[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46796-46798]
[FR Doc No: 2011-19691]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0882; FRL-8882-3]

Butylate; Registration Review Proposed Decision; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
registration review decision for the pesticide butylate and opens a
public comment period on the proposed decision. Registration review is
EPA's periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, that the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Through this program, EPA is ensuring that each pesticide's
registration is based on current scientific and other knowledge,
including its effects on human health and the environment.

DATES: Comments must be received on or before October 3, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0882, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket identification (ID)
number EPA-HQ-OPP-2008-0882. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov 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 regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: Steven Snyderman, Chemical Review Manager, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>    For general information on the registration review program,
contact: Kevin Costello, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5026; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may 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 chemical review manager listed under FOR FURTHER
INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a

Code of Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed registration review decision for the pesticide shown
in the following table, and opens a 60-day public comment period on the
proposed decision. Butylate is a thiocarbamate, soil-incorporated
herbicide and was registered for use on field corn, pop corn, and sweet
corn. The last butylate pesticide product registered for use in the
United States was terminated on March 23, 2011.

                               Table--Registration Review Proposed Final Decisions
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical review manager,
 Registration Review Case Name and No.           Pesticide Docket ID No.           telephone No., e-mail address
----------------------------------------------------------------------------------------------------------------
Butylate, 0071.........................  EPA-HQ-OPP-2008-0882...................  Steven Snyderman, (703) 347-
                                                                                0249,
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review of the case. For example,
the review opened with the posting of a Summary Document, containing a
Preliminary Work Plan, for public comment. A Final Work Plan was posted
to the docket following public comment on the initial docket.
    As stated in the documents in the initial butylate registration
review docket, the Agency had intended to revise the existing risk
assessments for butylate. However, after publication of the butylate
Final Work Plan, pursuant to Section 4(i)(5)(G) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, the
Agency issued a cancellation order, dated July 14, 2010, to the
technical registrant Tri-Ag, Inc., cancelling their butylate
registrations for non-payment of annual registration maintenance fees,
which were due January 15, 2010. This cancellation order established
July 14, 2010 as the effective cancellation date for Tri-Ag, Inc.'s
butylate registrations. Further, the Agency announced the issuance of
the cancellation order for non-payment of year 2010 registration
maintenance fees for butylate products in the Federal Register on July
28, 2010 (75 FR 44240; FRL-8835-2). For the remaining butylate product
registrations, pursuant to Section 6(f)(1) of FIFRA, as amended, the
Agency announced receipt of a request from the end-use registrant,
Arysta Lifescience North America, LLC, to voluntarily cancel the last
butylate product registration; and then granted this voluntary
cancellation request, establishing March 23, 2011, as the effective
cancellation date for the last butylate product registered for use in
the United States, as published in the Federal Register on March 23,
2011 (76 FR 16147, FRL-8867-8). Due to the cancellation orders issued
affecting the last remaining butylate product registrations in the
United States, the Agency has found that it is not necessary to conduct
new risk assessments for butylate and is, therefore, issuing a proposed
decision pursuant to 40 CFR 155.58. The Agency believes that mitigation
measures put into effect on product labeling through the reregistration
process are adequate to protect human health and the environment until
existing stocks of butylate are exhausted. This proposed registration
review decision is described in more detail in the Butylate Proposed
Registration Review Decision, available in the butylate docket.
Following public comment, the Agency will issue a final registration
review decision for products containing butylate.
    The registration review program is being conducted under
congressionally- mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of
FIFRA, as amended, required EPA to establish by regulation procedures
for reviewing pesticide registrations, originally with a goal of
reviewing each pesticide's registration every 15 years to ensure that a
pesticide continues to meet the FIFRA standard for registration. The
Agency's final rule to implement this program was issued in August 2006
and became effective in October 2006, and appears at 40 CFR part 155,
subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA)
was amended and extended in September 2007. FIFRA, as amended by PRIA
in 2007, requires EPA to complete registration review decisions by
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed registration
review decisions. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the proposed decision. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
docket for butylate. Comments received after the close of the comment
period will be marked ``late.'' EPA is not required to consider these
late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The final registration review decision will explain the
effect that any comments had on the decision and provide the Agency's
response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of this pesticide are
provided at: http://www.epa.gov/oppsrrd1/registration_review/butylate/.

B. What is the agency's authority for taking this action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Pesticides pest, and butylate.

    Dated: July 25, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2011-19691 Filed 8-2-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Rules and Regulations]
[Pages 58405-58409]
[FR Doc No: 2011-24288]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2011-0002; Internal Agency Docket No. FEMA-8197]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If the Federal
Emergency Management Agency (FEMA) receives documentation that the
community has adopted the required floodplain management measures prior
to the effective suspension date given in this

rule, the suspension will not occur and a notice of this will be
provided by publication in the Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Mitigation Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59. Accordingly, the communities will be
suspended on the effective date in the third column. As of that date,
flood insurance will no longer be available in the community. However,
some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain federal
      State and Location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region II
New Jersey:
    Allamuchy, Township of,           340480  May 13, 1975,       September 29, 2011....  September 29, 2011.
     Warren County.                            Emerg; August 15,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Alpha, Borough of, Warren         340576  October 2, 1975,    ......do..............   Do.
     County.                                   Emerg; December
                                               23, 1977, Reg;
                                               September 29,
                                               2011, Susp.
    Andover, Borough of,              340542  August 27, 1975,    ......do..............   Do.
     Sussex County.                            Emerg; March 4,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Belvidere, Town of, Warren        340481  November 12, 1974,  ......do..............   Do.
     County.                                   Emerg; December
                                               18, 1979, Reg;
                                               September 29,
                                               2011, Susp.
    Blairstown, Township of,          340482  July 3, 1975,       ......do..............   Do.
     Warren County.                            Emerg; September
                                               1, 1983, Reg;
                                               September 29,
                                               2011, Susp.

