[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41477-41483]
[FR Doc No: 2021-16408]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0659]

Medical Device User Fee Rates for Fiscal Year 2022

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) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV),
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. This notice establishes the fee
rates for FY 2022, which apply from October 1, 2021, through September
30, 2022, and provides information on how the fees for FY 2022 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: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
    For questions relating to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
    For questions relating to this notice: Andrew Bank, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62019A, Beltsville, MD 20705,<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, notices,
and requests (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)).
    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 2018 through FY 2022; the
base fee for a premarket application received by FDA during FY 2022 is
$329,000. From this starting point, this document establishes FY 2022
fee rates for certain 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 2018 through FY 2022; the base fee for an
establishment registration in FY 2022 is $4,978. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary of Health
and Human Services 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 2022

    The total revenue amount for FY 2022 is $213,687,660, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA directs FDA to use the yearly total revenue amount
as a starting point to set the standard fee rates for each fee type.
The fee calculations for FY 2022 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $213,687,660 is to be adjusted for
inflation increases for FY 2022 using two separate adjustments--one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2022 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
    The component of the inflation adjustment for payroll costs is 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 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 1 summarizes the 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 2022.
The 3-year average is 2.7383 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
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           Fiscal year                   2018                2019                2020           3-Year average
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Total PC&B......................      $2,690,678,000      $2,620,052,000      $2,875,592,000  ..................
Total FTE.......................              17,023              17,144              17,535  ..................
PC&B per FTE....................            $158,061            $152,826            $163,992  ..................
Percent change from previous                 4.2206%            -3.3120%             7.3063%             2.7383%
 year...........................
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    The payroll adjustment is 2.7383 percent multiplied by 60 percent,
or 1.6430 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2022 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 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)). As a result of a geographical revision made by
the Bureau of Labor and Statistics in January 2018,\1\ the
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and that provides the most current
data available, the Washington-Arlington-Alexandria index has been used
since FY 2020 and will be used in calculating the relevant adjustment
factors for FY 2022 and subsequent years.
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    \1\ The Bureau of Labor Statistics' Announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
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    Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

          Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
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           Fiscal year                   2018                2019                2020           3-Year average
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Annual CPI......................             261.445             264.777             267.157  ..................
Annual Percent Change...........             2.0389%             1.2745%             0.8989%  ..................
3-Year Average Percent Change in  ..................  ..................  ..................             1.4041%
 CPI............................
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    The non-payroll adjustment is 1.4041 percent multiplied by 40
percent, or 0.5616 percent. Next, the payroll adjustment (1.6430
percent or 0.016430) is added to the non-payroll adjustment (0.5616
percent or .005616), for a total of 2.2046 percent (or 0.022046). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.022046 for FY 2022.
    MDUFA IV provides for this inflation adjustment to be compounded
for FY 2022 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2022, the FY 2021 compounded adjustment (1.114808) is multiplied by
the FY 2022 base inflation adjustment (1.022046) to reach the
applicable inflation adjustment of 1.139385 (rounded) for FY 2022. We
then multiply the total revenue amount for FY 2022 ($213,687,660) by
1.139385, yielding an inflation adjusted total revenue amount of
$243,473,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2022

    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)).

A. Inflation Adjustment

    MDUFA specifies that the base fees of $329,000 (premarket
application) and $4,978 (establishment registration) are to be adjusted
for FY 2022 using the same methodology as that for the total revenue
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the compounded inflation adjustment of
1.139385 yields inflation adjusted base fees of $374,858 (premarket
application) and $5,672 (establishment registration).

B. Further Adjustments

    After the applicable inflation adjustment to fees is done, FDA may
increase, if necessary to achieve the inflation adjusted total revenue
amount, the base fee amounts on a uniform proportionate basis (see 21
U.S.C. 379j(c)(2)(D)(ii)). If necessary, after this adjustment, FDA may
further increase the base establishment registration fees to generate
the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

C. Calculation of Fee Rates

    Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2022.

                              Table 3--Three-Year Average of Fee-Paying Submissions
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                                                      FY 2018         FY 2019         FY 2020
                Application type                      actual          actual          actual      3-Year average
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Full Fee Applications...........................              38              32              30              33
    Small Business..............................               7               8               6               7
Panel-Track Supplement..........................              23              14              22              20

    Small Business..............................               5               4               6               5
De Novo Classification Request..................              27              12              11              17
    Small Business..............................              29              37              18              28
180-Day Supplements.............................             133             124             126             128
    Small Business..............................              27              23              21              24
Real-Time Supplements...........................             169             213             175             186
    Small Business..............................              34              43              29              35
510(k)s.........................................           2,122           2,069           2,049           2,080
    Small Business..............................           1,385           1,558           1,667           1,537
30-Day Notice...................................           1,058             925             867             950
    Small Business..............................              98             111             105             105
513(g) (21 U.S.C. 360c(g)) Request for                        84              75              96              85
 Classification Information.....................
    Small Business..............................              33              54              57              48
Annual Fee for Periodic Reporting...............             624             629             420             558
    Small Business \2\..........................              74              96              68              79
Establishment Registration......................          27,544          27,734          41,409          32,229
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    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 the FY 2022 base fees set in statute (column one) and the
inflation adjusted base fees (per calculations in section III.A.)
(column two). Using the inflation adjusted fees and the 3-year averages
of fee-paying submissions, collections are projected to total
$262,694,460, which is $19,221,460 higher than the inflation adjusted
total revenue amount (in section II). The fees in column two are those
we are establishing in FY 2022, which are the standard fees.

