[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61041-61049]
[FR Doc No: 2022-21967]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2353]

Medical Device User Fee Rates for Fiscal Year 2023

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) 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2022 (MDUFA V),
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 2023, which apply from October 1, 2022, through September
30, 2023, and provides information on how the fees for FY 2023 were
determined, the payment procedures you should follow, and how you may
qualify for reduced small business fees.

FOR FURTHER INFORMATION CONTACT: For information on Medical Device User
Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
    For questions related to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
    For questions related to this notice: Robert Marcarelli, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd, Rm. 61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>, and the User
Fees Support Staff at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FD&C Act, as amended by MDUFA V, 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. Section 738 of the FD&C Act (21 U.S.C. 379j) establishes
fees for certain medical device applications, submissions, supplements,
notices, and requests (for simplicity, this document refers to these
collectively as ``submissions'' or ``applications''); for periodic
reporting on class III devices; and for the registration of certain
establishments.
    Under 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 2023 through FY 2027; the
base fee for a premarket application received by FDA during FY 2023 is
$425,000. From this starting point, this document establishes FY 2023
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified

in the FD&C Act. 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)). For more information on fee
waivers, please see Section IX. Small Business Fee Reductions and Fee
Waivers.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2023 through FY 2027; the base fee for an
establishment registration in FY 2023 is $6,250. Each establishment
that is registered (or is required to register) with the Secretary of
Health and Human Services under section 510 of the FD&C Act (21 U.S.C.
360) because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a device is
required to pay the annual fee for establishment registration.

II. Total Revenue Amount for FY 2023

    The total revenue amount for FY 2023 is $312,606,000, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA V 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 2023 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $312,606,000 is to be adjusted for
inflation increases for FY 2023 using two separate adjustments: one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2023 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
    The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs, provides the percent change from the previous fiscal year, and
provides the average percent change over the first 3 of the 4 fiscal
years preceding FY 2023. The 3-year average is 1.3918 percent
(rounded).
[GRAPHIC] [TIFF OMITTED] TN07OC22.026

    The payroll adjustment is 1.3918 percent multiplied by 60 percent,
or 0.8351 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2023 is the average
annual percent change that occurred in the Consumer Price Index (CPI)
for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-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 Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

[GRAPHIC] [TIFF OMITTED] TN07OC22.027

    The non-payroll adjustment is 2.0434 percent multiplied by 40
percent, or 0.8174 percent. Next, the payroll adjustment (0.8351
percent or 0.008351) is added to the non-payroll adjustment (0.8174
percent or 0.008174), for a total of 1.6525 percent (or 0.016525). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.016525 for FY 2023.
    MDUFA V provides for this inflation adjustment to be compounded for
FY 2023 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2023, the FY 2022 base adjustment (1.022046) is multiplied by the FY
2023 base inflation adjustment (1.016525) to reach the applicable
inflation adjustment of 1.038935 (rounded) for FY 2023. We then
multiply the total revenue amount for FY 2023 ($312,606,000) by
1.038935, yielding an inflation-adjusted total revenue amount of
$324,777,000 (rounded to the nearest thousand dollar).

III. Adjustments to Base Fee Amounts for FY 2023

    Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)).

A. Inflation Adjustment

    MDUFA specifies that the base fees of $425,000 (premarket
application) and $6,250 (establishment registration) are to be adjusted
for FY 2023 using the same methodology as that for the total revenue
inflation adjustment in section

II (see 21 U.S.C. 379j(c)(2)(D)(i)). Multiplying the base fees by the
compounded inflation adjustment of 1.038935 yields inflation-adjusted
base fees of $441,547 (premarket application) and $6,493 (establishment
registration).

