[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49987-49993]
[FR Doc No: 2016-17903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Medical Device User Fee Rates for Fiscal Year 2017

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) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 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. This notice establishes
the fee rates for FY 2017, which apply from October 1, 2016, through
September 30, 2017. 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 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 making your submission to FDA; if you do not
qualify as a small business before making your submission to FDA, you
will have to pay the higher standard fee. 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 2017, you should
not submit a FY 2017 Small Business Qualification and Certification
request. This document provides information on how the fees for FY 2017
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/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
    For questions relating to this notice: Maurille Beheton, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202C), Silver Spring, MD 20993-0002,<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 2017 is
$268,443. From this starting point, this document establishes FY 2017
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 2017 is $3,872. 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 2017

    The total revenue amount for FY 2017 is $130,184,348, as set forth
in the statute prior to the inflation adjustment and offset of excess
collections (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 2017 are described
in this document.

A. Inflation Adjustment

    MDUFA specifies that the $130,184,348 is to be adjusted for
inflation increases for FY 2017 using two separate adjustments--one for
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)). The
base inflation adjustment for FY 2017 is the sum of one plus these two
separate adjustments, and is compounded as specified (see 21 U.S.C.
379j(c)(2)(C)(1) and 379j(c)(2)(B)(ii)).
    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 2017.
The 3-year average is 1.8759 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
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                                                                                3-Year
              Fiscal Year                       2013               2014               2015            average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................     $1,927,703,000     $2,054,937,000     $2,232,304,000  ..............
Total FTE..............................             13,974             14,555             15,484  ..............
PC&B per FTE...........................           $137,949           $141,184           $144,168  ..............
Percent change from previous year......            1.1690%            2.3451%            2.1136%         1.8759%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8759 percent multiplied by 60 percent,
or 1.1255 percent.
    The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2017 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)).
    Table 2 provides the summary data and the 3-year average 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
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                                                                                3-Year
                   Fiscal year                         2013            2014            2015           average
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Annual CPI......................................         152.500         154.847         155.353  ..............
Annual Percent Change...........................         1.5232%         1.5390%         0.3268%  ..............
3-Year Avg. Percent Change in CPI...............  ..............  ..............  ..............         1.1297%
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 1.1297 percent multiplied by 40 percent,
or 0.4519 percent.
    Next, the payroll adjustment (1.1255 percent or 0.011255) is added
to the non-pay adjustment (0.4519 percent or 0.004519), for a total of
1.5774 percent (or 0.015774). To complete the inflation adjustment, 1
(100 percent or 1.0) is added for a total base inflation adjustment of
1.015774 for FY 2017.
    MDUFA III provides for this inflation adjustment to be compounded
for FY 2015 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2017
(1.015774) is compounded by multiplying it by the compounded applicable
inflation adjustment for FY 2016 (1.064457), as published in the
Federal Register of August 3, 2015 (80 FR 46033 to 46039), to reach the
applicable inflation adjustment of 1.081248 (rounded) (1.015774 times
1.064457) for FY 2017. We then multiply the total revenue amount for FY
2017 ($130,184,348) by 1.081248, yielding an inflation adjusted total
revenue amount of $140,762,000 (rounded to the nearest thousand
dollars).

 B. Offset for Excess Collections Through FY 2016

    Under the offset provision of the FD&C Act (see section 738(i)(4)
(21 U.S.C. 379j(i)(4))), if the cumulative amount of fees collected
during FY 2013 through FY 2015, added to the amount estimated to be
collected for FY 2016, exceeds the cumulative amount appropriated for
these four FYs, the excess shall be credited to the appropriation
account of the Food and Drug Administration and shall be subtracted
from the amount of fees that would otherwise be authorized to be
collected for FY 2017. Table 3 presents the amount of MDUFA fees
collected during FY 2013 through FY 2015 (actuals), and the amount
estimated to be collected for FY 2016, and compares those amounts with
the fees specified to be appropriated in these four FYs.

          Table 3--Statement of Fees Appropriated, Fees Collected, and Differences as of June 30, 2016
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                                                          Fee
                    Fiscal year                      appropriated   Fees collected    Difference
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2013 Actual.......................................     $97,722,000    $103,991,182      $6,269,182
2014 Actual.......................................     114,833,000     124,297,628       9,464,628
2015 Actual.......................................     128,282,000     139,712,238      11,430,238
2016 Estimate.....................................     134,667,000     134,667,000               0
                                                   -------------------------------------------------------------
    Total.........................................     478,504,000     505,668,048      27,164,048
Unearned Revenue Included in Above Amount.........  ..............  ..............      12,485,897
Excess Collections Less Unearned Revenue (Offset    ..............  ..............      14,678,151
 Amount)..........................................
----------------------------------------------------------------------------------------------------------------

    The total amount FDA expects to have collected in excess of
appropriations by the end of FY 2016 is $27,164,048. However, of that
amount, a total of $12,485,897 represents unearned revenue--primarily
fees paid for applications that have not yet been received. The
unearned revenue is held in reserve either to refund, if no application
is submitted, or to apply toward the future FY when the application is
received. The net of these two figures, $14,678,151, is the amount that
FDA has received in excess of appropriations that is available for
obligation, and the amount by which fee revenue will be offset in FY
2017.
    For FY 2017, the statute authorizes $140,762,000 in user fees. In
order to determine the revised collection amount, we deduct the net
excess collection amount of $14,678,151 from $140,762,000, and the
revised revenue target for FY 2017 becomes $126,083,000 (rounded down
to the nearest thousand dollars).

III. Fees for FY 2017

    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)). Table 4 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 2017. Most of the fee paying submission counts are
published in the MDUFA Financial Report to Congress each year.

