harmonization is very important for future

	Reciprocity is also important

EU now has expanded and many of the new counties are compromising on
testing. It is easier to pass tests for certification to standards in
some EU counties. At the same time EPA is open to regulations that may
help US business in over seas markets.

ISO Standard

One approach could be to adopt ISO standards with some exceptions.  If
changes were made in the vague sections in ISO with more stringent US
requirements it would – should be accepted certification for selling
internationally. There still were concerns by industry whether this
would be accepted internationally.

Industry perspective for business development

 What is the industry’s market strategy for business development?

Most see US market as close to saturation. Looking over seas for market
growth

Generally business will follow areas of growth internationally

The are mow large international conglomerates that are exploiting world
markets

One focus is to prevent products that are not tested and certified to
meet labeling requirements from coming into US. If there is a foreign
standard and test procedure the US may accept it for use in US.

No one internationally is using a range of numbers in labeling. There is
no clear trend in world for method A or B.

Working Group 11

Working group 11 results could be useful for this EPA effort.

“A” weighted worked in most cases

In areas of more “C” weighted it may call for modification

Look at the handout from yesterday

Noise Statistic not level

Used 20% , 80% rating points as best

See page 6 as example of label

NSRG is a four number rating, HML other method.  NSRG is simpler to
calculate and understand. Both used for low frequency.

The proposed standard is about ready to go to ANISE for balloting and
approval. It could be out by this summer.

Evaluation of methods A and method B

Is there an overlap between method A and method B?

Suggest that even the primary label should be graphical not numerical
value. Example of method B was illustrated in the slide shown in the
meeting. Group liked the bar chart approach to show the performance of
hearing protector. There was some discussion of the size of the range
shown. Some questioned OSHA acceptance of the bar approach. Would this
label be subject to de-rating by OSHA? There should be some dialog
between EPA and OSHA on this approach before this would be finalized.
Current OSHA de-rating was based on marginal analysis. EPA would not
want their labeling to be modified in some way by OSHA. Take the
position that EPA has developed a leading new approach based on detailed
technical review and analysis.  This would then take president over the
OSHA approach of de-rating in any way. Ken noted that discussions within
EPA have been positive on graphic standard vs. numbers. Ken asked if
this approach would apply to all devices.

This approach could be used to describe passive performance of active
devices. It was noted that there should be some explanation of what the
bars mean. Could have two bars for devices that are designed to perform
two functions? For example, example ear plugs used in the military for
passive noise reduction and for weapon firing events.

There were questions about the two bar approach shown on Bill’s
slides. The concern was about treatment of active vs. passive ear muffs.
 The effect of automatic noise reduction (ANR) is very different at
different frequencies.   Note that some felt that ANR devices should be
only rated in the on position because that is what they were designed
for.  Suggest that the guidance on page 8 (applying the NRS graph) is
something that could be used to guide user on which graphs to use.

Ken suggested that the full range of performance of a single device
could be shown on the label graph.  The example of aviation and
industrial noise was used. Why not one bar over the full range of all
frequencies. Note the use in NIOSH 100 for industry exposure test. Other
frequencies are used to test for sound more dominated in low
frequencies. Suggest that more examples of appropriate application be
used on the red or blue bars.

Note the bar approach should not be used to do more than intended.
Suggest that products be labeled for specific markets (i.e. still only
one bar for designated customer base by manufacturer). Note that the
test/measurement environment is the same for both red and blue. The
difference is how the values are calculated. A different value and range
is calculated for the red and blue. Bose feels that there is a need if
not a requirement for educating people so they can understand the double
bar label.  For Air Force the spectral content is most important for
aviation.  Comment made that in this case may not have design for the
Air Force!

KISS principle:

Best rating is 40 to 50

Sample two numbers 10 and 25

Show some sample applications on the scale (feel to complex to show the
differences)

It is possible to have two different packaging approaches for the
consumer vs. professional market. Under this concept there could be just
one bar on the package label. Should this be mandated or left to
manufacturer?

Ken now feels that the two bars can not be combined and make sense.
Should the designed product user be designated as part of the label?
Specify, the label would state that this devise is intended to be used
to listen to music or in the operation of an aircraft.