B. Further Adjustments To Generate the Inflation-Adjusted Total Revenue
Amount

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

C. MDUFA V Adjustments Solely to Registration Fees

    MDUFA V has three new potential adjustments that will not change
the total revenue amount but may impact collections by increasing or
decreasing establishment registration base fees only. These adjustments
are the performance improvement adjustment, the hiring adjustment, and
the operating reserve adjustment. Only the operating reserve adjustment
is potentially applicable in FY 2023.
1. Performance Improvement Adjustment
    For FY 2023, there is no performance improvement adjustment.
Beginning with FY 2025, this adjustment allows FDA to collect fees in
addition to the total revenue amount in FYs 2025, 2026, and 2027, if
the Agency meets certain performance goals in FYs 2023, 2024, and 2025.
If applicable, this provision further increases base establishment
registration fee amounts to achieve an increase in total fee
collections equal to the applicable performance improvement adjustment,
which is set forth in the statute (see 21 U.S.C. 379j(c)(4)).
2. Hiring Adjustment
    For FY 2023, there is no hiring adjustment. Beginning with FY 2025,
this adjustment provides for the reduction of base establishment
registration fees in FYs 2025, 2026, and 2027, if specified hiring
goals for FYs 2023, 2024, and 2025 are not met by a certain threshold.
The hiring adjustment would serve to decrease the base establishment
registration fee amounts as necessary to achieve a reduction in total
fee collections equal to the hiring adjustment amount, which is set
forth in the statute (see 21 U.S.C. 379j(c)(5)).
3. Operating Reserve Adjustment
    For FYs 2023 to 2027, the operating reserve adjustment requires FDA
to decrease base establishment registration fees if the amount of
operating reserves of carryover user fees exceeds the ``designated
amount'' and such reduction is necessary to provide for not more than
such designated amount of operating reserves of carryover user fees
(see 21 U.S.C. 379j(c)(6)). In making this calculation for FYs 2023 to
2026, a certain amount is excluded from the designated amount and is
not subject to the decrease (see 21 U.S.C. 379j(c)(6)(C)). For FY 2023,
this excluded amount is $118,000,000.
    The designated amount is equal to the sum of 13 weeks of operating
reserves of carryover user fees plus 1 month of operating reserves
described in 21 U.S.C. 379j(c)(8) (see 21 U.S.C. 379j(c)(6)(B)).
    To determine the 13-week operating reserves of carryover user fees
amount, the FY 2023 inflation-adjusted total revenue amount,
$324,777,000 is divided by 52, and then multiplied by 13. The 13-week
operating reserve amount for FY 2023 is $81,194,250.
    To determine the 1 month of operating reserves described in 21
U.S.C. 379j(c)(8), the FY 2023 inflation-adjusted total revenue amount
of $324,777,000 is divided by 12. The 1 month of operating reserves for
FY 2023 is $27,064,750.
    For FY 2023, the designated amount is equal to the 13-week
operating reserve of $81,194,250 plus the 1 month of operating reserves
of $27,064,750, totaling $108,259,000.
    To determine the FY 2022 end-of-year operating reserves of
carryover user fees amount, FDA combined the actual collections and
obligations at the end of the third quarter (June 2022) and added the
forecasted collections and obligations for the fourth quarter of FY
2022 to generate a full year estimate for FY 2022. The estimated end-
of-year FY 2022 operating reserves of carryover user fees is
$40,290,467. (Note, this amount includes the 1-month reserve.)
    Note that under MDUFA V, for the purposes of calculating the
operating reserve adjustment, this amount does not include user fee
funds considered unappropriated ($26,680,243) or unearned revenue
($57,171,986). In addition, as noted above, for purposes of the
operating reserve adjustment, operating reserves of carryover user fees
do not include the $118,000,000 intended to support the Total Product
Life Cycle Advisory Program Pilot and Third-Party Review programs.
    Because the estimated end-of-year FY 2022 MDUFA operating reserves
of carryover user fees amount totaling $40,290,467 does not exceed the
FY 2023 designated amount of $108,259,105, FDA will not decrease the
base establishment registration fee amounts for FY 2023 to provide for
not more than such designated amount.

IV. Calculation of Fee Rates

    As noted in section II, the total revenue amount after the
applicable inflation adjustment is $324,777,000 (rounded to the nearest
thousand dollar). As noted in section III, there is no MDUFA V
adjustment solely to registration fees for FY 2023.
    Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2023.

[GRAPHIC] [TIFF OMITTED] TN07OC22.028

    The information in table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays the FY 2023 base fees set in statute (column one) and the
inflation-adjusted base fees (per calculations in section III.A.)
(column two). Using the inflation-adjusted fees and the 3-year averages
of fee-paying submissions, collections are projected to total
$330,787,011, which is $6,010,011 higher than the inflation-adjusted
total revenue amount (in section II). The fees in column two are those
FDA is establishing in FY 2023. The fees in column two are the standard
fees.

[GRAPHIC] [TIFF OMITTED] TN07OC22.029

    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $441,547 for FY 2023. The fees set by reference
to the standard fee for a premarket application are:
     For a panel-track supplement, 80 percent of the standard
fee;
     For a de novo classification request, 30 percent of the
standard fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
     For a 510(k) premarket notification, 4.5 percent of the
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee; and
     For a 513(g) request for classification information, 1.35
percent of the standard fee.
    For all submissions other than a 30-day notice and a 513(g) request
for classification information, the small business fee is 25 percent of
the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C)). For a 30-day notice and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)).
    The annual fee for establishment registration, after adjustment, is
set at $6,493 for FY 2023. For FY 2023, there is no small business
waiver for the annual establishment registration fee; all
establishments pay the same fee.
    For more information on reduced fees and waivers for small
businesses, please see Section IX. Small Business Fee Reductions and
Fee Waivers.
    Table 5 summarizes the FY 2023 rates for all medical device fees.

[GRAPHIC] [TIFF OMITTED] TN07OC22.030

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

    If your business, including your affiliates, has gross receipts or
sales of no more than $100 million for the most recent tax year, you
may qualify for reduced small business fees. If your business,
including your affiliates, has gross sales or receipts of no more than
$30 million, you may also qualify for a waiver of the fee for your
first premarket application (i.e., PMA, PDP, or BLA) or premarket
report. If you want to pay the small business fee rate for a submission
or you want to receive a waiver of the fee for your first premarket
application or premarket report, you should submit the materials
showing you qualify as a small business at least 60 days before you
send your submission to FDA. For more information on fee waivers or
reductions, please see Section IX. Small Business Fee Reductions and
Fee Waivers.
    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 2023, you should not submit a Small Business Certification
Request. FDA will review your information and determine whether you
qualify as a small business eligible for the reduced fee and/or fee
waiver. If you make a submission before FDA finds that you qualify as a
small business, you must pay the standard (full) fee for that
submission.
    If your business qualified as a small business for FY 2022, your
status as a small business will expire at the close of business on
September 30, 2022. You must re-qualify for FY 2023 in order to pay
small business fees during FY 2023.