                                Table 4--3-Year Average of Fee Paying Submissions
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                                                      FY 2013         FY 2014         FY 2015         3-Year
                Application type                      actual          actual          actual          average
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Full Fee Applications...........................              23              25              42              30
    Small Business..............................               9               5               7               7
Panel-Track Supplement..........................              19              12              22              18
    Small Business..............................               0               3               3               2
180-Day Supplements.............................             128             122             143             131
    Small Business..............................              21              24              15              20
Real-Time Supplements...........................             182             192             204             193
    Small Business..............................              23              19              28              23
510(k)s.........................................           3,149           3,034           2,768           2,984
    Small Business..............................           1,202           1,037           1,037           1,092
30-Day Notice...................................             956             934             920             937
    Small Business..............................              69              91              71              77
513(g) (21 U.S.C. 360c(g)) Request for                        65              69              75              70
 Classification Information.....................
    Small Business..............................              38              31              33              34
Annual Fee for Periodic Reporting \1\...........             614             514             544             557
    Small Business \1\..........................              54              56              68              59
Establishment Registration \2\..................          23,477          24,026          25,363          24,289
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\1\ Includes collection of quarter 4 billing for FY 2015 during FY 2016.
\2\ Establishment Registration total comes from the registration system and will vary from the financial report.

    The information in table 4 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 5
displays both the estimated revenue using the FY 2017 base fees set in
statute and the estimated revenue after the inflation adjustment and
offset of excess collections to the FY 2017 base fees. Using the fees
set in statute and the 3 year averages of fee paying submissions, the
collections would total $144,335,998, which is $18,252,998 higher than
the statutory revenue limit. Accordingly the PMA and establishment fee
need to be decreased so that collections come as close to the statutory
revenue limit of $126,083,000 as possible without exceeding the limit.
This is done by calculating the percentage difference between the
statutory revenue limit and the estimated resulting 2017 revenue
collections, and then lowering the fees proportionally by that
percentage (rounded to the nearest dollar). The fees in the second
column from the right are those we are establishing in FY 2017, which
are the standard fees.

                           Table 5--Fees Needed To Achieve New FY 2017 Revenue Target
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                                                                                Adjusted FY
                                                      FY 2017                      2017 fees to
                                                     Statutory       Estimated     meet revenue       FY 2017
                Application type                    fees  (base      resulting        target       Revenue from
                                                       fees)       2017  revenue     (standard     adjusted fees
                                                                                fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................        $268,443      $8,053,290        $234,495      $7,034,850
    Small Business..............................          67,111         469,777          58,624         410,368
Panel-Track Supplement..........................         201,332       3,623,976         175,871       3,165,678
    Small Business..............................          50,333         100,666          43,968          87,936
180-Day Supplements.............................          40,266       5,274,846          35,174       4,607,794
    Small Business..............................          10,067         201,340           8,794         175,880
Real-Time Supplements...........................          18,791       3,626,663          16,415       3,168,095
    Small Business..............................           4,698         108,054           4,104          94,392
510(k)s.........................................           5,369      16,021,096           4,690      13,994,960
    Small Business..............................           2,685       2,932,020           2,345       2,560,740
30-Day Notice...................................           4,295       4,024,415           3,752       3,515,624
    Small Business..............................           2,148         165,396           1,876         144,452
513(g) Request for Classification Information...           3,624         253,680           3,166         221,620
    Small Business..............................           1,812          61,608           1,583          53,822
Annual Fee for Periodic Reporting...............           9,396       5,233,572           8,207       4,571,299
    Small Business..............................           2,349         138,591           2,052         121,068
Establishment Registration......................           3,872      94,047,008           3,382      82,145,398
                                                 ---------------------------------------------------------------
    Total.......................................  ..............     144,335,998  ..............     126,073,976
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $234,495 for FY 2017. 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 510(k) premarket notification, 2 percent of the
standard fee;
     For a 30-day notice, 1.6 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 $3,382 for FY 2017. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 6 summarizes the FY 2017 rates for all medical device fees.

                                    Table 6--Medical Device Fees for FY 2017
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                                                 Standard fee  (as a percent of
             Application fee type                    the standard fee  for a          FY 2017      FY 2017 Small
                                                     premarket application)        Standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under    Base fee specified in statute at        $234,495         $58,624
 section 515(c)(1) of the FD&C Act (21 U.S.C.    $268,443, but multiplied by
 360e(c)(1)), a PDP submitted under section      87.3538 percent.
 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.............................         234,495          58,624
 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under   100.............................         234,495          58,624
 section 351 of the PHS Act).
Panel-track supplement........................  75..............................         175,871          43,968
180-day supplement............................  15..............................          35,174           8,794
Real-time supplement..........................  7...............................          16,415           4,104
510(k) premarket notification submission......  2...............................           4,690           2,345
30-day notice.................................  1.60............................           3,752           1,876
513(g) request for classification information.  1.35............................           3,166           1,583
Annual Fee Type:
    Annual fee for periodic reporting on a      3.50............................           8,207           2,052
     class III device.
    Annual establishment registration fee (to   Base fee specified in statute at           3,382           3,382
     be paid by the establishment engaged in     $3,872, but multiplied by
     the manufacture, preparation,               87.3538 percent.
     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. 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 2016, your
status as a small business will expire at the close of business on
September 30, 2016. You must re-qualify for FY 2017 in order to pay
small business fees during FY 2017.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2017, you must submit the following to FDA:
    1. A completed FY 2017 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
    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 2016,
except:
    If you submit your FY 2017 MDUFA Small Business Qualification
before April 15, 2017, and you have not yet filed your return for 2016,
you may use tax year 2015.
    If you submit your FY 2017 MDUFA Small Business Qualification on or
after April 15, 2017, and have not yet filed your 2016 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 2017, you must submit the following:
    1. A completed FY 2017 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
    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 (2016 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 between October 1, 2016, and September 30,
2017, you must pay the fee in effect for FY 2017. 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 2016 or FY 2017 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, 2016. One choice is for
applications and fees that will be received on or before September 30,
2016, which are subject to FY 2016 fee rates. A second choice is for
applications and fees received on or after October 1, 2016, which are
subject to FY 2017 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. Once you search for your
invoice, click ``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 less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
drawn on 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 the 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. 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:
U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Road, 14th Floor, Silver Spring, MD
20993-0002.
    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.

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 one of the following addresses:
    1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Control Center, 10903 New Hampshire Ave., Building 66, Rm.
0609, Silver Spring, MD 20993-0002.
    2. Biologics license applications and other medical device
submissions reviewed by the Center for Biologics Evaluation and
Research should be sent to: Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave, Building 71, Rm. G112, Silver Spring, MD 20993-0002.

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 PMA.
    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). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. Once you search for your invoice, click ``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 less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be drawn on 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 invoice number on the check.
     Mail the paper check and a copy of 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.)

    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 the 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 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. 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:
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, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.

