[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]
[Page 45014-45017]
[DOCID:fr01au08-75]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0420]

Medical Device User Fee Rates for Fiscal Year 2009

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2009. 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 2009 fee rates
are provided in this notice. These fees apply from October 1, 2008,
through September 30, 2009. 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 notice provides information on how the
fees for FY 2009 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/cdrh/mdufma.
    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 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this notice 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 2009 is
$200,725. From this starting point, this notice establishes FY 2009 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
2009 is $1,851. 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 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 2009 go into effect on October 1, 2008, and will
remain in effect through September 30, 2009.

II. Fees for FY 2009

    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 biologic
licensing application (BLA) and a premarket report, at $200,725 for FY
2009 (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)). There is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
Table 1 of this document sets out the FY 2009 rates for all medical
device fees.

                                    Table 1--Medical Device Fees for FY 2009
----------------------------------------------------------------------------------------------------------------
                                                            Standard Fee, as a
                                                              Percent of the          FY 2009      FY 2009 Small
                  Application Fee Type                      Standard Fee for a     Standard Fee    Business Fee
                                                          Premarket  Application
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under section         Set in statute             $200,725         $50,181
 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 under section 515(c)(2) of                  100%            $200,725         $50,181
 the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an approved BLA under section                   100%            $200,725         $50,181
 351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement                                                   75%            $150,544         $37,636
----------------------------------------------------------------------------------------------------------------
180-day supplement                                                       15%             $30,109          $7,527
----------------------------------------------------------------------------------------------------------------
Real-time supplement                                                      7%             $14,051          $3,513
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification submission                               1.84%              $3,693          $1,847
----------------------------------------------------------------------------------------------------------------
30-day notice                                                           1.6%              $3,212          $1,606
----------------------------------------------------------------------------------------------------------------
513(g) request for classification information                          1.35%              $2,710          $1,355
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class III device                 3.5%              $7,025          $1,756
----------------------------------------------------------------------------------------------------------------
Annual establishment registration fee (to be paid by         Set in statute               $1,851          $1,851
 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 2008, your
status as a small business will expire at the close of business on
September 30, 2008. You must re-qualify for FY 2009 in order to pay
small business fees during FY 2009.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2009, you must submit the following to FDA:
    (1) A completed FY 2009 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2009 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 certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2008,
except--
     If you submit your FY 2009 MDUFMA Small Business
Qualification before April 15, 2009, and you have not yet filed your
return for 2008, you may use tax year 2007.
     If you submit your FY 2009 MDUFMA Small Business
Qualification on or after April 15, 2008, and have not yet filed your
2008 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. 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(s) of each affiliate(s), or
that the applicant has no affiliates. The National Taxing Authority is
the foreign equivalent of the U.S. Internal Revenue Service.
    If you are a foreign business, and wish to qualify as a small
business for FY 2009, you must submit the following:
    (1) A completed FY 2009 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2009 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 (2007 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. 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(s) of each affiliate(s), or
that the applicant has no affiliates. The National Taxing Authority is
the foreign equivalent of the U.S. Internal Revenue Service.

IV. Procedures for Paying Application and Annual Report Fees

    If your application or submission is subject to a fee and is
received by FDA from October 1, 2008 through September 30, 2009, you
must pay the fee in effect for FY 2009. 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 2008 or FY 2009 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 2008 and FY 2009 fee
rates will be available on the Cover Sheet Web Site beginning on the
date of publication of this notice, and the FY 2008 rates will no
longer appear after September 30, 2008.)

    Log onto the MDUFMA Web site at http://www.fda.gov/oc/mdufma and,
under the 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, 2008. One choice is for applications that will
be received on or before September 30, 2008, which will be subject to
FY 2008 fee rates. A second choice is for applications that will be
received on or after October 1, 2008, which will be subject to FY 2009
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. Since 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--Mail Payment and a Copy of the Completed Medical Device
User Fee Cover Sheet to the St. Louis Address Specified in This Section

     Make the payment in U. S. currency by check, bank draft,
or U.S. Postal money order 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, bank draft, or U.S. Postal money order.
     Mail the payment and a copy of the completed Medical
Device User Fee Cover Sheet to: Food and Drug Administration, P.O. Box
956733, St. Louis, MO, 63195-6733.
(Note: 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.)
    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:
     The date the application was received by FDA.