A. Domestic (U.S.) Businesses

    If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2023, submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the United States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
    2. A signed copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2022, except:
    If you submit your MDUFA Small Business Certification Request for
FY 2023 before April 15, 2023, and you have not yet filed your return
for 2022, you may use tax year 2021.
    If you submit your MDUFA Small Business Certification Request for
FY 2023 on or after April 15, 2023, and have not yet filed your 2022
return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year, or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is

headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.
    4. Once you have completed your Form FDA 3602, print and sign the
form. Mail the completed form and your supporting documentation (copies
of the Federal (U.S.) income tax returns) to Medical Device User Fee
Small Business Certification Request mailing address, which is
available at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
    If you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

B. Foreign Businesses

    If you are a foreign business, and wish to qualify as a small
business for FY 2023, submit the following:
    1. A completed MDUFA Foreign Small Business Certification Request
for a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
    2. A National Taxing Authority Certification completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year (2021 or later), or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority, of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The business must also
submit a statement signed by the head of the business's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the business has no affiliates.
    4. Once you have completed your Form FDA 3602A, print and sign the
form. Mail the completed form and your supporting documentation
including the following to CDRH's Medical Device User Fee Small
Business Certification Request address, which is available at the
following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
     A copy of the most recent Federal (U.S.) income tax return
for each of your affiliates headquartered in the U.S. and
     A copy of an MDUFA Foreign Small Business Certification
Request for each of your foreign affiliates.
    If you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

VI. 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, 2022, and September 30,
2023, you must pay the fee in effect for FY 2023. To avoid delay in the
review of your application, you should pay the application fee at the
time you submit your application to FDA. The later of the date that the
application is received in the reviewing center's document room or the
date the U.S. Treasury recognizes the payment determines whether the
fee rates for FY 2022 or FY 2023 apply. FDA must receive the correct
fee at the time that an application is submitted or the application
will not be accepted for fling 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, 2022. One choice is for
applications and fees that will be received on or before September 30,
2022, which are subject to FY 2022 fee rates. A second choice is for
applications and fees received on or after October 1, 2023, which are
subject to FY 2023 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.

B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN

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

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

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Note: Only full payments are
accepted. No partial payments can be made online. Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.

    2. If paying with a paper check:
     All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
     Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
     Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
    If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery, contact U.S. Bank at<PHONE_NUMBER>. This telephone number is
only for questions about courier delivery).
    3. If paying with a wire transfer:
     Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
     The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee,
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St, New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
    FDA records the official application receipt date as the later of
the following: (1) the date the application was received by the FDA
Document Control Center for the reviewing Center or (2) the date the
U.S. Treasury recognizes the payment.

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

    Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.

VII. Procedures for Paying the Annual Fee for Periodic Reporting

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

VIII. Procedures for Paying Annual Establishment Registration Fees

    To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website address after this document publishes in the Federal Register.)
Create a DFUF order and you will be issued a PIN when you place your
order. After payment has been processed, you will be issued a payment
confirmation number (PCN). You will not be able to register your
establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2023 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).
    Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.

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

    To submit a DFUF order, you must create or have previously created
a user account and password for the user fee website listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2023 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.

B. Pay for Your DFUF Order

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

C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2023, or To Register a New Establishment for
FY 2023

    Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side of the page. This opens 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 2022. Manufacturers of
licensed biologics should register in the electronic Blood
Establishment Registration (eBER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
    Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
[email protected]a.gov or call<PHONE_NUMBER> for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the eBER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call<PHONE_NUMBER>.

D. Enter Your DFUF Order PIN and PCN

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

IX. Small Business Fee Reductions and Fee Waivers

    To qualify for reduced fees for small businesses or a small
business fee waiver, please see the requirements for qualification
provided in Section V. How To Qualify as a Small Business for Purposes
of Medical Device Fees. The applicant should submit a Small Business
Certification Request and the supporting materials showing you qualify
as a small business at least 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 you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

A. Premarket Approval Fee Reduction or Waiver

    A small business applicant may request to pay a reduced rate for
premarket approval fees. An applicant may also request a fee waiver for
their first premarket application or premarket report (see 21 U.S.C.
379j(d)).

B. Premarket Notification Submission Fee Reduction

    A small business applicant may request to pay a reduced rate for a
premarket notification submission.

C. Annual Establishment Registration Fee

    There is no small business waiver for the annual establishment
registration fee; all establishments pay the same fee.

X. Refunds

    To qualify for consideration for a refund, a person shall submit to
FDA a written request for a refund not later than 180 days after such
fee is due. FDA has discretion to refund a fee or a portion of the fee.
A determination by FDA concerning a refund shall not be reviewable. For
more information on qualifying and submitting a refund, see 21 U.S.C.
379j(a)(2)(D).

    Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21967 Filed 10-5-22; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66552-66557]
[FR Doc No: 2020-23170]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0077; FRL-10015-81]

Certain New Chemicals; Receipt and Status Information for
September 2020

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption

application (Biotech exemption); an application for a test marketing
exemption (TME), both pending and/or concluded; a notice of
commencement (NOC) of manufacture (including import) for new chemical
substances; and a periodic status report on new chemical substances
that are currently under EPA review or have recently concluded review.
This document covers the period from 09/01/2020 to 09/30/2020.