VII. Procedures for Paying Annual Establishment Fees

    To pay the annual establishment fee, firms must access the Device
Facility User Fee (DFUF) Web site at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site 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 2017
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. 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 2016 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 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:
    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. If you have any questions
concerning courier delivery contact the 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 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. 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: U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver Spring, MD 20993-0002. (If
needed, FDA's tax identification number is 53-0196965.)

C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2017, or To Register a New Establishment for
FY 2017

    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 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 2016.
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. 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
BERS should be directed to http://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 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17903 Filed 7-28-16; 8:45 am]
 BILLING CODE 4164-01-P


 [Federal Register: September 27, 2002 (Volume 67, Number 188)] [Notices] [Page 61094 61097] From the Federal Register Online via GPO Access [wais. access. gpo. gov] [DOCID: fr27se02 93]

ENVIRONMENTAL PROTECTION AGENCY [OPP 2002 0257; FRL 7275 4]

Nominations for FIFRA Scientific Advisory Panel; Request for Comments AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: This notice provides the names, addresses, professional affiliations, and selected biographical data of persons nominated to serve on the Federal Insecticide, Fungicide, and Rodenticide Act, Scientific Advisory Panel (FIFRA)/( SAP) established under section 25( d) of the FIFRA. The Panel was created on November 28, 1975, and made a statutory Panel by amendment to FIFRA, dated October 25, 1988. Public comment on the nominations is invited, as these comments will be used to assist the Agency in selecting three new chartered Panel members.

[[ Page 61095]]

DATES: Comments, identified by docket ID number OPP 2002 0257, must be received on or before October 28, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0257 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Steven Knott, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (202) 564 8450; fax number (202) 564 8382; e mail address:  knott. steven@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does This Action Apply to Me?

This action is directed to the public in general. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of This Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at  http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register Environmental Documents. '' You can also go directly to the Federal Register listings at  http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number OPP 2002 0257. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is availabe for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall <greek i> 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305 5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0257 in the subject line on the first page of your response. 1. By mail. Submit your written comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your written comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall <greek i> 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305 5805. 3. Electronically. You may submit your comments electronically by e mail to:  opp docket@ epa. gov. Do not su bmit any information electronically that you consider to be CBI. Use WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format, and avoid the use of special characters or any form of encryption. Be sure to identify by docket ID number OPP 2002 0257. You may also file a request online at many Federal Depository Libraries.

II. Background Amendments to FIFRA enacted November 28, 1975, include a requirement under section 25( d) that notices of intent to cancel or reclassify pesticide registrations pursuant to section 6( b)( 2), as well as proposed and final forms of rulemaking pursuant to section 25( a), be submitted to FIFRA/ SAP prior to being made public or issued to a registrant. In accordance with section 25( d), the FIFRA/ SAP is to have an opportunity to comment on the health and environmental impact of such actions. The Panel shall also make comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of analyses made by Agency scientists. In accordance with the statute, the FIFRA/ SAP is composed of seven permanent members, selected and appointed by the Deputy Administrator of EPA from nominees submitted by both the National Science Foundation (NSF) and the National Institutes of Health (NIH). The Agency is, at this time, selecting three new members to serve on the Panel as a result of membership terms that will expire this year. EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) requested nominations of experts to be selected from, but not limited to, the fields of pediatric medicine, biostatistics, and toxicology/ veterinary medicine. Nominees should be well published and current in their fields of expertise. The statute further stipulates that we publish the name, address, professional affiliation, and a brief biographical sketch of each nominee in the Federal Register and solicit public comments concerning the candidates nominated.

III. Charter A Charter for the FIFRA/ SAP, dated October 25, 2000, was issued in accordance with the requirements of the Federal Advisory Committee Act (FACA), Public Law 92 463, 86 Stat. 770 (5 U. S. C. App. I). The qualifications of members as provided by the Charter follow.

A. Qualifications of Members Members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact on health and the environment of regulatory actions under sections 6( b) and 25( a) of FIFRA. No persons shall be ineligible to serve on the Panel by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except EPA). The Deputy Administrator appoints individuals to serve on the Panel for staggered terms of 4 years. Panel members are subject to the provisions of 40 CFR part 3, subpart F, Standards of Conduct for Special Government Employees, which include rules regarding conflicts of interest. Each nominee selected by the Deputy Administrator, before being formally appointed, is required to submit a [[ Page 61096]]

Confidential Statement of Employment and Financial Interests, which shall fully disclose, among other financial interests, the nominee's sources of research support, if any. In accordance with section 25( d) of FIFRA, the Deputy Administrator shall require all nominees to the Panel to furnish information concerning their professional qualifications, educational background, employment history, and scientific publications. The Agency is required to publish in the Federal Register the name, address, and professional affiliations of each nominee and to seek public comment on the nominees.

B. Applicability of Existing Regulations With respect to the requirements of section 25( d) of FIFRA that the Administrator promulgate regulations regarding conflicts of interest, the Charter provides that EPA's existing regulations applicable to special government employees, which include advisory committee members, will apply to the members of the FIFRA/ SAP. These regulations appear in 40 CFR part 3, subpart F. In addition, the Charter provides for open meetings with opportunities for public participation.

C. Process of Obtaining Nominees In accordance with the provisions of section 25( d) of FIFRA, EPA, in April 2002, requested the NIH and NSF to nominate scientists to fill three vacancies occurring on the Panel. The Agency requested nomination of experts in the fields of toxicology/ veterinary medicine, clinical pediatric research, and biostatistics, and related fields. NIH and NSF responded by letter, providing the Agency with six nominees each. Three of the twelve nominees withdrew their names from consideration, because they believed their current responsibilities would preclude active participation in FIFRA/ SAP meetings.

IV. Nominees The following are the names, addresses, professional affiliations, and selected biographical data of nominees being considered for membership on the FIFRA/ SAP. The Agency expects to select three of the nominees to fill three vacancies occurring during the calendar year 2002.

