[Federal Register: March 23, 2006 (Volume 71, Number 56)]
[Notices]
[Page 14712-14716]
[DOCID:fr23mr06-58]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-2006-0005]
RIN 1660-ZA14

NEPA Alternative Arrangements for Critical Physical
Infrastructure in New Orleans

AGENCY: Federal Emergency Management Agency (FEMA), Department of
Homeland Security.

ACTION: Notice.

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SUMMARY: The Department of Homeland Security (DHS) and the Council on
Environmental Quality (CEQ) have established Alternative Arrangements
to meet the requirements of the National Environmental Policy Act
(NEPA) and the CEQ Regulations for Implementing the Procedural
Requirements of NEPA (CEQ Regulations) for FEMA Grants to Reconstruct
Critical Infrastructure in the New Orleans Metropolitan Area. These
Alternative Arrangements are designed to enable timely action on the
expected large number of grant applications to restore safe and
healthful living conditions in the New Orleans Metropolitan Area
(NOMA). These alternative arrangements will enable FEMA, as a component
of DHS, to consider the potential for significant impacts to the human
environment from its approval to fund the reconstruction of critical
physical infrastructure in NOMA through its grant programs.

DATES: Comments due on or before May 22, 2006.

ADDRESSES: You may submit comments, identified by Docket Number FEMA-
2006-0005, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the

instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>Include Docket Number FEMA-2006-0005 in
the subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail/Hand Delivery/Courier: Rules Docket Clerk, Office of General
Counsel, Federal Emergency Management Agency, Room 406, 500 C Street,
SW., Washington, DC 20472.
    Instructions: All Submissions received must include the agency name
and docket number (if available). Regardless of the method used for
submitting comments or material, all submissions will be posted,
without change, to the Federal eRulemaking Portal at http://www.regulations.gov
, and will include any personal

information you provide. Therefore, submitting this information makes
it public. You may wish to read the Privacy Act notice that is
available on the Privacy and Use Notice link on the Administration
Navigation Bar of http://www.regulations.gov.

    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://www.regulations.gov.
 Submitted comments may also be inspected at FEMA,

Office of General Counsel, 500 C Street, SW., Room 406, Washington, DC
20472.

FOR FURTHER INFORMATION CONTACT: Brent Paul, Environmental Officer,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472, or phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

1. What are NEPA Alternative Arrangements?

    NEPA Alternative Arrangements are a set of procedures, established
in consultation with CEQ, for complying with the requirements of the
National Environmental Policy Act and CEQ regulations when emergency
circumstances require taking actions with significant environmental
impacts and there is not sufficient time to follow the regular
Environmental Impact Statement process. These arrangements are limited
to actions necessary to control the immediate impacts of the emergency.
CEQ and DHS arrived at these alternative arrangements in accordance
with 40 CFR 1506.11 on December 6, 2005.

2. What is the nature of the emergency?

    Damages to the critical physical infrastructure in the New Orleans
Metropolitan Area (NOMA) from the impact of Hurricanes Katrina and Rita
have rendered parts of the city inoperable and uninhabitable. Without
the restoration of this critical infrastructure the city cannot
adequately support a safe and healthy reconstruction and repopulation
process.
    FEMA expects a large number of grant applications which would
overwhelm the available personnel and resources to assess each
application in an Environmental Impact Statement (EIS). Review and
approval of these applications must be accomplished in an expeditious
manner to provide safe and healthy conditions for the reconstruction
and repopulation of NOMA and will be required in a timeframe that does
not allow available staff and resources to complete the EIS process and
to issue the individual Record of Decision (ROD).

3. What authority exists for these Alternative Arrangements?

    These Alternative Arrangements were prepared pursuant to CEQ
regulations at 40 CFR 1506.11 and FEMA regulations at 44 CFR 10.13.

4. What types of critical physical infrastructure actions fall under
these Alternative Arrangements?

    Grant applications for the reconstruction of the following
categories of critical physical infrastructure would be included under
these Alternative Arrangements:
     Hospitals and health care facilities.
     Utilities and Wastewater Treatment Plants.
     Permanent police and fire stations.
     Government and court administration buildings.
     Detention Centers (jailhouses).
     Permanent schools.
    FEMA is developing a description for each category which it will
post on the Web site established per the alternative arrangements
(http://www.fema.gov/ehp/noma). This description will provide criteria

for determining whether a grant for a specific proposed project falls
within an identified critical infrastructure category and is subject to
the alternative arrangements. The description will also describe
mitigation measures that will be available to reduce environmental
impacts including any impacts to properties eligible for listing or
listed on the National Register of Historic Places.

5. Who was consulted during the preparation of these Alternative
Arrangements?

    The Department of Homeland Security and the White House Council on
Environmental Quality were heavily involved in the preparation of these
Alternative Arrangements to ensure that they were necessary to control
the immediate impacts of the emergency. This notice provides the
process for engaging other potentially interested parties.

6. How does FEMA plan to consult and involve affected disaster victims,
communities, and local governments?

    FEMA will continue to provide opportunities for stakeholders to
become involved in the environmental review process through its regular
outreach mechanisms including meetings sponsored by the Long Term
Community Recovery Emergency Support Function and Public Assistance
meetings with applicants and local officials. Other mechanisms provide
special efforts to involve NOMA residents that may have temporarily
relocated outside of NOMA, these mechanisms include the development of
a FEMA Internet page with environmental related information specific to
the proposed actions in NOMA (http://www.fema.gov/ehp/noma), and

linking to other public involvement forums such as State, parish, local
group, and committee hearings, and outreach through various groups like
faith-based organizations.

