[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Notices]
[Page 40735]
[FR Doc No: 2011-17271]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Joint Meeting of the Advisory Committee for Reproductive Health
Drugs and the Drug Safety and Risk Management Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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 Committees: Advisory Committee for Reproductive Health
Drugs and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 9, 2011, from
8 a.m. to 4:30 p.m.
    Location: The Marriott Inn and Conference Center, University of
Maryland University College (UMUC), The Ballroom, 3501 University
Boulevard East, Adelphi, MD. The conference center telephone number is:
301 985-7300.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. 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: On September 9, 2011, the committees will discuss the
benefits and risks of long-term bisphosphonate use for the treatment
and prevention of osteoporosis (thinning and weakening of bones that
increases the chance of having a broken bone) in light of the emergence
of the safety concerns of osteonecrosis of the jaw (jawbone death) and
atypical femur fractures (unusual broken thigh bone) that may be
associated with the long-term use of bisphosphonates. Bisphosphonates
for the treatment and prevention of osteoporosis include: FOSAMAX
(alendronate sodium) tablets and solution and FOSAMAX PLUS D
(alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.;
ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium)
delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged)
(risedronate sodium with calcium carbonate) tablets, Warner Chilcott,
LLC; BONIVA (ibandronate sodium) tablets and injection, Roche
Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis
Pharmaceuticals Corp.; and the generic equivalents for these products,
if any.
    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/AdvisoryCommittees/Calendar/default.htm. 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
August 25, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 August 17, 2011. 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 August 18, 2011.
    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 Kalyani Bhatt 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: June 27, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17271 Filed 7-8-11; 8:45 am]
BILLING CODE 4160-01-P


Table 1.  National Emission Standards for Hazardous Air Pollutants:

Halogenated Solvent Cleaning – List of Commenters on the Original Proposal

Docket ID	Commenter Name

2002-0009-0088	Ali Mirzakhalili, Administrator, State of Delaware Department of Natural Resources and Environmental Control (DNREC)

2002-0009-0089	David R. Crandall, Parts Cleaning Technologies, LLC

2002-0009-0090	Fiona M. Allen, Office of Deputy City Manager, City of Arlington, Texas

2002-0009-0091	Jeffrey M. Farina, Accellent Endoscopy, Incorporated

2002-0009-0092	Wayne H. Jochmann, Alcoa, Incorporated

2002-0009-0093	Tracy Grable, Delta Air Lines

2002-0009-0094	Donald R. Schregardus, Deputy Assistant Secretary of the Navy, Clean Air Act Services Steering Committee

2002-0009-0095	Steven P. Risotto, Halogenated Solvents Industry Alliance

2002-0009-0096	Albert V. Hartman, Ultra-Kool, Incorporated

2002-0009-0097	Hoai B. Huynh, Aerospace Industries Association of America

2002-0009-0098	Plymouth Tube Company

2002-0009-0099	Venson Hellwig, State and Territorial Air Pollution Program Administrators and

Robert Colby, Association of Local Air Pollution Control Officials (ALAPCO)

2002-0009-0100	Timothy R. Henderson, American Safety Razor Company

2002-0009-0101	Elizabeth McMeekin, PPG Industries, Incorporated

2002-0009-0102	Frederick J. Prossen, Salem Tube, Incorporated

2002-0009-0104	Charles G. Valeska, Eastman Kodak Company

2002-0009-0105	Phillip Bell, Fehr-Graham & Associates

2002-0009-0106	Douglas I. Greenhaus, National Automobile Dealers Association

2002-0009-0107	Tara L. Flynn, Drinker, Biddle & Reath, LLP on behalf of the Narrow Tube Industry Collective Comments

2002-0009-0108	Thelma Norman, American Airlines

2002-0009-0109	Laurie A. Miller, American Chemical Council

2002-0009-0110	Tod J. Wawzysko, Spirit Aerosystems, Incorporated

2002-0009-0111	Andrew C. Lawrence, Department of Energy

07455-C44-01	Confidential Business Information:  Anthony J. Jost, Superior Tube Company, Inc.

