[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Notices]
[Pages 62434-62435]
[FR Doc No: 2014-24726]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9918-06-Region 3]

Adequacy Status of the Submitted Maintenance Plans for the
Delaware Portion of the Philadelphia-Wilmington-New Jersey 1997 and
2006 Fine Particulate Matter National Ambient Air Quality Standard
Nonattainment Areas for Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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SUMMARY: In this notice, EPA is notifying the public that EPA has found
that the Motor Vehicle Emissions Budgets (MVEBs) in the Delaware
portion of the Philadelphia-Wilmington-New Jersey 1997 and 2006 fine
particulate matter (PM2.5) National Ambient Air Quality
Standard (NAAQS) Maintenance Plans, submitted as a State Implementation
Plan (SIP) revision by the Delaware Department of Natural Resources and
Environmental Control (DNREC), are adequate for transportation
conformity purposes.

DATE: This is effective on November 3, 2014.

FOR FURTHER INFORMATION CONTACT: Asrah Khadr, Environmental Engineer,
Office of Air Program Planning (3AP30), United States Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia, PA
19103,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Today's notice is simply an announcement of
a finding that EPA has already made. EPA Region III sent a letter to
the DNREC on September 12, 2014 stating that EPA has found that the
MVEBs in the Maintenance Plans for budget years 2017 and 2025,
submitted on December 12, 2012, are adequate for transportation
conformity purposes. As a result of EPA's finding, the State of
Delaware must use the 2017 and 2025 MVEBs from the December 12, 2012
Maintenance Plans for future conformity determinations in the Delaware
portion of the Philadelphia-Wilmington-New

Jersey 1997 PM2.5 NAAQS nonattainment area. Receipt of the
submittal was announced on EPA's transportation conformity Web site. No
comments were received. The findings letter is available at EPA's
conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm. The adequate direct PM and nitrogen oxides
(NOX) MVEBs are provided in Table 1.

 Table 1--Delaware Portion of the Philadelphia-Wilmington-New Jersey 1997 and 2006 PM2.5 NAAQS Maintenance Plans
                                           MVEBs for Direct PM and NOX
----------------------------------------------------------------------------------------------------------------
                                         Motor vehicle emissions budget for  Mobile vehicle emissions budget for
             Budget years                     direct PM-tons per year                 NOX-tons per year
----------------------------------------------------------------------------------------------------------------
2017..................................                                 199                                6,273
2025..................................                                 199                                6,273
----------------------------------------------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act (CAA). EPA's conformity rule requires that transportation
plans, transportation improvement programs, and projects conform to
SIPs and establishes the criteria and procedures for determining
whether or not they do. Conformity to a SIP means that transportation
activities will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the national ambient air
quality standards.
    The criteria by which we determine whether a SIP's MVEBs are
adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4).
EPA described the process for determining the adequacy of submitted SIP
budgets in a July 1, 2004 preamble starting at 69 FR 40038 and used the
information in these resources in making this adequacy determination.
Delaware did not provide emission budgets for sulfur dioxide
(SO2), volatile organic compounds (VOCs), or ammonia for the
Delaware portion of the Philadelphia-Wilmington-New Jersey
nonattainment area because it concluded that emissions of these
precursors from motor vehicles are not significant contributors to the
area's PM2.5 air quality problem. The transportation
conformity rule provision at 40 CFR 93.102(b)(2)(v) indicates that
conformity does not apply for these precursors, due to the lack of
MVEBs for these precursors and the State's conclusion that motor
vehicle emissions of SO2, VOCs, and ammonia do not
contribute significantly to the area's PM2.5 nonattainment
problem. This provision of the transportation conformity rule predates
and was not disturbed by the January 4, 2013 decision in the litigation
on the PM2.5 implementation rule.\1\ EPA has preliminarily
concluded that the State's decision to not include budgets for
SO2, VOCs, and ammonia is consistent with the requirements
of the transportation conformity rule. That decision does not affect
EPA's adequacy finding for the submitted direct PM and NOX
MVEBs for the Delaware portion of the Philadelphia-Wilmington-New
Jersey nonattainment area.
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    \1\ EPA issued conformity regulations to implement the 1997
PM2.5 NAAQS in July 2004 and May 2005 (69 FR 40004, July
1, 2004 and 70 FR 24280, May 6, 2005, respectively). Those actions
were not part of the final rule recently remanded to EPA by the
Court of Appeals for the District of Columbia in NRDC v. EPA, No.
08-1250 (Jan. 4, 2013), in which the Court remanded to EPA the
implementation rule for the PM2.5 NAAQS because it
concluded that EPA must implement that NAAQS pursuant to the PM-
specific implementation provisions of subpart 4 of Part D of Title I
of the CAA, rather than solely under the general provisions of
subpart 1.
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    Please note that an adequacy review is separate from EPA's SIP
review process. The Maintenance Plans containing the 2017 and 2025
MVEBs were approved by EPA on August 5, 2014 (79 FR 45350). The MVEBs
have been approved as part of the Delaware SIP, finding the MVEBs
adequate makes them available for use for transportation conformity
purposes.