7. How can affected disaster victims and the general public submit
comments to FEMA on these NEPA Alternative Arrangements?

    The general public and disaster victims can submit comments
regarding this procedure through one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the

instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>Include Docket Number FEMA-2006-0005 in
the subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail/Hand Delivery/Courier: Rules Docket Clerk, Office of General
Counsel, Federal Emergency Management Agency, Room 406, 500 C Street,
SW., Washington, DC 20472.
    The general public should submit comments on the content of the
website and project specific information to<EMAIL_ADDRESS>
8. Why are NEPA Alternative Arrangements needed for the FEMA-funded
reconstruction of critical infrastructure in NOMA?

    The NEPA Alternative Arrangements have been developed for the New
Orleans Metropolitan Area because it was a unique situation where the
sensitivity of the area, the level of devastation, and the density of
reconstruction that will be addressed through FEMA grants warranted the
agency to consider all FEMA funding of projects rather than
environmentally assessing the impacts of each grant application
individually. The combined effects of these numerous actions are highly
uncertain, may involve unknown risks, and are expected to result in
cumulatively significant environmental impacts.
    FEMA believes that actions in this small geographic area by one
applicant could likely result in an extensive land use change which may
be incompatible with existing or planned land use of the surrounding
area. In addition, the wind and flood damage from Hurricane Katrina in
NOMA was concentrated in

largely low-income and minority communities. As a result,
reconstruction of the critical infrastructure in these areas and its
related environmental effects (i.e. land-use changes, air quality
impacts of construction activities, air quality impacts of traffic
patterns, water quality impacts, etc.) may disproportionately impact
these communities.
    NOMA contains numerous historic properties, many of which are
listed or eligible to be listed in the National Register of Historic
Places. These historic properties may be adversely impacted by the
reconstruction activities.
    FEMA also believes that the accumulated effects of FEMA-funded
reconstruction actions together with other local, State, and Federal
planned actions for the New Orleans Metropolitan Area may result in
significant environmental impacts.

9. Will these Alternative Arrangements circumvent the basic concepts of
NEPA?

    The Alternative Arrangements cannot circumvent the National
Environmental Policy Act because they are imbedded in the procedures
established to comply with the Act. The intent of these arrangements is
to implement the basic principles of NEPA as reflected in the CEQ
regulations implementing the NEPA section 102(C) requirement for a
detailed statement to the extent practical in the time available. The
arrangements will provide expedited but effective fulfillment of the
public involvement, consideration of alternatives, impacts analyses,
and informed decision making objectives of NEPA. CEQ provided its
letter concurring with these alternative arrangements on December 6,
2005.

10. Will alternatives to projects be considered under these Alternative
Arrangements?

    Non-federal applicants may include alternatives in their
applications for funding for reconstruction of critical physical
infrastructure in NOMA. These Alternative Arrangements allow for, but
do not require, the submission or analysis of alternatives for
individual projects. However, evaluation of alternatives, such as
mitigation alternatives to meet other legal requirements like
Floodplain Management and Wetlands Protection regulations or Executive
Order 12898 on Environmental Justice, will be considered in the context
of the grant applications. For example, the evaluation of alternatives
may also be used to assist in the identification of treatment measures
for undertakings that may have adverse effects on properties that are
eligible for or listed in the National Register of Historic Places.
    The applicant may provide sector-specific Critical Infrastructure
Facility Plans. This plan will provide the needs identified by the
applicant for a particular sector and the development plan to meet
those needs. These plans may have an evaluation of alternatives for the
re-establishment of the sector's critical infrastructure.

11. What is the end date for these NEPA Alternative Arrangements?

    The NEPA Alternative Arrangements are limited to actions necessary
to control the immediate impacts of the emergency. The need for the
Alternative Arrangements will continue to exist as long as necessary to
process grant applications for the reconstruction of critical
infrastructure in NOMA. While there is no clear end date, grant
applications are expected to arrive as local, regional, State, and
interstate planning efforts conclude. For NOMA, the response time from
the receipt of the grant application, to action on the application, and
implementation or execution dates of approved grant applications is
further limited by public health and safety concerns. It is urgent to
restore the critical infrastructure needed to protect the health and
safety of the public in the New Orleans Metropolitan Area.

12. How are these NEPA Alternative Arrangements reviewed?

    DHS and CEQ will review these Alternative Arrangements on a
quarterly basis to assess their effectiveness and longevity. This
review will include a review of significant comments received during
the previous quarter. The review will be made available to the public
through the Web site prepared for the Alternative Arrangements
(http://www.fema.gov/ehp/noma).