    Branchville, Borough of,          340448  June 24, 1975,      ......* do............   Do.
     Sussex County.                            Emerg; March 11,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Frankford, Township of,           340526  October 1, 1975,    ......do..............   Do.
     Sussex County.                            Emerg; March 11,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Franklin, Borough of,             340449  July 7, 1975,       ......do..............   Do.
     Sussex County.                            Emerg; March 15,
                                               1984, Reg;
                                               September 29,
                                               2011, Susp.
    Frelinghuysen, Township           340564  September 30,       ......do..............   Do.
     of, Warren County.                        1975, Emerg;
                                               February 4, 1983,
                                               Reg; September
                                               29, 2011, Susp.
    Greenwich, Township of,           340483  May 19, 1975,       ......do..............   Do.
     Warren County.                            Emerg; August 2,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    Hackettstown, Town of,            340484  October 1, 1975,    ......do..............   Do.
     Warren County.                            Emerg; September
                                               1, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Hamburg, Borough of,              340450  August 29, 1975,    ......do..............   Do.
     Sussex County.                            Emerg; March 15,
                                               1984, Reg;
                                               September 29,
                                               2011, Susp.
    Hampton, Township of,             340531  August 4, 1975,     ......do..............   Do.
     Sussex County.                            Emerg; October 7,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Hardwick, Township of,            340528  April 7, 1976,      ......do..............   Do.
     Warren County.                            Emerg; January
                                               21, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Hopatcong, Borough of,            340452  December 10, 1974,  ......do..............   Do.
     Sussex County.                            Emerg; April 1,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Hope, Township of, Warren         340486  October 16, 1975,   ......do..............   Do.
     County.                                   Emerg; March 4,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Knowlton, Township of,            340488  July 11, 1975,      ......do..............   Do.
     Warren County.                            Emerg; January 6,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Liberty, Township of,             340489  January 21, 1976,   ......do..............   Do.
     Warren County.                            Emerg; March 18,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Mansfield, Township of,           340491  November 26, 1974,  ......do..............   Do.
     Warren County.                            Emerg; September
                                               15, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Montague, Township of,            340559  September 23,       ......do..............   Do.
     Sussex County.                            1976, Emerg;
                                               March 4, 1983,
                                               Reg; September
                                               29, 2011, Susp.
    Newton, Town of, Sussex           340453  March 11, 1975,     ......do..............   Do.
     County.                                   Emerg; April 18,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Ogdensburg, Borough of,           340454  July 16, 1975,      ......do..............   Do.
     Sussex County.                            Emerg; September
                                               5, 1984, Reg;
                                               September 29,
                                               2011, Susp.
    Oxford, Township of,              340492  July 8, 1975,       ......do..............   Do.
     Warren County.                            Emerg; March 11,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Pohatcong, Township of,           340494  August 19, 1974,    ......do..............   Do.
     Warren County.                            Emerg; September
                                               30, 1981, Reg;
                                               September 29,
                                               2011, Susp.
    Sandyston, Township of,           340455  April 11, 1985,     ......do..............   Do.
     Sussex County.                            Emerg; December
                                               17, 1991, Reg;
                                               September 29,
                                               2011, Susp.
    Sparta, Township of,              340535  July 29, 1975,      ......do..............   Do.
     Sussex County.                            Emerg; October
                                               16, 1984, Reg;
                                               September 29,
                                               2011, Susp
    Stillwater, Township of,          340560  August 4, 1975,     ......do..............   Do.
     Sussex County.                            Emerg; February
                                               25, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Sussex, Borough of, Sussex        340457  July 15, 1975,      ......do..............   Do.
     County.                                   Emerg; February
                                               2, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Vernon, Township of,              340561  July 29, 1975,      ......do..............   Do.
     Sussex County.                            Emerg; February
                                               15, 1984, Reg;
                                               September 29,
                                               2011, Susp.
    Walpack, Township of,             340458  August 16, 1977,    ......do..............   Do.
     Sussex County.                            Emerg; March 18,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    Wantage, Township of,             340562  July 28, 1975,      ......do..............   Do.
     Sussex County.                            Emerg; February
                                               15, 1984, Reg;
                                               September 29,
                                               2011, Susp.
    Washington, Borough of,           340495  June 24, 1975,      ......do..............   Do.
     Warren County.                            Emerg; August 16,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    White, Township of, Warren        340497  May 1, 1973,        ......do..............   Do.
     County.                                   Emerg; May 15,
                                               1984, Reg;
                                               September 29,
                                               2011, Susp.
           Region IV
Alabama:
    Collinsville, Town of,            010066  October 24, 1975,   ......do..............   Do.
     DeKalb County.                            Emerg; April 15,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    DeKalb County,                    010320  July 17, 2003,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; February
                                               20, 2008, Reg;
                                               September 29,
                                               2011, Susp.
    Fort Payne, City of,              010067  July 17, 1975,      ......do..............   Do.
     DeKalb County.                            Emerg; May 1,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    Fyffe, Town of, DeKalb            010355  November 2, 1979,   ......do..............   Do.
     County.                                   Emerg; September
                                               29, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Hammondville, Town of,            010388  N/A, Emerg;         ......do..............   Do.
     DeKalb County.                            October 14, 2009,
                                               Reg; September
                                               29, 2011, Susp.
    Henagar, City of, DeKalb          010357  June 6, 2005,       ......do..............   Do.
     County.                                   Emerg; February
                                               20, 2008, Reg;
                                               September 29,
                                               2011, Susp.