    Authority:  42 U.S.C. 7401-7671q.

    Dated: October 1, 2014.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2014-24726 Filed 10-16-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Notices]
[Pages 53123-53125]
[FR Doc No: 2011-21723]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0719, FRL-9456-1]

Agency Information Collection Activities; Proposed Collection;
Comment Request on Two Information Collection Requests

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this notice announces that EPA is planning to submit a
request to renew two existing Information Collection Requests (ICR) to
the Office of Management and Budget (OMB). Before submitting the ICRs
to OMB for review and approval, EPA is soliciting comments on specific
aspects of the information collections as described at the beginning of
SUPPLEMENTARY INFORMATION.

DATES: Comments must be submitted on or before October 24, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2008-0719, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>(Identify Docket ID No. EPA-HQ-
OW-2008-0719 in the subject line)
     Mail: Water Docket, Environmental Protection Agency,
Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of three copies.
     Hand Delivery: EPA Docket Center, EPA West, Room B102,
1301 Constitution Avenue, NW., Washington, DC 20460. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments identified by the Docket ID No.
EPA-HQ-OW-2008-0719. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online 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 http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
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 http://www.regulations.gov, your e-mail address will be
automatically captured 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. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Amelia Letnes, State and Regional
Branch, Water Permits Division, OWM Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For All ICRS:
    An Agency may not conduct or sponsor, and a person is not required
to respond to collection information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
are displayed in 40 CFR part 9.

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2008-0719, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in
the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able

to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

A. List of ICRS Planned To Be Submitted

    (1) Information Collection Request for Cooling Water Intake
Structures New Facility Final Rule (Renewal); EPA ICR No. 1973.05, OMB
Control No. 2040-0241; expiration date 12/31/2011.
    (2) National Pretreatment Program, EPA ICR Number 0002.14, OMB
Control Number 2040-0009, expiration date 12/31/2011.

