[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45359-45363]
[FR Doc No: 2012-18647]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0785]

Medical Device User Fee Rates for Fiscal Year 2013

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) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012
(Title 2 of the Food and Drug Administration Safety and Innovation Act,
Public Law 112-144, which was signed by the President on July 9, 2012)
(MDUFA III), authorizes FDA to collect user fees for certain medical
device submissions, and annual fees both for certain periodic reports
and for establishments subject to registration. The FY 2013 fee rates
are provided in this document. These fees apply from October 1, 2012,
through September 30, 2013. To avoid delay in the review of your
application, you should pay the fee before or at the time you submit
your application to FDA. The fee you must pay is the fee that is in
effect on the later of the date that your application is received by
FDA or the date your fee payment is recognized by the U.S. Treasury. If
you want to pay a reduced small business fee, you must qualify as a
small business before you make your submission to FDA; if you do not
qualify as a small business before you make your submission to FDA, you
will have to pay the higher standard fee. This document provides
information on how the fees for FY 2013 were determined, the payment
procedures you should follow, and how you may qualify for reduced small
business fees.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the FD&C Act (21 U.S.C 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this document refers to these collectively as
``submissions'' or ``applications''); for periodic reporting on class
III devices; and for the registration of certain establishments. Under
statutorily-defined conditions, a qualified applicant may receive a fee
waiver or may pay a lower small business fee. (See 21 U.S.C. 379j(d)
and (e).) Additionally, the Secretary may, at the Secretary's sole
discretion, grant a fee waiver or reduction if the Secretary finds that
such waiver or reduction is in the interest of public health. (See 21
U.S.C. 379j(f).)
    Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2013 through FY 2017; the
base fee for a premarket application received by FDA during FY 2013 is
$248,000. From this starting point, this document establishes FY 2013
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2013 through FY 2017; the registration fee for FY
2013 is $2,575. There is no reduction in the registration fee for small
businesses. Each establishment that is registered (or is required to
register) with the Secretary under section 510 of the FD&C Act (21
U.S.C. 360) because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a device is
required to pay the annual fee for establishment registration.

II. Fees for FY 2013

    Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application. (See 21 U.S.C. 379j(a)(2)(A).) For FY 2013, the standard
fee is the base fee; for FY 2014 through FY 2017, the base fee will be
adjusted as specified in the FD&C Act so for these fiscal years, the
standard fee will be the adjusted base fee. (See 21 U.S.C. 379j(b) and
(c).) The standard fee for a premarket application, including a BLA,
and for a premarket report and a BLA efficacy supplement, is $248,000
for FY 2013. (See 21 U.S.C. 379j(b).) The fees set by reference to the
standard fee for a premarket application are:
     For a panel-track supplement, 75 percent of the standard
fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For a 30-day notice, 1.6 percent of the standard fee;
     For a 510(k) premarket notification, 2 percent of the
standard fee;
     For a 513(g) request for classification information, 1.35
percent of the standard fee; and
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee.
    For all submissions other than a 510(k) premarket notification, a
30-day notice, and a 513(g) request for classification information, the
small business fee is 25 percent of the standard (full) fee for the
submission. (See 21 U.S.C. 379j(d)(2)(C).) For a 510(k) premarket
notification submission, a 30-day notice, and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission. (See 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C).)
    The statute sets the annual fee for establishment registration at
$2,575 in FY 2013. There is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
    Table 1 of this document set out the FY2013 rates for all medical
device fees.

