[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Page 42347]
[FR Doc No: 2016-15275]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1872-000]

Marshall Solar, 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
Marshall Solar, 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 July 11, 2016.
    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 electronic 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: June 20, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-15275 Filed 6-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Page 13841]
[FR Doc No: 2015-06027]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL15-52-000, QF13-403-002]

Winding Creek Solar LLC; Notice of Petition for Enforcement

    Take notice that on March 9, 2015, Winding Creek Solar LLC (Winding
Creek) filed a Petition for Enforcement, pursuant to section
210(h)(2)(B) of the Public Utility Regulatory Policies Act of 1978
(PURPA), requesting that the Federal Energy Regulatory Commission
(Commission) exercise its authority and initiate enforcement action
against the California Public Utilities Commission (CPUC), to remedy
the CPUC's implementation of PURPA. Winding Creek asserts that CPUC's
implementation is improper and contrary to the requirements of PURPA
and the Commission's regulations, as more fully explained in its
petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 30, 2015.

    Dated: March 10, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-06027 Filed 3-16-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38444-38449]
[DOCID:fr03au09-77]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0338]

Medical Device User Fee Rates for Fiscal Year 2010

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the

fee rates and payment procedures for medical device user fees for
fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the
act), as amended by the Medical Device User Fee and Modernization Act
of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005
(MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II
of the Food and Drug Administration Amendments Act of 2007 (FDAAA)),
authorizes FDA to collect user fees for certain medical device
submissions, and annual fees both for certain periodic reports and for
certain establishments subject to registration. The FY 2010 fee rates
are provided in this document. These fees apply from October 1, 2009,
through September 30, 2010. 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 received. 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 2010 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 MDUFMA: Visit FDA's Web site, http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeand/ModernizationActMDUFMA/default.htm.
    For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the act (21 USC 379j) establishes fees for certain
medical device applications, submissions, supplements, and notices (for
simplicity, this document refers to these collectively as
``submissions''); for periodic reporting on class III devices; and for
the registration of certain establishments. Under statutorily-defined
conditions, a qualified applicant may receive a fee waiver or may pay a
lower small business fee. (See 21 U.S.C. 379j(d) and (e).)
    Under the 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 licensing
application (BLA)). The act specifies the standard fee for a premarket
application for each year from FY 2008 through FY 2012; the standard
fee for a premarket application received by FDA during FY 2010 is
$217,787. From this starting point, this document establishes FY 2010
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the act.
    The act specifies the annual fee for establishment registration for
each year from FY 2008 through FY 2012; the registration fee for FY
2010 is $2,008. There is no reduction in the registration fee for small
businesses. An establishment must pay the registration fee if it is any
of the following types of establishments:
     Manufacturer. An establishment that makes by any means any
article that is a device, including an establishment that sterilizes or
otherwise makes such article for or on behalf of a specification
developer or any other person.
     Single-Use Device Reprocessor. An establishment that
performs additional processing and manufacturing operations on a
single-use device that has previously been used on a patient.
     Specification Developer. An establishment that develops
specifications for a device that is distributed under the
establishment's name but which performs no manufacturing, including an
establishment that, in addition to developing specifications, also
arranges for the manufacturing of devices labeled with another
establishment's name by a contract manufacturer.
    The fees for FY 2010 go into effect on October 1, 2009, and will
remain in effect through September 30, 2010.

II. Fees for FY 2010

    Under the 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)), and the act sets the
standard fee for a premarket application, including a BLA, a premarket
report, and an efficacy supplement, at $217,787 for FY 2010 (see 21
U.S.C. 379j(b)); this is referred to as the ``base fee''). The fees set
by reference to the base fee are--
     For a panel-track supplement, 75 percent of the base fee;
     For a 180-day supplement, 15 percent of the base fee;
     For a real-time supplement, 7 percent of the base fee;
     For a 30-day notice, 1.6 percent of the base fee;
     For a 510(k) premarket notification, 1.84 percent of the
base fee;
     For a 513(g) request for classification information, 1.35
percent of the base fee; and
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the base 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. (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. (See
21 U.S.C. 379j(e)(2)(C).)
    The statute sets the annual fee for establishment registration at
$2,008 on FY 2010, and there is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
The statute authorizes increases in the annual establishment fee for FY
2010 and subsequent years if the estimated number of establishments
submitting fees for FY 2009 is fewer than 12,250. (See 21 U.S.C.
379j(c)(2)(A).) FDA estimates that the number of establishments
submitting fees in FY 2009 will be in excess of 12,250, so no
establishment fee increase is warranted under this provision of the
statute.
    Table 1 of this document sets out the FY 2010 rates for all medical
device fees.