    Ider, Town of, DeKalb             010389  N/A, Emerg;         ......do..............   Do.
     County.                                   February 2, 2011,
                                               Reg; September
                                               29, 2011, Susp.
    Powell, Town of, DeKalb           010398  June 6, 2005,       ......do..............   Do.
     County.                                   Emerg; February
                                               20, 2008, Reg;
                                               September 29,
                                               2011, Susp.
    Rainsville, City of,              010368  July 16, 1975,      ......do..............   Do.
     DeKalb County.                            Emerg; May 1,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    Sylvania, Town of, DeKalb         010364  September 4, 2005,  ......do..............   Do.
     County.                                   Emerg; February
                                               20, 2008, Reg;
                                               September 29,
                                               2011, Susp.
    Valley Head, Town of,             010068  August 7, 1975,     ......do..............   Do.
     DeKalb County.                            Emerg; April 15,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
Florida:
    DeBary, City of, Volusia          120672  May 14, 1971,       ......do..............   Do.
     County.                                   Emerg; November
                                               23, 1973, Reg;
                                               September 29,
                                               2011, Susp.
    DeLand, City of, Volusia          120307  February 19, 1975,  ......do..............   Do.
     County.                                   Emerg; December
                                               22, 1980, Reg;
                                               September 29,
                                               2011, Susp.
    Deltona, City of, Volusia         120677  N/A, Emerg;         ......do..............   Do.
     County.                                   January 22, 1998,
                                               Reg; September
                                               29, 2011, Susp.
    Lake Helen, City of,              120674  N/A, Emerg; May     ......do..............   Do.
     Volusia County.                           19, 2005, Reg;
                                               September 29,
                                               2011, Susp.
    Orange City, City of,             120633  June 1, 1990,       ......do..............   Do.
     Volusia County.                           Emerg; September
                                               2, 1994, Reg;
                                               September 29,
                                               2011, Susp.
    Volusia County,                   125155  May 14, 1971,       ......do..............   Do.
     Unincorporated Areas.                     Emerg; November
                                               23, 1973, Reg;
                                               September 29,
                                               2011, Susp.
South Carolina:
    Anderson, City of,                450014  November 2, 1973,   ......do..............   Do.
     Anderson County.                          Emerg; December
                                               16, 1980, Reg;
                                               September 29,
                                               2011, Susp.
    Anderson County,                  450013  July 2, 1975,       ......do..............   Do.
     Unincorporated Areas.                     Emerg; January 2,
                                               1981, Reg;
                                               September 29,
                                               2011, Susp.
    Belton, City of, Anderson         450015  July 24, 1975,      ......do..............   Do.
     County.                                   Emerg; May 1,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    Iva, Town of, Anderson            450017  August 6, 1975,     ......do..............   Do.
     County.                                   Emerg; June 17,
                                               1986, Reg;
                                               September 29,
                                               2011, Susp.
    Williamston, Town of,             450020  July 18, 1975,      ......do..............   Do.
     Anderson County.                          Emerg; March 4,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
           Region V
Michigan:
    Burns, Township of,               260762  July 23, 1991,      ......do..............   Do.
     Shiawassee County.                        Emerg; December
                                               19, 1996, Reg;
                                               September 29,
                                               2011, Susp.
    Byron, Village of,                260601  May 23, 1990,       ......do..............   Do.
     Shiawassee County.                        Emerg; February
                                               1, 1991, Reg;
                                               September 29,
                                               2011, Susp.
    Caledonia, Charter                260300  July 3, 1974,       ......do..............   Do.
     Township of, Shiawassee                   Emerg; May 17,
     County.                                   1982, Reg;
                                               September 29,
                                               2011, Susp.
    Corunna, City of,                 260602  December 24, 1975,  ......do..............   Do.
     Shiawassee County.                        Emerg; January
                                               17, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Hazelton, Township of,            260925  N/A, Emerg; April   ......do..............   Do.
     Shiawassee County.                        2, 1998, Reg;
                                               September 29,
                                               2011, Susp.
    New Haven, Township of,           260521  November 13, 1986,  ......do..............   Do.
     Shiawassee County.                        Emerg; April 1,
                                               1988, Reg;
                                               September 29,
                                               2011, Susp.
    Owosso, Charter Township          260809  October 22, 1987,   ......do..............   Do.
     of, Shiawassee County.                    Emerg; October
                                               20, 1999, Reg;
                                               September 29,
                                               2011, Susp.
    Owosso, City of,                  260596  May 23, 1975,       ......do..............   Do.
     Shiawassee County.                        Emerg; March 1,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    Rush, Township of,                260522  January 3, 1979,    ......do..............   Do.
     Shiawassee County.                        Emerg; February
                                               1, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Shiawassee, Township of,          260523  September 10,       ......do..............   Do.
     Shiawassee County.                        1981, Emerg; July
                                               3, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Vernon, Village of,               260524  May 28, 1982,       ......do..............   Do.
     Shiawassee County.                        Emerg; May 17,
                                               1988, Reg;
                                               September 29,
                                               2011, Susp.
Ohio:
    Alliance, City of, Stark          390508  July 31, 1975,      ......do..............   Do.
     County.                                   Emerg; July 5,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    Canal Fulton, City of,            390511  June 23, 1975,      ......do..............   Do.
     Stark County.                             Emerg; July 5,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    Canton, City of, Stark            390512  April 17, 1975,     ......do..............   Do.
     County.                                   Emerg; January 6,
                                               1983, Reg;
                                               September 29,
                                               2011, Susp.
    East Canton, Village of,          390513  July 16, 1976,      ......do..............   Do.
     Stark County.                             Emerg; February
                                               16, 1979, Reg;
                                               September 29,
                                               2011, Susp.
    East Sparta, Village of,          390655  June 30, 1975,      ......do..............   Do.
     Stark County.                             Emerg; May 1,
                                               1981, Reg;
                                               September 29,
                                               2011, Susp.
    Minerva, Village of, Stark        390518  May 12, 1975,       ......do..............   Do.
     County.                                   Emerg; July 5,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.