DATES: Comments identified by the specific case number provided in this
document must be received on or before November 19, 2020.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0077, and the specific case number for the
chemical substance related to your comment, through the Federal
eRulemaking Portal at http://www.regulations.gov. Follow the online
instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jim Rahai, Information
Management Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 09/01/2020 to 09/30/2020. The Agency is providing notice of
receipt of PMNs, SNUNs and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
    EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

B. What is the Agency's authority for taking this action?

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: http://www.epa.gov/oppt/newchems.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.

C. Does this action apply to me?

    This action provides information that is directed to the public in
general.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the

passage of the Lautenberg amendments to TSCA in 2016, public interest
in information on the status of section 5 cases under EPA review and,
in particular, the final determination of such cases, has increased. In
an effort to be responsive to the regulated community, the users of
this information, and the general public, to comply with the
requirements of TSCA, to conserve EPA resources and to streamline the
process and make it more timely, EPA is providing information on its
website about cases reviewed under the amended TSCA, including the
section 5 PMN/SNUN/MCAN and exemption notices received, the date of
receipt, the final EPA determination on the notice, and the effective
date of EPA's determination for PMN/SNUN/MCAN notices on its website
at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is
updated on a weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                        Table I--PMN/SNUN/MCANs Approved * From 09/01/2020 to 09/30/2020
----------------------------------------------------------------------------------------------------------------
                                   Received
     Case No.         Version        date        Manufacturer               Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0345A........            7   08/31/2020  CBI...............  (G) Processing aid....  (G) Acrylamide,
                                                                                polymer with
                                                                                methacrylic acid
                                                                                derivatives.
P-16-0370A........            5   09/14/2020  CBI...............  (G) Crosslinker for     (G) Methoxy-terminated
                                                                   adhesives and           polysiloxanes.
                                                                   coatings.
P-16-0404A........            4   09/22/2020  CBI...............  (G) A colorant for      (G) Alkyl ester, 2-({4-
                                                                   dyeing various          [2-(trisubstituted
                                                                   synthetic fibers and    phenyl)azo]-5-
                                                                   fabrics. Open, non-     acetamido-2-
                                                                   dispersive use.         substitutedphenyl{tim
                                                                                e (substituted
                                                                                alkoxy)amino).
P-16-0589A........            5   09/25/2020  Chemtura            (G) Synthetic aircraft  (G) Pentaerythritol
                                               Corporation.        engine lubricant for    Ester of Mixed Linear
                                                                   contained use           and Branched
                                                                   Industrial lubricant.   Carboxylic Acids.
P-17-0193A........            3   09/25/2020  Chemtura            (G) Synthetic           (G) Dipentaerythritol
                                               Corporation.        lubricant for           Ester of Mixed Linear
                                                                   contained use           and Branched
                                                                   Industrial lubricant.   Carboxylic Acids; (G)
                                                                                Pentaerythritol Ester
                                                                                of Mixed Linear and
                                                                                Branched Carboxylic
                                                                                Acids;.
P-18-0128A........            4   09/02/2020  CBI...............  (G) Surface modifier..  (S) Inulin, 2-hydroxy-
                                                                                3-
                                                                                (trimethylammonio)pro
                                                                                pyl ether, chloride.
P-18-0143A........            9   08/29/2020  Huntsman            (G) Anti-corrosive      (G) Fatty acids, tall-
                                               International LLC.  primer for outdoor      oil polymers with
                                                                   industrial              aminoalkyl, dialkyl
                                                                   applications.           alkane diamine,
                                                                                polyalkylene
                                                                                polyamine
                                                                                alkanepolyamine
                                                                                fraction, and tris-
                                                                                [(alkylamino) alkyl]
                                                                                phenol.
P-18-0289A........            6   09/09/2020  CBI...............  (G) Gas scrubbing,      (G) 2-
                                                                   landfill deodorizing,   (2(methylcaboxymonocy
                                                                   wastewater              clic)amino)ethoxy)-
                                                                   deodorizing.            alcohol.
P-18-0289A........            7   09/23/2020  CBI...............  (G) Gas scrubbing,      (G) 2-
                                                                   landfill deodorizing,   (2(methylcaboxymonocy
                                                                   wastewater              clic)amino)ethoxy)-
                                                                   deodorizing.            alcohol.
P-18-0290A........            6   09/09/2020  CBI...............  (G) wastewater          (G) Carbomonocylic-
                                                                   deodorizing, Gas        oxazolidine.
                                                                   scrubbing, Landfill
                                                                   odor neutralizing.
P-18-0290A........            7   09/23/2020  CBI...............  (G) Gas scrubbing,      (G) Carbomonocylic-
                                                                   Landfill odor           oxazolidine.
                                                                   neutralizing,
                                                                   wastewater
                                                                   deodorizing.
P-18-0330A........            5   09/21/2020  CBI...............  (G) initiator.........  (G) Formaldehyde,
                                                                                polymer with alkyl
                                                                                aryl ketone.
P-18-0334A........            3   09/22/2020  Sirrus, Inc.......  (S) Intermediate use..  (S) Propanedioic acid,
                                                                                1,3-dihexyl ester.
P-18-0335A........            3   09/22/2020  Sirrus, Inc.......  (S) Intermediate use..  (S) Propanedioic acid,
                                                                                1,3-dicyclohexyl
                                                                                ester.
P-18-0336A........            5   09/22/2020  Sirrus, Inc.......  (S) Intermediate use..  (S) Propanedioic acid,
                                                                                2,2-
                                                                                bis(hydroxymethyl)-,
                                                                                1,3-dihexyl ester.
P-18-0337A........            5   09/22/2020  Sirrus, Inc.......  (S) Intermediate use..  (S) Propanedioic acid,
                                                                                2,2-
                                                                                bis(hydroxymethyl)-,
                                                                                1,3-dicyclohexyl
                                                                                ester.
P-18-0387A........            5   09/01/2020  CBI...............  (G) Plastic Additive..  (G) Alkanal, reaction
                                                                                products with
                                                                                alkanediyl bis[alkyl-
                                                                                tris(alkyl-
                                                                                heterocycle)-1,3,5-
                                                                                triazine-2,4,6-
                                                                                triamine and hydrogen
                                                                                peroxide.
P-18-0388A........            5   09/01/2020  CBI...............  (G) Plastic additive..  (G) 1,3,5-triazine-
                                                                                2,4,6-triamine,
                                                                                alkanediyl bis[alkyl-
                                                                                tris(alkyl-
                                                                                heterocycle)-, allyl
                                                                                derivs., oxidized,
                                                                                hydrogenated.
P-18-0407A........            5   09/08/2020  CBI...............  (S) Polyurethane        (S) 1,2-Ethanediamine,
                                                                   catalyst.               N,N-dimethyl-N-(1-
                                                                                methylethyl)-N-[2-
                                                                                [methyl(1-
                                                                                methylethyl)amino]eth
                                                                                yl]-.
P-18-0407A........            6   09/15/2020  CBI...............  (S) Polyurethane        (S) 1,2-Ethanediamine,
                                                                   catalyst.               N,N-dimethyl-N-(1-
                                                                                methylethyl)-N-[2-
                                                                                [methyl(1-
                                                                                methylethyl)amino]eth
                                                                                yl]-.