13. How is FEMA ensuring that projects comply with other Federal
environmental and historic preservation laws?

    Projects that are subject to the NEPA Alternative Arrangements must
comply with other environmental and historic preservation laws and
executive orders. Thus, projects subject to the Alternative
Arrangements will still be reviewed to ensure compliance with relevant
environmental and historic preservation laws and executive orders. The
results of this review will be made available to the public through the
web site.
    The Department of Homeland Security and CEQ have established
Alternative Arrangements to meet the requirements of NEPA and the CEQ
Regulations for Implementing the Procedural Requirements of NEPA for
FEMA Grants to Reconstruct Critical Infrastructure in the New Orleans
Metropolitan Area. These Alternative Arrangements are designed to
enable timely action on the expected large number of grant applications
to restore safe and healthful living conditions in the New Orleans
Metropolitan Area. These alternative arrangements will enable FEMA to
consider the potential for significant impacts to the human environment
from its approval to fund the reconstruction of critical physical
infrastructure in NOMA through its grant programs.
    The Alternative Arrangements to Meet National Environmental Policy
Act Requirements for the Reconstruction of New Orleans Metropolitan
Area Critical Infrastructure Funded by Federal Emergency Management
Agency Grant Programs follows: Alternative Arrangements to Meet
National Environmental Policy Act Requirements for the Reconstruction
of New Orleans Metropolitan Area Critical Infrastructure Funded by
Federal Emergency Management Agency Grant Programs

I. Scope of the Emergency

    Hurricanes Katrina and Rita caused sufficient damage in parts of
the State of Louisiana to trigger Presidential disaster declarations
for these areas. Damage was so severe and wide spread that the impact
of Hurricane Katrina was also designated as the first catastrophic
incident of national significance under the National Response Plan.
Disaster-related damages to the critical physical infrastructure in the
New Orleans Metropolitan Area (NOMA) have rendered parts of the city
inoperable and uninhabitable. Without this critical infrastructure the
city cannot adequately support a safe and healthful reconstruction and
repopulation process.
    The Department of Homeland Security's Federal Emergency Management
Agency (FEMA) expects numerous grant applications requiring agency
action in a timeframe \1\ that would not allow for completion of an
Environmental Impact Statement (EIS) and a Record of Decision (ROD).
This constitutes an emergency situation.
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    \1\ This limited timeframe is the time from the receipt of the
grant application to the approval and execution of the proposed
action.
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    The Department of Homeland Security and the Council on
Environmental Quality (CEQ) established these alternative

arrangements to enable timely action on grant applications to restore
safe and healthful living conditions in NOMA while observing the
requirements and objectives of the National Environmental Policy Act
(NEPA). These alternative arrangements will enable FEMA to consider the
potential for significant impacts to the human environment from its
funding the reconstruction of critical physical infrastructure in NOMA
through its grant programs. These alternative arrangements have been
developed in consultation with CEQ pursuant to NEPA regulations found
in 40 CFR 1506.11 and 44 CFR 10.13.

II. Actions Needed to Control the Immediate Impacts of the Emergency

    FEMA currently administers grant programs to fund the repair,
restoration, and replacement of eligible infrastructure that has been
damaged or destroyed in areas that have been included in a Presidential
disaster declaration. Although the restoration of eligible
infrastructure substantially to its pre-disaster conditions is excluded
from NEPA by section 316 of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5159) FEMA anticipates that the
applications from the State of Louisiana for NOMA will more strongly
reflect future demands than returning to pre-disaster conditions.
Proposed projects will not necessarily be the same size, nature, or
location; will use current building codes, and construction methods;
and take advantage of current community and urban planning principles,
and hazard mitigation opportunities. In such situations NEPA does
apply. The following types of critical physical infrastructure \2\
projects in NOMA that may qualify for FEMA grant funding are addressed
by these alternate arrangements:
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    \2\ While levees are considered critical infrastructure, their
restoration is not an eligible FEMA activity because they fall under
the purview of the U.S. Army Corps of Engineers.
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     Hospitals and health care facilities.
     Utilities and Wastewater Treatment Plants.
     Permanent police and fire stations.
     Government and court administration buildings.
     Detention Centers (jailhouses).
     Permanent schools.

III. Potential Significant Effects of the Proposed Action

    Both the Department of Homeland Security and FEMA consider this a
unique situation where the sensitivity of the area and the level of
devastation and the density of reconstruction warrant the agency to
consider the FEMA funded projects together rather than individually.
The combined effects of these numerous actions are highly uncertain and
may involve unknown risks. However, FEMA believes the following factors
that could trigger the need for an EIS may be present:
     Actions will likely result in an extensive change in land
use;
     Actions could result in a land use change which is
incompatible with existing or planned land use of the surrounding area;
     Many people, including low income and minority
communities, will be affected by these actions;
     The environmental impacts of these actions will likely be
controversial;
     Actions could adversely affect a significant amount of
properties listed or eligible to be listed in the National Register of
Historic Places; and
     Actions are likely to be either a part of or closely
related to other actions underway or planned for NOMA and the
cumulative nature of these projects could cause significant
environmental impacts.