    Stark County,                     390780  March 2, 1977,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               1, 1983, Reg;
                                               September 29,
                                               2011, Susp.
    Waynesburg, Village of,           390667  April 22, 1975,     ......do..............   Do.
     Stark County.                             Emerg; July 5,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
          Region VII
Iowa:
    Bronson, City of, Woodbury        190287  September 4, 1975,  ......do..............   Do.
     County.                                   Emerg; September
                                               1, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Cushing, City of, Woodbury        190289  April 28, 1975,     ......do..............   Do.
     County.                                   Emerg; September
                                               18, 1985, Reg;
                                               September 29,
                                               2011, Susp.
    Hornick, City of, Woodbury        190291  July 8, 1975,       ......do..............   Do.
     County.                                   Emerg; September
                                               27, 1985, Reg;
                                               September 29,
                                               2011, Susp.
    Lawton, City of, Woodbury         190292  August 8, 1975,     ......do..............   Do.
     County.                                   Emerg; September
                                               1, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Moville, City of, Woodbury        190293  February 23, 1976,  ......do..............   Do.
     County.                                   Emerg; September
                                               1, 1986, Reg;
                                               September 29,
                                               2011, Susp.
    Salix, City of, Woodbury          190296  November 3, 1975,   ......do..............   Do.
     County.                                   Emerg; April 25,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    Sioux City, City of,              190298  May 14, 1971,       ......do..............   Do.
     Woodbury County.                          Emerg; August 1,
                                               1979, Reg;
                                               September 29,
                                               2011, Susp.
    Sloan, City of, Woodbury          190299  August 12, 1975,    ......do..............   Do.
     County.                                   Emerg; June 10,
                                               1980, Reg;
                                               September 29,
                                               2011, Susp.
    Woodbury County,                  190536  October 29, 1974,   ......do..............   Do.
     Unincorporated Areas.                     Emerg; June 17,
                                               1991, Reg;
                                               September 29,
                                               2011, Susp.
    Winnebago Indian Tribe,           190984  August 6, 1996,     ......do..............   Do.
     Woodbury County.                          Emerg; January 6,
                                               2010, Reg;
                                               September 29,
                                               2011, Susp.
Kansas:
    Shawnee County,                   200331  June 23, 1978,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; June 1,
                                               1982, Reg;
                                               September 29,
                                               2011, Susp.
    Topeka, City of, Shawnee          205187  August 7, 1970,     ......do..............   Do.
     County.                                   Emerg; October
                                               23, 1971, Reg;
                                               September 29,
                                               2011, Susp.
Missouri:
    Allenville, Village of,           290905  N/A, Emerg; April   ......do..............   Do.
     Cape Girardeau County.                    17, 1998, Reg;
                                               September 29,
                                               2011, Susp.
    Cape Girardeau, City of,          290458  May 14, 1974,       ......do..............   Do.
     Cape Girardeau County.                    Emerg; November
                                               5, 1980, Reg;
                                               September 29,
                                               2011, Susp.
    Jackson, City of, Cape            295265  September 10,       ......do..............   Do.
     Girardeau County.                         1971, Emerg; May
                                               4, 1973, Reg;
                                               September 29,
                                               2011, Susp.
    Whitewater, Village of,           290903  N/A, Emerg; April   ......do..............   Do.
     Cape Girardeau County.                    2, 1998, Reg;
                                               September 29,
                                               2011, Susp.
----------------------------------------------------------------------------------------------------------------
*do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2011-24288 Filed 9-20-11; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Page 49774]
[FR Doc No: 2014-20038]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9016-6]

Environmental Impact Statements; Notice of Availability

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

Weekly receipt of Environmental Impact Statements
Filed 08/11/2014 Through 08/15/2014
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: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20140230, Final EIS, BLM, ID, Jarbidge Proposed Resource
Management Plan, Review Period Ends: 09/22/2014, Contact: Heidi
Whitlach<PHONE_NUMBER>.
EIS No. 20140231, Final EIS, USFS, WA, Bailey, Aeneas, Revis, and Tunk
Livestock Grazing Analysis, Review Period Ends: 09/22/2014, Contact:
Phillip Christy<PHONE_NUMBER>.
EIS No. 20140232, Draft Supplement, NMFS, FL, Adjustments to the Annual
Catch Limit and Accountability Measures for Royal Red Shrimp, Comment
Period Ends: 10/06/2014, Contact: Susan Gerhart<PHONE_NUMBER>.
EIS No. 20140233, Draft EIS, BIA, WA, Samish Indian Nation Trust
Acquisition and Casino Project, Comment Period Ends: 10/06/2014,
Contact: Dr. B.J. Howerton<PHONE_NUMBER>.
EIS No. 20140234, Draft Supplement, USN, AK, Gulf of Alaska Navy
Training Activities, Comment Period Ends: 10/20/2014, Contact: Amy Burt
360-396-0924.
EIS No. 20140235, Draft EIS, NRC, NJ, PSEG Site, Early Site Permit
NUREG-2168, Comment Period Ends: 11/06/2014, Contact: Allen Fetter 301-
415-8556.
EIS No. 20140236, Final EIS, USACE, WA, Lower Snake River Programmatic
Sediment Management Plan, Review Period Ends: 09/22/2014, Contact:
Sandra Shelin<PHONE_NUMBER>.
EIS No. 20140237, Final Supplement, NOAA, AK, Management of the
Subsistence Harvest of Northern Fur Seals on St. George Island, Review
Period Ends: 09/22/2014, Contact: Michael Williams<PHONE_NUMBER>.
EIS No. 20140238, Final EIS, USFS, CO, Vail Mountain Recreation
Enhancement Project, Review Period Ends: 09/22/2014, Contact: Roger
Poirier<PHONE_NUMBER>.
EIS No. 20140239, Draft EIS, FTA, CA, Eastside Transit Corridor Phase
2, Comment Period Ends: 10/21/2014, Contact: Mary Nguyen<PHONE_NUMBER>.
EIS No. 20140240, Draft Supplement, USACE, WA, Mount St. Helens Long-
Term Sediment Management Plan, Comment Period Ends: 09/29/2014,
Contact: Tina Teed<PHONE_NUMBER>.

Amended Notices

EIS No. 20140183, Draft EIS, USFS, AZ, Tonto National Forest Travel
Management, Comment Period Ends: 09/17/2014, Contact: Marianne Thomas
602-225-5213.

    Revision to the FR Notice Published 07/03/2014; Extending Comment
Period from 08/18/2014 to 09/17/2014.