                                    Table 1--Medical Device Fees for FY 2013
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                                                  Standard fee, as a percent of
             Application fee type               the standard fee for a premarket      FY 2013      FY 2013 small
                                                           application             standard fee    business fee
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Premarket application (a PMA submitted under    Base Fee Adjusted as Specified          $248,000         $62,000
 section 515(c)(1) of the FD&C Act (21 U.S.C.    in the Statute.
 360e(c)(1)), a PDP submitted under section
 515(f) of the FD&C Act (21 U.S.C. 360e(f)),
 or a BLA submitted under section 351 of the
 Public Health Service (PHS) Act (42 U.S.C.
 262)).
Premarket report (submitted under section       100%............................         248,000          62,000
 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under   100%............................         248,000          62,000
 section 351 of the PHS Act).
Panel-track supplement........................  75%.............................         186,000          46,500
180-day supplement............................  15%.............................          37,200           9,300
Real-time supplement..........................  7%..............................          17,360           4,340
510(k) premarket notification submission......  2%..............................           4,960           2,480
30-day notice.................................  1.6%............................           3,968           1,984
513(g) (21 U.S.C. 360c(g)) request for          1.35%...........................           3,348           1,674
 classification information.
----------------------------------------------------------------------------------------------------------------
                                                 Annual Fee Type
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Annual fee for periodic reporting on a class    3.5%............................           8,680           2,170
 III device.
Annual establishment registration fee (to be    Base Fee Adjusted as Specified             2,575           2,575
 paid by the establishment engaged in the        in the Statute.
 manufacture, preparation, propagation,
 compounding, or processing of a device, as
 defined by 21 U.S.C. 379i(13)).
----------------------------------------------------------------------------------------------------------------

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

    If your business has gross receipts or sales of no more than $100
million for the most recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. If you want to pay
the small business fee rate for a submission, or you want to receive a
waiver of the fee for your first premarket application or premarket
report, you should submit the materials showing you qualify as a small
business 60 days before you send your submission to FDA. If you make a
submission before FDA finds that you qualify as a small business, you
must pay the standard (full) fee for that submission.
    If your business qualified as a small business for FY 2012, your
status as a small business will expire at the close of business on
September 30, 2012. You must re-qualify for FY 2013 in order to pay
small business fees during FY 2013.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2013, you must submit the following to FDA:
    1. A completed FY 2013 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2013 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/mdufa. This form is not available separate from the
guidance document.
    2. A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2012,
except:
     If you submit your FY 2013 MDUFA Small Business
Qualification before April 15, 2013, and you have not yet filed your
return for 2012, you may use tax year 2011.
     If you submit your FY 2013 MDUFA Small Business
Qualification on or after April 15, 2013, and have not yet filed your
2012 return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The applicant must also submit a
statement signed by the head of the applicant's firm or by its chief
financial officer that the applicant has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the applicant has no affiliates.
    If you are a foreign business, and wish to qualify as a small
business for FY 2013, you must submit the following:
    1. A completed FY 2013 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2013 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/mdufa. This form is not available separate from the
guidance document.
    2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This Certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2011 or later), or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing

Authority Certification completed by, and bearing the official seal of,
the National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The applicant must also
submit a statement signed by the head of the applicant's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the applicant has no affiliates.

IV. Procedures for Paying Application Fees

    If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2012, through September 30,
2013, you must pay the fee in effect for FY 2013. 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 2012 or FY 2013 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
    FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: In no case should the
check for the fee be submitted to FDA with the application.)

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

    Log on to the MDUFA Web site at: http://www.fda.gov/mdufa, click on
``MDUFA FORMS'' at the left side of the page, and then under the MDUFA
Forms heading, click on the link ``Create MDUFA User Fee Cover Sheet.''
Complete the Medical Device User Fee cover sheet. Be sure you choose
the correct application submission date range. (Two choices will be
offered until October 1, 2012. One choice is for applications that will
be received on or before September 30, 2012, which will be subject to
FY 2012 fee rates. A second choice is for applications that will be
received on or after October 1, 2012, which will be subject to FY 2013
fee rates.) After completing data entry, print a copy of the Medical
Device User Fee cover sheet and note the unique PIN located in the
upper right-hand corner of the printed cover sheet.

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

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

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

    1. If paying with a paper check:
     All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. (FDA's tax
identification number is 53-0196965, should your accounting department
need this information.)
     Please write your application's unique PIN, from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet, on your check.
     Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 956733, St. Louis, MO
63195-6733. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
    If you prefer to send a check by a courier (such as Federal Express
(FedEx), DHL, United Parcel Service (UPS), etc.), the courier may
deliver the check to: U.S. Bank, Attn: Government Lockbox 956733, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This address is for
courier delivery only. Contact the U.S. Bank at<PHONE_NUMBER> if you
have any questions concerning courier delivery.)
    FDA records the official application receipt date as the later of
the following: (1) The date the application was received by FDA or (2)
the date the U.S. Treasury recognizes the payment. It is helpful if the
fee payment arrives at the bank at least 1 day before the application
arrives at FDA.
    2. If Paying With Credit Card or Electronic Check (Automated
Clearing House (ACH)):
    FDA has partnered with the U.S. Department of the Treasury to
utilize www.Pay.gov, a Web-based payment system, for online electronic
payment. You may make a payment via electronic check or credit card
after submitting your cover sheet. To pay online, select the ``Pay
Now'' button. Credit card transactions for cover sheets are limited to
$5,000.00.
    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 will be
delayed.
     The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
cover sheet is fully paid.
    Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Drive,
Rockville, MD 20850.