A. Nominations for the Field of Toxicology/ Veterinary Medicine 1. Nominee. Faustman, Elaine M., Ph. D., D. A. B. T., Professor and Director, Institute for Risk Analysis and Risk Communication, School of Public Health and Community Medicine, University of Washington. i. Expertise. Reproductive and developmental toxicology of metals, in vitro and molecular biological methodologies, quantitative risk assessment. ii. Education. A. B. Chemistry and Zoology, Hope College, 1976; Ph. D., Pharmacology/ Toxicology, Michigan State University, 1980; postdoctoral studies in Toxicology and Environmental Pathology, School of Medicine, University of Washington. iii. Professional experience. Dr. Faustman has served on the National Institute of Environmental Health Sciences/ National Toxicology Program (NIEHS NTP) Board of Scientific Counselors and the National Academy of Sciences Committee in Toxicology. She has also served as Associate Editor of Fundamental and Applied Toxicology and on the editorial boards of Reproductive Toxicology and Toxicology Methods. Dr. Faustman is the Director of EPA NIEHS funded Child Health Care Center which is evaluating key mechanisms defining children's susceptibility to pesticides. She is an elected Fellow of the American Association for the Advancement of Science, and has recently served as Chair for the American Academy of Sciences Committee on Developmental Toxicology. She is a member of the NIEHS NTP Committee on Alternative Toxicology Methods. 2. Nominee. Froines, John R., Ph. D., Professor, Department of Environmental Health Sciences, UCLA School of Public Health; Director, UCLA Center for Occupational and Environmental Health; Director, Southern California Particle Center and Supersite. i. Expertise. Chemical toxicology and risk assessment, biomarkers and toxicokinetics of chemical carcinogens, policy and priorities in environmental and occupational health. ii. Education. B. S. Chemistry, University of California, Berkeley, 1963; M. S., Physical Organic Chemistry, Yale University, 1964; Ph. D., Physical Organic Chemistry, Yale University, 1967. iii. Professional experience. Dr. Froines has served on the National Academy of Sciences (NAS) Committee on Environmental Epidemiology, including principal authorship of two chapters on exposure assessment in two NAS reports. He has served as chair of the Advisory Panel for the Office of Technology Assessment project, `` Gauging Control Technology and Regulatory Impacts in Occupational Safety and Health'' (1992 1995). He has served on the Federal Committee to the Department of Energy (DOE) on the Beryllium Standard (1997 1998), on the Carcinogen Identification Committee (1995 2001), and the President's (University of California U. C.) committees on health, safety, and environmental concerns with the three national laboratories managed by U. C. Dr. Froines is presently Chairman of the Scientific Review Panel, Air Resources Board; member of the National Toxicology Program Board of Scientific Counselors; member of several committees of the South Coast Air Quality Management District in southern California, and a member of the Scientific Advisory Board, Center for Vulnerable Populations Research. 3. Nominee. Isom, Gary E., Ph. D., Professor of Toxicology, Vice President for Research, and Dean of the Graduate School, Purdue University. i. Expertise. Chemical and cyanide toxicology and related neurological disorders. ii. Education. B. S., Pharmacy, Idaho State University, Ph. D., Pharmacology, Washington State University, 1973. iii. Professional experience. Associate Professor of Toxicology at Idaho State University and at Purdue University. Dr. Isom has served on numerous review panels for NIH and NSF. He has published in the journals Toxicology and Applied Pharmacology, Journal of Neurochemistry, Neurotoxicology, and the Journal of Pharmacology and Experimental Therapeutics. Dr. Isom presently serves on the Advisory Committee for the Engineering Directorate at NSF. In 1999 he was appointed to the Science and Technology Advisory Board of the Defense Intelligence Agency. 4. Nominee. Russell, Stephen W., D. V. M., Ph. D., Wilkinson Distinguished Professor of Cancer Research, University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, KS (emeritus since 2001). i. Expertise. Immunopathology. ii. Education. B. S. Enology, University of California, Davis, 1960; D. V. M., UC Davis, 1966; Ph. D., Comparative Pathology, UC Davis, 1972; postdoctoral fellowship, Scripps Clinic and Research Foundation, immunopathology, 1972 1973. iii. Professional experience. Dr. Russell has served as member and as Chair of the Animal Resources Review Committee of NIH (1986 1990). He has served on a Special Review Committee on Animal Models of Solid Tumors for NIH; the Immunological Sciences Review Panel, US Army Breast Cancer Research Program; and on the Board of Scientific Counselors, National Center for Research Resources, NIH. Dr. Russell has served on editorial boards of, and [[ Page 61097]]

has published in, several professional journals, including Journal of Leucocyte Biology, Journal of Immunology, Yearbook of Pathology and Clinical Pathology, Infection and Immunity, and Gene. Dr. Russell was Director of the University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, KS from 1991 1995. He was Associate Director for Research at the University of Kansas Cancer Center from 1987 1991. From 1980 1987 he was Professor and Chairman of the Department of Comparative and Experimental Pathology, College of Veterinary Medicine, and Professor, Departments of Pathology and Immunology and Medical Microbiology, College of Medicine, University of Florida, Gainesville, FL.

B. Nominations for the Field of Clinical Pediatrics Research 1. Nominee. Frank, Michael M., M. D., Professor and Chairman, Department of Pediatrics; Professor of Medicine; Professor of Immunology, Duke University. i. Expertise. Pediatric Immunology and Toxicology. Education. A. B., Zoology, University of Wisconsin, 1956; M. D., Harvard Medical School, 1960. ii. Professional experience. Chief, Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 1977 1990; Clinical Director, NIAID, NIH, 1977 1990; Head, Clinical Immunology Section, Laboratory of Clinical Investigation, NIAID, NIH, 1971 1990; Senior Investigator, LCI, NIAID, NIH, 1968 1971. Dr. Frank has served on editorial boards of, and has published in, several professional journals, including Journal of Immunology, Journal of Clinical Investigation, Blood, Reviews in Infectious Diseases, Current Opinions in Pediatrics, and Medicine. 2. Nominee. Handwerger, Stuart, M. D., Director of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Robert and Mary Shoemaker Professor of Pediatrics and Professor of Cell Biology, Neurobiology and Anatomy, University of Cincinnati College of Medicine, Cincinnati, OH. i. Expertise. Placental and uterine biology, fetal and reproductive endocrinology, diagnosis and treatment of growth disorders. ii. Education. B. A., Biological Sciences, Johns Hopkins University, Baltimore, MD, 1960; M. D., University of Maryland, Baltimore, MD, 1964. iii. Professional experience. Professor of Cell Biology, Neurobiology and Anatomy, Senior Member, Developmental Biology Program, Member, Barrett Cancer Center, University of Cincinnati College of Medicine, 1990 to present; Director, Post Doctoral Training, Department of Pediatrics, Cincinnati Children's Medical Center, Cincinnati, OH 1993 to present. Dr. Handwerger was Director of the Division of Endocrinology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, 1979 to 1990. During this same time period, he was a Senior Member, Duke Comprehensive Cancer Center, Duke University School of Medicine.