                           Table 4--Fees Needed To Achieve New FY 2022 Revenue Target
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                                                            FY 2022 Inflation
                                                                 adjusted      3-Year average   FY 2022 revenue
            Application type             FY 2022 statutory    statutory base    of fee-paying    from adjusted
                                          fees (base fees)    fees (standard     submissions          fees
                                                                  fees)
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Full Fee Applications..................           $329,000           $374,858              33        $12,370,303
    Small Business.....................             82,250             93,714               7            656,001
Panel-Track Supplement.................            246,750            281,143              20          5,622,865
    Small Business.....................             61,688             70,286               5            351,429
De Novo Classification Request.........             98,700            112,457              17          1,911,774
    Small Business.....................             24,675             28,114              28            787,201
180-Day Supplements....................             49,350             56,229             128          7,197,267
    Small Business.....................             12,338             14,057              24            337,372
Real-Time Supplements..................             23,030             26,240             186          4,880,647
    Small Business.....................              5,758              6,560              35            229,600
510(k)s................................             11,186             12,745           2,080         26,509,934
    Small Business.....................              2,797              3,186           1,537          4,897,328
30-Day Notice..........................              5,264              5,998             950          5,697,837
    Small Business.....................              2,632              2,999             105            314,880
513(g) Request for Classification                    4,442              5,061              85            430,149
 Information...........................
    Small Business.....................              2,221              2,530              48            121,454
Annual Fee for Periodic Reporting......             11,515             13,120             558          7,320,970
    Small Business.....................              2,879              3,280              79            259,120
Establishment Registration.............              4,978              5,672          32,229        182,798,329
                                        ------------------------------------------------------------------------
        Total..........................  .................  .................  ..............        262,694,460
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    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $374,858 for FY 2022. 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 de novo classification request, 30 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 an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
     For a 510(k) premarket notification, 3.4 percent of the
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee; and
     For a 513(g) request for classification information, 1.35
percent of the standard fee.
    For all submissions other than 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)
and (e)(2)(C)). For 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)).
    The annual fee for establishment registration, after adjustment, is
set at $5,672 for FY 2022. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 5 summarizes the FY 2022 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2022
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                                                 Standard fee  (as a percent of
             Application fee type                    the standard  fee for a          FY 2022      FY 2022 small
                                                     premarket  application)       standard fee    business fee
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Premarket application (a PMA submitted under    Base fee specified in statute...        $374,858         $93,714
 section 515(c)(1) of the FD&C Act (21 U.S.C.
 360e(c)(1)), a PDP submitted under section
 515(f) of the FD&C Act, 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.............................         374,858          93,714
 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under   100.............................         374,858          93,714
 section 351 of the PHS Act).
Panel-track supplement........................  75..............................         281,143          70,286
De novo classification request................  30..............................         112,457          28,114
180-day supplement............................  15..............................          56,229          14,057
Real-time supplement..........................  7...............................          26,240           6,560
510(k) premarket notification submission......  3.40............................          12,745           3,186
30-day notice.................................  1.60............................           5,998           2,999
513(g) request for classification information.  1.35............................           5,061           2,530
Annual Fee Type
    Annual fee for periodic reporting on a      3.50............................          13,120           3,280
     class III device.
Annual establishment registration fee (to be    Base fee specified in statute...           5,672           5,672
 paid by the establishment engaged in the
 manufacture, preparation, propagation,
 compounding, or processing of a device, as
 defined by 21 U.S.C. 379i(14)).
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IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees

    If your business, including your affiliates, 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,
including your affiliates, 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 (i.e. PMA, PDP, or BLA) or premarket
report. 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 at least 60 days before you
send your submission to FDA. Please note that the establishment
registration fee is not eligible for a reduced small business fee. As a
result, if the establishment registration fee is the only medical
device user fee that you will pay in FY 2022, you should not submit a
Small Business Certification Request. FDA will review your information
and determine whether you qualify as a small business eligible for the
reduced fee and/or fee waiver. 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 2021, your
status as a small business will expire at the close of business on
September 30, 2021. You must re-qualify for FY 2022 in order to pay
small business fees during FY 2022.

A. Domestic (U.S.) Businesses

    If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2022, submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the United States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
    2. A signed copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2021, except:
    If you submit your MDUFA Small Business Certification Request for
FY 2022 before April 15, 2022, and you have not yet filed your return
for 2021, you may use tax year 2020.
    If you submit your MDUFA Small Business Certification Request for
FY 2022 on or after April 15, 2022, and have not yet filed your 2021
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 signed
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 business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.