P-18-0407A........            7   09/21/2020  CBI...............  (S) Polyurethane        (S) 1,2-Ethanediamine,
                                                                   catalyst.               N,N-dimethyl-N-(1-
                                                                                methylethyl)-N-[2-
                                                                                [methyl(1-
                                                                                methylethyl)amino]eth
                                                                                yl]-.
P-19-0048A........            8   09/23/2020  CBI...............  (G) Coating additive..  (S) Poly(oxy-1,2-
                                                                                ethanediyl), .alpha.-
                                                                                hydro-.omega.-hydroxy-
                                                                                , mono-C12-14-alkyl
                                                                                ethers, phosphates,
                                                                                sodium salts.
P-19-0162A........            3   09/18/2020  CBI...............  (G) Component in Oil    (G) fatty acid alkyl
                                                                   Production.             amide, (dialkyl)
                                                                                amino alkyl, alkyl
                                                                                quaternized, salts.
P-19-0162A........            4   09/29/2020  CBI...............  (G) Component in Oil    (G) fatty acid alkyl
                                                                   Production.             amide, (dialkyl)
                                                                                amino alkyl, alkyl
                                                                                quaternized, salts.
P-20-0030A........            3   09/10/2020  CBI...............  (S) Plasticizer for     (G) Hexanedioic acid,
                                                                   Plastisols, in caulks   carbomonocyclic
                                                                   and sealants.           esters.
P-20-0066A........            3   09/14/2020  CBI...............  (G) Antiwear additive   (G) 2-Propenoic acid,
                                                                   for lubricants.         2-hydroxyethyl ester,
                                                                                reaction products
                                                                                with dialkyl hydrogen
                                                                                heterosubstituted
                                                                                phosphate and
                                                                                dimethyl phosphonate.
P-20-0073A........            5   09/25/2020  CBI...............  (G) Oil and gas         (G) 2,5-Furandione,
                                                                   production chemistry.   reaction products
                                                                                with alkylamine, 1-
                                                                                octanol and
                                                                                polyethylene glycol
                                                                                alkoxy-ether,
                                                                                acetates (salts).
P-20-0099A........            7   09/15/2020  Materion Advanced   (S) A material used     (G) Mixed Metal Oxide.
                                               Chemicals.          for the production of
                                                                   Li ion conductive
                                                                   separators for
                                                                   rechargeable
                                                                   batteries.
P-20-0100A........            5   09/02/2020  Evonik Corporation  (S) Manual dish         (S) Refer to
                                                                   detergent, hard         attachment ``Chemical
                                                                   Surface cleaner,        Identity''.
                                                                   laundry detergent.
P-20-0100A........            6   09/11/2020  Evonik Corporation  (S) Manual dish         (G) Rhamnolipids,
                                                                   detergent, hard         modified pseudomonas-
                                                                   Surface cleaner,        fermented, from
                                                                   laundry detergent.      dextrose.
P-20-0108A........            4   09/11/2020  CBI...............  (G) Film-forming        (G) Alkanoic acid,
                                                                   polymer.                compds. with
                                                                                diphenolmethane
                                                                                derivative-N1,N1-
                                                                                dialkyl-1,3-
                                                                                alkanediamine-
                                                                                epiclorohydrin-2-
                                                                                cyclic ester
                                                                                homopolymer with
                                                                                dialkylene glycol
                                                                                (2:1) polymer-
                                                                                dialkanolamine
                                                                                reaction products.
P-20-0111A........            2   09/25/2020  CBI...............  (G) Component in        (S) 1,2,4-
                                                                   flexible automotive     Benzenetricarboxylic
                                                                   interior parts.         acid, 1,2,4-trinonyl
                                                                                ester.
P-20-0144.........            2   09/16/2020  CBI...............  (G) Asphalt emulsion    (S) Fatty acids, soya,
                                                                   applications.           reaction products
                                                                                with
                                                                                polyethylenepolyamine
                                                                                s.
P-20-0162.........            2   08/31/2020  CBI...............  (G) Photolithography..  (G) Sulfonium, triaryl-
                                                                                , 3,3,3-trihalo-2-
                                                                                sulfoalkyl
                                                                                polycycloalkane-1-
                                                                                carboxylate (1:1).
P-20-0166.........            1   08/21/2020  Sun Chemical......  (G) Component of ink..  (G) Formaldehyde,
                                                                                polymer with 2-
                                                                                methylcarbomonocycle,
                                                                                glycidyl ether,
                                                                                acrylate hydrogen 1,2-
                                                                                carbomonocyledicarbox
                                                                                ylate,
P-20-0167.........            2   08/31/2020  W. R. Grace & Co.-- (G) Catalyst..........  (G) Phenylene, alkyl
                                               Conn.                                       and
                                                                                polycarbomonocycle
                                                                                substituted, 1,2-
                                                                                dicarboxylate.
P-20-0168.........            2   09/14/2020  CBI...............  (S) Lubricating         (G) Polyolefin
                                                                   additives for engine    polyamine
                                                                   oils, transmission      succinimide,
                                                                   and hydraulic fluid     carbopolycycle
                                                                   and gear oil            alkoxylated.
                                                                   applications.
P-20-0168A........            3   09/22/2020  CBI...............  (S) Lubricating         (G) Polyolefin
                                                                   additives for engine    polyamine
                                                                   oils, transmission      succinimide,
                                                                   and hydraulic fluid     carbopolycycle
                                                                   and gear oil            alkoxylated.
                                                                   applications.
P-20-0170.........            3   09/09/2020  Tetramer            (G) Component in        (G) Glycerin,
                                               Technologies, LLC.  Lubricants.             alkoxylated alkyl
                                                                                acid esters.
P-20-0171.........            3   09/09/2020  Tetramer            (G) Component in        (G) Glycerin,
                                               Technologies, LLC.  Lubricants.             alkoxylated alkyl
                                                                                acid esters.
P-20-0172.........            3   09/09/2020  Tetramer            (G) Component in        (G) Glycerin,
                                               Technologies, LLC.  Lubricants.             alkoxylated alkyl
                                                                                acid esters.
P-20-0173.........            1   09/01/2020  ICM Products Inc..  (G) Use as a Coating    (G) Silsesquioxanes,
                                                                   Additive.               alkyl, alkoxy- and
                                                                                hydroxy- terminated.
P-20-0174.........            3   09/17/2020  P2 Science, Inc...  (S) For use in          (S) 6-Octen-1-ol, 3,7-
                                                                   consumer products, as   dimethyl-,
                                                                   well as direct          homopolymer,
                                                                   addition to consumer    monoacetate.
                                                                   products.
P-20-0175.........            2   09/21/2020  Materia Inc.......  (G) Resin formulation   (G) acid N-[4-(4-
                                                                   additive.               diarylalkyl]-,
                                                                                carbopolycyclic
                                                                                alkenyl, methyl
                                                                                ester.
P-20-0176.........            2   09/21/2020  Materia Inc.......  (G) Resin formulation   (G) acid N-
                                                                   additive.               (diarylalkyl)-,
                                                                                carbopolycyclic
                                                                                alkenyl, methyl
                                                                                ester.
P-20-0177.........            2   09/21/2020  Materia Inc.......  (G) Resin formulation   (G) carbopolycyclic
                                                                   additive.               alkenyl, 2-carboxylic
                                                                                acid, 2-[[[4-(4-
                                                                                diarylalkyl)]carbonyl
                                                                                ]oxy]ethyl ester.
P-20-0178.........            2   09/21/2020  Materia Inc.......  (G) Resin formulation   (G) carbopolycyclic
                                                                   additive.               alkenyl, 2-carboxylic
                                                                                acid, 2-
                                                                                [[[(diarylalkyl)]carb
                                                                                onyl]oxy]ethyl ester.
P-20-0179.........            1   09/08/2020  CBI...............  (S) Reactive polymer    (G) 1,3-
                                                                   for use in surface      Benzenedicarboxylic
                                                                   pre-treatment.          acid, polymer with
                                                                                1,4-
                                                                                benzenedicarboxylic
                                                                                acid, branched alkyl
                                                                                diol, and alkyldiol,
                                                                                bis[[[[bis(isocyanato
                                                                                phenoxy)phosphinothio
                                                                                yl]oxy]phenyl]carbama
                                                                                te],