    Dated: August 19, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2014-20038 Filed 8-21-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 16, 2007 (Volume 72, Number 158)]
[Notices]
[Page 46055]
[DOCID:fr16au07-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-562-000]

Williston Basin Interstate Pipeline Company; Notice of Request
for Waiver of Disbursement of GRI Funds

August 9, 2007.
    Take notice that on August 3, 2007, Williston Basin Interstate
Pipeline Company (Williston Basin or Company), P.O. Box 5601, Bismarck,
North Dakota 58506-5601, filed with the Commission a request for a
waiver of the disbursement of GRI refunds to its customers as required
pursuant to a 1998 Settlement Agreement in Docket No. RP97-371-000, et
al. In lieu of that obligation, Williston Basin requests that it be
allowed to make donation of such refund to the Low Income Home Energy
Assistance Program (LIHEAP).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practices and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    The filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-16028 Filed 8-15-07; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM

TO:  Portland Cement NESHAP Docket

FROM:  Keith Barnett, USEPA/OAQPS/SPPD/MMG

DATE:  August 7, 2008

SUBJECT:  July 31, 2008 meeting between US Environmental Protection
Agency (EPA) and Portland Cement Association (PCA) at the EPA Offices in
Research Triangle Park, NC

I.  Introduction and Objectives

Representatives from the EPA and the PCA met on July 31, 2008 at EPA’s
headquarters in Research Triangle Park, NC.  The meeting was led by Mr.
Keith Barnett of EPA’s Sector Policies and Programs Division in the
Office of Air Quality Planning and Standards. The meeting agenda is
included as Attachment 1

The purpose of the meeting was to describe EPA’s current regulatory
activities as they relate to the portland cement manufacturing industry
and to solicit discussion and input regarding these activities from the
industry representatives. Current regulatory activities include the
NESHAP for portland cement, the review of the NSPS for portland cement
manufacturing, and the cement sector project.

II.  Meeting Participants

A list of persons attending the meeting and those participating by
telephone and their affiliation is included as Attachment 2.

III.  Meeting Summary

NESHAP

A. Section 114 data and subcategorization methodology

Mercury

PCA presented an approach for subcategorization and establishment of the
MACT floor. In their approach they subcategorized kilns based on the
mercury concentration of the kiln feed: kilns where the mercury
concentration of the kiln feed is <= 20ppb, > 20 ppb, and high emitting
kilns. In arriving at a suggested MACT floor, the PCA approach assessed
the variability associated with fuels, limestone, and other raw
materials and then combined the variability’s to arrive at the floor.
Identical kilns at a cement facility were treated as a single source for
purposes of evaluating MACT floors; PCA understood that for compliance
purposes identical kilns could not be treated as a single source.  In
the PCA analysis additives are everything except limestone.

EPA briefly described some of the approaches it was considering to
subcategorizing kilns.

Variability of mercury data was discussed including the variability in
the 30 days of sampled material, plant-to-plant variability and
month-to-month variability.

PCA agreed to provide EPA with a copy of their statistical analysis for
review.  (This item is included as an attachment to this docket entry
along with the mercury and THC data provided by EPA to the PCA at the
meeting).

EPA reminded the PCA that they had submitted a request to PCA and the
nine companies that responded to the ICR for mercury and total organic
carbon (TOC) data for supplemental information on the sources of raw
materials. EPA stated that this information was important to EPA’s
development and assessment of MACT floor options.

THC

PCA described an approach to arrive at a MACT floor for THC. Looking at
THC emissions data by type of kiln, they found THC emissions varied by
whether the raw mill was on or off. EPA stated that they did not see
much variation between the raw mill on and off conditions in the THC
emissions data they examined. Differences in the THC data sets used by
PCA and EPA may explain some of the observed differences.

PCA recommended that, as part of their evaluation of RTO for THC
control, EPA should consider factors such as the nonavailability of
natural gas in some parts of the country, as well as any adverse impacts
such as increased greenhouse gas emissions from RTOs.

B. Reconsideration Schedule

EPA explained that currently they are proceeding under the premise that
they will propose a rule by the middle of September as promised to the
DC Circuit Court.

NSPS

A. Proposed scope

The proposed rule applies to new kilns, all of which the PCA and EPA
expect to be PH/PC kilns.  Since 1990, all new kilns have been PH/PC
kilns. Also, kilns that are reconstructed and converted to PH/PC kilns
would be subject to the proposed rule.

If a kiln is modified such that it causes regulated emissions to
increase, NSPS is triggered. The PCA stated that it is likely that some
existing long wet or dry kilns will undergo some modifications that will
cause them to become subject to the proposed NOx and SO2 limits, which
they will not be able to meet. EPA stated that they will address this in
the final rule. PCA suggested that only PH/PC kilns be subject to the
NOx and SO2 limits. EPA stated that another option mentioned was to
subcategorize by kiln type and have different limits for each
subcategory.

B. Proposed NOx, SO2 and PM standards

NOx

The PCA identified the 1.5 lb/ton NOx limit as the most significant
issue in the proposed NSPS amendments and stated that the proposed
emission limit was only achievable at research facilities. According to
the PCA, problems with the NOx limit include NOx emissions from alkali
bypasses where the gases are diverted before they can be subject to
SNCR. A white paper describing the alkali bypass issue was prepared by
the industry and sent to EPA previously. PCA stated that data used as a
basis for the limit came from kilns in Florida and California where the
raw materials burn more easily and have lower alkali content.

EPA stated that a possible approach would be to set separate NOx limits
for the alkali bypass. EPA asked for information on the specifications
that define feed burnability and what limits would be appropriate where
such material is part of the raw feed.

PCA also questioned EPA’s use of a 50% removal efficiency for SNCR
systems and asked for the information source for the 50% efficiency,
stating that they could not find supporting documentation in the NSPS
docket. EPA stated that they would locate the documentation and get back
to the PCA with the information source.

PM

PCA stated that the proposed PM limit, including the use of lb/ton of
clinker units, was problematic for several reasons. In some cases, PM
emissions in gr/dscf were converted to lb/ton of clinker using a
standard value of 54,000 dscf/ton of feed. They stated that the
conversion value is not appropriate in all cases. Also, factors such as
moisture content, exhaust gases from clinker cooler combined with kiln
gases increases the mass to the baghouse. They suggested that a
concentration-based PM limit would avoid many of the problems associated
with the output based standard.

EPA stated that historically one of the problem associated with the
concentration-based limit is the potential for leakage into the exhaust
gases.

PCA stated that there are problems associated with the use of membrane
bags that EPA should consider. They stated that in the power industry,
membrane bags have the disadvantage of not forming a cake which reduces
acid gas emissions as well as Hg removal. PCA stated that EPA did not
account for situation in which clinker cooler and coal mill exhaust
gases are routed to the baghouse along with the exhaust gases from
kilns. The longevity and cost of membrane bags were also mentioned as
negative factors.

