[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19668-19669]
[FR Doc No: 2015-08359]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1082]

Preparation for International Conference on Harmonization
Steering Committee and Expert Working Group Meetings in Fukuoka, Japan;
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a
regional public meeting entitled ``Preparation for ICH Steering
Committee and Expert Working Group Meetings in Fukuoka, Japan'' to
provide information and receive comments on the International
Conference on Harmonization (ICH) as well as the upcoming meetings in
Fukuoka, Japan. The topics to be discussed are the topics for
discussion at the forthcoming ICH Steering Committee Meeting. The
purpose of the meeting is to solicit public input prior to the next
Steering Committee and Expert Working Group meetings in Fukuoka, Japan,
scheduled on June 6 through 11, 2015, at which the discussion of the
topics underway and ICH reforms will continue.

DATES: The public meeting will be held on May 15, 2015, from 1 p.m. to
4 p.m. Registration to attend the meeting and requests for oral
presentations must be received by May 11, 2015. See the SUPPLEMENTARY
INFORMATION section for information on how to register for the meeting.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, Great Room
(Rm. 1503 A), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit either electronic or written comments by June 14, 2015.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tracy Porter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1173, Silver Spring, MD 20993, 301-796-
7789, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The ICH was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory obligations of safety and effectiveness.

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory Agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. Members of the ICH Steering Committee include
the European Union; the European Federation of Pharmaceutical
Industries Associations; the Japanese Ministry of Health, Labor, and
Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA;
the Pharmaceutical Research and Manufacturers of America; Health
Canada; Swissmedic; and the World Health Organization (as an Observer).
The ICH process has achieved significant harmonization of the technical
requirements for the approval of pharmaceuticals for human use in the
ICH regions over the past two decades.
    The current ICH process and structure can be found at the following
Web site: http://www.ich.org. (FDA has verified the Web site addresses
in this document, but FDA is not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)

II. Meeting Attendance and Participation

A. Registration

    If you wish to attend the meeting, visit https://www.eventbrite.com/e/international-conference-on-harmonization-regional-public-meeting-tickets-16183519342. Please register for the
meeting by May 11, 2015. Seating may be limited, so early registration
is recommended. Registration is free and will be on a first-come,
first-served basis. However, FDA may limit the number of participants
from each organization based on space limitations. Registrants will
receive confirmation once they have been accepted. Onsite registration
on the day of the meetings will be based on space availability.
    If you need special accommodations because of a disability, please
contact Tracy Porter (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the meeting.

B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally
or in writing on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 3:30 p.m. and 4
p.m. Time allotted for oral presentations may be limited to 5 minutes.
Those desiring to make oral presentations should notify Tracy Porter
(see FOR FURTHER INFORMATION CONTACT) by May 11, 2015, and submit a
brief statement of the general nature of the evidence or arguments they
wish to present; the names and addresses, telephone number, fax, and
email of proposed participants; and an indication of the approximate
time requested to make their presentation.
    The agenda for the public meeting will be made available on the
Internet at http://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.

III. Comments

    Interested persons may submit either electronic or written comments
to the public docket (see ADDRESSES) by June 14, 2015. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

IV. Transcripts

    Please be advised that as soon as a meeting transcript is
available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.

    Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08359 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 65 (Tuesday, April 5, 2022)]
[Notices]
[Pages 19724-19725]
[FR Doc No: 2022-07081]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on a Proposed Release of
Airport Property for Non-Aeronautical Use at Curtis Field Airport,
Brady, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA is considering a request from Curtis Field Airport to

release approximately 0.39 acres of airport property located on U.S.
Route 377 on the eastern portion of the Airport property as shown on
the approved Airport Layout Plan (ALP).

DATES: Comments must be received on or before May 5, 2022.