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

    Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to one of the following addresses:
    1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Mail Center, Bldg. 66, rm. 0609, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002.
    2. Biologic applications should be sent to: Food and Drug
Administration, Center for Biologics Evaluation and Research, Document
Control Center (HFM-99), Suite 200N, 1401 Rockville Pike, Rockville, MD
20852-1448.

V. Procedures for Paying the Annual Fee for Periodic Reporting

    As of FY 2011, you are no longer able to create a cover sheet and
obtain a PIN to pay the MDUFA Annual Fee for Periodic Reporting.
Instead, you will be invoiced at the end of the quarter in which your
PMA Periodic Report is due. Invoices will be sent based on the details
included on your PMA file; you are responsible to ensure your billing
information are kept up-to-date (you can

update your contact for the PMA by submitting an amendment).
    1. If paying with a paper check:
    All paper checks must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. (FDA's tax identification
number is 53-0196965, should your accounting department need this
information.)
     Please write your invoice number.
     Mail the paper check and a copy of invoice to: Food and
Drug Administration, P.O. Box 956733, St. Louis, MO 63195-6733. (Please
note that this address is for payments of application and annual report
fees only and is not to be used for payment of annual establishment
registration fees.)
    If you prefer to send a check by a courier (such as FedEx, DHL,
UPS, etc.), the courier may deliver the check to: U.S. Bank, Attn:
Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. Contact the U.S. Bank
at<PHONE_NUMBER> if you have any questions concerning courier delivery.)
    2. If paying with a wire transfer:
     Please include your invoice number in your wire transfer.
Without the invoice number, your payment may not be applied and you may
be referred to collections.
     The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
invoice is fully paid.
    Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD 20850.

VI. Procedures for Paying Annual Establishment Fees

    In order to pay the annual establishment fee, firms must access the
Device Facility User Fee (DFUF) Web site at https://fdasfinapp8.fda.gov/OA_HTML/fdaCAcdLogin.jsp. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
You will create a DFUF order and you will be issued a PIN once you
place your order. After payment has been processed, you will be issued
a payment confirmation number (PCN). You will not be able to register
your establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2013 until it has completed the steps below to
register and pay any applicable fee. (See 21 U.S.C. 379j(g)(2).)
    Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.

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

    To submit a DFUF Order, you must create or have previously created
a user account and password for the User Fee Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2013 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. Once you are satisfied that the data on the order 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. Step Two--Pay for Your DFUF Order

    Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
    1. If paying by credit card or electronic check (ACH):
    The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
    2. If paying with a paper check:
    If you prefer not to pay online, you may pay by a check, in U.S.
dollars and drawn on a U.S. bank, mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. (Note: This
address is different from the address for payments of application and
annual report fees and is to be used only for payment of annual
establishment registration fees.)
    If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only; do not send mail to this
address.)
    Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. A copy of your printed order should
also be mailed along with your check. FDA's tax identification number
is 53-0196965.
    3. If paying with a wire transfer:
    Wire transfers may also be used to pay annual establishment fees.
To send a wire transfer, please read and comply with the following
information:
     Include your order's unique PIN, from the upper right-hand
corner of your completed Device Facility User Fee order, in your wire
transfer. Without the PIN your payment may not be applied to your
facility and your registration will be delayed.
     The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
order is fully paid. Use the following account information when sending
a wire transfer: New York Federal Reserve Bank, U.S. Dept of Treasury,
TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099,
Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard
Drive, Rockville, MD 20850.