     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.

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:
     Medical device applications should be submitted to: Food
and Drug Administration, Center for Devices and Radiological Health,
Document Mail Center (HFZ-401), 9200 Corporate Blvd., Rockville, MD
20850.
     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. 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 2009 until it has completed the steps in this section
to register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).

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 in this
section. After creating a user name and password, log onto the Annual
Facility User Fee 2009 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 DFUF Order

    Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank. 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. 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 numbers 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.
    Wire transfers may also be used to pay annual establishment fees.
For wire transfer information, please contact the user fee helpdesk at
301-827-9539 or<EMAIL_ADDRESS>
C. Step Three--Complete the Information Online to Update Your
Establishment's Annual Registration for FY 2009, or to Register a New
Establishment for FY 2009

    Go to CDRH's Web site at http://www.fda.gov/cdrh/reglistpage.html
and click the ``Electronic Registration and Listing System (FURLS)''
link on the left of the page. This opens up a new page with important
information about FURLS. After reading this information click on the
link at the bottom of the page. That 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
2008.
    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 240-
276-0111 for assistance.
(Note: This e-mail address and phone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.)

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. Fees are only required for those establishments
defined in section I of this document.

    Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17739 Filed 7-31-08; 8:45 am]

BILLING CODE 4160-01-S


AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

November 15 - 17, 2006

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ- OPP-2006-0693

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington,VA 22202

Studies Evaluating the Impact of Surface Coatings on the Level of
Dislodgeable Arsenic, Chromium and Copper from Chromated Copper Arsenate
(CCA)-Treated Wood

Wednesday, November 15, 2006

8:30 A.M.	Introduction and Identification of Panel Members -

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)

8:40 A.M.	Administrative Procedures by Designated Federal Official -

		Mr. Joseph E. Bailey, Office of Science Coordination and Policy, EPA

8:45 A.M.	Welcome and Opening Remarks – Mr. Jim Jones, Director,
Office of 			Pesticide Programs, EPA

8:50 A.M.	Introductory Remarks - Mr. Frank Princiotta, National Risk
Management 			Research Laboratory, Office of Research and Development,
EPA

8:55 A.M.	Introduction and Background - Nader Elkasabanny, Ph.D.,
Antimicrobials Division, Office of Pesticide Programs, EPA

9:15 A.M	Overview of EPA Surface Coating Study - Mr. Mark Mason, Air
Pollution 		Prevention and Control Division, National Risk Management
Research 			Laboratory, Office of Research and Development, EPA

10:00 A.M.	BREAK

10:15 A.M	Overview of EPA Surface Coating Study (continued)

10:45 A.M	Overview of CPSC Staff Surface Coating Study -

		Jacqueline Ferrante, Ph.D., Directorate for Health Sciences, U.S.
Consumer Product Safety Commission

12:00 P.M.	LUNCH

1:15 A.M.	Public Comments

2:15 P.M.	Questions to Panel

	Question 1:  The Scientific Advisory Panel (SAP) members are asked to
identify the scientific merits and limitations of the design of the
studies and the analyses of the results.  The SAP members are also asked
to comment on the quality of the data, including its objectivity and
utility.

3:15 P.M.	BREAK

3:30 P.M.	Questions to Panel

		Question 2:  Please comment on whether the reports have captured the
critical findings of the studies objectively and appropriately
consistent with the data.  Please identify any other conclusions that
can be drawn from the data.