B. Foreign Businesses

    If you are a foreign business, and wish to qualify as a small
business for FY 2022, submit the following:
    1. A completed MDUFA Foreign Small Business Certification Request
For a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.

    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 signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year (2021 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 business must also
submit a statement signed by the head of the business'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 business 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 between October 1, 2021, and September 30,
2022, you must pay the fee in effect for FY 2022. To avoid delay in the
review of your application, you should pay the application fee before
or at the time you submit your application to FDA. 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 2021 or FY 2022 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: Do not send your user fee
check to FDA with the application.)

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

    Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. 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, 2021. One choice is for
applications and fees that will be received on or before September 30,
2021, which are subject to FY 2021 fee rates. A second choice is for
applications and fees received on or after October 1, 2021, which are
subject to FY 2022 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. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN

    When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). 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.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Note: only full payments are
accepted. No partial payments can be made online. Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.
    2. 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. If needed, FDA's
tax identification number is 53-0196965.
     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 979033, St. Louis, MO
63197-9000. (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, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery contact U.S. Bank at<PHONE_NUMBER>. This telephone number is
only for questions about courier delivery.)
    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. If the financial institution charges a wire transfer fee
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
    FDA records the official application receipt date as the later of
the following: (1) The date the application was received by the FDA
Document Control Center for the reviewing Center 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.

D. 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 the address located at https://www.fda.gov/cdrhsubmissionaddress.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    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 for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
    1. The preferred payment method is online using electronic check
(ACH also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay (Note:
only full payments are accepted. No partial payments can be made
online). Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be made using U.S. bank
accounts as well as U.S. credit cards.
    2. If paying with a paper check:
    The check must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. If needed, FDA's tax
identification number is 53-0196965.
     Please write your invoice number on the check.
     Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(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.)
    To send a check by a courier, the courier must deliver the check
and printed copy of the cover sheet to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery).
    3. When paying by a wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, the invoice amount would
be referred to collections. The originating financial institution may
charge a wire transfer fee. If the financial institution charges a wire
transfer fee, it is required that you add that amount to the payment to
ensure that the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

VII. Procedures for Paying Annual Establishment Registration Fees

    To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website address after this document publishes in the Federal Register.)
Create a DFUF order and you will be issued a PIN when 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 2022 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(f)(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. 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 website listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2022 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is 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. Pay for Your DFUF Order

    Unless paying by U.S. 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 or eCheck):
    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:
    The check must be in U.S. currency and drawn on a U.S. bank, and
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. If you have any questions
concerning courier delivery, contact U.S. Bank at<PHONE_NUMBER>. This
telephone number is only for questions about courier delivery.)
    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. Include a copy of your printed order
when you mail your check.
    3. If paying with a wire transfer:
    Wire transfers may also be used to pay annual establishment
registration fees. To send a wire transfer, please read and comply with
the following information:
    Include your order's unique PIN (in 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 may
be delayed.
    The originating financial institution may charge a wire transfer
fee. If the financial institution charges a wire transfer fee, it is
required that you add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.

C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2022, or To Register a New Establishment for
FY 2022

    Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side 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
``Access Electronic Registration'' link in the middle 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 2021. Manufacturers of
licensed biologics should register in the BER system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
    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. When 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; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the BER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call<PHONE_NUMBER>.

D. 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 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16408 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3060-3064]
[FR Doc No: 2013-00634]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68613; File No. SR-NASDAQ-2012-141]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC
Notice; of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Penny Pilot Options

January 9, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 31, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by NASDAQ.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ proposes to modify Chapter XV, Section 2 of the rules
governing the NASDAQ Options Market (``NOM''), NASDAQ's facility for
executing and routing standardized equity and index options.
Specifically, NOM proposes to amend its pricing to modify the
Professional Rebate to Add Liquidity in Penny Pilot Options.\3\
---------------------------------------------------------------------------

    \3\ The Penny Pilot was established in March 2008, expanded in
October 2009, and, through a series of orders, extended through
December 31, 2012. See Securities Exchange Act Release Nos. 57579
(March 28, 2008), 73 FR 18587 (April 4, 2008) (SR-NASDAQ-2008-026)
(notice of filing and immediate effectiveness establishing Penny
Pilot); 60874 (October 23, 2009), 74 FR 56682 (November 2, 2009)
(SR-NASDAQ-2009-091) (notice of filing and immediate effectiveness
expanding and extending Penny Pilot); 60965 (November 9, 2009), 74
FR 59292 (November 17, 2009) (SR-NASDAQ-2009-097) (notice of filing
and immediate effectiveness adding seventy-five classes to Penny
Pilot); 61455 (February 1, 2010), 75 FR 6239 (February 8, 2010) (SR-
NASDAQ-2010-013) (notice of filing and immediate effectiveness
adding seventy-five classes to Penny Pilot); 62029 (May 4, 2010), 75
FR 25895 (May 10, 2010) (SR-NASDAQ-2010-053) (notice of filing and
immediate effectiveness adding seventy-five classes to Penny Pilot);
65969 (December 15, 2011), 76 FR 79268 (December 21, 2011) (SR-
NASDAQ-2011-169) (notice of filing and immediate effectiveness
extension and replacement of Penny Pilot); and 67325 (June 29,
2012), 77 FR 40127 (July 6, 2012) (SR-NASDAQ-2012-075) (notice of
filing and immediate effectiveness and extension and replacement of
Penny Pilot through December 31, 2012). See also NOM Rules, Chapter
VI, Section 5.
---------------------------------------------------------------------------

    While the changes proposed herein are effective upon filing, the
Exchange

has designated that the amendments be operative on January 2, 2013.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaq.cchwallstreet.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 Exchange included statements
concerning the purpose of and basis for the proposed rule change. The
text of these 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 aspects of such
statements.