PM Session: Primary and Secondary Labels

Focus on what should go on primary and secondary label

Federal agencies want numbers

Maybe a range of values

Rating using graphic

Time frame for implementing labeling regulations

Should we package according to anticipated customer or use

Home applications are often as high as industrial environment, example
is home depot now the source power tools for contractors

Separate by bulk packaging for industry and home use

Military maybe exempt from labeling

Limited production maybe exempted, provided not be offered at large
retail outlets (Wal-Mart). Do not want to shift markets i.e. Play
helmets with ear devise. Manufacture may choose to just make helmet and
let others make ear piece.

Military exemption may not be as applicable since now buy off shelf
concept

Double protection items. How to label these products. Double labeled?
Use secondary label to do more education about the product and the use
and suggestions for different application environments

Important to provide information on assessing the effectiveness of the
device after using it and suggestions for better use and alternative
devices for better protection

Industry questioned if it should be EPA or manufacture to provide
educational information on use etc.

Secondary label maybe shorter with just short instruction on use and a
web site link or other link like phone, fax, email etc.

There should be contractor help desk support for major retail outlets.
Right now there is not that kind of support at the home depot etc. Now
must go to manufacturer to get this kind of information. Manufacturer
should have some incentive to provide this kind of information to the
retail level.

Dispenser box is an other location for additional information

Require the manufacture to identify an intended use statement and what
it is not intended for other stated uses. Problem is that space is
limited for the identification of all uses or the time of exposure
factor that has to be considered.

Note: noise accumulates so the approach of separating out home vs. other
use locations is counter to real life accumulative noise exposure.

OSHA: the communication challenge is similar for the small contractor
and home user.

Consider separation by occasional user vs. the industrial user with the
idea of simpler information for occasional user class.

For consumer enhancement products i.e. listening to music etc. these
should not be labeled with numbers etc. but just labeled as not intended
as a hearing protector. Suggest that the language be not for use in
hazardous noise environments.

What about ear devices to protect swimmers from water in the ear.

Put hearing protector words on the primary label. For example, this
device is designed to protect you ears from hazardous noise and other
high sound levels.

Ken interested in word changes that could be used on label. To include
consideration of liability chain relative to federal enforcement of
labeling regulation.  Who provides the information on the label

Should the information developed by the manufacturer be submitted to EPA
as data base for the labeling program?

 EPA is working with NIOSH for a calculator that will automatically send
information to EPA and post on official record. The data base would be
available to everyone but could not be changed once entered into data
base.

Putting icons on label to identify use application may help communicate
information. Many of the people liked the simplicity of the icon
approach.

Ken supported the development of a set of hearing protect icons for
different applications.

Three categories: 1) recreational/industrial continuous noise, 2)
Impulse noise and 3) Low-frequency noise

What information should be on bulk shipment products?

Ken’s summary at 3:00pm

Two numbers better than one

Bar approach good

Icon also has merits

Suggest secondary label be small and simple with contact link to
manufacture (prevent waste etc)

NIOSH: When product is put on the market all labeling information is
sent to official data base site. Most seemed this was reasonable.

Ken: Primary label will have manufacturer contact information.

Suggest that if icon used also show bar. Majority seemed to like one
with bar or a bar with symbol.

Icons: airplane, round bomb with fuse

When manufacturers send to second party provider to private label
situation is created. The private labeler is held responsible to have
all records to verify testing etc of the product including any
applicable manufacturer information.

Adding color will add a lot of cost of labeling. Consider this carefully
in the regulation.

NIOSH Calculator

Standardized NIOSH Calculator: Does this have merit

generally very supportive

Discussion of what data would go into the calculator (i.e. using
averages)

Attendees would like some time to review in detail the calculator

Generally seemed to be a lot of interest in this tools and potential
enhancements to it

Some felt it was too much to put this amount of data into the tool

The standard will have the details of the data base input and may
include the detail of an ANSI standard if by reference or modification
and reference

Greatest benefit is to manufactures that are not doing the full testing
that the representatives here today are doing

There was multiple support for no decimal places in the report

Wrap up Comments on Testing

Duration of exposure to noise will not be part of the EPA regulation.
The will be left to manufacture to define their product and
differentiate from others.  Same for third octave band information.

Implementation by Manufacturers should have up to 32 weeks for testing
to properly label. Considering everything else (labeling, inventory,
etc.) it may require up to 18-24 months to be in compliance.