                                    Table 1.--Medical Device Fees for FY 2010
----------------------------------------------------------------------------------------------------------------
                                Standard Fee, as a Percent
     Application Fee Type        of the Standard Fee for a     FY 2010 Standard Fee   FY 2010 Small Business Fee
                                   Premarket Application
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA                 Set in statute                 $217,787                     $54,447
 submitted under section
 515(c)(1) of the act (21
 U.S.C. 360e(c)(1)), a PDP
 submitted under section
 515(f) of the Act, or a BLA
 submitted under section 351
 of the Public Health Service
 (PHS) Act (42 U.S.C. 262))
----------------------------------------------------------------------------------------------------------------
Premarket report (submitted                            100%                 $217,787                     $54,447
 under section 515(c)(2) of
 the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an                             100%                 $217,787                     $54,447
 approved BLA under section
 351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement                                  75%                 $163,340                     $40,835
----------------------------------------------------------------------------------------------------------------
180-day supplement                                      15%                  $32,668                      $8,167
----------------------------------------------------------------------------------------------------------------
Real-time supplement                                     7%                  $15,245                      $3,811
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification                         1.84%                   $4,007                      $2,004
 submission
----------------------------------------------------------------------------------------------------------------
30-day notice                                          1.6%                   $3,485                      $1,742
----------------------------------------------------------------------------------------------------------------
513(g) (21 U.S.C. 360c(g))                            1.35%                   $2,940                      $1,470
 request for classification
 information
----------------------------------------------------------------------------------------------------------------
Annual Fee Type                                                                       ..........................
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic                                3.5%                   $7,623                      $1,906
 reporting on a class III
 device
----------------------------------------------------------------------------------------------------------------
Annual establishment                         Set in statute                   $2,008                      $2,008
 registration fee (to be paid
 by each establishment that
 is a manufacturer, a single-
 use device reprocessor, or a
 specification developer, 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 fee for that submission.
    If your business qualified as a small business for FY 2009, your
status as a small business will expire at the close of business on
September 30, 2009. You must re-qualify for FY 2010 in order to pay
small business fees during FY 2010.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2010, you must submit the following to FDA:
    (1) A completed FY 2010 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2010 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. This form is
not available separate from the guidance document.
    (2) A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2009,
except--
     If you submit your FY 2010 MDUFMA Small Business
Qualification before April 15, 2010, and you have not yet filed your
return for 2009, you may use tax year 2008.
     If you submit your FY 2010 MDUFMA Small Business
Qualification on or after April 15, 2010, and have not yet filed your
2009 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 should 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 2010, you must submit the following:
    (1) A completed FY 2010 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2010 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/cdrh/mdufma. 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 (2008 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 should 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 and Annual Report Fees

    If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2009, through September 30,
2010, you must pay the fee in effect for FY 2010. The later of the date
that the application or annual report is received in the reviewing
center's document room or the date that the check is received by U.S.
Bank determines whether the fee rates for FY 2009 or FY 2010 apply. FDA
must receive the correct fee at the time that an application or annual
report is submitted, or the application or annual report will not be
accepted for filing or review.
    FDA requests that you follow the steps below before submitting a
medical device application or annual report subject to a fee. Please
pay close attention to these procedures 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 (Note: Both the FY 2009 and FY 2010 fee
rates will be available on the Cover Sheet Web Site beginning on the
date of publication of this document, and only the FY 2010 rates will
appear after September 30, 2009)

    Log on to the MDUFMA Web site at: http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and, under
the MDUFMA Forms heading, click on the link ``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, 2009. One choice is for applications that will
be received on or before September 30, 2009, which will be subject to
FY 2009 fee rates. A second choice is for applications that will be
received on or after October 1, 2009, which will be subject to FY 2010
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.)
    It is helpful if the fee arrives at the bank at least 1 day before
the application arrives at FDA. 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 U.S. Bank receives the
payment. U.S. Bank is required to notify FDA within 1 working day,
using the PIN described previously in this document.
    (2) If Paying With Credit Card or Electronic Check (Automated
Clearing House (ACH)):
    FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a web based payment application, for online electronic
payment. Pay.gov can now be used to submit online payments for cover
sheets to the FDA. You now have the option to make a payment via
electronic check or credit card after submitting your coversheet. To
pay online, select the ``Pay Now'' button. Credit card transactions for
cover sheets are limited to $4,000.00.
    (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 you
application will be delayed.
     The originating financial institution usually charges a
wire transfer fee between $15.00 and $35.00. 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 Treasury, TREAS NYC, 33 Liberty St, New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane, Rockville, MD 20857.