IV. Components of the NEPA Process that Add Value and Will Be Used

a. Public Involvement

    FEMA will continue to provide opportunities for stakeholders to
become involved in the environmental review process through regular
outreach mechanisms. An example of these mechanisms is meetings with
the applicant and local officials to explain the Public Assistance
Program requirements, including those environmental and historic
preservation compliance requirements and related environmental, social,
economic, cultural, and historic consequences. Other existing venues
for the involvement of stakeholders will be identified and utilized to
the extent practical. Public input will be used to further develop
appropriate outreach mechanisms best suited to assist in assessing the
potential for impact to the human environment from the reconstruction
of critical physical infrastructure projects required to restore safe
and healthful conditions for the repopulation of NOMA.
    Special effort will be taken to involve the general public and NOMA
residents, including those that have temporarily relocated outside of
NOMA. FEMA will develop an internet page for environmentally related
public notices and environmentally related information specific to the
proposed actions in NOMA. This page would also track other projects in
NOMA in order to provide the public with information on the individual
and the cumulative nature of impacts of the FEMA funded actions.
Efforts would be made to link to other public involvement forums such
as State, parish, local group, and committee hearings and make this
information available via electronic and non-electronic modes of
outreach to assure availability to all those potentially affected.
    For each project type, such as those identified above, FEMA will
develop public involvement strategies that take into consideration the
nature of that project type and the likely stakeholders that would have
an interest in or be affected by those projects. Such strategies will
include addressing national, State and local media, notifying groups
linked to the various types of infrastructure, involving various civic,
ethic, and religious groups, etc. When an action also requires public
involvement to satisfy requirements under other Federal laws,
regulations, or Executive Orders, including the National Historic
Preservation Act and Executive Order 11988, Floodplains, FEMA will work
to integrate those public involvement requirements into the alternate
arrangements public involvement process.

b. Alternatives and Mitigation Measures

    FEMA has developed the list of types of critical infrastructure
projects (section II) that would be addressed by these alternative
arrangements when applications are received from the State of
Louisiana. Grant applications are project specific and provide the
proposed sites or alternative sites. Potential alternatives also
include whether to approve or condition the grant.
    FEMA will establish criteria that will be followed for each type of
critical physical infrastructure reconstruction project to mitigate or
avoid significant environmental impacts whenever possible. Public input
and consultation with the appropriate Federal, tribal, and State
resource agencies will be used to help identify appropriate measures to
minimize the potential for adverse environmental impacts associated
with the reconstruction of each type of critical infrastructure. As
these environmental impact evaluations are completed and mitigation
measures are developed, FEMA will post available and relevant documents
on the internet site and make copies available to interested groups and
members of the public upon request.
    Given the urgency of the reconstruction effort, it is likely that

some environmental impact analyses will need to proceed with incomplete
or unavailable information. When information on the environmental
effects of a type of critical physical infrastructure reconstruction is
limited by incomplete or unavailable information, FEMA will use the
direction in the Council on Environmental Quality regulations at 40 CFR
1502.22.

c. Environmental (including related social, cultural, historic, and
economic) Impacts and Incorporation of Other Environmental/Historic
Preservation Documentation and Processes

    FEMA will post on the internet site prepared for NOMA and use the
public outreach described above to provide the projects and associated
environmental reviews. This will allow the public and environmental
reviewers an opportunity to track all the projects and associated
impacts in a given area in NOMA.
    FEMA will refer to and incorporate other available environmental
and planning documents and data prepared for the NOMA area that provide
useful information. The agency also intends to incorporate and utilize,
to the extent feasible and practical, the environmental documentation
or information prepared or gathered by other agencies before this event
and those that will be prepared during the reconstruction and
rebuilding efforts in NOMA. Examples of documents incorporated by
reference include:
     New Orleans International Airport EIS.
     New Orleans Regional Transit Authority EIS for city's
streetcar system.
     East-West Corridor Environmental Impact Study.
     New Orleans Riverfront Redevelopment Master Plan.
    FEMA will also document and incorporate its ongoing consultation
efforts with other regulatory and environmental agencies including the
State Historic Preservation Offices and the Advisory Council on
Historic Preservation.

V. Duration of the Emergency

    The emergency identified above started at the moment of the
Presidential disaster declaration and will continue until critical
infrastructure in NOMA that is immediately necessary to protect the
health and safety of the public is fully restored. Although the
submission of some project applications may be contingent upon the
occurrence of an independent event (i.e. reconstruction of levees,
development of local plans, etc.), the need for the alternative
arrangements would continue to exist so long as the amount of time
(from the submission of the application to the date agency action on
the application is necessary to allow timely implementation or
execution of the action) is limited. FEMA and DHS will review these
alternative arrangements with the Council on Environmental Quality on a
quarterly basis to assess their effectiveness and longevity.

VI. Documentation

    Documentation of the analysis of the proposed actions on grant
applications and the potential for significant impacts to the human
environment will consist of these alternative arrangements and the
evolving website and available documents incorporated by reference,
with updates as new information becomes available, and the posting of
agency actions (receiving, approving, conditioning, or denying) on
critical infrastructure grant applications as well as notices of other
actions being taking in the NOMA.

    Dated: March 20, 2006.
David Paulison,
Acting Director, Federal Emergency Management Agency, Department of
Homeland Security.
 [FR Doc. E6-4191 Filed 3-22-06; 8:45 am]

BILLING CODE 9110-41-P


[Federal Register Volume 82, Number 146 (Tuesday, August 1, 2017)]
[Notices]
[Page 35774]
[FR Doc No: 2017-16164]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR17-18-000]

Medallion Pipeline Company, LLC; Notice of Petition For
Declaratory Order

    Take notice that on July 21, 2017, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2016), Medallion Pipeline
Company, LLC (Medallion), filed a petition for a declaratory order
seeking approval of the overall tariff and rate structure, and open-
season procedures for Medallion's proposed Wolfcamp Connector expansion
and Howard Lateral expansion to transport crude oil from Midland Basin
in West Texas to Colorado City Hub, as more fully explained in the
petition.
    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
Practice and Procedure (18 CFR 385.211, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible online 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 email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on August 21, 2017.