5:00 P.M. 	Adjournment

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

	November 15 - 17, 2006

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ- OPP-2006-0693

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

Arlington,VA 22202

Studies Evaluating the Impact of Surface Coatings on the Level of
Dislodgeable Arsenic, Chromium and Copper from Chromated Copper Arsenate
(CCA)-Treated Wood

Thursday, November 16, 2006

8:30 A.M.	Introduction and Identification of Panel Members -

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)

8:40 A.M.	Administrative Procedures by Designated Federal Official -

		Mr. Joseph E. Bailey, Office of Science Coordination and Policy, EPA

8:45 A.M.	Questions to the Panel

		Question 3:  Please comment on whether the statistical methods
employed by EPA and CPSC staff represent a scientifically justifiable
and 			robust approach to evaluation of the data. Have the statistical
analyses, 			including the analyses of variance, been presented in an
appropriate, 			useful, clear and transparent manner?

10:00 A.M.	Break

10:15 A.M.	Questions to the Panel

		Question 4:  Certain specific issues, such as the impact of abrasion
and coating reapplication, were not examined in these studies.  Please
comment on how these data gaps have been sufficiently accounted for in
the discussion of the results of these studies.

11:15 A.M.	Questions to the Panel

		Question 5:  The studies were performed under limited study conditions
(one climatic region, i.e., the mid-Atlantic U.S., the structures were
not subjected to normal use or wear, etc.) with a limited set of
products.   Please comment on whether it is appropriate to extrapolate
these results to other conditions.

12:15 P.M.	LUNCH

1:30 P.M.	Questions to the Panel

		Question 6:  Please comment on whether the methodology is suitable for
use by others (e.g., the coating industry, wood treaters, or consumer
groups) for evaluating and developing new products.  Are there elements
of the protocol that you recommend be modified or explored (e.g., the
moisture content of the wipe material, wipe contact time on the wood
surface, etc.)?

2:30 P.M.	Break

2:45 P.M.	Questions to the Panel

		Question 7:	Please comment on whether these studies are of sufficient
quality and breadth to be used to assist in developing conclusions about
the ability of certain coatings to substantially reduce dislodgeable CCA
chemicals.  Have the agencies identified the most important information
and findings?  Are there other findings/conclusions that could be made
from these studies?

4:30 P.M.	Adjournment

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

	November 15 - 17, 2006

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ- OPP-2006-0693

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

Arlington,VA 22202

Studies Evaluating the Impact of Surface Coatings on the Level of
Dislodgeable Arsenic, Chromium and Copper from Chromated Copper Arsenate
(CCA)-Treated Wood

Friday, November 17, 2006

( 8:30 A.M.	Introduction and Identification of Panel Members -

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)

( 8:40 A.M.	Administrative Procedures by Designated Federal Official -

		Mr. Joseph E. Bailey, Office of Science Coordination and Policy, EPA

( 8:45 A.M.	Continuation of Questions to the Panel (as needed)

(10:30 A.M.	Break

(10:15 A.M.  Continuation of Questions to the Panel (as needed)

(12:00 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Mr. Joseph Bailey, via telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>


[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72603-72604]
[FR Doc No: 2021-27719]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0756]

Validation and Verification of Analytical Testing Methods Used
for Tobacco Products; Draft Guidance for Industry; Availability;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Validation and Verification of Analytical Testing Methods used for
Tobacco Products'' and requesting comments, including scientific and
other information, concerning the recommendations set forth in the
draft guidance. The draft guidance, when finalized, would provide
information and recommendations related to the validation and
verification of analytical test methods, including analytical testing
of tobacco product constituents, ingredients, and additives, as well as
stability testing of tobacco products. This draft guidance would help
industry produce more consistent and reliable analytical data used to
support regulatory submissions for finished tobacco products.