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

1. Purpose
    NASDAQ proposes to modify Chapter XV, entitled ``Options Pricing,''
at Section 2(1) governing the rebates and fees assessed for option
orders entered into NOM. The Exchange is proposing to amend the
Professional Rebate to Add Liquidity in Penny Pilot Options to attract
additional order flow to the Exchange.
    The Exchange currently pays a flat Professional Rebate to Add
Liquidity in Penny Pilot Options of $0.29 per contract. The Exchange is
now proposing to pay Professionals, a tiered rebate instead.
Specifically, the Exchange proposes to eliminate the flat $0.29 per
contract Professional Rebate to Add Liquidity and instead pay
Professionals rebates based on total number of Customer and
Professional contracts that add liquidity in Penny Pilot Options in a
given month as follows:

------------------------------------------------------------------------
                                                           Rebate to add
                     Monthly volume                          liquidity
------------------------------------------------------------------------
Tier 1--Participant adds Customer and Professional                 $0.26
 liquidity of up to 34,999 contracts per day in a month.
Tier 2--Participant adds Customer and Professional                  0.43
 liquidity of 35,000 to 74,999 contracts per day in a
 month..................................................
Tier 3--Participant adds Customer and Professional                  0.44
 liquidity of 75,000 or more contracts per day in a
 month..................................................
Tier 4--Participant adds (1) Customer and Professional              0.42
 liquidity of 25,000 or more contracts per day in a
 month, (2) the Participant has certified for the
 Investor Support Program set forth in Rule 7014; and
 (3) the Participant executed at least one order on
 NASDAQ's equity market.................................
Tier 5--Participant has Total Volume of 130,000 or more             0.46
 contracts per day in a month...........................
------------------------------------------------------------------------

    Professionals would be entitled to the same Rebate to Add Liquidity
in Penny Pilot Options that Customers receive today. The Exchange would
pay a Tier 1 rebate of $0.26 per contract to market participants that
add Customer and Professional liquidity of up to 34,999 contracts per
day in a month. A Tier 2 rebate would pay $0.43 per contract to market
participants that add Customer and Professional liquidity between
35,000 and 74,999 contracts per day in a month. A Tier 3 rebate would
pay a $0.44 per contract rebate to market participants that add
Customer and Professional liquidity of 75,000 contracts or more per day
in a month. The Tier 4 rebate would pay a $0.42 rebate to market
participants that add Customer and Professional liquidity of 25,000 or
more contracts per day in a month. In addition, to qualify for Tier 4,
the Participant must have certified for the Investor Support Program
(``ISP'') as set forth in Rule 7014; \4\ and executed at least one
order on NASDAQ's equity market.\5\ The Tier 5 rebate would pay a $0.46
per contract Rebate to Add Liquidity to NOM Options Participants that
have Total Volume of 130,000 or more contracts per day in a month.\6\
Total Volume is defined to include Customer, Professional, Firm, Non-
NOM Market Maker and NOM Market Maker volume in Penny Pilot Options and
Non-Penny Pilot Options which either adds or removes liquidity.\7\
---------------------------------------------------------------------------

    \4\ For a detailed description of the ISP, see Securities
Exchange Act Release No. 63270 (November 8, 2010), 75 FR 69489
(November 12, 2010) (NASDAQ-2010-141) (notice of filing and
immediate effectiveness). See also Securities Exchange Act Release
Nos. 63414 (December 2, 2010), 75 FR 76505 (December 8, 2010)
(NASDAQ-2010-153) (notice of filing and immediate effectiveness);
and 63628 (January 3, 2011), 76 FR 1201 (January 7, 2011) (NASDAQ-
2010-154) (notice of filing and immediate effectiveness).
    \5\ For purposes of Tier 4, the Exchange will allow a NOM
Participant to qualify for the rebate if a NASDAQ member under
common ownership with the NOM Participant has certified for the
Investor Support Program and executed at least one order on NASDAQ's
equity market. Common ownership is defined as 75 percent common
ownership or control.
    \6\ For purposes of Tier 5, the Exchange allows NOM Participants
under common ownership to aggregate their volume to qualify for the
rebate. Common ownership is defined as 75 percent common ownership
or control.
    \7\ See the Exchange's Rules at Chapter XV, Section 2.
---------------------------------------------------------------------------