C. Step Three--Complete the Information Online To Update Your
Establishment's Annual Registration for FY 2013, or To Register a New
Establishment for FY 2013

    Go to the Center for Devices and Radiological Health's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left of the page. This
opens up a new page with important information about the FDA Unified
Registration and Listing System (FURLS). After reading this
information, click on the link (Access Electronic Registration) at the
bottom of the page. This link takes you to an FDA Industry Systems page
with tutorials that demonstrate how to create a new FURLS user account
if your establishment did not create an account in FY 2012.
Manufacturers of licensed biologics should register in the BER system
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
    Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to

register and existing establishments will update their annual
registration using choices on the DRLM menu. Once you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
<EMAIL_ADDRESS>or call<PHONE_NUMBER> for assistance. (Note: this
email address and this telephone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.) Problems with BERS should be directed to
<EMAIL_ADDRESS>or call<PHONE_NUMBER>.

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

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

    Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18647 Filed 7-30-12; 8:45 a.m.]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Page 73061]
[FR Doc No: 2014-28743]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP15-225-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Cap Rel Neg Rate
Agmt Filing (JW Operating 34690 to QWest 43528) to be effective 12/1/
2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5092.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-226-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate Agmt and
Amendment Filing (SW 43521 & ExGen 43198-1) to be effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5093.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-227-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Amendment to Neg
Rate Agmts (Santa Rosa 42487-3 & Mobile 42488-3) to be effective 12/1/
2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5094.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-228-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Cap Rel Neg Rate
Agmts (QEP 37657 & 36601 to Trans LA & Texla, various) to be effective
12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5095.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-229-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate 2012-12-
01 A&R BP, Encana, EOG Vanguard CR to be effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5106.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-230-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Non-Conforming
Agmt due to Perm Rel (JP Morgan 27225 to Mercuria 34366) to be
effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5107.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-231-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 12/01/14
Negotiated Rates--Castleton Commodities Merchant Trading (RTS) 4010-02
to be effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5151.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-232-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Section 4 Update
to be effective 1/1/2015.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5154.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-233-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 12/01/14
Negotiated Rates--Mercuria Energy Gas Trading LLC (RTS)--7540-02 to be
effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5252.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-234-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Calculation of
Reservation Charge Credits & Voluntary Interruption Commitments to be
effective 1/1/2015.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5265.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-235-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Substitute
Published Index Prices Filing to be effective 1/1/2015.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5274.
    Comments Due: 5 p.m. ET 12/15/14.

    Docket Numbers: RP15-236-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Chesapeake Energy
Negotiated Rate to be effective 12/1/2014.
    Filed Date: 12/1/14.
    Accession Number: 20141201-5281.
    Comments Due: 5 p.m. ET 12/15/14

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 2, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-28743 Filed 12-8-14; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM
SUBJECT: Comments Submitted on the National Ambient Air Quality Standards: Determinations of Attainment, Extensions of the Attainment Date, and Reclassification of Several Areas Classified as Moderate for the 2008 Ozone Standards for the Denver Area.
FROM: Abby Fulton, EPA Region 8, Air Quality Planning Branch
TO:  Docket EPA-R08-OAR-2019-0354
DATE: August 5, 2019
Attached are pertinent comments submitted to docket EPA-HQ-OAR-2018-0226 in response to EPA's November 14, 2018 (83 FR 56781) proposal to grant the State of Colorado's request for a 1-year attainment date extension for the Denver Area. These comments are being considered in this action (docket EPA-R08-OAR-2019-0354).


[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Notices]
[Pages 18297-18299]
[FR Doc No: 2014-06884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0329]

Guidance for Industry on Fees for Human Drug Compounding
Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Fees for Human Drug
Compounding Outsourcing Facilities Under Sections 503B and 744K of the
FD&C Act.'' The guidance is intended for entities that compound human
drugs and elect to register as outsourcing facilities (outsourcing
facility) under section 503B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA).
Entities that elect to register as outsourcing facilities must pay
certain fees to be considered outsourcing facilities. This guidance
describes the annual establishment fee, the reinspection fee, annual
adjustments to fees required by law, how to submit payment, the effect
of failure to pay fees, and how to qualify as a small business to
obtain a reduction of the annual establishment fee.