Bootstrap Model: Bootstrapping the NRR

See Bill’s slides on the process for estimating NRR

Doing this to get understanding to get an understanding of the standard
error on individual measurements

If there is a two number labeling system then both would have to be
tested.

For determining retest: If second test falls outside confidence interval
consider retesting.

Everyone will retest periodically: test is usually at same lab as the
first test.  Under regulation, however, EPA can do testing at any lab
for compliance with regulation. If another lab test was significantly
different may result in retesting with witness in same lab as originally
tested.

Six lab test results showed (method B) the variation of test results.
These test results showed a large variation in results. Method A in
similar lab tests showed much better clustering of results.

If went to third party testing would method B be more successful?  But
example showed better results using method A (with training). The factor
of subject attention to details is not well measured or assessed and
this may be a factor in the variation. Suggest the subject to read aloud
the instructions to assure instructions were understood.

Ken: have a variable with subject and variable of the tester.  May have
recording to get uniform instruction and the reading aloud instruction
by the subject to reduce variance.

This should improve the out come of the test.  Training the testers is
most effective use of resources vs. training the subjects based on
number people involved.

Method B is measuring the ability to learn and understanding by the
subject in addition to testing the device. There are different methods
used across the board by different industry representatives in testing
under both Method A and B.

History of regulation is not to look to detail requirements of testing
in depth.  In auto regulations it was more the competition that raised
an issue that then was investigated by EPA. Better to come with
forthright, honest testing and sharing of lessons learned.


[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Proposed Rules]
[Pages 50493-50495]
[FR Doc No: 2021-19321]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0704; Airspace Docket No. 21-AWP-32]
RIN 2120-AA66

Proposed Amendment of United States Area Navigation Route Q-73 in
the Vicinity of Twentynine Palms, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend United States Area Navigation
(RNAV) route Q-73 due to the creation of Special Activity Airspace
(SAA) (Bristol Air Traffic Control Assigned Airspace (ATCAA)) in the
vicinity of Twentynine Palms, CA.

DATES: Comments must be received on or before October 25, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0704; Airspace Docket No. 21-AWP-32 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington,

DC 20591; telephone:<PHONE_NUMBER>. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of FAA Order 7400.11E at NARA,
email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0704; Airspace Docket No. 21-AWP-32) and be submitted in
triplicate to the Docket Management Facility (see ``ADDRESSES'' section
for address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0704; Airspace Docket No. 21-AWP-32.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ``ADDRESSES'' section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Western
Service Center, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

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

Background

    The Los Angeles Air Route Traffic Control Center (ZLA) is
responsible for managing the NAS for much of the Desert Southwest
portion of the United States. This responsibility requires close
coordination with the many military installations to ensure a proper
balance between the NAS user needs and military mission requirements.
    The United States Marine Corps (USMC) in Yuma, AZ has requested
additional airspace (higher altitude) above the existing Bristol
Military Operations Area (MOA) northeast of Twentynine Palms, CA. The
airspace in the Bristol MOA has a ceiling to but not including 18,000
feet MSL, however the USMC has determined that to be inadequate to
support Marine Expeditionary Brigade sized training events. A recent
agreement between the USMC in Yuma, AZ, and ZLA provides two ATCAAs
above the current Bristol MOAs to support the need for higher
altitudes. Creating this additional airspace, however, conflicts with
traffic on RNAV route Q-73. A slight modification of Q-73 will be
required to provide safe passage of non-participating aircraft
transitioning this area.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend United
States Area Navigation (RNAV) route Q-73 due to the creation of SAA,
Bristol ATCAA in the vicinity of Twentynine Palms, CA. The proposal
would add two additional waypoints between LVELL and HAKMN in order to
provide an adequate buffer between military activities in that area.
The full legal description is provided in the ``Rule'' area below.
    Q-73: Q-73 currently extends from the MOMAR, CA, waypoint (WP) to
the CORDU, ID, WP. The FAA proposes to add two additional WPs. The
first WP would be BLKWL between LVELL and ZELMA and the other KRLIE,
WP, between ZELMA and HAKMN. These proposed WP would provide safe
segregation of air traffic along Q-73 from military activity operating
within the adjacent SAA. The rest of the route would remain unchanged.
    United States Area Navigation Routes are published in paragraph
2006 of FAA Order 7400.11E dated July 21, 2020 and effective September
15, 2020, which is incorporated by reference in 14 CFR 71.1. The RNAV
route listed in this document would be published subsequently in the
Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant

regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-73 MOMAR, CA to CORDU, ID [Amended]