P-20-0179A........            2   09/14/2020  CBI...............  (S) Reactive polymer    (G) 1,3-
                                                                   for use in surface      Benzenedicarboxylic
                                                                   pre-treatment.          acid, polymer with
                                                                                1,4-
                                                                                benzenedicarboxylic
                                                                                acid, branched alkyl
                                                                                diol, and alkyldiol,
                                                                                bis[[[[bis(isocyanato
                                                                                phenoxy)phosphinothio
                                                                                yl]oxy]phenyl]carbama
                                                                                te],
P-20-0180.........            1   09/08/2020  Evonik Degussa      (S) Curing agent for    (S)
                                               Corporation.        Industrial epoxy        Cyclohexanemethanamin
                                                                   Composite.              e,5-amino-1,3,3-
                                                                                trimethy-, N-sec-Bu
                                                                                dervis.
P-20-0181.........            1   09/11/2020  Guardian            (S) Additive to         (S) flue dust, glass-
                                               Industries Corp.    influence melting       manugf.
                                                                   temperature of raw      desulfurization,
                                                                   material and physical   calcium hydroxide-
                                                                   characteristics of      treated.
                                                                   the final product
                                                                   during the
                                                                   manufacture of flat
                                                                   glass, Animal bedding
                                                                   additive used as a
                                                                   dessicant.
P-20-0182.........            1   09/15/2020  Eastman Chemical    (G) Plasticizer for     (S) 1,4-
                                               Company, Inc.       PVC formulations.       Benzenedicarboxylic
                                                                                acid, bis[2-(2-
                                                                                butoxyethoxy)ethyl]
                                                                                ester (9CI).
P-20-0183.........            1   09/16/2020  CBI...............  (G) Intermediate......  (G) Aryl ether
                                                                                epoxide, homopolymer,
                                                                                ether with
                                                                                alkanolamine.
P-20-0184.........            1   09/24/2020  P2 Science, Inc...  (S) For use in          (S) 6-Octen-1-ol, 3,7-
                                                                   fragrances for          dimethyl-,
                                                                   consumer products, as   homopolymer.
                                                                   well as direct
                                                                   addition to consumer
                                                                   products.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission prior to the start of the 90 day review
  period, and in no way reflects the final status of a complete submission review.