DATES: Submit either electronic or written comments on FDA guidances at
any time. Submit either electronic or written comments concerning the
collection of information proposed in the draft guidance by June 2,
2014.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of User Fee Management and Budget Formulation, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 2163, Silver Spring, MD 20903. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: M. Jonathan Gil, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Silver Spring, MD 20903,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under
Sections 503B and 744K of the FD&C Act.'' On November 27, 2013,
President Obama signed the DQSA (Pub. L. 113-54) into law. The DQSA
added a new section 503B to the FD&C Act that created a category of
entities called outsourcing facilities. Outsourcing facilities, as
defined in section 503B(d)(4) of the FD&C Act, are facilities that meet
certain conditions described in section 503B(a), including, registering
with FDA as an outsourcing facility and paying associated fees. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from two sections of
the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
the labeling of drugs with adequate directions for use); and (2)
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
    This guidance describes in detail the fee types and amounts an
entity must pay to satisfy the fee requirements of sections 503B(a)(9)
and 744K of the FD&C Act to be deemed an outsourcing facility and
maintain its status as an outsourcing facility, the adjustments to the
fees required by law, how to qualify as a small business to obtain a
reduction of the annual establishment fee, how and when to submit
payment to FDA, the effect of failure to pay fees, and fee-related
dispute resolution.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection are given under this section with an estimate of the
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Guidance for Industry on Fees for Human Drug Compounding
Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act;
Availability.
    Description: The draft guidance pertains to entities that compound
human drugs and elect to register as outsourcing facilities. These
outsourcing facilities must pay certain fees to FDA. The draft guidance
describes the fee