MOMAR, CA                              FIX                                    (Lat. 33[deg]30'54.13'' N, long. 115[deg]56'40.14'' W)
LVELL, CA                              WP                                     (Lat. 34[deg]12'37.38'' N, long. 115[deg]36'53.25'' W)
BLKWL, CA                              WP                                     (Lat. 34[deg]22'01.06'' N, long. 115[deg]29'56.81'' W)
ZELMA, CA                              WP                                     (Lat. 34[deg]46'59.99'' N, long. 115[deg]19'47.51'' W)
KRLIE, CA                              WP                                     (Lat. 35[deg]08'24.42'' N, long. 115[deg]13'59.57'' W)
HAKMN, NV                              WP                                     (Lat. 35[deg]30'28.31'' N, long. 115[deg]04'47.04'' W)
LAKRR, NV                              WP                                     (Lat. 36[deg]05'07.72'' N, long. 114[deg]17'09.16'' W)
GUNTR, AZ                              WP                                     (Lat. 36[deg]24'39.65'' N, long. 114[deg]02'11.55'' W)
ZAINY, AZ                              WP                                     (Lat. 36[deg]39'24.73'' N, long. 113[deg]54'03.50'' W)
EEVUN, UT                              WP                                     (Lat. 37[deg]02'52.90'' N, long. 113[deg]42'42.56'' W)
WINEN, UT                              WP                                     (Lat. 37[deg]56'00.00'' N, long. 113[deg]30'00.00'' W)
CRITO, NV                              WP                                     (Lat. 39[deg]18'00.00'' N, long. 114[deg]33'00.00'' W)
BROPH, ID                              WP                                     (Lat. 42[deg]43'15.71'' N, long. 114[deg]52'31.80'' W)
DERSO, ID                              WP                                     (Lat. 43[deg]21'42.63'' N, long. 115[deg]08'01.66'' W)
ZATIP, ID                              WP                                     (Lat. 46[deg]13'17.48'' N, long. 116[deg]31'37.57'' W)
CORDU, ID                              FIX                                    (Lat. 48[deg]10'46.41'' N, long. 116[deg]40'21.84'' W)

* * * * *

    Issued in Washington, DC, on August 30, 2021.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-19321 Filed 9-8-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 159 (Thursday, August 18, 2022)]
[Notices]
[Pages 50906-50909]
[FR Doc No: 2022-17749]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95498; File No. SR-NYSE-2022-37]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Adopt a New Rule 7.39 and Delete Current Rules 900-907

August 12, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 5, 2022, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (1) adopt a new Rule 7.39 governing its
Off-Hours Trading Facility based on the rule adopted by its affiliate
NYSE American LLC for the Pillar trading platform, and (2) delete
current Rules 900-907 governing Off-Hours Trading. The proposed rule
change is available on the Exchange's website at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes (1) adopt a new Rule 7.39 governing its Off-
Hours Trading Facility based on the rule adopted by its affiliate NYSE
American LLC for the Pillar trading platform, and (2) delete current
Rules 900-907 governing Off-Hours Trading.
Background
    In 2017, in connection with the transition to the Pillar trading
platform, the Exchange's affiliate NYSE American LLC (then NYSE MKT
LLC) (``NYSE American'') adopted NYSE American Rule 7.39E in order to
maintain certain functionality in its Off-Hours Trading Facility. At
the time, NYSE American Rules 900--Equities through 907--Equities
governed off-hours trading activity on NYSE American.\3\ NYSE American
Rules 900--Equities through 907--Equities were based in turn on the
Exchange's current Rules 900-907.\4\ When NYSE American added Rule
7.39E, it described how each element of Rule 7.39E was related to
former NYSE American Rules 900-Equities through 907- Equities.\5\
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    \3\ See Securities Exchange Act Release No. 80590 (May 4, 2017),
82 FR 21843, 21847 (May 10, 2017) (SR-NYSEMKT-2017-01) (Order
Granting Accelerated Approval of Proposed Rule Change, as Modified
by Amendment No. 1, To Adopt New Equity Trading Rules To Transition
Trading on the Exchange From a Floor-Based Market With a Parity
Allocation Model to a Fully Automated Market With a Price-Time
Priority Model on the Exchange's New Trading Technology Platform,
Pillar).
    \4\ See Securities Exchange Act Release No. 58705 (Oct. 1,
2008), 73 FR 58995 (Oct. 8, 2008) (SR-Amex-2008-63) (approving
adoption of new equity trading rules by NYSE American that are
substantially identical to the equity trading rules of NYSE).
    \5\ See Securities Exchange Act Release No. 79993 (February 9,
2017), 82 FR 10814, 10822-10823 (February 15, 2017) (SR-NYSEMKT-
2017-01) (``NYSE American Notice'').
---------------------------------------------------------------------------