C. Nominations for the Field of Biostatistics 1. Nominee. Bailer, A. John, Ph. D., Professor, Department of Mathematics and Statistics, and affiliate member, Department of Zoology, Miami University, Oxford, OH. i. Expertise. Biostatistics, risk estimation and characterization. ii. Education. B. S., Mathematics and Statistics, 1978; B. A., Psychology, 1982, Miami University, Oxford, OH; M. A., Quantitative Psychology, University of North Carolina, Chapel Hill, 1984; Ph. D., Biostatistics, University of North Carolina, Chapel Hill, 1986. iii. Professional experience. Professor of Statistics, Miami University, Oxford, OH, 1988 to present; invited participant in technical workshop on Whole Effluent Toxicity sponsored by the Society of Environmental Toxicology and Chemistry, September 1995; member on two subcommittees of the Board of Scientific Counselors of the National Toxicology Program, 1997 to 2000; member of International Statistical Institute risk assessment committee, 2000 to present; member of statistics subcommittee at NIEHS/ NTP Low Dose Peer Review for Endocrine Disruptors, Research Triangle, NC, 2000; member of National Research Council Subcommittee Toxologic Assessment of Low Level Exposures to Chemical Warfare, 2001 to present; consultant to NAS committee `` Implications of Dioxin in the Food Supply'' 2001. 2. Nominee. Doerge, Rebecca W., Ph. D., Associate Professor of Agronomy and Statistics, Purdue University, West Lafayette, IN. i. Expertise. Statistical genomics, biostatistics. ii. Education. B. S., Mathematics, University of Utah, 1986; M. Stat., University of Utah, 1988; Ph. D., Statistics, North Carolina State University, 1993; post doctoral fellow, Department of Biometrics and Plant Breeding, Cornell University, 1995. iii. Professional experience. Dr. Doerge has won awards for her teaching skills, among them, Outstanding Teacher of Undergraduates in the School of Science, Purdue University, 1998. Dr. Doerge has published in Endocrinology, Journal of Immunology, American Journal of Pathology, Statistical Science, Heredity, Genetics, and Trends in Genetics. She will co chair a meeting on Quantitative Genetics and Genomics, in February 2003. 3. Nominee. Heeringa, Steven G., Ph. D., Director of the Division of Surveys and Technologies, Institute for Social Research, University of Michigan, Ann Arbor, MI. i. Expertise. Statistical methods, design and analysis. ii. Education. Ph. D., Biostatistics, University of Michigan. iii. Professional experience Dr. Heeringa has over 25 years of statistical sampling experience, directing the development of the Michigan Institute for Social Research (ISR), national sample design as well as sample designs for ISR's major longitudinal and cross sectional survey programs. During this period he has been actively involved in research in statistical methods and procedures such as weighting, variance estimation and the imputation of missing data that are required in the analysis of sample survey data. His publications in these areas have been extensive. He has served as an advisor to panels of the NIH and the World Health Organization (WHO). Since 2000, Dr. Heeringa has served as an ad hoc member of more than 10 EPA scientific review panels. He teaches survey sampling methods internationally, and serves as a sample design consultant to a wide variety of international research programs.

List of Subjects Environmental protection, Pesticide and pests.

Dated: September 19, 2002. Joseph Merenda, Director, Office of Science Coordination and Policy. [FR Doc.  02 24647  Filed 9 26  02; 8: 45 am] BILLING CODE 6560 50 S


[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Proposed Rules]
[Pages 29219-29222]
[FR Doc No: 2021-11395]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0249; FRL-10022-26-Region 9]

Rescission of Clean Data Determination and Call for Attainment
Plan Revision for the Yuma, AZ 1987 PM10 Moderate Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
rescind its previously issued clean data determination for the Yuma,
Arizona ``Moderate'' nonattainment area for the 1987 24-hour national
ambient air quality standard (NAAQS) for particulate matter with an
aerodynamic diameter less than or equal to a nominal 10 micrometers
(PM10) because recent complete, quality-assured monitoring
data show that the area has subsequently violated this NAAQS. We are
also proposing to find that the Arizona State Implementation Plan (SIP)
is substantially inadequate to attain or maintain the PM10
standard and to call for Arizona to revise the SIP to address this
inadequacy.

DATES: Any comments must arrive by July 1, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2021-0249 at http://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. For either manner of submission, the EPA may publish
any comment received to its public docket. Do not submit electronically
any information you consider to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a language other than English or if
you are a person with disabilities who needs a reasonable accommodation
at no cost to you, please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: John J. Kelly, Air Planning Office
(AIR-2), EPA Region IX,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background
    A. The 1987 PM10 NAAQS
    B. Designation and Classification of the Yuma PM10
Nonattainment Area
    C. The Clean Data Policy and the 2006 Clean Data Determination
II. Current Monitoring Data
III. Proposed Action and Request for Public Comment
IV. Statutory and Executive Order Reviews

I. Background

A. The 1987 PM10 NAAQS

    The EPA sets NAAQS for certain ambient air pollutants at levels
required to protect human health and the environment. The primary NAAQS
represent ambient air quality standards the attainment and maintenance
of which the EPA has determined are requisite to protect public health,
including an adequate margin of safety. The secondary NAAQS represent
ambient air quality standards the attainment and maintenance of which
the EPA has determined are requisite to protect public welfare from any
known or anticipated adverse effects associated with the presence of
such air pollutant in the ambient air. PM10 is one of these
ambient air pollutants for which the EPA has established NAAQS. On July
1, 1987, the EPA promulgated two primary standards for PM10:
A 24-hour standard of 150 micrograms per cubic meter ([mu]g/m\3\) and
an annual PM10 standard of 50 [mu]g/m\3\. The EPA also
promulgated secondary PM10 standards that were identical to
the primary standards.\1\ Effective December 18, 2006, the EPA revoked
the annual PM10 NAAQS but retained the 24-hour
PM10 NAAQS.\2\ Because they are identical, we refer to the
primary and secondary 24-hour standards using the single term, NAAQS.
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    \1\ 52 FR 24634 (July 1, 1987).
    \2\ 71 FR 61144 (October 17, 2006).
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    The 24-hour PM10 NAAQS is attained when the expected
number of exceedances, averaged over a three-year period, is less than
or equal to one. The expected number of exceedances averaged over a
three-year period at any given monitor is known as the PM10
design value for that site. The PM10 design value for the
nonattainment area is the highest design value from a monitor within
that area. The methodologies for calculating expected exceedances for
the 24-hour PM10 NAAQS are found in 40 CFR part 50, appendix
K, Section 2.1(a).