DATES: Submit either electronic or written comments on the draft
guidance by February 22, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0756 for ``Validation and Verification of Analytical Testing
Methods used for Tobacco Products.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Center for Tobacco Products, Food and Drug Administration, 10903
New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nathan Mease or Matthew Brenner,
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002, 1-877-287-1373, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft document entitled
``Validation and Verification of Analytical Testing Methods used for
Tobacco Products; Draft Guidance for Industry.'' This draft guidance,
when finalized, provides information and recommendations on how tobacco
product manufacturers can produce validation and verification data for
the analytical procedures and

methods used to support regulatory submissions for finished tobacco
products including substantial equivalence (SE) applications, premarket
tobacco product applications (PMTA), and modified risk tobacco product
applications (MRTPA). These recommendations include analytical testing
of tobacco product constituents, ingredients, and additives, as well as
stability testing of finished tobacco products. The principles in this
guidance may also be used for finished tobacco product testing and
reporting of harmful and potentially harmful constituents (HPHCs) in
tobacco products and tobacco smoke.
    The FD&C Act requires, among other things, premarket review for new
tobacco products and modified risk tobacco products (see sections 910
and 911 (21 U.S.C. 387j and 21 U.S.C. 387k) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act)), and also reporting of HPHCs under section
904 of the FD&C Act (21 U.S.C. 387d). Information about constituents,
for example, might be required by law or otherwise support the findings
for premarket authorization. Regulatory submissions often contain data
from analytical testing, such as data about ingredients, constituents,
and additives. In standard practice, analytical testing is done through
validation of the analytical method. In these cases, the applicant will
want to use analytical methods that are sufficiently precise, accurate,
selective, and sensitive. Validation involves documenting, through the
use of specific laboratory investigations, that the performance
characteristics of the method are suitable and reliable for the
intended analytical applications, in terms of precision, accuracy,
selectivity, and sensitivity. When finalized, this guidance is intended
to help industry produce more consistent and reliable analytical data
used to support regulatory submissions for finished tobacco products,
such as SE applications, PMTAs, MRTPAs, and for finished tobacco
product testing and reporting of HPHCs in tobacco products and tobacco
smoke.
    FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Validation
and Verification of Analytical Testing Methods used for Tobacco
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    We believe that the information collection provisions in the draft
guidance do not create a new burden for respondents. We believe the
recordkeeping provisions are part of usual and customary business
practice. Tobacco manufacturers would have in-house analysts or
contractual agreements with outside analytical laboratories and
suppliers, as applicable for the type of tobacco product, to address
all these information collection provisions.
    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in section 910(c)(1)(A)(i) of the FD&C Act
have been approved under OMB control number 0910-0768; the collections
of information in section 905(j) of the FD&C Act (21 U.S.C. 387e(j))
have been approved under OMB control number 0910-0673; and the
collections of information in 21 CFR part 1107 have been approved under
OMB control number 0910-0684, the collections of information in section
904(a)(3) of the FD&C Act have been approved under OMB control number
0910-0732.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27719 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3489-3490]
[FR Doc No: 2016-01060]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76910; File No. SR-Phlx-2016-02]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Delete
Obsolete Rules 1000B-1012B and To Amend Rule 722

January 14, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\, and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 5, 2016, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to delete obsolete Rules 1000B--1012B,
collectively captioned Rules Applicable to Trading of Cash Index
Participations, and to amend Rule 722, Miscellaneous Securities Margin
Accounts.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    Cash Index Participations (``CIPs'') were listed on the Exchange in
the late 1980s.\3\ A CIP was a security based on the spot value of an
index of stocks, of indeterminate duration, and paying its purchasers a
proportionate share of dividends declared on the component stocks of
the CIP. CIPs are no longer listed or traded on Phlx. Accordingly the
Exchange proposes to delete the caption ``Rules Applicable to Trading
of Cash Index Participations (Rules 1000B-1012B)'' found immediately
before Rule 1000B. It also proposes to delete the text following Rule
1000B and replace it with the word ``Reserved.'' Rules 1001B- 1012B are
proposed to be deleted in their entirety. Finally, the Exchange
proposes to make a conforming change to Rule 722, Miscellaneous
Securities Margin Accounts, by deleting from it the language dealing
with margin requirements for CIPs.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 26709 (April 11,
1989), 54 FR 15280 (April 17, 1989).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \4\ in general, and furthers the objectives of Section
6(b)(5) of the Act \5\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
In particular, this proposed change removes from the Phlx rulebook the
Rules Applicable to Trading of Cash Index Participations. These rules
are no longer applicable because they deal solely with CIPs which have
not been listed or traded on Phlx for many years. Removing these CIP
rules from the Phlx rulebook will help eliminate potential member and
investor confusion about products listed and traded on Phlx.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed change is not
designed to address any competitive issue but would merely remove
references to CIPs that are no longer relevant to the Exchange's
business in any respect.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \6\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2016-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2016-02 and should be
submitted on or before February 11, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-01060 Filed 1-20-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Notices]
[Page 53925]
[DOCID:fr17se08-157]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Smyrna/Rutherford County Airport, Smyrna, TN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comment.