    As described in NYSE American Rule 7.39E, the only functionality
available on its Off-Hours Trading Facility following the transition to
Pillar is for ETP Holders to enter aggregate-price coupled orders. NYSE
American Rules 900--Equities through 907--Equities were designated as
inapplicable to trading on the Pillar trading platform and later
deleted.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 82212 (December 4,
2017), 82 FR 58036 (December 8, 2017) (SR-NYSEAMER-2017-34) (Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Exchange Rules To Delete Obsolete Cash Equities Rules That Are
Not Applicable to Trading on the Pillar Trading Platform and To
Delete Other Obsolete Rules).
---------------------------------------------------------------------------

    NYSE American recently determined to cease offering an after-hours
crossing session and that it would delete NYSE American Rule 7.39E.
    Currently, the Exchange offers an off-hours trading facility known
as Crossing Session II pursuant to NYSE Rules 900-907 that operates
between 4:00 p.m. and 6:30 p.m.\7\ Like the NYSE American after-hours
trading facility, the NYSE's off-hours trading facility only accepts
aggregate-price coupled orders. In 2018, NYSE began its own multi-phase
transition to the Pillar trading platform.\8\ As described below, the
Exchange proposes to continue to offer the current functionality
pursuant to an updated and streamlined rule modeled on NYSE American
Rule 7.39E that reflects current Pillar terminology.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 52026 (July 13,
2005), 70 FR 41806 (July 20, 2005) (SR-NYSE-2005-26) (Order)
(extending hours of operation of Crossing Session II from 4:00 p.m.
to 6:30 p.m., instead of 6:15 p.m.); NYSE Information Memo 05-57
(August 19, 2005).
    \8\ See Securities Exchange Act Release No. 82945 (March 26,
2018), 83 FR 13553 (March 29, 2018) (SR-NYSE-2017-36) (Notice of
Filing of Amendment No. 1 and Order Granting Accelerated Approval of
a Proposed Rule Change, as Modified by Amendment No. 1, To Adopt New
Equity Trading Rules To Trade Securities Pursuant to Unlisted
Trading Privileges, Including Orders and Modifiers, Order Ranking
and Display, and Order Execution and Routing on Pillar, the
Exchange's New Trading Technology Platform); Securities Exchange Act
Release No. 85962 (May 29, 2019), 84 FR 26188 (June 5, 2019) (SR-
NYSE-2019-05) (Notice of Filing of Amendment No. 3 and Order
Granting Accelerated Approval of Proposed Rule Change, as Modified
by Amendment No. 3, To Amend NYSE Rules 7.31, 7.36, 7.37; Make
Conforming Amendments to NYSE Rules 1.1, 7.11, 7.12, 7.16, 7.18,
7.32, 7.34, and 7.36; and Amend the Preambles on Current Exchange
Rules Relating to Their Applicability to the Pillar Trading
Platform).
---------------------------------------------------------------------------

Proposed Rule Change
    The Exchange proposes to delete Rules 900-907 and add new Rule 7.39
to describe the Exchange's Off-Hours-Trading Facility. With this
proposed rule change, the Exchange would permit member organizations to
enter into the Off-Hours Trading Facility Aggregate-Price Coupled
Orders, defined as orders to buy or sell a group of securities, which
group includes no fewer than 15 Exchange-listed or traded securities
having a total market value of $1 million or more. The Exchange would
not otherwise change the functionality available on the current Off-
Hours Trading Facility. The Exchange believes that proposed Rule 7.39,
which would be located in the rule book together with rules describing
trading on the Exchange and is based on NYSE American Rule 7.39E, would
streamline the Exchange's rules and make them easier to navigate.