ADDRESSES: Send comments on this document to Mrs. Jessica Bryan,
Federal Aviation Administration, Texas Airports District Office, 10101
Hillwood Parkway, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Ms. Lisa Perry, Airport Manager,
Curtis Field Airport, 3825 N Bridge Street, Brady, TX 76825, telephone
325-597-2152; or Mrs. Jessica Bryan, Federal Aviation Administration,
Texas Airports District Office, 10101 Hillwood Parkway, Fort Worth, TX
76177, telephone<PHONE_NUMBER>. Documents reflecting this FAA action
may be reviewed at the above locations.

SUPPLEMENTARY INFORMATION: The proposal consists of 0.39 acres of
airport property (Tract 1) which was part of 325.09 acres of land that
was conveyed to the City of Brady via a Quitclaim Deed dated November
22, 1946, by the United States of America acting by and through the War
Assets Administrator under the provisions of the Surplus Property Act
of 1944. This portion of land is outside the forecasted need for
aviation development and is not needed for indirect or direct
aeronautical use. A water tower will be constructed on the converted
parcel, as part of the City of Brady's water improvement project. This
new water tower will increase water pressure and supply needed to
support improvements to the City, the Airport, and Airport Operations.
Approval does not constitute a commitment by the FAA to financially
assist in the conversion of the subject airport property nor a
determination of eligibility for grant-in-aid funding from the FAA. The
disposition of proceeds from the conversion of the airport property
will be in accordance with FAA's Policy and Procedures Concerning the
Use of Airport Revenue, published in the Federal Register on February
16, 1999. In accordance with section 47107(h) of title 49, United
States Code, this notice is required to be published in the Federal
Register 30 days before modifying the land-use assurance that requires
the property to be used for an aeronautical purpose.

    Issued in Fort Worth, TX, on March 30, 2022.
Ignacio Flores,
Director, Airports Division, FAA, Southwest Region.
[FR Doc. 2022-07081 Filed 4-4-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50484-50485]
[FR Doc No: 2011-20603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0567]

Draft Guidance for Industry, Clinical Investigators, and Food and
Drug Administration Staff; Design Considerations for Pivotal Clinical
Investigations for Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Design Considerations for
Pivotal Clinical Investigations for Medical Devices.'' This document is
intended to provide guidance to those involved in designing clinical
studies intended to support premarket submissions for medical devices
and for FDA staff who review those submissions. This guidance document
describes different study design principles relevant to the development
of medical device clinical studies that can be used to fulfill
premarket clinical data requirements. This draft guidance is not final
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Design Considerations for Pivotal Clinical
Investigations for Medical Devices'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-
0002, or to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Greg Campbell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2110, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

    For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document is intended to provide guidance to
those involved in designing clinical studies intended to support
premarket submissions for medical devices and for FDA staff who review
those submissions. Although the Agency has articulated policies related
to design of studies intended to support specific device types, and a
general policy of tailoring the evidentiary burden to the regulatory
requirement, the Agency has not attempted to describe the different
clinical study designs that may be appropriate to support a device
premarket submission or to define how a sponsor should decide which
pivotal clinical study design should be used to support a submission
for a particular device. The draft guidance document describes
different study design principles relevant to the development of
medical device clinical studies that can be used to fulfill premarket
clinical data requirements. The draft guidance is not intended to
provide a comprehensive tutorial on the best clinical and statistical
practices for investigational medical device studies.
    A medical device pivotal study is a definitive study in which
evidence is gathered to support the safety and effectiveness evaluation
of the medical device for its intended use. Evidence from one or more
pivotal clinical studies generally serves as the primary basis for the
determination of reasonable assurance of safety and effectiveness of
the medical device of a premarket approval application (PMA) and FDA's
overall risk-benefit assessment. In some cases, a PMA may include
multiple studies designed to answer different scientific questions.
    The draft guidance describes principles that should be followed for
the design of premarket clinical studies that are pivotal in
establishing the safety and effectiveness of a medical device.
Practical issues and pitfalls in pivotal clinical study design are
discussed, along with their effects on the conclusions that can be
drawn from the studies concerning safety and effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on design
considerations for pivotal clinical investigations for medical devices.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or on the Division of Dockets Management Internet site at
http://www.regulations.gov. To receive ``Design Considerations for
Pivotal Clinical Investigations for Medical Devices,'' you may either
send an e-mail request to<EMAIL_ADDRESS>to receive an electronic
copy of the document or send a fax request to<PHONE_NUMBER> to receive a
hard copy. Please use the document number 1776 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