    The Exchange proposes to apply the Rebate to Add Liquidity tiers to
Professionals transacting Penny Pilot Options. The Exchange proposes to
amend Chapter XV, Section 2 by noting that the tiers would apply to
Professionals.
    Additionally, the Exchange also proposes to add contracts executed
in the ``Professional'' capacity to the tier requirements. NOM
Participants would be able to count Customer and Professional contracts
toward the number of contracts eligible to qualify for a tier as
specified herein. The addition of Professional orders to the number of
contracts eligible for each rebate tier will enable NOM Participants to
achieve higher rebates.
2. Statutory Basis
    NASDAQ believes that the proposed rule changes are consistent with
the provisions of Section 6 of the Act,\8\ in general, and with Section
6(b)(4) of the Act,\9\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed tier structure for
Professional Rebates to Add Liquidity in Penny Pilot Options is
reasonable, equitable and not unfairly discriminatory because by
incentivizing NOM Participants to select the Exchange as a venue to
post Customer and Professional orders, the Exchange will attract
additional Professional order flow to the benefit of all market
participants.
    The Exchange believes that the proposed monthly volume tier Rebates
to Add Liquidity in Penny Pilot Options are equitable and not unfairly
discriminatory because members that account for more volume would be
able to add greater value to the Exchange's trading environment.
Additionally, with the exception of Tier 1, Professionals will have an
opportunity to earn higher rebates than they earned in the past.

With respect to Tier 1, the Exchange is proposing to pay a $0.26 per
contract Rebate to Add Liquidity in Penny Pilot Options as compared to
a $0.29 per contract rebate. The Exchange believes that this proposal
is equitable and not unfairly discriminatory because the Professional
has an opportunity to earn higher rebates with the tier structure as
compared the current $0.29 per contract Rebate to Add Liquidity in
Penny Pilot Options. In addition, the Exchange believes that the
proposed monthly tier structure for Professional Rebates to Add
Liquidity in Penny Pilot Options is equitable and not unfairly
discriminatory because the Exchange would uniformly pay a Rebate to Add
Liquidity to Professionals executing Penny Pilot Options based on the
monthly tiers proposed herein.
    The Exchange believes that paying Professionals a tiered Rebate to
Add Liquidity in Penny Pilot Options as proposed herein is equitable
and not unfairly discriminatory as compared to other market
participants. For example, Customers are entitled to the same rebates.
NOM Market Makers are entitled to a $0.30 per contract Rebate to Add
Liquidity in Penny Pilot Options, and that rebate is higher than
Professionals that achieve a Tier 1 rebate because NOM Market Makers
add value through continuous quoting \10\ and the commitment of
capital. With respect to Tiers 2, 3 and 4, pursuant to this proposal, a
Professional earns a higher rebate as compared to a NOM Market Maker.
In addition, a Professional would earn a higher rebate with any tier as
compared to a Firm and Non-NOM Market Maker. Today, Professionals are
paid a higher Rebate to Add Liquidity in Penny Pilot Options as
compared to Firms and Non-NOM Market Makers however the differential
would become larger. The Exchange believes that paying Professionals
higher Tier 2, 3 and 4 rebates as compared to NOM Market Makers and
paying Professionals higher rebates as compared to Firms and Non-NOM
Market Makers is equitable and not unfairly discriminatory because the
Exchange does not believe that the amount of the rebate offered by the
Exchange has a material impact on a NOM Participant's ability to
execute orders in Penny Pilot Options. The Exchange has been assessing
the impact of rebates since it first began to offer them and has also
observed the impact of fees and rebates on other options exchanges in
terms of quoting and liquidity. The Exchange believes that the Fees for
Adding Liquidity in Penny Pilot Options, as compared to rebates, impact
a market participant's decision-making more prominently with respect to
posting order flow on different venues and price. In modifying its
rebates, the Exchange hopes to simply remain competitive with other
venues so that it remains a choice for market participants when posting
orders and the result may be additional Professional order flow for the
Exchange. In addition, a NOM Participant may not be able to gauge the
exact rebate tier it would qualify for until the end of the month
because Professional volume would be commingled with Customer volume in
calculating tier volume. Other participants have a known rebate rate at
which they would execute the entire month. A Professional could only
otherwise presume the Tier 1 rebate would be achieved in a month when
determining price.
---------------------------------------------------------------------------

    \10\ Pursuant to Chapter VII (Market Participants), Section 5
(Obligations of Market Makers), in registering as a market maker, an
Options Participant commits himself to various obligations.
Transactions of a Market Maker in its market making capacity must
constitute a course of dealings reasonably calculated to contribute
to the maintenance of a fair and orderly market, and Market Makers
should not make bids or offers or enter into transactions that are
inconsistent with such course of dealings. Further, all Market
Makers are designated as specialists on NOM for all purposes under
the Act or rules thereunder. See Chapter VII, Section 5.
---------------------------------------------------------------------------