    Proposed Rule 7.39 would be titled ``Off-Hours Trading'' and the
current ``Reserved'' designation would be deleted.
    Proposed Rule 7.39(a) would provide that Rule 7.39 would apply to
all Exchange contracts made on the Exchange through its ``Off-Hours
Trading Facility.'' This proposed rule text is identical to current
NYSE American Rule 7.39E(a).
    Proposed Rule 7.39(b) would establish the definitions for the Off-
Hours Trading Facility.
    Proposed Rule 7.39(b)(i) would define the term ``Aggregate-Price
Coupled Order'' to mean an order to buy or sell a group of securities,
which group includes no fewer than 15 Exchange-listed or traded
securities having a total market value of $1 million or more. This
proposed definition is identical to that in NYSE American Rule
7.39E(b)(i).
    Proposed Rule 7.39(b)(ii) would define the term ``Off-Hours Trading
Facility,'' to mean the Exchange facility that permits member
organizations to effect securities transactions on the Exchange under
proposed Rule 7.39. Except for the non-substantive difference to use
the term ``member organization'' rather than ``ETP Holder,'' proposed
Rule 7.39(b)(ii) would be identical to NYSE American Rule 7.39E(b)(ii).
Proposed Rule 7.39(b)(ii) would also define the term ``Off-Hours
Trading'' to mean trading through the Off-Hours Trading Facility. This
text is based on NYSE American Rule 7.39E(b)(ii) without difference.
Because the Exchange would only be trading Aggregate-Price Coupled
Orders in the Off-Hours Trading Facility, the Exchange proposes that
Rule 7.39(b) would not include definitions for ``closing price,''
``closing-price order,'' or ``guaranteed price coupled order,'' which
are defined in current Rule 900(e)(ii)-(iv).
    Proposed Rule 7.39(c) would establish that only such NMS Stocks, as
the Exchange may specify, including Exchange-listed securities and UTP
Securities, would be eligible to trade in the Off-Hours Trading
Facility. The proposed rule text is based on NYSE American Rule
7.39E(c) without difference.
    Proposed Rule 7.39(d) would establish the procedures for entering
Aggregate-Price Coupled Orders into the Off-Hours Trading Facility. As
proposed, a member organization may only enter into the Off-Hours
Trading Facility an Aggregate-Price Coupled Order to buy (sell) that is
matched with an Aggregate-Price Coupled Order to sell (buy) the same
quantities of the same securities, including in odd lot and mixed lot
quantities. The proposed rule text is based on NYSE American Rule
7.39E(d) with a non-substantive difference to use the term ``member
organization'' instead of ``ETP Holder.''
    Proposed Rule 7.39(d)(i) would provide that transactions effected
through the Off-Hours Trading Facility pursuant to Aggregate-Price
Coupled Orders may be for delivery at such time as the parties entering
the orders may agree. The proposed rule text is identical to NYSE
American Rule 7.39E(d)(i).
    Proposed Rule 7.39(d)(ii) would provide that member organizations
would mark all sell orders as ``long'' as appropriate. The proposed
rule text is based on NYSE American Rule 7.39E(d)(ii) with a non-
substantive difference to use the term ``member organization'' instead
of ``ETP Holder.''
    Proposed Rule 7.39(d)(iii) would provide that each side of an
Aggregate-Price Coupled Order entered on a matched basis would be
traded on entry against the other side without regard to the priority
of other orders entered into the Off-Hours Trading Facility. The
proposed rule text would be identical to NYSE American Rule
7.39E(d)(iii).
    Proposed Rule 7.39(d)(iv) would provide that a transaction
described in the Rule would be an Exchange contract that is binding in
all respects and without limit on the member organization that enters
any of the transaction's component orders and that the member
organization would be fully responsible for the Exchange contract. The
proposed rule text is identical to NYSE American Rule 7.39E(d)(iv) with
non-substantive differences to use the term ``member organization''
instead of ``ETP Holder.''
    Proposed Rule 7.39(e) would provide that each member organization
would report to the Exchange such information, in such manner, and at
such times, as the Exchange may from time to time prescribe in respect
of Off-Hours Trading, including reports relating to Off-Hours Trading
orders, proprietary or agency activity and activity in related
instruments. This proposed rule text is based on NYSE American Rule
7.39E(e) with a non-substantive difference to use the term ``member
organization'' instead of ``ETP Holder.''
    Proposed Rule 7.39(f) would provide that each member organization
would maintain and preserve such records, in such manner, and for such
period of time, as the Exchange may from time to time prescribe in
respect of Off-Hours Trading, including, but not limited to, records
relating to orders, cancellations, executions and trading volume,
proprietary trading activity, activity in related instruments and
securities and other records necessary to allow the member organization
to comply with the reporting provisions of proposed paragraph (e) of
proposed Rule 7.39. The proposed rule text is based on NYSE American
Rule 7.39E(f) with non-substantive differences to use the term ``member
organization'' instead of ``ETP Holder.''
    Proposed Rule 7.39(g) would provide that notwithstanding a trading
halt in any security (other than a trading halt pursuant to Rule 7.12
(Trading Halts Due to Extraordinary Market Volatility)) or a corporate
development, member organizations may enter Aggregate-Price Coupled
Orders into the Off-Hours Trading Facility under this Rule. The
proposed rule text is based on NYSE American Rule 7.39E(g) with non-
substantive differences to cross-reference Rule 7.12 instead of Rule
7.12E and to use the term ``member organizations'' instead of ``ETP
Holders.''
    The Exchange notes that, like its affiliate, the Exchange would not
include rule text from Rule 903(d)(ii) and Rule 906(b) in proposed Rule
7.39E because these provisions relate to Floor-based use of the Off-
Hours Trading Facility, which the Exchange proposes would not be
available once the new rule is operative. In addition, the Exchange
proposes that proposed Rule 7.39 would not include any provisions from
Rule 907, which describes now obsolete crossing session functionality.
    Finally, the Exchange will announce the implementation date by
Trader Update. Although the Exchange is not proposing any new or
different functionality for its the Off-Hours Trading Facility, the
Exchange wants to provide member organizations utilizing the Off-Hours
Trading Facility with sufficient time to transition to the new rule
set. The Exchange anticipates that the proposed change will be
implemented on September 1, 2022.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\9\ in general, and furthers the objectives of Section 6(b)(5),\10\
in particular, because it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to, and perfect the mechanism of, a free and open market