Table 2.  National Emission Standards for Hazardous Air Pollutants:

Halogenated Solvent Cleaning – List of Commenters on the NODA

Docket ID	Commenter Name

2002-0009-0119	R. T. Winward, CHMM

2002-0009-0120	John B. Durkee, II, Ph.D., P.E., Consultant in ?Critical and Metal Cleaning

2002-0009-0121	Tracy Grable, Delta Air Lines

2002-0009-0122	Steven P. Risotto, Halogenated Solvents Industry Alliance

2002-0009-0123	W. Caffey Norman, Patton Boggs LLP on behalf of Halogenated Solvents Industry Alliance, Inc.

2002-0009-0124	Steven J. Lemon, Attorney, Jone, Lemon, Graham & Normal, LLP representing Plymouth Tube Company

2002-0009-0125	Robert J. Fensterheim, Continuous Web Cleaning Machine Association

2002-0009-0126	Jeffrey M. Farina, Accellent Endoscopy

2002-0009-0127	Grant Coddington, P.E., Bell Helicopter – Textron, Inc.

2002-0009-0128	David R. Crandell, Parts Cleaning Technologies, LLC

2002-0009-0129	Charles G. Valeska, Eastman Kodak Company

2002-0009-0130	Rob Holt, Super Radiator Coils

2002-0009-0131	Mark C. Hammond, Biddle & Reath, LLP on behalf of the Superior Tube Narrow Tube Industry Collective Comments

	Confidential Business Information:  Anthony J. Jost, Superior Tube Company, Inc.


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Page 7466]
[FR Doc No: 2016-02955]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 97

[FRL-9942-27-OAR]

Allocations of Cross-State Air Pollution Rule Allowances From New
Unit Set-Asides for the 2015 Compliance Year

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; notice of data availability (NODA).

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

SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of emission allowance allocations to certain units under the new unit
set-aside (NUSA) provisions of the Cross-State Air Pollution Rule
(CSAPR) federal implementation plans (FIPs). EPA has completed final
calculations for the second round of NUSA allowance allocations for the
2015 compliance year of the CSAPR NOX Annual, SO2
Group 1, and SO2 Group 2 Trading Programs. EPA has posted
spreadsheets showing the second-round 2015 NUSA allocations of CSAPR
NOX Annual, SO2 Group 1, and SO2 Group
2 allowances to new units as well as the allocations to existing units
of the remaining CSAPR NOX Annual, SO2 Group 1,
and SO2 Group 2 allowances not allocated to new units in
either round of the 2015 NUSA allocation process. EPA will record the
allocated CSAPR NOX Annual, SO2 Group 1, and
SO2 Group 2 allowances in sources' Allowance Management
System (AMS) accounts by February 15, 2016.

DATES: February 12, 2016.