    The Exchange initially established Professional pricing in order to
``* * * bring additional revenue to the Exchange.'' \11\ The Exchange
noted in the Professional Filing that it believes ``* * * that the
increased revenue from the proposal would assist the Exchange to recoup
fixed costs.'' \12\ Further, the Exchange noted in that filing that it
believes that establishing separate pricing for a Professional, which
ranges between that of a Customer and market maker, accomplishes this
objective.\13\ Herein, the Exchange is not proposing to amend fees,
which fees continue to meet the objectives noted in the Professional
Filing. Rather, the Exchange desires to amend the rebates it pays
because it believes that NOM Participants would view NOM as a favorable
venue to transact Professional volume. The Exchange does not believe
that providing Professionals with the opportunity to obtain higher
rebates would create a competitive environment where Professionals
would be necessarily advantaged on NOM as compared to other NOM Market
Makers, Firms or Non-NOM Market Makers. First, a Professional would be
assessed the same fees as these other market participants, as is the
case today. Second, a Professional only has the opportunity to achieve
the higher rebate by sending in more than 35,000 contracts, otherwise
the Professional only achieves a Tier 1 rebate with at least one trade
and the differential in that scenario as between market participants
remain the same.\14\ The Exchange recognizes that the rebate tiers
provide an incentive to Professionals, but it is not a guaranteed
rebate.
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 64494 (May 13,
2011), 76 FR 29014 (May 19, 2011) (SR-NASDAQ-2011-066)
(``Professional Filing''). In this filing, the Exchange addressed
the perceived favorable pricing of Professionals who were assessed
fees and paid rebates like a Customer prior to the filing. The
Exchange noted in that filing that a Professional, unlike a retail
Customer, has access to sophisticated trading systems that contain
functionality not available to retail Customers.
    \12\ See Securities Exchange Act Release No. 64494 (May 13,
2011), 76 FR 29014 (May 19, 2011) (SR-NASDAQ-2011-066).
    \13\ See Securities Exchange Act Release No. 64494 (May 13,
2011), 76 FR 29014 (May 19, 2011) (SR-NASDAQ-2011-066) The Exchange
also in the Professional Filing that it believes the role of the
retail Customer in the marketplace is distinct from that of the
Professional and the Exchange's fee proposal at that time accounted
for this distinction by pricing each market participant according to
their roles and obligations.
    \14\ If a Professional earned a Tier 1 rebate, the Professional
would continue to receive a lower rebate as compared to a NOM Market
Maker and a higher rebate as compared to a Firm and a Non-NOM Market
Maker, as is the case today. The rebate differential, however, for a
Professional as compared to a Firm and a Non-NOM Market Maker would
be lower than it is today.
---------------------------------------------------------------------------

    Additionally, the Exchange believes the proposed tiered Rebates to
Add Liquidity in Penny Pilot Options are reasonable, equitable and not
unfairly discriminatory because the rebates are similar to a tiered
rebate offered by NYSE Arca, Inc. (``NYSE Arca''). NYSE Arca pays a per
contract rate on all posted liquidity in Customer Penny Pilot Issues by
aggregating total contracts from customer posted orders in Penny Pilot
Issues in a given month.\15\ Of note, NYSE Arca does not have a
professional category similar to NOM and therefore, orders that would
otherwise be classified as Professionals orders on NOM \16\ are being
counted towards customer volume at NYSE Arca.
---------------------------------------------------------------------------

    \15\ See NYSE Arca's Fee Schedule.
    \16\ See Securities Exchange Act Release No. 63028 (October 1,
2010), 75 FR 62443 (October 8, 2010) (SR-NASDAQ-2012-099). In this
rule filing, the Exchange noted that NOM Participants will be
required appropriately to mark all Professional orders. To comply
with this requirement, Participants will be required to review their
Public Customers' activity on at least a quarterly basis to
determine whether orders that are not for the account of a broker-
dealer should be represented as Professional orders.
---------------------------------------------------------------------------

    The Exchange proposes to count both Customer and Professional
orders in the number of contracts eligible for the Rebate to Add
Liquidity in Penny Pilot Options. NOM Participants would

benefit from the addition of Professional orders to the number of
contracts eligible for the rebate and as a result may qualify for a
higher tier. The Exchange believes the addition of Professional orders
to the types of orders eligible for a rebate tier is reasonable because
it will incentivize NOM Participants to send additional Professional
orders to the Exchange as well as Customer orders. The Exchange
believes that adding Professional orders to the types of orders
eligible for a rebate tier is equitable and not unfairly discriminatory
because all NOM Participants will benefit from the additional liquidity
the amendment may attract to the Exchange as a result of the increased
incentive to send Professional as well as Customer orders. Also, all
NOM Participants are eligible for the rebate and are able to earn a
rebate by simply transacting one Customer or Professional order in a
Penny Pilot Option.\17\
---------------------------------------------------------------------------