    Dated: July 26, 2017.
 Kimberly D. Bose,
Secretary.
[FR Doc. 2017-16164 Filed 7-31-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14803-14804]
[FR Doc No: 2013-04998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1167]

Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 19 new animal drug applications (NADAs) and 1 abbreviated new animal
drug application (ANADA) from multiple holders of these applications.
The basis for the withdrawals is that the holders of these applications
have repeatedly failed to file required annual reports for the
applications.

DATES: Withdrawal of approval is effective March 18, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new animal drugs are required to submit annual reports to FDA
concerning each of their approved applications in accordance with Sec.
514.80 (21 CFR 514.80).
    In the Federal Register of December, 17, 2012 (77 FR 74672), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of 19 NADAs and 1 ANADA because the
sponsors had failed to submit the required annual reports for these
applications. The holders of these applications did not respond to the
NOOH. Failure to file a written notice of participation and request for
a hearing as required by Sec.  514.200(b) (21 CFR 514.200(b))
constitutes an election by the applicant not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and a waiver of any contentions concerning the
legal status of the drug products. Therefore, the Director, Center for
Veterinary Medicine, is withdrawing approval of the 20 applications
listed in Table 1 of this document.

        Table 1--NADAs and ANADA for Which Approval Is Withdrawn
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        Application No.          Trade Name  (drug)       Applicant
------------------------------------------------------------------------
NADA 009-252..................  FUMIDIL B            Mid-Continent
                                 (bicyclohexylammon   Agrimarketing,
                                 ium fumagillin).     Inc., 8833 Quivira
                                                      Rd., Overland
                                                      Park, KS 66214.
NADA 034-601..................  SYNCHRO-MATE         G. D. Searle LLC,
                                 (flurogestone        Pharmacia Corp.,
                                 acetate).            4901 Searle Pkwy.,
                                                      Skokie, IL 60077.
NADA 039-284..................  Swisher Super        Swisher Feed
                                 Broiler 300-108      Division, William
                                 (amprolium,          Davies Co., Inc.,
                                 ethopabate,          P.O. Box 578,
                                 bacitracin zinc,     Danville, IL
                                 and roxarsone).      61832.
NADA 040-920..................  Chick Grower-        Honeggers and Co.,
                                 Developer            Inc., 201 W.
                                 Fortified            Locust St.,
                                 (amprolium).         Fairbury, IL
                                                      61739.
NADA 094-223..................  Canine Worm Caps (n- K. C. Pharmacal,
                                 butyl chloride).     Inc., 8345 Melrose
                                                      Dr., Lenexa, KS
                                                      66214.
NADA 098-429..................  Medic-Meal-T Premix  J. C. Feed Mills,
                                 (tylosin             1050 Sheffield,
                                 phosphate).          P.O. Box 224,
                                                      Waterloo, IA
                                                      50704.
NADA 098-639..................  TYLAN Sulfa-G        Bioproducts, Inc.,
                                 (tylosin phosphate   320 Springside
                                 and                  Dr., suite 300,
                                 sulfamethazine).     Fairlawn, OH 44333-
                                                      2435.
NADA 106-507..................  TYLAN 10 (tylosin    Custom Feed
                                 phosphate).          Blenders Corp.,
                                                      540 Hawkeye Ave.,
                                                      Fort Dodge, IA
                                                      50501.
NADA 110-044..................  PRO-TONE Plus Pak    Peavey Co., 730
                                 GF T-1 (tylosin      Second Ave. South,
                                 phosphate).          Minneapolis, MN
                                                      55402.
NADA 117-688..................  Dichlorophene and    Texas Vitamin Co.,
                                 Toluene Capsules.    P.O. Box 18417,
                                                      10695 Aledo St.,
                                                      Dallas, TX 57218.
NADA 120-614..................  TYLAN Sulfa-G        Webel Feeds, Inc.,
                                 (tylosin phosphate   R.R. 3,
                                 and                  Pittsfield, IL
                                 sulfamethazine).     62363.
NADA 120-671..................  Pet-Worm-Caps        K. C. Pharmacal,
                                 (dichlorophene and   Inc., 8345 Melrose
                                 toluene).            Dr., Lenexa, KS
                                                      66214.
NADA 121-147..................  Nutra-Mix TYLAN      Ag-Mark, Inc., P.O.
                                 (tylosin             Box 127, Teachey,
                                 phosphate).          NC 28464.
NADA 122-522..................  TYLAN Sulfa-G        Custom Feed
                                 (tylosin phosphate   Blenders Corp.,
                                 and                  540 Hawkeye Ave.,
                                 sulfamethazine).     Fort Dodge, IA
                                                      50501.
NADA 124-391..................  Nutra-Mix TYLAN-     Ag-Mark, Inc., P.O.
                                 Sulfa Premixes       Box 127, Teachey,
                                 (tylosin phosphate   NC 28464.
                                 and
                                 sulfamethazine).
NADA 127-195..................  TYLAN 10 (tylosin    I.M.S. Inc., 13619
                                 phosphate).          Industrial Rd.,
                                                      Omaha, NE 68137.
NADA 129-415..................  Custom Ban Wormer    Custom Feed
                                 9.6 BANMINTH         Blenders Corp.,
                                 (pyrantel            540 Hawkeye Ave.,
                                 tartrate).           Fort Dodge, IA
                                                      50501.
NADA 130-092..................  ALFAVET              Vetem, S.p.A.,
                                 (alfaprostol).       Viale E. Bezzi 24,
                                                      20146 Milano,
                                                      Italy.
NADA 141-101..................  PREEMPT              Bioscience
                                 (competitive         Division, of Milk
                                 exclusion culture).  Specialties Co.,
                                                      1902 Tennyson
                                                      Lane, Madison, WI
                                                      53704.
ANADA 200-187.................  Isoflurane, USP....  Marsam
                                                      Pharmaceuticals,
                                                      LLC, Bldg. 31, 24
                                                      Olney Ave., Cherry
                                                      Hill, NJ 08034.
------------------------------------------------------------------------