B. Individual ICRs

    (1) Information Collection Request for Cooling Water Intake
Structures New Facility Final Rule (Renewal); EPA ICR No. 1973.05, OMB
Control No. 2040-0241; expiration date 12/31/2011.
    Affected entities: Entities potentially affected by this action are
new facilities that are point sources (i.e., subject to a NPDES permit)
that use or propose to use a cooling water intake structure (CWIS),
have at least one cooling water intake structure that uses at least 25
percent (measured on an average monthly basis) of the water withdrawn
for cooling purposes, withdraw the water from surface waters, and have
a design intake flow greater than two million gallons per day (MGD).
Generally, facilities that meet these criteria fall into two major
groups: new power producing facilities and new manufacturing
facilities. Power producers affected by the final rule are likely to be
both utility and nonutility power producers since they typically have
large cooling water requirements. EPA identified four categories of
manufacturing facilities that tend to require large amounts of cooling
water: paper and allied products, chemical and allied products,
petroleum and coal products, and primary metals. However, the New
Facility Rule is not limited to manufacturers in these sectors; any new
manufacturer that meets the criteria above is subject to the rule.
    Abstract: The section 316(b) New Facility Rule requires the
collection of information from new facilities that use a CWIS and meet
the other eligibility requirements. Section 316(b) of the CWA requires
that any standard established under section 301 or 306 of the CWA and
applicable to a point source must require that the location, design,
construction and capacity of CWISs at that facility reflect the best
technology available (BTA) for minimizing adverse environmental impact.
See 66 FR 65256. Such impact occurs as a result of impingement (where
fish and other aquatic life are trapped on technologies at the entrance
to cooling water intake structures) and entrainment (where aquatic
organisms, eggs, and larvae are taken into the cooling system, passed
through the heat exchanger, and then pumped back out with the discharge
from the facility). The rule establishes standard requirements
applicable to the location, design, construction, and capacity of
cooling water intake structures at new facilities. These requirements
seek to minimize the adverse environmental impact associated with the
use of CWISs.
    Burden Statement: The annual average reporting and recordkeeping
burden for the collection of information by facilities responding to
the section 316(b) New Facility Rule is estimated to be 1,620 hours per
respondent (i.e., an annual average of 131,188 hours of burden divided
among an anticipated annual average of 81 facilities). The State
reporting and recordkeeping burden for the review, oversight, and
administration of the rule is estimated to average 154 hours per
respondent (i.e., an annual average of 7,233 hours of burden divided
among an anticipated 47 States on average per year).
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 86 facilities and
47 States and Territories.
    Frequency of response: Annual, every 5 years.
    Estimated total average number of responses for each respondent:
5.8 for facilities (467 annual average responses for 81 average
facility respondents) and 8.9 for States and Territories (420 annual
average responses for 47 average State respondents).
    Estimated total annual burden hours: 138,421 (131,188 for
facilities and 7,233 for States and Territories).
    Estimated total annual costs: $10.6 million per year. This includes
an estimated burden cost of $8.1 and an estimated cost of $2.5 for
capital investment or maintenance and operational costs.
    Change in Burden: There is an increase of 20,212 hours in the total
estimated respondent burden compared with that identified in the ICR
currently approved by OMB. This increase is due to the addition of the
newly built facilities, as well as the continued performance of annual
activities by facilities that received their permit during the previous
ICR approval periods. In addition, this ICR includes additional
repermitting burden and costs because more facilities are entering the
renewal phase of their permits.
    (2) National Pretreatment Program, EPA ICR Number 0002.14, OMB
Control Number 2040-0009, expiration date 12/31/2011.
    Affected entities: Various industrial categories, publicly owned
treatment works (POTWs), local and State governments.
    Abstract: This ICR calculates the burden and costs associated with
managing and implementing the National Pretreatment Program as mandated
under CWA sections 402(a) and (b) and 307(b). This ICR includes all
existing tasks under the National Pretreatment Program, as amended by
the EPA's Streamlining Rule.
    EPA's Office of Wastewater Management (OWM) in the Office of Water
(OW) is responsible for the management of the pretreatment program. The
CWA requires EPA to develop national pretreatment standards to control
discharges from Industrial Users (IUs) into POTWs. These standards
limit the level of certain pollutants allowed in non-domestic
wastewater that is discharged to a POTW. EPA administers the
pretreatment program through the NPDES permit program. Under the NPDES
permit program, EPA may approve State or individual POTW implementation
of the pretreatment standards at their respective levels. Data
collected from IUs during implementation of the pretreatment program
include the mass, frequency,