    Dated: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20603 Filed 8-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10222-10223]
[FR Doc No: 2014-03993]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Ads in Motion, Inc., Premier Beverage Group
Corp., Pulmo BioTech, Inc., TriMedia Entertainment Group, Inc., and
Zanett, Inc., Order of Suspension of Trading

February 20, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Ads In Motion, Inc. because it has not filed any periodic reports since
the period ended February 26, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Premier Beverage Group Corp. because it has not filed any periodic
reports since the period ended September 30, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Pulmo BioTech, Inc. because it has not filed any periodic reports since
the period ended December 31, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
TriMedia Entertainment Group, Inc. because it has not filed any
periodic reports since the period ended July 31, 2008.

    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Zanett, Inc. because it has not filed any periodic reports since the
period ended March 31, 2011.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EST on February 20, 2014, through 11:59
p.m. EST on March 5, 2014.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-03993 Filed 2-20-14; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Notices]
[Page 14004]
[FR Doc No: 2022-05204]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-007]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly Receipt of Environmental Impact Statements (EIS)

Filed February 28, 2022 10 a.m. EST Through March 7, 2022 10 a.m. EST

    Pursuant to 40 CFR 1506.9.
    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.
    EIS No. 20220029, Draft, FERC, PA, Regional Energy Access Expansion
Project, Comment Period Ends: 04/25/2022, Contact: Office of External
Affairs<PHONE_NUMBER>.

    Dated: March 7, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-05204 Filed 3-10-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 21, 2006 (Volume 71, Number 140)]
[Notices]
[Page 41488-41489]
[DOCID:fr21jy06-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54152; File No. SR-ISE-2006-36]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Payment for Order Flow Fee Changes

July 14, 2006.
    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 July 3, 2006, the International Securities Exchange, Inc. (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The ISE
has designated this proposal as one changing a fee imposed by the ISE
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to amend its Schedule of Fees regarding the
payment for order flow fees collected by the Exchange. The text of the
proposed rule change is available on the ISE's Web site at http://www.iseoptions.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 ISE 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 ISE 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
    The ISE is proposing to amend its Schedule of Fees regarding the
payment for order flow (``PFOF'') fees collected by the Exchange. The
Exchange states that it currently operates a PFOF program as approved
by the Commission.\5\ The PFOF program is funded through a fee,
currently set at $0.55 per contract, paid by Exchange market makers for
each customer contract they execute. Currently, all funds collected by
the Exchange are administered by specified market makers.\6\ PFOF fees
collected by the Exchange that are not distributed are rebated back to
the market makers.
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    \5\ See Securities Exchange Act Release No. 43833 (January 10,
2001), 66 FR 7822 (January 25, 2001) (SR-ISE-00-10).
    \6\ The Exchange states that initially only Primary Market
Makers administered PFOF pools. However, the Exchange recently
amended its PFOF program to allow a Competitive Market Maker
(``CMM'') to administer the PFOF funds collected by the Exchange
with respect to orders in a group of options classes preferenced to
that CMM. See Securities Exchange Act Release No. 53127 (January 13,
2006), 71 FR 3582 (January 23, 2006) (SR-ISE-2005-57).
---------------------------------------------------------------------------

    The Exchange proposes to increase its PFOF fee to $0.65 per
contract to match the fee that the Chicago Board Options Exchange,
Incorporated (``CBOE''), under the PFOF program it administers,
currently charges its members. Additionally, the Exchange states that
Complex Orders \7\ are currently exempt from the ISE's PFOF fee. The
Exchange represents that other options exchanges, however, notably
CBOE, do not provide a similar exception. Accordingly, and also for
competitive reasons, the Exchange proposes to charge a PFOF fee on
Complex Orders traded on the ISE.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 46646 (October 11,
2002), 67 FR 64428 (October 18, 2002) (Approving SR-ISE-2002-20,
ISE's Complex Order Rule, on a permanent basis).
---------------------------------------------------------------------------