    The Director, Center for Veterinary Medicine, under section
512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(e)(2)(A)), and under authority delegated by the Commissioner,
finds that the holders of the applications listed in this document have
repeatedly failed to submit reports required by Sec.  514.80. In
addition, under Sec.  514.200(b), we find that the holders of the
applications have waived any contentions concerning the legal status of
the drug products. Therefore, under these findings, approval of the
applications listed in this document, and all amendments and
supplements thereto, is hereby withdrawn, effective March 18, 2013.

    In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these applications.

    Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-04998 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: January 31, 2006 (Volume 71, Number 20)]
[Notices]
[Page 5055-5059]
[DOCID:fr31ja06-39]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2005-0458; FRL-7753-5]

Reporting and Recordkeeping Requirements under EPA's Hospitals
for a Healthy Environment (H2E) Program; Request for Comment on Renewal
of Information Collection Activities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.) EPA is seeking public comment on the following
Information Collection Request (ICR): Reporting and Recordkeeping
Requirements under EPA's Hospitals for a Healthy Environment (H2E)
Program (EPA ICR No. 2088.02; OMB Control No. 2070-0166). This ICR
involves a collection activity that is currently approved and scheduled
to expire on July 31, 2006. The information collected under this ICR
relates to recordkeeping and reporting as part of a voluntary program
to help hospitals enhance work place safety, reduce waste and waste
disposal costs, and become better environmental stewards and neighbors.
Before submitting this ICR to the Office of Management and Budget (OMB)
for review and approval under the PRA, EPA is soliciting comments on
specific aspects of the collection.

DATES: Written comments, identified by the docket identification (ID)
number EPA-HQ-OPPT-2005-0458, must be received on or before April 3,
2006.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Chen Wen, Pollution Prevention
Division (7409M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-8901; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
establishment or organization engaged in furnishing medical, surgical,
or other health services to individuals. Potentially affected entities
may include, but are not limited to:
     Offices of physicians (NAICS 6211), e.g., cardiologists'
offices, family physicians' offices, gynecologists' offices,
internists' offices, medical doctors' offices, neurologists' offices,
obstetricians' offices, orthopedic physicians' offices, pediatricians'
(except mental health) offices, surgeons' (except dental) offices, etc.
     Offices of dentists (NAICS 6212), e.g., dental surgeons'
offices, dentists' offices, endodontists' offices, orthodontists'
offices, periodontists' offices, etc.
     Outpatient care centers (NAICS 6214), e.g., birth control
clinics, family planning centers, fertility clinics, pregnancy
counseling centers, reproductive health services centers, etc.
     Medical and diagnostic laboratories (NAICS 6215), e.g.,
blood analysis laboratories, cytology health laboratories, DNA testing
laboratories, forensic laboratories (medical), genetic testing
laboratories, medical laboratories (except radiological, x-ray),
medical pathology laboratories, parasitology health laboratories,
pathology laboratories (medical), testing laboratories (medical),
toxicology health laboratories, etc.
     Home health care services (NAICS 6216), e.g., home health
agencies, home health care agencies, home nursing services (except
private practices), hospice care services (in home), visiting nurse
associations, etc.
     General medical and surgical hospitals (NAICS 6221), e.g.,
children's hospitals (general), general medical and surgical hospitals,
general pediatric hospitals, osteopathic hospitals, etc.
     Psychiatric and substance abuse hospitals (NAICS 6222),
e.g., alcoholism rehabilitation hospitals, children's hospitals,
psychiatric or substance abuse, detoxification hospitals, drug
addiction rehabilitation hospitals, hospitals, substance abuse, mental
(except mental retardation) hospitals, mental health hospitals,
psychiatric hospitals (except convalescent), rehabilitation hospitals,
alcoholism and drug addiction, etc.
     Nursing care facilities (NAICS 6231), e.g., convalescent
homes or convalescent hospitals (except psychiatric), group homes for
the disabled with nursing care, homes for the elderly with nursing
care, hospices (inpatient care), nursing care facilities, nursing
homes, retirement homes with nursing care, skilled nursing facilities,
etc.
     Residential mental retardation, mental health, and
substance abuse facilities (NAICS 6232), e.g., group homes (mental
retardation), intermediate care facilities (mental retardation), mental
retardation homes, mental retardation hospitals, etc.
     Community care facilities for the elderly (NAICS 6233),
e.g., assisted-living facilities with on-site nursing facilities,
continuing care retirement communities, etc.
     Grant-making and giving services (NAICS 8132), e.g.,
charitable trusts, awarding grants, community foundations, corporate
foundations, awarding grants, educational trusts, awarding grants,
grant-making foundations, philanthropic trusts, awarding grants,
scholarship trusts (i.e., grant-making, charitable trust foundations),
trusts, religious, awarding grants, etc.
     Social advocacy organizations (NAICS 8133), e.g.,
associations for retired persons, advocacy, civil liberties
organizations, developmentally disabled advocacy organizations, human
rights advocacy organizations, mentally retarded advocacy groups,
senior citizens advocacy organizations, veterans' rights organizations,
etc.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket ID number EPA-HQ-OPPT-2005-0458. The official
public docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The EPA Docket Center Reading Room telephone
number is<PHONE_NUMBER> and the telephone number for the OPPT Docket,
which is located in EPA Docket Center, is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