    \17\ A NOM Participant qualifies for a Tier 1 rebate of $0.26
per contract by adding Customer and Professional liquidity of up to
34,999 contracts per day in a month.
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule changes will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.
    While the Exchange's proposal would result in a Professional
receiving a higher rebate as compared to a NOM Market Maker if a
Professional qualified for a Tier 2, 3 or 4 rebate and the differential
in the rebate would increase as between a Professional and a Firm and a
Non-NOM Market Maker, the Exchange does not believe the proposed rebate
tiers would result in any burden on competition as between market
participants on NOM. The Exchange does not believe that the amount of
the rebate offered by the Exchange has a material impact on a NOM
Participant's ability to execute orders in Penny Pilot Options.
    The Exchange has been assessing the impact of rebates since it
first began to offer them and has also observed the impact of fees and
rebates on other options exchanges in terms of quoting and liquidity.
The Exchange believes that the Fees for Adding Liquidity, as compared
to rebates, impact a market participant's decision-making more
prominently with respect to posting order flow on different venues and
price. The Exchange does not believe that allowing a Professional to
obtain a higher rebate than other market participants, if a certain
number of contracts where to be executed on the Exchange, results in a
burden on competition among market participants on NOM for the reasons
noted herein.
    The Exchange believes that offering Professionals the proposed
tiered rebates creates competition among options exchanges because the
Exchange believes that the rebates may cause market participants to
select NOM as a venue to send Professional order flow. The fees that
the Exchange assesses are not being amended with this proposal, rather
the Exchange is offering to pay increased rebates in exchange for
additional Professional order flow being executed at the Exchange,
which additional order flow should benefit other market participants.
    The Exchange operates in a highly competitive market comprised of
eleven U.S. options exchanges in which sophisticated and knowledgeable
market participants can readily send order flow to competing exchanges
if they deem fee levels at a particular exchange to be excessive. The
Exchange believes that the proposed rebate structure and tiers are
competitive with rebates and tiers in place on other exchanges. The
Exchange believes that this competitive marketplace impacts the rebates
present on the Exchange today and substantially influences the
proposals set forth above.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\18\ At any time within 60 days of the
filing of the 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 to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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_ADDRESS>Please include
File Number SR-NASDAQ-2012-141 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2012-141. 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 Web site (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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2012-141, and should be submitted on or before February 5, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-00634 Filed 1-14-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27650-27651]
[FR Doc No: 2022-09888]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1112]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Interstate Shellfish
Dealer's Certificate and Participation in the National Shellfish
Sanitation Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by June 8, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0021. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Interstate Shellfish Dealer's Certificate and Participation in the
National Shellfish Sanitary Program

OMB Control Number 0910-0021--Extension

    Under section 243 of the Public Health Service Act (42 U.S.C. 243),
FDA is required to cooperate with and aid State and local authorities
in the enforcement of their health regulations and is authorized to
assist States in the prevention and suppression of communicable
diseases. Under this authority, FDA participates with State regulatory
agencies, some foreign nations, and the U.S. molluscan shellfish
industry in the National Shellfish Sanitation Program (NSSP).
    The NSSP is a voluntary, cooperative program to promote the safety
of molluscan shellfish by providing for the classification and patrol
of shellfish growing waters and for the inspection and certification of
shellfish dealers. Each participating State and foreign nation monitors
its molluscan shellfish production and issues certificates for those
dealers that meet the State or foreign shellfish control authority's
criteria. Each participating State and nation provides a certificate of
its certified shellfish dealers to FDA on Form FDA 3038, ``Interstate
Shellfish Dealer's Certificate'' (available at https://www.fda.gov/media/72094/download). FDA uses this information to publish the
``Interstate Certified Shellfish Shippers List (ICSSL),'' a monthly
comprehensive listing of all molluscan shellfish dealers certified
under the cooperative program (available at https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list). If FDA did not collect the information necessary to compile this
list, participating States would not be able to identify and prevent
the distribution in the United States of shellfish processed by
uncertified dealers. Consequently, the NSSP would not be able to
control the distribution of uncertified and possibly unsafe shellfish
in interstate commerce. Without the ICSSL, the effectiveness of the
NSSP would be nullified. The ICSSL is also used to identify U.S.
shellfish dealers eligible to obtain health certificates and export to
certain countries or regions.
    FDA has been collecting information to construct the ICSSL since
2001. FDA is seeking to add one new data field to Form FDA 3038, the
``FDA Establishment Identifier'' (FEI number). The FEI number is a
unique number assigned by FDA to identify FDA-regulated facilities. FDA
will explore whether the FEI can be used to retrieve data on shellfish
dealers from existing FDA systems, which could reduce the number of
required data elements that firms have to submit on Form FDA 3038.
    The information collection also includes providing certain
documents demonstrating compliance with the NSSP. When a competent
authority in another country conducts an evaluation to determine
whether the U.S. food safety control measures for molluscan shellfish
are equivalent to their system of controls, the competent authority may
require FDA to provide information and records demonstrating compliance
with the provisions of the NSSP. Only those firms that comply with the
NSSP would be permitted to export molluscan shellfish to a country
whose competent authority determined that the U.S. system of controls
is equivalent to their own controls. FDA uses this information to
support the export of U.S. shellfish to countries whose competent
authorities have determined the U.S. system of food safety controls to
be equivalent to their own system of controls by demonstrating that the
exporter is in compliance with the U.S. system of controls specified in
the NSSP.
    For example, to implement the European Commission's (EC)
determination that the U.S. system of food safety controls for raw
bivalve molluscan shellfish is equivalent to the European Union's (EU)
system of controls, the EC is requiring FDA to provide documentation
collected from NSSP-participating shellfish control authorities with
firms seeking to export raw molluscan shellfish to the EU. This
documentation includes, but is not limited to:
     A list of growing areas with an Approved classification;
     the most recent sanitary survey for each growing area with
an Approved classification; and
     the most recent inspection report for each firm seeking to
export shellfish to the EU.
    Some competent authorities may require additional information to
conduct an equivalence assessment or to implement an equivalence
determination, or both. We plan to provide respondents with information
about the specific documentation that is required for each equivalence
assessment. For those competent authorities that recognize the U.S.
system as equivalent, additional documentation may be needed to
implement that determination.
    Description of Respondents: Respondents to this collection are
participating State and local regulatory agencies and foreign nations.