    The ISE states that it is committed to matching other exchanges'
PFOF programs in order to maintain its competitive position. The ISE
states that its Board has provided management with delegated authority
to increase the ISE's PFOF fee further in the event that increases in
the PFOF fee of other exchanges present competitive challenges to the
ISE.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(4) of the Act \9\ in particular, in that it is an equitable
allocation of reasonable dues, fees, and other charges among ISE
members and other persons using its facilities.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \10\ and Rule
19b-4(f)(2) \11\ thereunder, because it establishes or changes a due,
fee, or other charge imposed by the Exchange. Accordingly, the proposal
will take effect upon filing with the Commission. At any time within 60
days of the filing of such proposed rule change the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2006-36 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.

All submissions should refer to File Number SR-ISE-2006-36. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. 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-ISE-2006-36 and should be submitted on or before August
11, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 Jill M. Peterson,
 Assistant Secretary.
 [FR Doc. E6-11570 Filed 7-20-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76738-76740]
[FR Doc No: 2011-31630]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public
meeting to discuss proposed recommendations for enactment of a Generic
Drug User Fee Act (GDUFA), which will authorize FDA to collect fees and
use them for the process for the review of human generic drug
applications and associated Type II Active Pharmaceutical Ingredient
Drug Master Files (DMFs) and for conducting associated inspections for
fiscal years (FYs) 2013-2017. New legislation would be required for FDA
to establish and collect user fees under such a program. FDA and the
regulated industry have developed a proposal for Congressional
consideration. In the interest of transparency, and in an effort to
voluntarily follow a process similar to the ones set forth in the
Federal Food, Drug, and Cosmetic Act for FDA's other user fee programs,
FDA is publishing the negotiated recommendations (the goals letter),
holding a meeting at which the public may present its views on such
recommendations, and providing an opportunity for the public to provide
written comments on such recommendations.
    Date and Time: The public meeting will be held on December 19,
2011, from 10 a.m. to 5 p.m. Registration to attend the meeting must be
received by December 12, 2011. The meeting will also be Web cast. See
Section III. B. of this document for information on how to register for
the meeting and Section III.C. on information about how to access the
Web cast. Please submit any comments that you plan to present at the
public meeting to the docket by the date of the public meeting but note
that written or electronic comments must be submitted by January 6,
2011.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 2, rm. 2047, Silver Spring, MD 20993. Submit
electronic comments to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the

heading of this document. Transcripts of the meeting will be available
for review at the Division of Dockets Management and on the Internet at
http://www.fda.gov and http://www.regulations.gov as soon as they are
prepared after the public meeting (see Section III.C. of this
document).