    Agency Website: EDOCKET, EPA's electronic public docket and comment
system was replaced on November 25, 2005, by an enhanced federal-wide
electronic docket management and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions.

    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in

the system, select ``search,'' then key in the appropriate docket ID
number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and to Whom Do I Submit the Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.

Once in the system, select ``search,'' and then key in docket ID number
EPA-HQ-OPPT-2005-0458. The system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number EPA-HQ-OPPT-2005-0458. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
EPA-HQ-OPPT-2005-0458. The DCO is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
DCO is<PHONE_NUMBER>.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider when I Prepare My Comments for EPA?

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

F. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate whether the proposed collections of information are
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burdens
of the proposed collections of information.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collections of information on those
who are to respond, including through the use of appropriate automated
or electronic collection technologies or other forms of information
technology, e.g., permitting electronic submission of responses.

II. What Information Collection Activity or ICR Does this Action Apply
to?

    EPA is seeking comments on the following ICR:
    Title: Reporting and Recordkeeping Requirements under EPA's
Hospitals for a Healthy Environment (H2E) Program.
    ICR numbers: EPA ICR No. 2088.02, OMB Control No. 2070-0166.
    ICR status: This ICR is currently scheduled to expire on July 31,
2006. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
    Abstract: The H2E program is a voluntary partnership program
jointly administered by EPA and the American Hospital Association (AHA)
that helps hospitals enhance work place safety, reduce waste and waste
disposal costs, and become better environmental stewards and neighbors.
The program is based on a 1998 Memorandum of Understanding signed by
AHA and EPA to provide health care professionals with the tools and
information necessary to reduce mercury waste, reduce the overall
volume of waste, and identify pollution prevention opportunities.
    The H2E program has two elements, the Partners for Change program
and the Champions for Change program. The Partners for Change program
recognizes health care facilities that pledge support to the H2E
mission and develop goals for reducing waste and mercury in their own
facilities. The Champions for Change program recognizes organizations
that encourage and aid health care facilities to participate as H2E
Partners, provide on-going promotional or technical assistance
information, or make changes that support the goals of the H2E program
in their own institutions. An organization's decision to participate in
the H2E program is completely voluntary.
    This information collection addresses reporting and recordkeeping
activities that support the administration of the H2E program.
    Responses to the collection of information are voluntary.
Respondents may claim all or part of a notice confidential. EPA will
disclose information that is covered by a claim of confidentiality only
to the extent permitted by, and in accordance with, the procedures in
TSCA section 14 and 40 CFR part 2.

III. What are EPA's Burden and Cost Estimates for this ICR?

    Under PRA ``burden'' means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal Agency. For this
collection it includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purposes
of collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized in this notice. The annual public burden for
this collection of information is estimated to range between 0.5 and 20
hours per response, depending upon the type of information the
respondent provides. The following is a summary of the estimates taken
from the ICR:
    Respondents/affected entities: Establishment or organization
engaged in furnishing medical, surgical, or other health services to
individuals.
    Estimated total number of potential respondents: 630.
    Frequency of response: Annually.
    Estimated total/average number of responses for each respondent: 1.
    Estimated total annual burden hours: 5,501.
    Estimated total annual burden costs: $188,723.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 4,609 hours (from 10,110 hours to 5,501
hours) in the total estimated respondent burden compared with that
identified in the information collection most recently approved by OMB.
The changes in the burden estimates are based on actual program
experience from conducting the H2E program over the past three years.
The number of new partner facilities recruited per year has been
revised downward to reflect average recruit numbers. Similarly, the
number of award applicants has also been revised downward to reflect
the number of award applications received per year.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval

process, please contact the technical person listed under FOR FURTHER
INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: January 19, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E6-1206 Filed 1-30-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Rules and Regulations]
[Pages 2090-2092]
[FR Doc No: 2016-00191]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2015-0790; FRL-9941-03-Region 7]

Approval of Missouri's Air Quality Implementation Plans;
Reporting Emission Data, Emission Fees and Process Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: Environmental Protection Agency (EPA) is taking direct final
action to approve revisions to the Operating Permits Program for the
State of Missouri submitted on March 16, 2015. These revisions update
the emissions fee for permitted sources as set by Missouri Statute from
$40 to $48 per ton of air pollution emitted annually, effective January
1, 2016.

DATES: This direct final rule will be effective March 15, 2016, without
further notice, unless EPA receives adverse comment by February 16,
2016. If EPA receives adverse comment, we will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2015-0790, to http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Stephen Krabbe, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is EPA taking?