FOR FURTHER INFORMATION CONTACT: Questions concerning this action
should be addressed to Robert Miller at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or to Kenon Smith at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the CSAPR FIPs, a portion of each
state budget for each of the four CSAPR trading programs is reserved as
a NUSA from which allowances are allocated to eligible units through an
annual one- or two-round process. EPA has described the CSAPR NUSA
allocation process in five NODAs previously published in the Federal
Register (80 FR 30988, June 1, 2015; 80 FR 44882, July 28, 2015; 80 FR
55061, September 14, 2015; 80 FR 69883, November 12, 2015; 80 FR 77591,
December 15, 2015). In the most recent of these previous NODAs, EPA
provided notice of preliminary lists of new units eligible for second-
round 2015 NUSA allocations of CSAPR NOX Annual,
SO2 Group 1, and SO2 Group 2 allowances and
provided an opportunity for the public to submit objections.
    EPA received no objections to the preliminary lists of new units
eligible for second-round 2015 NUSA allocations of CSAPR NOX
Annual, SO2 Group 1, or SO2 Group 2 allowances
whose availability was announced in the December 15 NODA. EPA is
therefore making second-round 2015 NUSA allocations of CSAPR
NOX Annual, SO2 Group 1, and SO2 Group
2 allowances to the new units identified on these lists in accordance
with the procedures set forth in 40 CFR 97.412(a)(9) and (12),
97.612(a)(9) and (12), and 97.712(a)(9) and (12).
    As described in the December 15 NODA, any allowances remaining in
the CSAPR NOX Annual, SO2 Group 1, and
SO2 Group 2 NUSAs for a given state and control period after
the second round of NUSA allocations to new units is completed are to
be allocated to the existing units in the state according to the
procedures set forth in 40 CFR 97.412(a)(10) and (12), 97.612(a)(10)
and (12), and 97.712(a)(10) and (12). EPA has determined that CSAPR
NOX Annual, SO2 Group 1, and SO2 Group
2 allowances do remain in the NUSAs for a number of states following
completion of second-round 2015 NUSA allocations; accordingly, EPA is
allocating these allowances to existing units. The NUSA allowances are
generally allocated to the existing units in proportion to the
allocations previously made to the existing units under 40 CFR
97.411(a)(1), 97.611(a)(1), and 97.711(a)(1), adjusted for rounding.
    Under 40 CFR 97.412(b)(10), 97.612(b)(10), and 97.712(b)(10), any
allowances remaining in the CSAPR NOX Annual, SO2
Group 1, and SO2 Group 2 Indian country NUSAs for a given
state and control period after the second round of Indian country NUSA
allocations to new units are added to the NUSA for that state or are
made available for allocation by the state pursuant to an approved SIP
revision. No new units eligible for allocations of CSAPR NOX
Annual, SO2 Group 1, and SO2 Group 2 allowances
from any 2015 Indian country NUSA have been identified, and no state
has an approved SIP revision governing allocation of 2015 CSAPR
allowances. The Indian country NUSA allowances are therefore being
added to the NUSAs for the respective states and are included in the
pools of allowances that are being allocated to existing units under 40
CFR 97.412(b)(10) and (12), 97.612(b)(10) and (12), and 97.712(b)(10)
and (12).
    The final unit-by-unit data and allowance allocation calculations
are set forth in Excel spreadsheets titled
``CSAPR_NUSA_2015_NOx_Annual_2nd_Round_Final_Data_New_Units'',
``CSAPR_NUSA_2015_SO2_2nd_Round_Final_Data_New_Units'',
``CSAPR_NUSA_2015_NOx_Annual_2nd_Round_Final_Data_Existing_Units'', and
``CSAPR_NUSA_2015_SO2_2nd_Round_Final_Data_Existing_Units'',
available on EPA's Web site at http://www.epa.gov/crossstaterule/actions.html.
    Pursuant to CSAPR's allowance recordation timing requirements, the
allocated NUSA allowances will be recorded in sources' AMS accounts by
February 15, 2016. EPA notes that an allocation or lack of allocation
of allowances to a given unit does not constitute a determination that
CSAPR does or does not apply to the unit. EPA also notes that NUSA
allocations of CSAPR NOX Annual, SO2 Group 1, and
SO2 Group 2 allowances are subject to potential correction
if a unit to which NUSA allowances have been allocated for a given
compliance year is not actually an affected unit as of January 1 of the
compliance year.\1\
---------------------------------------------------------------------------

    \1\ See 40 CFR 97.411(c), 97.611(c), and 97.711(c).
---------------------------------------------------------------------------

    (Authority: 40 CFR 97.411(b), 97.611(b), and 97.711(b).)

    Dated: February 1, 2016.
Reid P. Harvey,
Director, Clean Air Markets Division, Office of Atmospheric Programs,
Office of Air and Radiation.
[FR Doc. 2016-02955 Filed 2-11-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67749-67750]
[FR Doc No: 2023-21643]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0430; FRL-11382-01-OCSPP]

Pesticides; Draft Guidance and Proposed Method for Antimicrobial
Product Efficacy Claims Against Planktonic Legionella Pneumophila in
Cooling Tower Water; Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on a draft guidance
document and proposed method for adding efficacy claims to
antimicrobial products for use in cooling tower water to reduce the
level of planktonic Legionella pneumophila. The draft guidance document
describes efficacy testing for antimicrobial products to support claims
for the reduction of planktonic L. pneumophila in water within cooling
tower systems and how to prepare an application for registration. The
proposed method is for evaluating the efficacy of antimicrobial
products in water of cooling towers against planktonic L. pneumophila.
The draft guidance does not address adherent or sessile bacteria that
attach to a surface (e.g., biofilm) of the cooling tower system or any
other microorganism other than L. pneumophila which may be found in the
water of cooling tower systems.