SO2

The PCA stated that the proposed rule is not clear as to where the 90%
reduction option applies. They stated it could be interpreted to mean
90% reduction of the sulfur in the system as well as 90% reduction of
the sulfur (SO2) in the kiln exhaust gases.

C. EPA approach used for technology cost effectiveness analyses

EPA described the approaches used to establish a best demonstrated
technology for each of the pollutants and the data and factors taken
into account in establishing the proposed emission limits.

D. Schedule/PCA Request for Comment Extension

EPA noted that the proposed rule was signed on May 30, 2008 and
published in the Federal Register on June 16, 2008. It was available on
EPA’s web site prior to appearing in the Federal Register.

Citing their efforts to collect and analyze data in order to properly
respond to the proposed rule, PCA requested a 60-day extension of the
comment period (to October 16, 2008). EPA responded that they often
grant extensions to allow commenters additional time to prepare their
comments. However, due to the court ordered deadline of May 31, 2009 for
promulgation, EPA will consider extending the comment period to
September 30, 2008.

V. Sector Approach

EPA described recent activity in their program to develop integrated
rulemakings for industry sectors. Recent activities include continuation
of economic modeling and evaluating combinations of controls to reduce
multiple air pollutants.

 PAGE

 PAGE   2


[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46980-46984]
[FR Doc No: 2013-18624]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]

Prescription Drug User Fee Rates for Fiscal Year 2014

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for

fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Prescription Drug User Fee Amendments of
2012, which was signed by the President on July 9, 2012 (PDUFA V),
authorizes FDA to collect user fees for certain applications for
approval of drug and biological products, on establishments where the
products are made, and on such products. Base revenue amounts to be
generated from PDUFA fees were established by PDUFA V, with provisions
for certain adjustments. Fee revenue amounts for applications,
establishments, and products are to be established each year by FDA so
that one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This document establishes fee
rates for FY 2014 for application fees for an application requiring
clinical data ($2,169,100), for an application not requiring clinical
data or a supplement requiring clinical data ($1,084,550), for
establishment fees ($554,600), and for product fees ($104,060). These
fees are effective on October 1, 2013, and will remain in effect
through September 30, 2014. For applications and supplements that are
submitted on or after October 1, 2013, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2014 will be
issued in August 2013 using the new fee schedule.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr.,
PI50, Rm. 210J, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for approval of drug and biological products; (2) certain
establishments where such products are made; and (3) certain products
(section 736(a) of the FD&C Act). When certain conditions are met, FDA
may waive or reduce fees (section 736(d) of the FD&C Act).
    For FY 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013, which becomes the base amount for the
remaining 4 FYs of PDUFA V, is $718,699,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). That FY 2013 base
revenue amount is further adjusted each year after FY 2013 for
inflation and workload. Fees for applications, establishments, and
products are to be established each year by FDA so that revenues from
each category will provide one-third of the total revenue to be
collected each year.

II. Fee Revenue Amount for FY 2014

    The base revenue amount for FY 2014 is $718,699,000, prior to
adjustment for inflation and workload (see section 736(c)(1) of the
FD&C Act).

A. FY 2014 Statutory Fee Revenue Adjustments for Inflation

    PDUFA V specifies that the $718,699,000 is to be further adjusted
for inflation increases for FY 2014 using 2 separate adjustments--one
for payroll costs and one for non-pay costs (see section 736(c)(1) of
the FD&C Act).
    The component of the inflation adjustment for payroll costs shall
be 1 plus the average annual percent change in the cost of all
personnel compensation and benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the first 3 of the 4 preceding
FYs, multiplied by the proportion of PC&B costs to total FDA costs of
the review of human drug applications for the first 3 of the preceding
4 FYs (see section 736(c)(1)(B) of the FD&C Act). The data on total
PC&B paid and numbers of FTE paid, from which the average cost per FTE
can be derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
    Table 1 of this document summarizes that actual cost and FTE data
for the specified FYs, and provides the percent change from the
previous FY and the average percent change over the first 3 of the 4
FYs preceding FY 2014. The 3-year average is 2.05 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,634,108,000     $1,761,655,000     $1,824,703,000  .................
Total FTE...........................             12,526             13,331             13,382  .................
PC&B per FTE........................           $130,457           $132,147           $136,355  .................
Percent Change from Previous Year...              1.67%              1.30%              3.18%              2.05%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.05 percent should be multiplied
by the proportion of PC&B for the review of human drug applications.
Table 2 of this document shows the amount of PC&B and the total amount
obligated for the process for the review of human drug applications for
the same 3 FYs.

    Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................       $573,603,582       $596,627,595       $592,642,252  .................
Total Costs.........................       $931,845,581     $1,025,621,707     $1,032,419,218  .................
PC&B Percent........................                62%                58%                57%                59%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.05 percent multiplied by 59 percent (or
1.21 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2014 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual

index) for the first 3 of the preceding 4 years of available data
multiplied by the proportion of all costs of the process for the review
of human drug applications other than PC&B (see section 736(c)(1)(C) of
the FD&C Act). Table 3 of this document provides the summary data for
the percent change in the specified CPI for the Baltimore-Washington
area. The data is published by the Bureau of Labor Statistics and can
be found on their Web site at http://data.bls.gov/cgi-bin/surveymost?cu
by checking the box marked ``Washington-Baltimore All Items, November
1996=100--CUURA311SA0'' and then clicking on the ``Retrieve Data''
button.

               Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
                Year                         2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            142.218            146.975            150.212  .................
Annual Percent Change...............              1.72%              3.34%              2.20%              2.42%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we
multiply the 2.42 percent by the proportion of costs of the process for
the review of human drug applications obligated for costs other than
PC&B. Since 59 percent was obligated for PC&B as shown in table 2 of
this document, 41 percent is the portion of costs other than PC&B (100
percent minus 59 percent equals 41 percent). The non-payroll adjustment
is 2.42 percent times 41 percent, or 0.99 percent.
    To complete the inflation adjustment, we add the payroll component
(1.21 percent) to the non-pay component (0.99 percent), for a total
inflation adjustment of 2.20 percent (rounded), and then add one,
making 1.0220. We then multiply the amount base revenue amount for FY
2014 ($718,669,000) by 1.0220, yielding an inflation adjusted amount of
$734,479,718.