B. Designation and Classification of the Yuma PM10 Nonattainment Area

    Upon enactment of the 1990 Amendments to the Clean Air Act (CAA or
``Act''), the Act itself designated specific areas as nonattainment by
operation of law, and classified these areas as Moderate.\3\ These
areas included all former Group I PM10 planning areas
identified in Federal Register documents published on August 7,
1987,\4\ and October 31, 1990,\5\ and any other areas violating the
1987 PM10 NAAQS prior to January 1, 1989. The EPA published
a Federal Register document announcing the areas designated
nonattainment for PM10 upon enactment of the 1990 CAA
Amendments, known as ``initial'' PM10 nonattainment areas,
on March 15, 1991.\6\ The EPA published a subsequent Federal Register
document correcting some of these areas on August 8, 1991.\7\ These
nonattainment designations and Moderate area classifications were
codified in 40 CFR part 81 on November 6, 1991.\8\ The EPA designated
as ``unclassifiable'' all other areas in the Nation not designated
nonattainment

upon enactment of the 1990 CAA Amendments.\9\
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    \3\ 42 U.S.C. 7407(d)(4)(B), 7513(a).
    \4\ 52 FR 29383.
    \5\ 55 FR 45799.
    \6\ 56 FR 11101.
    \7\ 56 FR 37654.
    \8\ 56 FR 56694.
    \9\ See CAA section 107(d)(4)(B)(iii).
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    The Yuma PM10 nonattainment area (``Yuma NAA'') was one
of the areas specified by Congress and designated by the 1990 CAA
Amendments. Specifically, the Yuma NAA was designated nonattainment by
section 107(d)(4)(B)(i) of the Act and classified as Moderate because
it had been previously categorized as a Group I area.\10\ The EPA
announced the Yuma NAA designation, as required by section 107(d)(2) of
the Act, on March 15, 1991.\11\ In accordance with CAA section
189(a)(2), Arizona was required to submit a SIP revision meeting
applicable nonattainment plan requirements by November 15, 1991,
demonstrating attainment of the 1987 p.m.10 NAAQS in the
Yuma NAA by December 31, 1994.\12\
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    \10\ 52 FR 29383 (August 7, 1987).
    \11\ 56 FR 11101.
    \12\ Arizona submitted a Moderate area plan for the Yuma NAA on
November 14, 1991. The EPA found this plan to be incomplete on May
14, 1992. Arizona submitted a revised plan for the Yuma NAA on July
12, 1994, but withdrew this plan in 2006, following the EPA's
issuance of a clean data determination for the Yuma NAA.
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C. The Clean Data Policy and the 2006 Clean Data Determination

    In nonattainment areas where monitored data demonstrate that the
NAAQS has been attained, the EPA interprets certain requirements of the
Act as no longer being applicable for so long as air quality continues
to meet the NAAQS in the area. This interpretation is known as the
``clean data policy,'' and EPA findings issued under this policy are
known as ``clean data determinations.'' On March 14, 2006, the EPA
issued a clean data determination for the Yuma NAA for the 1987 24-hour
PM10 NAAQS, based on complete, quality-assured and certified
PM10 monitoring data for 2002-2004.\13\ Because the data
from 2002-2004 were complete and showed no exceedances of the relevant
NAAQS, and because preliminary data for 2005 also indicated no such
exceedances, the EPA concluded that the Yuma NAA was in attainment for
the 1987 24-hour PM10 NAAQS.\14\ Based on this finding, the
EPA determined that certain nonattainment plan requirements in the Yuma
NAA were not applicable for so long as the Yuma NAA continued to
monitor attainment of the 1987 24-hour PM10 and annual
NAAQS.\15\
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    \13\ 71 FR 13021 (March 14, 2006).
    \14\ The clean data determination also applied to the annual
PM10 NAAQS, but that NAAQS was revoked later that year.
See 71 FR 61144 (October 17, 2006).
    \15\ In the same Federal Register document, the EPA also
determined pursuant to CAA sections 179(c)(1) and 188(b)(2) that the
Yuma NAA had attained the NAAQS by the Moderate area attainment date
of December 31, 1994. Because that determination was tied to that
specific attainment date, it would not be affected by the rescission
of the clean data determination proposed in this action.
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II. Current Monitoring Data