DATES: Comments must be received on or before December 1, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0430, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For information on the proposed method contact: Lisa S. Smith,
Microbiology Laboratory Branch (7503M), Biological and Economic
Analysis Division, Office of Pesticide Programs, Environmental
Protection Agency, Environmental Science Center, 701 Mapes Road Ft.
Meade, MD 20755-

5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].
    For information on the draft guidance contact: C[eacute]sar E.
Cordero, Efficacy Branch (7510M), Antimicrobials Division, Office of
Pesticide Programs, Environmental Protection Agency, William Jefferson
Clinton East Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general; although this
action may be of particular interest to those persons who are or may be
required to conduct efficacy testing of chemical substances under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 person listed under FOR FURTHER
INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the
part or all of the information that you claim to be CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    Legionella pneumophila is a bacterium that is often identified as
the causative agent of Legionnaires' Disease, which is a disease
acquired by inhaling water droplets contaminated with Legionella
bacteria. Legionellae are found naturally in freshwater environments
but can become a health concern when they grow and spread in human-made
building water systems like cooling towers. Cooling towers are a
potential breeding ground for L. pneumophila and subsequent
aerosolization of L. pneumophila can occur if cooling towers are not
properly disinfected and maintained. Following a Legionnaires' disease
outbreak in New York City in 2015, New York State began requiring
cooling towers to be registered with the state and monitored and
treated for L. pneumophila. However, EPA currently does not have
guidance providing a framework for those seeking to register
antimicrobial products with public health claims to reduce Legionella
in cooling tower water. EPA received requests to develop a test method
and guidance for registration of antimicrobial products intended to
reduce L. pneumophila in water used in cooling tower systems. There is
significant interest from stakeholders and the public in the
availability of antimicrobial products with these claims.

III. Guidance Documents Do Not Contain Binding Requirements

    As guidance, these documents are not binding on the Agency or any
outside parties, and the Agency may depart from these documents where
circumstances warrant and without prior notice. While EPA has made
every effort to ensure the accuracy of the discussion in the guidance,
the obligations of EPA and the regulated community are determined by
statutes, regulations, or other legally binding documents. In the event
of a conflict between the discussion in the guidance documents and any
statute, regulation, or other legally binding document, the guidance
documents will not be controlling.
    Authority: 7 U.S.C. 136 et seq.

    Dated: September 26, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-21643 Filed 9-29-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Page 58984]
[FR Doc No: 2012-23525]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP12-1041-000.
    Applicants: Hess Corporation, Delta Energy, LLC, DE of Ohio, LLC.
    Description: Joint Petition of Delta Energy, LLC, DE of Ohio, LLC
and Hess Corporation for Temporary Waiver of Capacity Release
Regulations and Policies, and Request for Expedited Consideration.
    Filed Date: 9/17/12.
    Accession Number: 20120917-5165.
    Comments Due: 5 p.m. ET 9/25/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP10-1410-005.
    Applicants: Kern River Gas Transmission Company.
    Description: 2012 Reservation Charge September Compliance to be
effective 12/1/2010.
    Filed Date: 9/17/12.
    Accession Number: 20120917-5138.
    Comments Due: 5 p.m. ET 10/1/12.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: September 18, 2012.
Nathaniel J. Davis, Sr.
Deputy Secretary
[FR Doc. 2012-23525 Filed 9-24-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Notices]
[Page 55845]
[FR Doc No: 2012-22208]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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: Anti-Infective 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 November 2, 2012, from 8
a.m. to 5 p.m.
    Location: DoubleTree by Hilton Hotel Washington DC-Silver Spring,
The Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel's phone
number is<PHONE_NUMBER>.
    Contact Person: Philip Bautista, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out further information regarding FDA advisory committee information. 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss biologics license application
(BLA) 125346, raxibacumab injection, a humanized monoclonal antibody
against protective antigen of Bacillis anthracis, by Human Genome
Sciences, Inc., for the proposed indication of treatment of
inhalational anthrax.
    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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
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
October 19, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 October 11, 2012. 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 October 12, 2012.
    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 Philip Bautista 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: September 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-22208 Filed 9-10-12; 8:45 am]
BILLING CODE 4160-01-P