and content of IU discharges and IU schedules for installing
pretreatment equipment. Data also include actual or anticipated IU
discharges of wastes that violate pretreatment standards, have the
potential to cause problems at the POTW, or are considered hazardous
under the Resource Conservation and Recovery Act (RCRA). OWM uses the
data collected under the pretreatment program to monitor and enforce
compliance with the pretreatment regulations, as well as to authorize
program administration at the State or local (POTW) level. States and
POTWs applying for approval of their pretreatment programs submit data
concerning their legal, procedural, and administrative bases for
establishing such programs. This information may include surveys of
IUs, local limits for pollutant concentrations, and schedules for
completion of major project requirements. IUs and POTWs submit written
reports to the approved State or EPA. These data may then be entered
into the NPDES databases by the approved State or by EPA.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 73.1
hours per respondent per year, or 18.1 hours per response.
    Estimated total number of potential respondents: 24,411 (36 States,
1,548 POTWs and 22,827 industrial users).
    Frequency of response: On occasion, semi-annually, annually, and as
needed.
    Estimated total average number of responses for each respondent:
4.0.
    Estimated total annual burden hours: 1,784,568 hours.
    Estimated total annual costs: $76,773,776. This includes an
estimated burden cost of $74,454,863 and an estimated cost of
$2,318,913 for capital investment or maintenance and operational costs.
    Change in Burden: There is a decrease of 12,5195 (0.7%) hours in
the total estimated respondent burden compared with that identified in
the ICR currently approved by OMB. Most of the decrease in burden is
attributed to the decrease in the number of SIUs. EPA revised the
estimated number of SIUs and pretreatment programs after extensive
consultation with the EPA regions and a thorough examination of PCS
data. This ICR shows a shift in burden from POTWs to States as a
consequence of EPA's updated estimates of of SIUs regulated by POTWs
and States. However, EPA does not believe this is the result of
programmatic changes but simply a reflection of more accurate
information about the implementation of the pretreatment program.

What is the next step in the process for these ICRs?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: August 12, 2011.
James A. Hanlon,
Director, Office of Wastewater Management.
[FR Doc. 2011-21723 Filed 8-24-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Proposed Rules]
[Page 34297-34298]
[DOCID:fr14jn06-26]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0367; FRL-8182-4]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania, VOC and NOX RACT Determinations for Twelve Individual
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the

Commonwealth of Pennsylvania to establish and require reasonably
available control technology (RACT) for twelve major sources of
volatile organic compounds (VOC) and nitrogen oxides (NOX).
In the Final Rules section of this Federal Register, EPA is approving
the Commonwealth's SIP submittal as a direct final rule without prior
proposal because the Agency views this as a noncontroversial submittal
and anticipates no adverse comments. A detailed rationale for the
approval is set forth in the direct final rule. If no adverse comments
are received in response to this action, no further activity is
contemplated. If EPA receives adverse comments, the direct final rule
will be withdrawn and all public comments received will be addressed in
a subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time.

DATES: Comments must be received in writing by July 14, 2006.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2006-0367 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2006-0367, Makeba Morris, Chief, Air Quality
Planning Branch, Mailcode 3AP21, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2006-0367. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
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 http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

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 http://www.regulations.gov, your e-mail address will be

automatically captured 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 electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., 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 electronically in http://www.regulations.gov
 or in hard copy during normal business hours at the

Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at the Pennsylvania Department of
Environmental Resources Bureau of Air Quality Control, P.O. Box 8468,
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, Approval of
Pennsylvania's VOC and NOX RACT Determinations for Twelve
Individual Sources, that is located in the ``Rules and Regulations''
section of this Federal Register publication. Please note that if EPA
receives adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, EPA may adopt as final those provisions of the rule that are not
the subject of an adverse comment.

    Dated: June 1, 2006.
Donald S. Welsh,
Regional Administrator, Region III.
[FR Doc. 06-5294 Filed 6-13-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15740]
[DOCID:fr07ap09-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 19, 2009, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001; FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss the safety and efficacy of new
drug application (NDA) 21-761, SANVAR (vapreotide acetate) by
Debiovision, Inc., for the proposed indication as an adjunctive therapy
to endoscopic intervention for the control of acute esophageal bleeding
as a result of portal hypertension.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
5, 2009. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before April 27, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by April 28,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristine T. Khuc at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-7857 Filed 4-6-09; 8:45 am]

BILLING CODE 4160-01-S