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SUMMARY: The Federal Aviation Administration is requesting public
comment on the release of land at the Smyrna/Rutherford County Airport
in the city of Smyrna, Tennessee. This property, approximately 15.65
acres plus associated buildings, will change to ownership by the
Tennessee Air National Guard. This action is taken under the provisions
of Section 125 of the Wendell H. Ford Aviation Investment Reform Act
for the 21 Century (AIR 21).

DATES: Comments must be received on or before October 17, 2008.

ADDRESSES: Documents are available for review at the Smyrna/Rutherford
County Airport, 278 Doug Warpoole Road, Smyrna, Tennessee 37167, the
Tennessee Department of Transportation, Division of Aeronautics, 424
Knapp Blvd, Bldg 4219, Nashville, TN 3721 and the FAA Airports District
Office, 2862 Business Park Drive, Building G, Memphis, TN 38118.
Written comments on the Sponsor's request must be delivered or mailed
to: Mr. Phillip J. Braden, Manager, Memphis Airports District Office,
2862 Business Park Drive, Building G, Memphis, TN 38118.
    In addition, a copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Bob Woods, Director, TDOT, Division of
Aeronautics, P.O. Box 17326, Nashville, TN 37217 and Mr. John Black,
Executive Director, Smyrna/Rutherford County Airport, 278 Doug Warpoole
Road, Smyrna, Tennessee 37167.

FOR FURTHER INFORMATION CONTACT: Mr. Michael Thompson, Program Manager,
Federal Aviation Administration, Memphis Airports District Office, 2862
Business Park Drive, Building G, Memphis, TN 38118. The application may
be reviewed in person at this same location, by appointment.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the request to release property at the Smyrna/Rutherford
County Airport, Smyrna, TN. Under the provisions of AIR 21 (49 U.S.C.
47107(h)(2)).
    On August 29, 2008, the FAA determined that the request to release
property at Smyrna/Rutherford County Airport submitted by the airport
owner meets the procedural requirements of the Federal Aviation
Administration. The FAA may approve the request, in whole or in part,
no later than October 17, 2008.
    The following is a brief overview of the request:
    The Smyrna/Rutherford County Airport Authority, owners of the
Smyrna/Rutherford County Airport, are proposing the release of
approximately 15.65 acres of airport property so the property can be
sold to the Tennessee Air National Guard. The aeronautical use of the
property will remain unchanged.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon appointment and request, inspect
the request, notice and other documents germane to the request in
person at the Tennessee Department of Transportation, Division of
Aeronautics or the Smyrna/Rutherford County Airport.

    Issued in Memphis, TN, on August 29, 2008.
Phillip J. Braden,
Manager, Memphis Airports District Office, Southern Region.
[FR Doc. E8-21515 Filed 9-16-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Notices]
[Page 43737-43740]
[DOCID:fr02au06-66]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0657; FRL-8083-5]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
review the evaluation of the resistance risks from using 100% Bollgard
and Bollgard II cotton as part of a pink bollworm eradication program
in the state of Arizona.

DATES: The meeting will be held on October 24-26, 2006, from 8:30 a.m.
to approximately 5 p.m., eastern time.
    Comments: For the deadlines for the submission of requests to
present oral comments and submission of written comments, see Unit I.C.
of the SUPPLEMENTARY INFORMATION.
    Nominations: Nominations of scientific experts to serve as ad hoc
members of the FIFRA SAP for this meeting should be provided on or
before August 23, 2006.
    Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION CONTACT at least 10 business days prior
to the meeting, to give EPA as much time as possible to process your
request.