B. FY 2014 Statutory Fee Revenue Adjustments for Workload

    Title I of the Food and Drug Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112-144) specifies that after the $718,699,000
has been adjusted for inflation, the inflation adjusted amount
($734,479,718) shall be further adjusted for workload (see section
736(c)(2) of the FD&C Act). Title I also requires an independent
accounting or consulting firm to review the adequacy of the adjustment
for workload in FY 2013 and FY 2015 and publish the results of those
reviews (see section 103(c)(2) of FDASIA). The reports must evaluate
whether the adjustment reasonably represents actual changes in workload
volume and complexity of human drug review and present recommendations
to discontinue, retain, or modify any elements of the adjustment. After
review of the reports and receipt of public comments, FDA may adopt
appropriate changes to the workload adjustment methodology. FDA
contracted with an independent consulting firm in FY 2013 to conduct
the first required assessment of the workload adjuster. This assessment
examined the performance of the workload adjuster and its ability to
effectively measure changes in workload volume and complexity during
the FY 2009-2013 period. The report is available online at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM350567.pdf. The report found that the current methodology reasonably
represents workload volume associated with the human drug review
process. However, the report concluded that the methodology is flawed
with respect to measuring workload complexity, known as the adjustment
for changes in review activities (``Complexity Factor''), because it
does not represent the total amount of work per submission. The report
further notes that work complexity increased substantially during the
evaluation period, but the Complexity Factor produced negative
adjustments to the overall Workload Adjuster, indicating that human
drug review became less complex over this period. Accordingly, the
report recommends that FDA consider removing the current Complexity
Factor. The report also found that the statute's use of 5-year rolling
averages to measure changes in workload against the base years was not
as sensitive to recent trends as 3-year rolling averages would be.
After reviewing the report, FDA is removing the Complexity Factor from
the workload adjustment methodology and adopting 3-year averages to
measure changes in workload volume, rather than the 5-year averages
used in prior adjustments. This is consistent with the use of 3-year
averages for inflation adjustment calculations as called for under
PDUFA V (section 736(c)(1) of the FD&C Act). The public comment
received on the report indicated that changes to the workload adjuster
methodology should be considered in the context of other aspects of the
PDUFA financial model, including standard costs and time reporting in
the human drug review process. FDA agrees with this point and will
consider multiple aspects of the PDUFA financial model as the Agency
investigates alternative methods to more accurately account for work
complexity in the workload adjuster.
    The statute specifies that changes FDA adopts are effective the
first FY after FDA adopts the changes and each subsequent FY. Since FDA
is adopting the changes in FY 2013, the changes are effective for FY
2014 fees.
    To calculate the FY 2014 adjustment factor, FDA calculated the
average number of each of the four types of applications specified in
the workload adjustment provision: (1) Human drug applications; (2)
active commercial investigational new drug applications (INDs)
(applications that have at least one submission during the previous 12
months); (3) efficacy supplements; and (4) manufacturing supplements
received over the 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3 year period that ended June 30, 2013.
    The calculations are summarized in table 4 of this document. The 3-
year averages for each application category are provided in column 1
(``3-Year Average Base Years 2010-2012'') and column 2 (``3-Year
Average 2011-2013'').
    Column 3 of table 4 of this document reflects the percent change in
workload from column 1 to column 2. Column 4 of table 4 of this
document shows the weighting factor for each type of application,
estimating how much of the total FDA drug review workload was accounted
for by each type of application in the table during the most recent 3
years. Column 5 of table 4 of this document is the weighted percent
change in each category of workload. This was derived by multiplying
the weighting factor in each line in column 4 by the percent change
from the base years in column 3. At the bottom right of table 4 of this
document is the sum of the values in column 5 that are added,
reflecting an increase in workload of 3.07 percent for FY 2014 when
compared to the base years.

                                                   Table 4--Workload Adjuster Calculation for FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Application type                           Column 1           Column 2           Column 3           Column 4           Column 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             3-year average                        Percent change
                                                            base years 2010-    3-year average      (Column 1 to     Weighting factor   Weighted percent
                                                                  2012            2011-2013          Column 2)          (percent)            change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Drug Applications/Biologics License Applications.....              124.4              131.0               5.39               38.6               2.08
Active Commercial INDs...................................             6830.0             6965.0               1.98               41.4               0.82
Efficacy Supplements.....................................              136.3              140.3               2.93                9.3               0.27
Manufacturing Supplements................................             2548.3             2524.7              -0.93               10.7              -0.10
                                                          ----------------------------------------------------------------------------------------------
    FY 2014 Workload Adjuster............................  .................  .................  .................  .................               3.07
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FY 2014 workload adjustment in the last line of Table 4 of this
document is 3.07 percent.
    Table 5 of this document shows the calculation of the revenue
amount for FY 2014. The $718,669,000 subject to adjustment on the first
line is multiplied by the inflation adjustment factor of 1.0220,
resulting in the inflation adjusted amount on the third line,
$734,479,718. That amount is then multiplied by one plus the workload
adjustment of 3.07 percent, resulting in the inflation and workload
adjusted amount of $757,028,000 on the fifth line, rounded to the
nearest thousand dollars.

     Table 5--PDUFA Revenue Amount for FY 2014, Summary Calculation
------------------------------------------------------------------------

------------------------------------------------------------------------
FY 2013 Revenue Amount and Base Subsequent FYs as           $718,669,000
 published in the Federal Register of August 1, 2012
 (77 FR 45639) (rounded to nearest thousand dollars).
Inflation Adjustment Factor for FY 2014 (1 plus 2.20              1.0220
 percent)............................................
Inflation Adjusted Amount............................       $734,479,718
Workload Adjustment Factor for FY 2013 (1 plus 3.07               1.0307
 percent)............................................
                                                      ------------------
    Inflation and Workload Adjusted Amount (rounded         $757,028,000
     to nearest thousand dollars)....................
------------------------------------------------------------------------

    PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the FD&C Act).
Accordingly, one third of the total revenue amount ($757,028,000), or a
total of $252,342,667, is the amount of fee revenue that will be
derived from each of these fee categories: Application Fees,
Establishment Fees, and Product Fees.

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate one-third of the total fee
revenue amount, or $252,342,667 in FY 2014, as calculated previously in
this document.