I. What is being addressed in this document?

    EPA is taking direct final action to approve the Operating Permits
Program revision submitted by the state of Missouri for 10 CSR 10-
6.110, ``Reporting Emission Data, Emission Fees, and Process
Information,'' on March 16, 2015. Section (3)(A) revised the emission
fees section, which is approved under the Operating Permits Program
only, and updates the emissions fee for permitted sources as set by
Missouri Statute from $40 to $48 per ton of air pollution emitted
annually, effective January 1, 2016, as set by Missouri statute.

II. Have the requirements for approval of an operating permits program
been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, the revision meets the substantive SIP requirements of the
Clean Air Act (CAA), including section 110 and implementing
regulations.

III. What action is EPA taking?

    We are publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and anticipate
no adverse comment. However, in the ``Proposed Rules'' section of this
Federal Register, we are publishing a separate document that will serve
as the proposed rule to this Operating Permits Fee revision if adverse
comments are received on this direct final rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so at this time. For further information about
commenting on this rule, see the ADDRESSES section of this document. If
EPA receives adverse comment, we will publish a timely withdrawal in
the Federal Register informing the public that this direct final rule
will not take

effect. We will address all public comments in any subsequent final
rule based on the proposed rule.

Incorporation by Reference

    In this action, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Missouri amendments to 40 CFR part 52 set forth below. EPA has made,
and will continue to make, these documents generally available
electronically through www.regulations.gov and at the appropriate EPA
office (see the ADDRESSES section of this preamble for more
information).

Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The action is not approved to apply on any Indian reservation land
or in any other area where EPA or an Indian tribe has demonstrated that
a tribe has jurisdiction. In those areas of Indian country, the rule
does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 15, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.

    Dated: December 23, 2015.
Mark Hague,
Regional Administrator, Region 7.
    For the reasons stated in the preamble, the EPA amends 40 CFR parts
52 and 70 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. Amend Sec.  52.1320(c) by revising the entry for 10-6.110 to read as
follows:

Sec.  52.1320  Identification of Plan.

* * * * *
    (c) * * *

                                                            EPA-Approved Missouri Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               State effective
        Missouri citation                    Title                  date                   EPA approval date                       Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Missouri Department of Natural Resources
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of Missouri
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-6.110.........................  Reporting Emission Data,           11/20/14  1/15/16 [Insert Federal Register        Section (3)(A), Emissions Fees,
                                    Emission Fees, and                           citation].                              has been updated from $40 to
                                    Process Information.                                                                 $48 per ton of air pollution
                                                                                emitted annually, effective
                                                                                January 1, 2016.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
3. The authority citation for part 70 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
4. Appendix A to part 70 is amended by adding new paragraph (ee) under
Missouri to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

Missouri

* * * * *
    (ee) The Missouri Department of Natural Resources submitted
revisions to Missouri rule 10 CSR 10-6.110, ``Reporting Emission
Data, Emission Fees, and Process Information'' on March 16, 2015.
The state effective date is November 20, 2014. This revision is
effective March 15, 2016.
* * * * *
[FR Doc. 2016-00191 Filed 1-14-16; 8:45 am]
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[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Proposed Rules]
[Page 11563]
[DOCID:fr08mr06-24]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[PA-4091; FRL-8042-4]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; VOC and NOX RACT Determinations for Twenty-Six
Individual Sources; Partial Withdrawal of Proposed Rule for Three
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Partial withdrawal of proposed rule.

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

SUMMARY: On April 18, 2000, EPA published a proposed rule (65 FR 20788)
to approve reasonably available control technology (RACT)
determinations submitted by the Pennsylvania Department of
Environmental Protection (DEP) for twenty-six major sources of nitrogen
oxides (NOX) and/or volatile organic compounds (VOC). In
separate final rules, EPA has already approved the RACT determinations
for ten of the twenty-six sources covered by the April 18, 2000
proposed rule. In the rules portion of today's Federal Register, EPA is
approving the RACT determinations for an additional thirteen of twenty-
six sources covered by the April 18, 2000 proposed rule. EPA is hereby
withdrawing its April 18, 2000 proposed rule with regard to the
remaining three sources. The April 18, 2000 (65 FR 20788) proposed rule
is being withdrawn with regard to Doverspike Brothers Coal Co.,
Hedstrom Corporation, and the thermal coal dryers at EME Homer City,
LP. These three formerly RACT-subject sources have been permanently
shut down and the Pennsylvania DEP has indicated to EPA that no RACT
need be approved for them.

DATES: Effective Date: The proposed rule for Doverspike Brothers Coal
Co., Hedstrom Corporation, and the thermal coal dryers at EME Homer
City published at 65 FR 20788 is withdrawn as of March 8, 2006.

FOR FURTHER INFORMATION CONTACT: Marcia L. Spink,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: See the information provided in the proposed
rule located in the Proposed Rules section of the April 18, 2000
Federal Register (65 FR 20788). EPA is withdrawing the proposed rule
for only three sources, namely, Doverspike Brothers Coal Co., Hedstrom
Corporation and the thermal coal dryers at EME Homer City, LP. These
formerly RACT-subject sources have been permanently shut down and the
Pennsylvania DEP has indicated to EPA that no RACT need be approved for
them. The other actions in the April 18, 2000 Federal Register are not
affected.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: February 28, 2006.
William Early,
Acting Regional Administrator, Region III.
[FR Doc. 06-2149 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-P