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

    For all applications sent after August 1, 2009, 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-- WO66, 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 Annual Establishment Fees

    If you are required to pay an annual establishment registration
fee, you must pay for each establishment prior to registration. Payment
must be submitted by first creating a Device Facility Use Fee (DFUF)
order through the User Fee 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 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 2010 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 and Research
(CBER) will send establishment registration fee invoices annually to
these companies.

A. Step One--Submit a Device Facility User Fee 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 2010 store. Complete the DFUF order
by entering the number of establishments you are registering. 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 Device Facility User Fee Order

    Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
    (1) If paying with 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 checks.
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 70961, Charlotte, NC 28272-0961. (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: Wachovia Bank, Attn: Food and Drug
Administration--Lockbox 70961, rm. NC0810, 1525 West WT Harris Blvd.,
Charlotte, NC 28262. (Note: This Wachovia 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 70961) 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 Medical Device 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 usually charges a
wire transfer fee between $15.00 and $35.00. 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, US.. Dept
of Treasury, TREAS NYC, 33 Liberty St, New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
5600 Fishers Lane, Rockville, MD 20857.

C. Step Three--Complete the Information Online to Update Your
Establishment's Annual Registration for FY 2010, or to Register a New
Establishment for FY 2010

    Go to CDRH'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 2009. Biologics license
manufacturers 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, there will be a button that you
will click to go to the Device Registration and Listing Module (DRLM)
of FURLS. 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, e-mail:
<EMAIL_ADDRESS>or call<PHONE_NUMBER> for assistance. (Note: this
e-mail 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 BER 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 licensed biologic
devices. CBER will send invoices for payment of the establishment
registration fee to companies who only manufacture licensed biologics
devices. Fees are only required for those establishments defined in
section I of this document.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18456 Filed 7-31-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50638-50639]
[FR Doc No: 2015-20557]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2768]

Collecting On-Farm Antimicrobial Use and Resistance Data; Public
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA), in collaboration with the
U.S. Department of Agriculture (USDA) and the Centers for Disease
Control and Prevention (CDC), is announcing plans for a jointly
sponsored public meeting to obtain public input on possible approaches
for collecting additional on-farm antimicrobial drug use and resistance
data. Such data are important for assessing the impact of measures
being implemented to foster the judicious use of medically important
antimicrobial drugs in food-producing animals.
    Date and Time: The public meeting will be held September 30, 2015,
from 8 a.m. to 4:30 p.m. Although you can comment on the interagency
plan for collecting on-farm antimicrobial drug use and resistance data
at any time, to ensure that the Agencies consider your comment before
updating this plan, submit either electronic or written comments by
November 30, 2015.
    Location: The public meeting will be held in the USDA Jefferson
Auditorium (South Building), 1400 Independence Avenue SW., Washington,
DC 20250. Please arrive between 7 a.m. and 7:30 a.m. to provide time to
get through security. Attendees must provide a valid government issued
photo ID (Driver's License, Identification Card, or Passport) to enter
the facility. Attendees should enter the building via Wing 5 on the
Independence Avenue side of the building. The South Building is
accessible by the Smithsonian Metro station (exit Metro station through
the ``Independence Avenue Exit'' and walk toward 15th Street on
Independence Avenue to reach Wing 5). For more information on
directions and parking, visit http://smithsonianassociates.org/ticketing/help/locations/jefferson.htm.
    Contact Person: Kelly Covington, Center for Veterinary Medicine
(HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Registration is
required for this public meeting. Please send registration information
(including name, title, organization, address, telephone and fax
numbers) by email to<EMAIL_ADDRESS>by September 18, 2015.
There is no fee to register for the public meeting, and registration
will be on a first-come, first-served basis. If you need special
accommodations due to a disability, please contact Kelly Covington (see
Contact Person) at least 7 days in advance.
    Oral presentations can be made by members of the public during the
open public comment period of the public meeting. These presentations
will be scheduled between approximately 3 p.m. and 4 p.m. on September
30, 2015. Those persons desiring to make an oral presentation should
notify the contact person listed in this notice by September 16, 2015,
and submit a brief statement of the general nature of information they
wish to present. In an effort to accommodate all who desire to speak,
time allotted for each presentation may be limited. The contact person
will inform each speaker prior to the meeting of the time they are
scheduled to speak.
    Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, by (see Date and Time). 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial drugs have been widely used in human and veterinary
medicine for more than 50 years, with tremendous benefits to both human
and animal health. The development of resistance to this important
class of drugs, and the resulting loss of their effectiveness as
antimicrobial therapies, poses a serious threat to public and animal
health. Because antimicrobial drug use can contribute to the emergence
of drug-resistant organisms, these important drugs must be used
judiciously in both animal and human medicine to slow the development
of resistance.
    In December 2013, FDA published Guidance for Industry (GFI) #213
(http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), which
calls on animal drug sponsors of approved medically important
antimicrobials administered through medicated feed or water to
voluntarily remove production (growth promotion and feed efficiency)
uses from their product labels, and bring the remaining therapeutic
uses of these products (to treat, control, or prevent disease) under
the oversight of a veterinarian by the end of December 2016. All 25
affected drug sponsors have committed to implementing the changes
described in GFI #213 by the December 2016 target date. Once the
changes are fully implemented, it will be illegal to use these
medically important antibiotics for production purposes, and animal
producers will need to obtain authorization from a licensed
veterinarian to use them for prevention, control, or treatment of a
specifically identified disease.
    On March 27, 2015, the White House released the National Action
Plan for Combating Antibiotic-resistant Bacteria (``National Action
Plan'') (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).
Developed in response to Executive Order 13676, which was issued by
President Barack Obama on September 18, 2014, the National Action Plan
is intended to guide the activities of the U.S. Government as well as
the actions of public health, health care, and veterinary partners in a
common effort to address the urgent and serious public health threat of
drug-resistant bacterial infections. Objective 2.4 of the National
Action Plan is to enhance monitoring of antibiotic resistance patterns,
as well as antibiotic sales, usage, and management practices, at
multiple points in the production chain for food animals and retail
meat. The public meeting being announced in this Federal Register
notice is consistent with Sub-Objective 2.4.3 of the National Action
Plan, which calls for the USDA and FDA to seek public input on a plan
for collecting drug use and resistance data on farms.
    In April 2015, USDA's Animal and Plant Health Inspection Service
published an Info Sheet entitled ``Proposed Initiatives From the USDA
Antimicrobial Resistance Action Plan'' (http://www.aphis.usda.gov/animal_health/nahms/amr/downloads/ProposedInitiatives.pdf). The Info
Sheet provides a brief synopsis of initiatives