and a national market system and, in general, to protect investors and
the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that proposed Rule 7.39 would
remove impediments to and perfect the mechanism of a free and open
market and a national market system because it would permit member
organizations to continue using the Exchange's off-hours trading
facility pursuant to a streamlined and updated rule that reflects
current Pillar terminology. As noted, the Exchange proposes to adopt
NYSE American's streamlined rule for off-hours trading utilizing Pillar
terminology to permit entry into the Off-Hours Trading Facility of
Aggregate-Price Coupled Orders, defined as orders to buy or sell a
group of securities, which group includes no fewer than15 Exchange-
listed or traded securities having a total market value of $1 million
or more. The Exchange believes that using text based on NYSE American
Rule 7.39E would remove impediments and perfect the mechanism of a free
and open market and a national market system because, as described in
the NYSE American Notice, NYSE American Rule 7.39E is based on former
NYSE American Rule 900--Equities through Rule 907--Equities, which in
turn were based on NYSE Rules 900-907. The proposed rule, like the NYSE
American rule on which it is based, would permit member organizations
to enter Aggregate-Price Coupled Orders while deleting obsolete text
and references and updating the rule language to reflect trading on the
Pillar trading platform. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rules would promote competition by providing a streamlined
and modernized rule governing off-hours trading on the Exchange based
on the version adopted by the Exchange's affiliate without substantive
differences. The Exchange believes that the proposed rules would not
impose any burden on competition that is not necessary or appropriate
because the proposed rules are designed to provide member organizations
with continuity in utilizing the after-hours facility by offering the
ability to enter Aggregate-Price Coupled Orders as currently provided
for under the Rule 900 Series while deleting obsolete text and
references and updating the rule language to reflect trading on the
Pillar trading platform.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6)(iii) thereunder.\14\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative on September 1, 2022.
---------------------------------------------------------------------------

    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiver of the operative delay is
consistent with the protection of investors and the public interest
because it will allow member organizations to continue to utilize the
Exchange's current off-hours trading facility without interruption.
Accordingly, the Commission hereby waives the 30-day operative delay
and designates the proposal operative on September 1, 2022.\17\
---------------------------------------------------------------------------

    \17\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \18\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2022-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2022-37. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the

public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2022-37 and should be submitted on or before September 8, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-17749 Filed 8-17-22; 8:45 am]
BILLING CODE 8011-01-P