    In accordance with 40 CFR part 50, appendices J and K, a finding of
whether an area has attained or is currently attaining the 1987 24-hour
PM10 NAAQS must generally be based upon certified, complete,
quality-assured data gathered at monitoring sites in the nonattainment
area and entered into the EPA's Air Quality System (AQS) database. For
the 1987 24-hour PM10 NAAQS, appendix K provides that all
data produced by state and local air monitoring sites (SLAMS) and other
sites submitted to the EPA in accordance with the part 58 requirements
be used for evaluating attainment.\16\
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    \16\ 40 CFR part 50, appendix K, section 2.3(a).
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    In order to assess whether an area is currently attaining the
NAAQS, the PM10 ambient air quality monitoring data
collected by the state within the area for the three-year period must
meet data completeness criteria, or otherwise unambiguously establish
nonattainment according to 40 CFR part 50, appendix K, section 2.3. The
ambient air quality monitoring data completeness requirements are met
when quarterly data capture rates for all four quarters in a calendar
year over a three-year period are at least 75 percent. For purposes of
this proposal, we reviewed the data for the 2017-2019 period for
completeness and determined that the PM10 data met the
completeness criterion for all 12 quarters at the Yuma Supersite
PM10 monitoring site in the Yuma NAA.\17\
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    \17\ EPA, AQS ``Design Value Report,'' dated March 31, 2021.
This report is included in the docket.
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    The Arizona Department of Environmental Quality (ADEQ) is the
governmental agency with the authority and responsibilities under the
State's laws for collecting ambient air quality data for the Yuma NAA.
ADEQ submits annual monitoring network plans to the EPA.\18\ These
plans discuss the status of the ambient air monitoring network, as
required under 40 CFR part 58. The EPA reviews these annual network
plans for compliance with the applicable reporting requirements in 40
CFR 58.10. With respect to PM10, the EPA has found that the
2018-2020 annual network plans submitted by ADEQ, which reflect the
network during the 2017-2019 design value period, met the applicable
requirements under 40 CFR part 58.\19\ Furthermore, we concluded from
our 2018 technical systems audit of ADEQ's ambient air quality
monitoring program that the ambient air monitoring network currently
meets or exceeds the requirements for the minimum number of monitoring
sites designated as SLAMS for PM10 in the Yuma NAA.\20\ ADEQ
certifies annually that the data it submits to AQS are quality-assured
and has done so for each year relevant to our proposed action, 2017-
2019.\21\
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    \18\ See, e.g., ``State of Arizona Air Monitoring Network Plan
for the Year 2020.'' Copies of Arizona's Annual Network Plans for
2018-2020 are included in the docket.
    \19\ See, e.g., letter dated November 8, 2019, from Gwen
Yoshimura, Manager, EPA Region IX, Air Quality Analysis Office, to
Daniel Czecholinksi, Acting Director, Air Quality Division, ADEQ.
Copies of EPA letters responding to Arizona's Annual Network Plans
for 2018-2020 are included in the docket.
    \20\ Letter dated April 25, 2019, from Elizabeth Adams,
Director, EPA Region 9 Air Division to Timothy Franquist, Director,
Air Quality Division, ADEQ, enclosure titled ``Technical Systems
Audit of the Ambient Air Monitoring Program: Arizona Department of
Environmental Quality, April 2-April 6, 2018,'' Network Requirements
section, 8.
    \21\ See, e.g., letter dated April 13, 2020, from Daniel
Czecholinksi, Director, Air Quality Division, ADEQ, to Gwen
Yoshimura, Manager, EPA Region IX, Air Quality Analysis Office.
Copies of ADEQ certifications and their respective transmittal
letters for years 2017-2019 are included in the docket.
---------------------------------------------------------------------------

    Table 1 provides the 2019 p.m.10 design value for the
Yuma Supersite, the sole regulatory monitoring site measuring ambient
PM10 within the Yuma NAA, expressed as a single value
representing the average expected annual exceedances over the three-
year period, 2017-2019. The PM10 data show that the design
value is greater than 1.0 estimated annual average exceedances of the
1987 24-hour PM10 NAAQS. Consequently, the EPA proposes to
determine, based upon three years of complete, quality-assured and
certified data from 2017-2019, that the Yuma NAA is no longer attaining
the 1987 24-hour PM10 NAAQS.

 Table 1--2017-2019 Design Value for the 1987 24-Hour PM10 NAAQS for the
                                Yuma NAA
------------------------------------------------------------------------
                                                  AQS
             Monitoring site                 identification     Design
                                                  No.            value
------------------------------------------------------------------------
Yuma Supersite...........................       04-027-8011         5.7
------------------------------------------------------------------------
Source: EPA, AQS ``Design Value Report,'' dated March 31, 2021, 15.

    We have also reviewed preliminary 2020 data, which indicate that
the Yuma NAA had a 2018-2020 design value of 5.4.\22\ This preliminary
design value

also does not show attainment of the 1987 24-hour PM10 NAAQS
and is therefore consistent with the proposed determination. We also
reviewed preliminary data from the Yuma Supersite monitor for 2021,
which is not a full year of data.\23\ As of March 31, 2021, there were
no exceedances in 2021. We note, however, that even with no exceedances
in 2021, given the number of expected exceedances in the certified year
2019, plus those in the preliminary year 2020, the 2021 three-year
preliminary design value violates the NAAQS and is therefore also
consistent with our proposed determination.
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    \22\ EPA, AQS ``Design Value Report,'' dated March 3, 2021.
    \23\ Id.
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III. Proposed Action and Request for Public Comment

    Based on our proposed determination that the Yuma NAA is no longer
attaining the 1987 24-hour PM10 NAAQS, we propose to rescind
the clean data determination for the Yuma NAA and reinstate the
requirements that were suspended under that determination. We
anticipate that Arizona's submission of a new, approvable Moderate
nonattainment plan in response to the ``SIP call'' discussed below
would satisfy these obligations.
    In addition, we propose to find, pursuant to CAA section 110(k)(5),
that the Arizona SIP is substantially inadequate to attain or maintain
the 1987 24-hour PM10 NAAQS in the Yuma NAA. This proposed
finding is based both on the most recent monitoring data discussed in
section II of this document, as well as longer-term air quality trends
in the Yuma NAA. In particular, we note that the Yuma NAA has had a
violating design value for the 1987 24-hour PM10 NAAQSs
every year since issuance of the clean data determination in 2006.\24\
Collectively, these recent and longer term monitoring data indicate
that the current Arizona SIP is substantially inadequate to attain or
maintain the 1987 24-hour PM10 NAAQS in the Yuma NAA.
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