ADDRESSES: The meeting will be held at the Holiday Inn Rosslyn Hotel,
1900 North Fort Myer Dr., Arlington, VA 22209. The telephone number for
the Holiday Inn Rosslyn Hotel is<PHONE_NUMBER>.
    Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0657, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P),

Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One Potomac Yard South Bldg., 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays). Special arrangements should be made
for deliveries of boxed information. The Docket telephone number is
(703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0657. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although, listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard South Bldg.,
2777 S. Crystal Drive, Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket telephone number is (703) 305-
5805.
    Nominations, requests to present oral comments, and special
accommodations: See Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Myrta R. Christian, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail addresses:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    When preparing and submitting comments, remember to use these tips:
    1. Identify the document by docket ID number and other identifying
information, (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

C. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2006-0657 in the subject line
on the first page of your request.
    1. Oral comments. Oral comments presented at the meetings should
not be repetitive of previously submitted oral or written comments.
Although requests to present oral comments are accepted until the date
of the meeting (unless otherwise stated), to the extent that time
permits, the Chair of the FIFRA SAP may permit the presentation of oral
comments at the meeting by interested persons who have not previously
requested time. However, each individual or group wishing to make brief
oral comments to the FIFRA SAP is strongly advised to submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than noon, eastern time, October 17, 2006, in order to be
included on the meeting agenda. The request should identify the name of
the individual making the presentation, the organization (if any) the
individual will represent, and any requirements for audiovisual
equipment, e.g., overhead projector, 35 mm projector, chalkboard. Oral
comments before the FIFRA SAP are limited to approximately 5 minutes
unless prior arrangements have been made. In addition, each speaker
should bring 30 copies of his or her comments and presentation slides
for distribution to the FIFRA SAP at the meeting.
    2. Written comments. Although written comments are accepted until
the date of the meeting (unless otherwise stated), the Agency
encourages that written comments be submitted, using the instructions
in ADDRESSES, no later than noon, eastern time, October 10, 2006, to
provide the FIFRA SAP the time necessary to consider and review the
written comments. It is requested that persons submitting comments
directly to the docket also notify the DFO listed under FOR FURTHER
INFORMATION CONTACT. Persons wishing to submit written comments at the
meeting should bring 30 copies. There is no limit on the extent of
written

comments for consideration by the FIFRA SAP.
    3. Seating at the meeting. Seating at the meeting will be on a
first-come basis. Individuals requiring special accommodations at this
meeting, including wheelchair access, should contact the DFO at least
10 business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT so that appropriate arrangements can be
made.
    4. Request for nominations of prospective candidates for service as
ad hoc members of the FIFRA SAP for this meeting. As part of a broader
process for developing a pool of candidates for each meeting, the FIFRA
SAP staff routinely solicit the stakeholder community for nominations
of prospective candidates for service as ad hoc members of the FIFRA
SAP. Any interested person or organization may nominate qualified
individuals to be considered as prospective candidates for a specific
meeting. Individuals nominated for the meeting announced in this notice
should have expertise in one or more of the following areas:
     Familiarity with western cotton production,
     Knowledge of pink bollworm biology,
     Knowledge of insect resistance management for Bt cotton
(principles and applications),
     Knowledge of pink bollworm eradication programs in western
cotton,
     Knowledge of population dynamics modeling. Sterile Insect
Technology (SIT),
     Resistance modeling,
     Knowledge of statics.
    Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the issues for this meeting. Nominees
should be identified by name, occupation, position, address, and
telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before August 14, 2006. The
Agency will consider all nominations of prospective candidates for this
meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency.
    The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency (except EPA). Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Though financial conflicts of interest, the appearance of lack of
impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 10 ad hoc scientists.
    If a prospective candidate for service on the FIFRA SAP is
considered for participation in a particular session, the candidate is
subject to the provisions of 5 CFR part 2634, Executive Branch
Financial Disclosure, as supplemented by EPA in 5 CFR part 6401. As
such, the FIFRA SAP candidate is required to submit a Confidential
Financial Disclosure Form for Special Government Employees Serving on
Federal Advisory Committees at the Environmental Protection Agency (EPA
Form 3110-48 5-02) which shall fully disclose, among other financial
interests, the candidate's employment, stocks and bonds, and where
applicable, sources of research support. The EPA will evaluate the
candidate's financial disclosure form to assess that there are no
financial conflicts of interest, no appearance of lack of impartiality,
and no prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on the FIFRA SAP.
    Those who are selected from the pool of prospective candidates will
be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP website or may be obtained by
contacting the OPP Regulatory Public Docket at the address or telephone
number listed under ADDRESSES.