B. Estimate of the Number of Fee-Paying Applications and the
Establishment of Application Fees

    For FY 2013 through FY 2017, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
three most recently completed FYs. This will avoid having FDA try to
estimate the number it expects to receive in the current FY.
    In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half an FAE, as does a supplement requiring
clinical data. An application that is withdrawn, or refused for filing,
counts as one-fourth of an FAE if the applicant initially paid a full
application fee, or one-eighth of an FAE if the applicant initially
paid one-half of the full application fee amount.
    As table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 3-year period is 116.333
FAEs. FDA will set fees for FY 2014 based on this estimate as the
number of full application equivalents that will pay fees.

                                     Table 6--Fee-Paying FAE 3-Year Average
----------------------------------------------------------------------------------------------------------------
                     FY                             2010             2011             2012        3-year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.............................         118.375          108.250          122.375          116.333
----------------------------------------------------------------------------------------------------------------

    The FY 2014 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
116.333, into the fee revenue amount to be derived from application
fees in FY 2014, $252,342,667. The result, rounded to the nearest $100,
is a fee of $2,169,100 per full application requiring clinical data,
and $1,084,550 per application not requiring clinical data or per
supplement requiring clinical data.

IV. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

    At the beginning of FY 2013, the establishment fee was based on an
estimate that 455 establishments would be subject to and would pay
fees. By the

end of FY 2013, FDA estimates that 490 establishments will have been
billed for establishment fees, before all decisions on requests for
waivers or reductions are made. FDA estimates that a total of 20
establishment fee waivers or reductions will be made for FY 2013. In
addition, FDA estimates that another 15 full establishment fees will be
exempted this year based on the orphan drug exemption in section 736(k)
of the FD&C Act. Subtracting 35 establishments (20 waivers, plus the
estimated 15 establishments under the orphan exemption) from 490 leaves
a net of 455 fee-paying establishments. FDA will use 455 for its FY
2014 estimate of establishments paying fees, after taking waivers and
reductions into account. The fee per establishment is determined by
dividing the adjusted total fee revenue to be derived from
establishments ($252,342,667) by the estimated 455 establishments, for
an establishment fee rate for FY 2014 of $554,600 (rounded to the
nearest $100).

B. Product Fees

    At the beginning of FY 2013, the product fee was based on an
estimate that 2,435 products would be subject to and would pay product
fees. By the end of FY 2013, FDA estimates that 2,510 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 45 waivers and reductions granted. In addition, FDA estimates
that another 40 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,425 products will qualify for product fees in FY 2013, after
allowing for waivers and reductions, including the orphan drug
products, and will use this number for its FY 2014 estimate. The FY
2014 product fee rate is determined by dividing the adjusted total fee
revenue to be derived from product fees ($252,342,667) by the estimated
2,425 products for a FY 2014 product fee of $104,060 (rounded to the
nearest $10).

V. Fee Schedule for FY 2014

    The fee rates for FY 2014 are set out in table 7 of this document:

                    Table 7--Fee Schedule for FY 2014
------------------------------------------------------------------------
                                                        Fee rates for FY
                     Fee category                             2014
------------------------------------------------------------------------
Applications:
    Requiring clinical data..........................         $2,169,100
    Not requiring clinical data......................          1,084,550
    Supplements requiring clinical data..............          1,084,550
Establishments.......................................            554,600
Products.............................................            104,060
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2013. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee identification (ID) number on your check, bank
draft, or postal money order. Your payment can be mailed to: Food and
Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only. Contact the
U.S. Bank at<PHONE_NUMBER> if you have any questions concerning courier
delivery.)
    Please make sure that the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
    Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and add it to your
payment to ensure that your fee is fully paid. The account information
is as follows: New York Federal Reserve Bank, U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
1350 Piccard Drive, Rockville, MD.
    Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
use Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    The tax identification number of FDA is 53-0196965.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY
2014 under the new fee schedule in August 2013. Payment will be due on
October 1, 2013. FDA will issue invoices in November 2014 for any
products and establishments subject to fees for FY 2014 that qualify
for fee assessments after the August 2013 billing.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18624 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


Docket ID:		EPA-HQ-OAR-2009-0171

Docket Title:	Proposed Endangerment Finding for Greenhouse Gases under
the Clean Air Act (CAA)

Document ID:		EPA-HQ-OAR-2009-0171-0001

Document Title:	Proposed Endangerment and Cause or Contribute Findings
for Greenhouse Gases Under Section 202 (a) of Clean Air Act

Allison Paulish

5/19/09

	I accept the EPA’s proposal that the emission of greenhouse gases is
the result of global warming.  I think this because it is more
reasonable theory to believe.  The theory states that temperatures are
rising due to the release of greenhouse gases particularly carbon
dioxide, which is put into the atmosphere due to burning fossil fuels.
I believe it is because of the emission of carbon dioxide because the
more carbon dioxide that got released into the air the higher the
temperatures got, more ice started to melt, and sea levels started to
rise.

The carbon dioxide levels are rising and so are temperatures.
Temperatures have been increasing for the past century and I think that
it is due to the increase of carbon dioxide in the atmosphere.  When
there wasn’t so much carbon dioxide the temperature was at an average
instead of at an all time high.

	Another reason why I think carbon dioxide is the reason for global
warming is because ice and snow cover are disappearing.  The ice and
snow are disappearing due to the increase of temperature and the
increase of temperature is from the increase of carbon dioxide emissions
into the atmosphere.  Since all the ice and snow are melting the polar
bears are going to become extinct because they use the ice to hold them
self up and when they are melted the ice isn’t strong enough to holed
them up so they drown.  Also the land and water reflect less solar
radiation than ice, which exposes to melting ice.  Which makes higher
temperatures and melts more ice.

	The last reason that got me to believe that this theory is true is sea
levels are rising. They are rising because the temperatures are so warm
that they are increasing the temperatures of the oceans. While the
oceans are getting warmer they also expand which is causing the sea
levels to rise.

	The EPA should regulate the emission of greenhouse gases.  They need to
take charge and help prevent letting carbon dioxide into the atmosphere.
 Hopefully the EPA will do something that will lower the amount of
carbon dioxide so global warming will come to an end.