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.

                             Table II--NOCs Approved * From 09/01/2020 to 09/30/2020
----------------------------------------------------------------------------------------------------------------
                                                                      If amendment,
            Case No.              Received date   Commencement date      type of          Chemical substance
                                                                        amendment
----------------------------------------------------------------------------------------------------------------
J-20-0012......................      09/18/2020          08/31/2020               N  (G) Biofuel producing
                                                                                saccharomyces cerevisiae
                                                                                modified, genetically
                                                                                stable.
P-14-0787......................      09/21/2020          08/27/2020               N  (S) Bismuth, 1,1',1'',1'''-
                                                                                (1,2-
                                                                                ethanediyldinitrilo)tetrak
                                                                                is[2-propanol]
                                                                                neodecanoate complexes.
P-17-0333......................      09/15/2020          09/13/2020               N  (G) 2-propenoic acid, mixed
                                                                                esters with heterocyclic
                                                                                dimethanol and
                                                                                heterocyclic methanol.
P-17-0395......................      09/21/2020          09/16/2020               N  (G) Alkyl tri
                                                                                dithiocarbmate tri salt.
P-18-0329......................      09/28/2020          09/09/2020               N  (G) Substituted
                                                                                carbopolycyclic
                                                                                dicarboxylic acid dialkyl
                                                                                ester, polymer with
                                                                                alkanediol and
                                                                                carbopolycyclic bis
                                                                                (substituted
                                                                                carbopolycycle)
                                                                                bisalkanol.
P-19-0053......................      08/31/2020          08/26/2020               N  (S) 1-butanamine, n-butyl-n-
                                                                                [(triethoxysilyl)methyl]-.
P-20-0038......................      09/10/2020          08/21/2020               N  (S) 1,3,5-triazine-
                                                                                2,4,6(1h,3h,5h)-trione,
                                                                                1,3,5-tris[3-(2-
                                                                                oxiranyl)propyl]-.
P-20-0104......................      09/16/2020          09/01/2020               N  (G) Alkenoic acid, polymer
                                                                                with (alkyl alkenyl)
                                                                                polyether.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.

   Table III--Test Information Received From 09/01/2020 to 09/30/2020
------------------------------------------------------------------------
                                        Type of test        Chemical
      Case No.         Received date     information        substance
------------------------------------------------------------------------
P-16-0370...........      09/14/2020  Subchronic        (G) Methoxy-
                                       Inhalation        terminated
                                       Toxicity 90-Day   polysiloxanes.
                                       Study (OECD
                                       Test Guideline
                                       413).
P-16-0370...........      09/14/2020  Subchronic        (G) Polysiloxane
                                       Inhalation        with functional
                                       Toxicity 90-Day   groups.
                                       Study (OECD
                                       Test Guideline
                                       413).
P-16-0543...........      09/17/2020  Exposure          (G)
                                       Monitoring        Halogenophospho
                                       Report.           ric acid metal
                                                         salt.