FOR FURTHER INFORMATION CONTACT: Mari Long, Office of Policy, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4237,
Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Peter C. Beckerman, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4238,
Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting to discuss
proposed recommendations for the enactment of a GDUFA that would
authorize FDA to collect user fees related to human generic drugs and
use them for the process of the review of human generic drug
applications and associated submissions, to conduct related
inspections, and to engage in other related activities for FYs 2013 to
2017. New legislation is required for FDA to establish and collect user
fees for generic drugs. In furtherance of such a program, FDA engaged
in negotiations with three industry trade associations over aspects of
a joint proposal for a generic drug user fee program, including fees
and performance goals, from February through September 2011. The Agency
held four prior public meetings on the topic before and during this
process, posted meeting minutes after each negotiation session as well
as posting other related materials, held a public docket open during
the negotiation, and considered all comments that were submitted.
    FDA and industry were able to reach agreement on a GDUFA program
that, if enacted, is expected to place FDA's generic drug program on a
sound financial footing and would further the fundamental interests of
safety, access, and transparency. The GDUFA proposal that resulted from
this process is focused on three key aims:
     Safety: To ensure that industry participants, foreign or
domestic, who participate in the U.S. generic drug system are held to
consistent high quality standards and are inspected biennially, using a
risk-based approach, with foreign and domestic parity.
     Access: To expedite the availability of low-cost, high-
quality generic drugs by bringing greater predictability to the review
times for abbreviated new drug applications, amendments and
supplements, increasing predictability, and timeliness in the review
process.
     Transparency: To enhance FDA's ability to protect
Americans in the complex global supply environment by requiring the
identification of facilities involved in the manufacture of generic
drugs and associated active pharmaceutical ingredients and improving
FDA's communications and feedback with industry in order to expedite
product access.
    Generic drugs play a critical role in providing more affordable,
therapeutically equivalent medicine, and the GDUFA program is designed
to keep individual fee amounts as low as possible to supplement
appropriated funding to ensure that consumers continue to receive the
significant benefits offered by generic drugs. Generic drugs provided
more than $824 billion dollars in savings to the nation's health care
system in the last decade alone. The additional resources called for
under the agreement, an inflation-adjusted $299 million annually for
each of the 5 years of the program, will provide FDA with the ability
to perform critical program functions that could not otherwise occur.
This program is not expected to add significantly to the cost of
generic drugs: Given that a reported 3.99 billion retail prescriptions
per year were dispensed in the United States in 2010 and assuming that
78 percent of these prescriptions were filled by generic drugs, it
equates to less than a dime per prescription for the average cost of a
prescription filled by a generic drug in the United States. Moreover,
with the adoption of user fees and the associated savings in
development time, the overall expense of bringing a product to market
may decline and result in reduced costs.
    In addition to the public health benefits, the proposed program is
expected to provide significant value to companies, and in particular
to small companies and first time entrants in the generic market, who
will benefit significantly from the certainty associated with
performance review metrics that offer the potential to dramatically
reduce the time needed to commercialize a generic drug when compared to
pre-GDUFA review times.
    Because FDA remains interested in hearing from nonaffiliated
companies in addition to patient and consumer stakeholders, the Agency
is holding this final public meeting prior to providing recommendations
to Congress. The meeting will provide an explanation of the negotiated
joint recommendations and provide an opportunity for additional
stakeholder reaction and input.

II. The Proposed GDUFA Program

A. Recommendations

    Key attributes of the proposed GDUFA Program, as negotiated, are
memorialized in a goals letter that FDA has posted on its generic drug
user fee Web page, which is accessible at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.

B. Summary of the Program

    If enacted as negotiated, the program would provide FDA with
additional funding for all aspects of the generic drug program in the
amount of $299 million per year, adjusted for inflation, for 5 years.
With those additional user fee funds, FDA would agree to undertake a
series of immediate program enhancements and performance goals. A
nonexclusive list of major end goals for the program includes:
    1. Application metrics that increase to an eventual year 5 goal of
FDA reviewing and acting on 90 percent of complete electronic
abbreviated new drug applications (ANDAs) within 10 months after the
date of submission;
    2. Backlog metrics of FDA reviewing and acting on 90 percent of all
ANDAs, ANDA amendments, and ANDA prior approval supplements pending on
October 1, 2012, by the end of FY 2017; and
    3. Current good manufacturing practice (CGMP) inspection metrics
under which FDA will conduct risk-adjusted biennial CGMP inspections of
generic active pharmaceutical ingredient (API) and generic finished
dosage form (FDF) manufacturers with the goal of achieving parity of
inspection frequency between foreign and domestic firms in FY 2017.
    Many additional, and interim, performance metrics and efficiency
enhancements are set forth in the negotiated documents.
    Under the program, fees would derive from two primary sources:
Generic drug-related submissions and generic drug-related facilities.
Submission fees would include fees for ANDAs and prior approval
supplements, as well as for DMFs (for first reference only, as DMFs may
be referenced multiple times by different sponsors). Facility fees
would include fees for facilities that manufacture APIs for generic
drugs as well and facilities that manufacture