    In the Federal Register of November 4, 2022 (86 FR 60840), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Number of
              Activity                 Form FDA No.      Number of     responses per   Total annual       Average burden per response       Total hours
                                                        respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish              3038              40              57           2,280  0.10 (6 minutes)..................             228
 Dealer's Certificate.
Submission of Other Records Related              N/A              13               1              13  0.25 (15 minutes).................            3.25
 to Participation in the NSSP.
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ..............  ..............  ..............  ..............  ..................................          231.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. This estimate is based on our experience with this
information collection and the number of certificates received in the
past 3 years, which has remained constant.

    Dated: May 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09888 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54613-54615]
[FR Doc No: 2019-22117]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0944]

Investigational In Vitro Diagnostics in Oncology Trials:
Streamlined Submission Process for Study Risk Determination; Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined
Submission Process for Study Risk Determination.'' This guidance,
developed by the Oncology Center of Excellence at FDA, describes an
optional streamlined submission process to determine whether use of an
investigational in vitro diagnostic in an oncology clinical trial is
considered significant risk, nonsignificant risk, or exempt from
investigational device exemption requirements. In the streamlined
process, the sponsor submits all information about the oncology trial
(including information about the investigational in vitro diagnostic)
to the investigational new drug application (IND). As part of IND
review, the Center for Biologics Evaluation and Research (CBER) works
with the Center for Drug Evaluation and Research (CDER), or CDER or
CBER works with the Center for Devices and Radiological Health (CDRH),
as appropriate, to determine if the investigational in vitro diagnostic
is significant risk, nonsignificant risk, or exempt.

DATES: The announcement of the guidance is published in the Federal
Register on October 10, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-0944 for ``Investigational In Vitro Diagnostics in Oncology
Trials: Streamlined Submission Process for Study Risk Determination.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of
Communication and Education, CDRH-Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver
Spring, MD 20993-0002; or the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julie Schneider, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2208, Silver Spring, MD 20993,<PHONE_NUMBER>; Yun-Fu Hu,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5676, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Investigational In Vitro Diagnostics in Oncology Trials:
Streamlined Submission Process for Study Risk Determination.'' This
guidance describes an optional streamlined submission process for
determining whether use of an investigational in vitro diagnostic in an
oncology clinical trial under an IND (an oncology codevelopment
program) is significant risk, nonsignificant risk, or exempt from
investigational device exemption requirements.
    In the traditional submission process, many sponsors submitted a
study risk determination Q-submission to the appropriate center (CDRH
or CBER) and an IND to the appropriate center (CBER or CDER). In the
streamlined process, all information regarding the oncology
codevelopment program (including investigational in vitro diagnostic
information) is initially submitted to the IND. CBER or CDER works with
CDRH or CDER works with CBER, as appropriate, to determine whether the
investigational in vitro diagnostic is significant risk, nonsignificant
risk, or exempt. If the investigational in vitro diagnostic in the
trial is determined to be significant risk in the streamlined process,
the sponsor may need to submit an investigational device exemption to
CDRH in addition to submitting an IND to CDER.
    This guidance finalizes the draft guidance of the same name issued
on April 16, 2018 (83 FR 16366). All public comments received on the
draft guidance have been considered, and the guidance has been revised
as appropriate along with a few editorial changes. Major changes from
the draft to the final version included adding language to clarify that
sponsors will receive significant risk determinations within the 30-day
review period for the IND and to clarify that the streamlined
submission process only applies to new INDs (not additional protocols
added to an existing IND, or IND amendments) and adding the definition
of noninvasive in 21 CFR 812.3(k) to the glossary.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Investigational In Vitro Diagnostics in
Oncology Trials: Streamlined Submission Process for Study Risk
Determination.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of
information. These collections of information are subject to review by
the Office of

Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
809 have been approved under OMB control number 0910-0485. The
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0755. The collections of information in
21 CFR 56.115 have been approved under OMB control number 0910-0130.
The collections of information in 21 CFR 50.23 have been approved under
OMB control number 0910-0586. The collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078. The
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073. The collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014; and the
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001. The collections of information in the
guidance document entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (available at
https://www.fda.gov/media/114034/download) have been approved under OMB
control number 0910-0756.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22117 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P