P-19-0098...........      09/16/2020  Algal, Growth     (G) Phosphoric
                                       Inhibiton Test    acid, polymer
                                       with              with
                                       Pseudokirchneri   (hydroxyalkyl)-
                                       ella              alkanediol and
                                       subcapitata, 72   alkanediol.
                                       hours (OECD
                                       Test Guideline
                                       201) and Acute
                                       Immobilization
                                       Test to Daphnia
                                       magna, Semi-
                                       static, 48
                                       hours (OECD
                                       Test Guideline
                                       202).
P-20-0062...........      09/16/2020  Cobalt Oxide      (S) Multi-walled
                                       Test Data.        carbon
                                                         nanotubes;
                                                         closed; 4.4-
                                                         12.8 nm
                                                         diameter;
                                                         bundle length
                                                         10.6-211.1 um;
                                                         grade: Jenotube
                                                         6 (substance-
                                                         1).
P-20-0098...........      09/22/2020  Eye Irritation    (G) Calcium
                                       Study, Dermal     cycloalkylcarbo
                                       Irritation        xylate.
                                       Study, Acute
                                       Oral Toxicity
                                       Study, Acute
                                       Dermal Toxicity
                                       Study, 90-Day
                                       Oral Toxicity
                                       Study, Ames
                                       Test,
                                       Chromosomal
                                       Aberration
                                       Test, Mouse
                                       Lymphoma Assay,
                                       and Skin
                                       Sensitization
                                       Test. All test
                                       submitted on an
                                       analogue.
SN-17-0011..........      09/21/2020  Acute             (G)
                                       Immobilization    Polyfluorohydro
                                       Test with         carbon.
                                       Daphnia magna.
------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.

(Authority: 15 U.S.C. 2601 et seq.)

    Dated: October 7, 2020.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2020-23170 Filed 10-19-20; 8:45 am]
BILLING CODE 6560-50-P


From: Kissell. Mary@ epamail. epa. gov [ mailto: Kissell. Mary@ epamail. epa. gov] Sent: Friday, August 01, 2003 10: 52 AM To: Bradfield, John Cc: Dail. Lynn@ epamail. epa. gov; kphanks@ rti. org; jwalke@ nrdc. org; tim_ hunt@ afandpa. org Subject: RE: MACT Definitions John,

I'm not recommending to our management adding antifungal treatments to PCWP and don't feel we need any clarification on this issue. As proposed, only kiln dried lumber ( not all lumber) is considered to be a PCWP. Therefore, application of coatings such as antifungals/ moisture retardants to lumber is outside of the scope of the PCWP source category.

We reviewed information you submitted on the proposed wood building products ( surface coating) rule relating to application of wood treatments, fire retardants, and antifungal coatings to PCWP products. We determined that these chemicals can be applied using different techniques during different stages of production ( e. g., during blending or forming of the substrate, or after manufacturing of the substrate is complete). Application of wood treatments, fire retardants, and antifungal coatings to PCWP that occurs after the substrate manufacturing process ( i. e., following completion of hot pressing) are subject to the wood building products ( surface coating) rule. Likewise, we determined that laminates ( e. g., foils and paper) applied to PCWP prior to pressing of the substrate would be covered by the PCWP rule, while laminates applied following pressing are covered by the wood building products ( surface coating) rule. ( see comment 2.1.2 in EPA document EPA 453/ R 03 003, Summary of Public Comments and Responses for the Wood Building Products ( Surface Coating) NESHAP  Background Information for Final Standards).

" Bradfield, John" < jbradfield@ cpama To: " Hanks, Katie P." < kphanks@ rti. org> il. org> cc: Mary Kissell/ RTP/ USEPA/ US@ EPA, " Otwell Lawrence ( Otwell, Lawrence)" 07/ 31/ 03 04: 52 PM < lpotwell@ gapac. com>, " Otwell Lawrence ( home) ( Otwell, Lawrence ( home))" < lpotwell@ mindspring. com>, " Vasquez Paul ( Vasquez, Paul)" < pjvasque@ gapac. com>, " Hunt Tim ( Hunt, Tim)" < tim_ hunt@ afandpa. org>, " George Ellis ( E mail)" < george. ellis1@ ipaper. com>, " Ferguson, Phil" < phil. ferguson@ ipaper. com>, " Bigbee Kurt ( Bigbee, Kurt)" < Kurt. Bigbee@ APAWood. org>, " Wagner, Louis" < lwagner@ cpamail. org> Subject: RE: MACT Definitions Katie,

On our conference call a couple of weeks ago we left a number of items on the table to deal with later. Do you have any time in Mid August to talk about antifungal treatments? If you have any other definitional questions by that time we can talk about them, too.

John Bradfield: jbradfield@ cpamail. org Director of Environmental Affairs Composite Panel Association 18922 Premiere Court Gaithersburg, MD 20879 1574 USA 301.670.0604 x229 Fax: 301.840.1252 Visit the CPA Web Site: http:\\ www. pbmdf. com


[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Page 1406]
[FR Doc No: 2015-00186]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-742-000]

Chief Energy Power LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Chief Energy Power LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 22, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-00186 Filed 1-8-15; 8:45 am]
BILLING CODE 6717-01-P