proposed in the USDA Action plan, including a number of initiatives
related to collecting on-farm antibiotic use and resistance data.
    Gathering information on the way medically important antimicrobials
are used in food-producing animals is essential to measuring the impact
of the FDA's GFI #213. FDA is collaborating with USDA and CDC to
develop a plan for collecting additional on-farm data on antimicrobial
use and resistance. Such data are intended to supplement existing
information, including data on the quantity of antimicrobials sold or
distributed for use in food-producing animals (reported under section
105 of the Animal Drug User Fee Amendments of 2008) and data on
antimicrobial resistance (e.g., collected under the National
Antimicrobial Resistance Monitoring System and the National Animal
Health Monitoring System). Data from multiple sources are needed to
provide a comprehensive and science-based picture of antimicrobial drug
use and resistance in animal agriculture.
    A data collection plan is needed to obtain additional information
necessary to: (1) Assess the rate of adoption of changes outlined in
the FDA's GFI #213; (2) help gauge the success of antibiotic
stewardship efforts and guide their continued evolution and
optimization; and (3) assess associations between antibiotic use
practices and resistance. FDA is continuing to work with the USDA and
CDC in developing this plan, and is holding this public meeting in
order to obtain input from the public. This meeting is the first
opportunity for public input as part of our ongoing effort to develop
and implement plans for collecting additional on-farm antimicrobial
drug use and resistance data.

II. Agenda

    The public meeting will provide an opportunity for public comment
on possible approaches for collecting additional antimicrobial drug use
data. The final agenda for the public meeting will be made available on
the Agency's Web site at
    http://www.fda.gov/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/ucm456380.htm no later than 2 weeks prior
to the meeting.

III. Transcript

    FDA will prepare a meeting transcript and make it available on the
Agency's Web site (see section II) after the meeting. FDA anticipates
that the transcript will be available approximately 60 business days
after the meeting. A copy of the transcript will be available for
public examination at the Division of Dockets Management (see Comments)
between 9 a.m. and 4 p.m., Monday through Friday. In addition, copies
of the transcript will be available in either hardcopy or on CD-ROM
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov.

    Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20557 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P