generic FDFs. In the first year of the program, there would also be a
fee assessed for applications that are pending on October 1, 2012, the
so-called ``backlog''.
    As under the prescription drug user fee act (PDUFA), individual fee
amounts would be set annually, with the total annual revenue provided
by the user fee specified in statute. Of the total generic drug user
fee revenue, 80 percent would be provided by the FDF manufacturers and
20 percent by API manufacturers. Additionally, 70 percent of the
overall GDUFA revenue would be generated by facility fees and 30
percent would be generated by submission fees; though in the first year
those splits will be slightly different because of the one-time backlog
fee.
    While it is not possible to provide actual individual fee amounts
until such fees are set by a Federal Register notice, it is expected
that individual GDUFA fees will be orders of magnitude less than PDUFA
fees, a factor due to the larger fee paying base in GDUFA. In
negotiating the program, FDA was cognizant that generic drugs are a
tremendous public health success story, responsible for saving $824
billion over the last decade. Consequently, the Agency worked to
achieve a program that would not appreciably add to the cost of generic
drugs, change the structure of the industry, or advantage any
particular industry sector, regardless of size or location.
    The program, as negotiated, is aimed at putting FDA's generic drugs
program on a firm financial footing and providing additive resources
necessary to assure timely access to safe, high-quality, affordable
generic drugs.

III. What information should you know about the meeting?

A. When and where will the meeting occur? What format will FDA use?

    Through this notice, we are announcing a public meeting to update
stakeholders and hear stakeholder views on the negotiated proposal for
a generic drug user fee program. We will conduct the meeting on
December 19, 2011, from 10 a.m. to 5 p.m. at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 2, rm. 2047, Silver Spring, MD 20993.
In general, the meeting format will include a presentation by FDA and
presentations by stakeholders and members of the public who have
registered in advance to present at the meeting. The amount of time
available for presentations will be determined by the number of people
who register to make a presentation. We will also provide an
opportunity for organizations and individuals to submit written
comments to the docket after the meeting. FDA policy issues are beyond
the scope of this initiative. Accordingly, the presentations should
focus on process and funding issues, and reactions to the GDUFA
recommendations, and not focus on policy.

B. How do you register for the meeting or submit comments?

    If you wish to attend and/or present at the meeting, please
register by email to<EMAIL_ADDRESS>by December 12, 2011.
Your email should contain complete contact information for each
attendee, including name, title, affiliation, address, email address,
and telephone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization, as well as the total number of participants, based on
space limitations. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. We will try to accommodate all persons who
wish to make a presentation. The time allotted for presentations may
depend on the number of persons who wish to speak, and if the entire
meeting time is not needed for presentations, FDA reserves the right to
terminate the meeting early. If you need special accommodations because
of disability, please contact Mari Long or Peter Beckerman (see FOR
FURTHER INFORMATION CONTACT) at least 7 days before the meeting.
    In addition, any person may submit written or electronic comments
to the Division of Dockets Management (see ADDRESSES). Submit a single
copy of electronic comments or two paper copies of any mailed comments,
except that individuals may submit one paper copy. Comments are to be
identified 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. To ensure
consideration, all comments must be received by January 6, 2012.
Submission of comments prior to the meeting is strongly encouraged.

C. Will the meeting be Web cast?

    For those unable to attend in person, FDA will Web cast and provide
a telephone audio link to the meeting. To join the Web meeting, please
go to https://collaboration.fda.gov/gdufa/. For audio, please call 301-
796-2700 and enter participant code 121947. If you have never attended
a Connect Pro meeting before, you may wish to test your connection by
going to: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.

D. Will meeting transcripts be available?

    Please be advised that as soon as a transcript is available it will
be accessible at http://www.regulations.gov and http://www.fda.gov. It
may be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be made available in either hard copy or on CD-
ROM, after submission of a Freedom of Information request. Written
requests are to be sent to the Division of Freedom of Information
(ELEM)-1029, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
 [FR Doc. 2011-31630 Filed 12-6-11; 4:15 pm]
BILLING CODE 4160-01-P