II. Background

A. Purpose of the FIFRA SAP

    Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)),
include a requirement under section 25(d) of FIFRA that notices of
intent to cancel or reclassify pesticide regulations pursuant to
section 6(b) of FIFRA, as well as proposed and final forms of
regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP
prior to being made public or issued to a registrant. In accordance
with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to
comment on the health and environmental impact of such actions. The
FIFRA SAP also shall make comments, evaluations, and recommendations
for operating guidelines to improve the effectiveness and quality of
analyses made by Agency scientists. Members are scientists who have
sufficient professional qualifications, including training and
experience, to be capable of providing expert comments as to the impact
on health and the environment of regulatory actions under sections 6(b)
and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals
to serve on the FIFRA SAP from nominations provided by the National
Institutes of Health and the National Science Foundation.
    Section 104 of FQPA (Public Law 104-170) established the FQPA
Science Review Board (SRB). These scientists shall be available to the
FIFRA SAP on an ad hoc basis to assist in reviews conducted by the
FIFRA SAP.

B. Public Meeting

    The FIFRA SAP will meet to consider and review the evaluation of
the resistance risks from using 100% Bollgard and Bollgard II cotton as
part of a pink bollworm eradication program in the state of Arizona.
The State of Arizona issued two special local need registrations under
FIFRA section 24(c) in March 2006 permitting the use of 100%
Bollgard[reg] and Bollgard II[reg] cotton varieties along with sterile
pink bollworm moths (i.e., sterile insect technology or SIT),
pheromones, and limited use of chemical insecticides in a sanctioned
pink bollworm (PBW) eradication program. As a provision of these
registrations, the State of Arizona agreed to provide the Agency with
data to support the continued use of the FIFRA 24(c) registrations.
These data will focus on addressing the uncertainties associated with
the

expected effectiveness of the PBW eradication program using sterile
insect technology, 100% Bollgard and Bollgard II cotton, pheromones,
and limited insecticide use. The Agency is concerned with the potential
increased insect resistance that may be posed by the use of 100%
Bollgard and Bollgard II cotton (i.e., no structured non-Bt cotton
refuge, very high selection intensity) and whether the SIT can be used
effectively to manage PBW resistance should it occur during the 4-year
eradication program. The State of Arizona, in consultation with USDA
and University experts, devised a plan that replaces the biological
function served by non-Bt cotton refuges with artificially raised
sterile pink bollworm moths. The Panel will be asked to comment on the
Agency's review of the effectiveness of this plan using field level
systematic monitoring and mapping data in conjunction with modeling
simulations.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP
composition (i.e., members and consultants for this meeting), and the
meeting agenda will be available by the end of September 2006. In
addition, the Agency may provide additional background documents as the
materials become available. You may obtain electronic copies of these
documents, and certain other related documents that might be available
electronically, from the regulations.gov website and the FIFRA SAP
homepage at http://www.epa.gov/scipoly/sap.

    The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 90 days after the
meeting. The meeting minutes will be posted on the FIFRA SAP website or
may be obtained by contacting the OPP Regulatory Public Docket at the
address or telephone number listed under ADDRESSES.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 27, 2006.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-12435 Filed 8-1-06; 8:45 am]

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