types and amounts, the adjustments to fees required by law, how to
submit payment, the effect of failure to pay fees, and how to qualify
as a small business to obtain a reduction of the annual establishment
fee. The draft guidance contains the following collections of
information:
    1. As described in section III.A of the draft guidance, upon
receiving registration information from a facility seeking to register
as an outsourcing facility, FDA will send an invoice for an
establishment fee to the outsourcing facility. The invoice contains
instructions for paying the establishment fee, as discussed in section
III.E of the draft guidance. This process would be repeated annually
under the timeframes described in the draft guidance. An outsourcing
facility is not considered registered until the required establishment
fee is paid for that fiscal year.
    We estimate that annually a total of approximately 20 outsourcing
facilities (``no. of respondents'' in table 1, row 1) will pay to FDA
approximately 20 establishment fees (``total annual responses'' in
table 1, row 1) as described in the draft guidance. We also estimate
that it will take an outsourcing facility approximately 0.5 hours to
prepare and submit to FDA each establishment fee (``average burden per
response'' in table 1, row 1).
    2. As described in section III.C of the draft guidance, outsourcing
facilities that are reinspected will be assessed a reinspection fee for
each reinspection. The reinspection fee is designed to reimburse FDA
when it must visit a particular outsourcing facility more than once
because of noncompliance identified during a previous inspection. A
reinspection fee will be incurred for each reinspection that occurs.
After FDA conducts a reinspection, we will send an invoice to the email
address indicated in the facility's registration file. The invoice
contains instructions for paying the reinspection fee, as discussed in
section III.E of the draft guidance.
    We estimate that annually a total of approximately 5 outsourcing
facilities (``no. of respondents'' in table 2, row 1) will pay to FDA
approximately 5 reinspection fees (``total annual responses'' in table
2, row 1) as described in the draft guidance. We also estimate that it
will take an outsourcing facility approximately 0.5 hours to prepare
and submit to FDA each reinspection fee (``average burden per
response'' in table 2, row 1).
    3. As described in section III.D of the draft guidance, certain
outsourcing facilities may qualify for a small business reduction in
the amount of the annual establishment fee. To qualify for this
reduction, an outsourcing facility must submit to FDA a written request
and a certification that the entity meets the requirements for the
reduction. For every fiscal year that the firm seeks to qualify as a
small business and receive the fee reduction, the written request must
be submitted to FDA by April 30 of the preceding the fiscal year. For
example, an outsourcing facility must submit a written request for the
small business reduction by April 30, 2014, to qualify for a reduction
in the fiscal year 2015 annual establishment fee. As described in the
guidance, section 744K of the FD&C Act also requires an outsourcing
facility to submit its written request for a small business reduction
in a format specified by FDA in the guidance. The draft guidance
specifies that Form FDA 3908 is the format for submitting requests for
a small business fee reduction; Form FDA 3908 is attached as Appendix
1.
    We estimate that annually a total of approximately 10 outsourcing
facilities (``no. of respondents'' in table 1, row 2) will submit to
FDA a request for a small business reduction in the amount of the
annual establishment fee. We estimate that approximately 10 Form FDA
3908 (``total annual responses'' in table 1, row 2) will be submitted
to FDA annually, as described in the draft guidance, and that it will
take an outsourcing facility approximately 25 hours to prepare and
submit to FDA each Form FDA 3908 (``average burden per response'' in
table 1, row 2).
    4. As described in section III.D of the draft guidance, those
outsourcing facilities that request a small business reduction in the
amount of the annual establishment fee will receive a small business
designation letter notifying the facility of FDA's decision.
Outsourcing facilities eligible to pay a reduced fee should maintain a
copy of the small business designation letter applicable to that fiscal
year for their records.
    We estimate that annually a total of approximately 10 outsourcing
facilities (``no. of recordkeepers'' in table 3) will keep a copy of
their small business designation letter (``total annual records'' in
table 3), and that maintaining each record will take approximately 0.5
hours (``average burden per recordkeeping'' in table 3).
    5. As described in section V.B of the draft guidance, an
outsourcing facility may request a reconsideration under 21 CFR 10.75
of an FDA decision related to the fee provisions of section 744K of the
FD&C Act. As explained in the draft guidance, the request should state
the facility's rationale for its position that the decision was in
error and include any additional information that is relevant to the
outsourcing facility's argument.
    We estimate that a total of approximately 2 outsourcing facilities
(``no. of respondents'' in table 2, row 2) will submit to FDA a request
for reconsideration as described in the draft guidance. We estimate
that approximately 1 request for reconsideration (``total annual
responses'' in table 2, row 2) will be submitted to FDA by each
facility, and that it will take an outsourcing facility approximately 1
hour to prepare and submit to FDA each request for reconsideration
(``average burden per response'' in table 2, row 2).
    6. As described in section V.B of the draft guidance, an
outsourcing facility may appeal, as set forth in 21 CFR 10.75, an FDA
denial of a request for reconsideration of an FDA decision related to
the fee provisions of section 744K of the FD&C Act.
    We estimate that a total of approximately 1 outsourcing facility
(``no. of respondents'' in table 2, row 3) will submit an appeal of an
FDA denial of a request for reconsideration. We estimate that
approximately 1 appeal will be made by each facility containing the
information described in the draft guidance (``total annual responses''
in table 2, row 3), and that it will take an outsourcing facility
approximately 1 hour to prepare and submit each appeal under 21 CFR
10.75 (``average burden per response'' in table 2, row 3).
    In the Federal Register of December 4, 2013 (78 FR 72899), FDA
announced the availability of a draft guidance for industry entitled
``Registration for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' In that
notice, we estimated the burden under the PRA for submitting
outsourcing facility registration information to FDA.
    The total estimated reporting and recordkeeping burdens for this
collection of information are as follows:

                        Table 1--Estimated Annual Reporting Burden--Establishment Fee \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        Type of reporting            Number of    responses  per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Payment of annual establishment               20               1              20             0.5              10
 fee............................
Request for Small Business                    10               1              10              25             250
 Establishment Fee Reduction
 (Form FDA 3908)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             260
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

        Table 2--Estimated Annual Reporting Burden--Reinspection Fee and Dispute Resolution Requests \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Type of reporting           Number of    responses  per   Total annual    Average burden    Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Payment of re-inspection fee..               5               1               5              0.5              2.5
Reconsideration request.......               2               1               2              1                2
Appeal request................               1               1               1              1                1
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ...............              5.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of        Number of records       Total annual      Average burden per
             Type of recordkeeping                  recordkeepers       per recordkeeper         records           recordkeeping         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of small business designation letter......                  10                    1                   10                  0.5                    5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm or http://www.regulations.gov. Use the FDA Web site
listed in the previous sentence to find the most current version of the
guidance.

    Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06884 Filed 3-31-14; 8:45 am]
BILLING CODE 4160-01-P