    In order to address this inadequacy, we propose to issue a SIP call
under CAA section 110(k)(5), requiring the State to submit a SIP
revision establishing that the Yuma NAA meets the applicable
nonattainment plan requirements of the CAA for Moderate PM10
NAAs.\25\ These requirements include: (i) An approved permit program
for construction of new and modified major stationary sources; \26\
(ii) a demonstration that the plan provides for attainment by no later
than the applicable Moderate area attainment date or a demonstration
that attainment by that date is impracticable; \27\ (iii) provisions
for the implementation of reasonably available control measures (RACM)
and reasonably available control technology (RACT); \28\ (iv)
quantitative milestones that will be used to evaluate compliance with
the requirement to demonstrate reasonable further progress (RFP); \29\
(v) evaluation and regulation of PM10 precursors; \30\ (vi)
a description of the expected annual incremental reductions in
emissions that will demonstrate RFP; \31\ (vii) emissions inventories,
as necessary; \32\ (viii) other control measures besides RACM and RACT
as may be needed for attainment; \33\ (ix) contingency measures,\34\
and (x) a motor vehicle emissions budget for the purpose of determining
the conformity of transportation programs and plans developed by state
transportation agencies.\35\ The EPA's longstanding guidance on these
statutory requirements is embodied in the ``The General Preamble for
Implementation of Title I of the Clean Air Act (CAA) Amendments.'' \36\
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    \25\ See CAA section 110(k)(5) (``Any finding under this
paragraph shall, to the extent the Administrator deems appropriate,
subject the State to the requirements of this chapter to which the
State was subject when it developed and submitted the plan for which
such finding was made . . .'').
    \26\ CAA section 189(a)(1)(A).
    \27\ CAA section 189(a)(1)(B).
    \28\ CAA section 189(a)(1)(C).
    \29\ CAA section 189(c).
    \30\ CAA section 189(e).
    \31\ CAA section 172(c)(2).
    \32\ CAA section 172(c)(3).
    \33\ CAA section 172(c)(6).
    \34\ CAA section 172(c)(9).
    \35\ 40 CFR 93.102(b)(1). Effective June 27, 2007 (see 72 FR
32295, June 12, 2007), the EPA found adequate for transportation
conformity purposes the motor vehicle emissions budgets in the Yuma
PM10 Maintenance Plan (August 2006). However, if we take
final action to withdraw the clean data determination and issue a
SIP call, we expect also to reverse our previous finding to a
finding of inadequacy pursuant to 40 CFR 93.118(f)(1)(vi). Our
inadequacy finding for the motor vehicle emissions budget would
require transportation agencies to determine conformity using
interim emission tests pursuant to 40 CFR 93.119, instead of the
current practice of using the past maintenance plan motor vehicle
emissions budgets as part of a budgets test.
    \36\ 57 FR 13498 (April 16, 1992).
---------------------------------------------------------------------------

    We propose to require Arizona to submit this Moderate nonattainment
plan SIP submission within 18 months of finalizing the SIP call, which
is the maximum time permitted under CAA 110(k)(5). This is longer than
the original Moderate nonattainment plan submittal deadline of one year
from the date of the 1990 CAA Amendments under CAA 189(a)(2)(A), but is
in line with the deadline specified in CAA 189(a)(2)(B) for other PM
nonattainment areas.\37\ Similarly, because the original maximum
attainment date for this area was December 31, 1994 (approximately four
years from the original designation),\38\ we propose, pursuant to CAA
110(k)(5), that the new attainment date shall be as expeditious as
practicable, but no later than December 31, 2025.\39\ In line with this
proposed attainment date, we propose to require implementation of RACM/
RACT by no later than January 1, 2025.\40\ Lastly, in the event we
finalize the above proposals, we propose to reverse our previous budget
adequacy finding to a finding of inadequacy pursuant to 40 CFR
93.118(f)(1)(vi).
---------------------------------------------------------------------------

    \37\ CAA section 189(a)(2).
    \38\ CAA section 188(c)(1).
    \39\ CAA section 110(k)(5), ``the Administrator may adjust any
dates applicable under such requirements as appropriate (except that
the Administrator may not adjust any attainment date prescribed
under part D of this subchapter, unless such date has elapsed).''
    \40\ Given that exceedances of the 1987 24-hour PM10
NAAQS in the Yuma NAA are often associated with high wind that could
potentially qualify for treatment as ``natural events'' under the
EPA's Exceptional Events Rule, we recommend RACM/RACT be fully
implemented as early as January 1, 2023, so that anthropogenic
sources would be reasonably controlled during the three-year period
preceding the proposed attainment date. See, e.g., 40 CFR
50.14(b)(5)(ii) (``The Administrator will consider high wind dust
events to be natural events in cases where windblown dust is
entirely from natural undisturbed lands in the area or where all
anthropogenic sources are reasonably controlled . . .'').
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    The EPA is soliciting public comments on the issues discussed in
this document. We will accept comments from the public on this proposal
until the date listed in the DATES section above. We will consider
these comments before taking final action.

IV. Statutory and Executive Order Reviews

    This action proposes a determination that the Yuma NAA is no longer
attaining the 1987 PM10 NAAQS, based on the EPA's review of
air quality data, and a SIP call under section 110(k)(5) of the CAA.
Upon a finding that a SIP is deficient, section 110(k)(5) of the CAA
directs the Agency to require the state to correct the deficiency.
Therefore, this action does not impose additional requirements beyond
those required by the CAA itself. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions

of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed action does not have Tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP obligations discussed herein do not apply to Indian
Tribes and thus this proposed action will not impose substantial direct
costs on Tribal governments or preempt Tribal law. Nonetheless, the EPA
intends to notify the Cocopah and Fort Yuma (Quechan) tribes, which
have lands within the Yuma NAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate Matter, Pollution.

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

    Dated: May 24, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-11395 Filed 5-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Page 59926]
[FR Doc No: 2013-23750]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL13-91-000; QF83-142-002; QF83-143-002; QF83-144-002;
QF92-64-002]

Clearwater Paper Corporation; Notice of Petition for Enforcement

    Take notice that on September 20, 2013, pursuant to section 210(h)
of the Public Utility Regulatory Policies Act of 1978 (PURPA)
Clearwater Paper Corporation filed a Petition for Enforcement,
requesting the Federal Energy Regulatory Commission (Commission) to
initiate enforcement action against the Idaho Public Utilities
Commission (IPUC), or in the alternative declare that Final IPUC Order
No. 32697 \1\ and IPUC Order No. 32802 \2\ are inconsistent with PURPA.
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    \1\ In the Matter of the Commission's Review of PURPA QF
Contract Provisions Including the Surrogate Avoided Resource (SAR)
and Integrated Resource Planning (IRP) Methodologies for Calculating
Avoided Cost Rates, IPUC Case No. GNR-E-11-03, Order No. 32697
(December 18, 2012).
    \2\ In the Matter of the Commission's Review of PURPA QF
Contract Provisions Including the Surrogate Avoided Resource (SAR)
and Integrated Resource Planning (IRP) Methodologies for Calculating
Avoided Cost Rates, IPUC Case No. GNR-E-11-03, Order No. 32802 (May
6, 2013)
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 11, 2013.

    Dated: September 23, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-23750 Filed 9-27-13; 8:45 am]
BILLING CODE 6717-01-P