Approval and Promulgation of Implementation Plans, State Plans for Designated Facilities and Pollutants, and Operating Permits Program; State of Missouri, 14632-14633 [2014-05684]
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14632
Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules
significant impact of a rule on small
entities. Because this proposed rule
would not impose any compliance costs
on sponsors of animal drug products
that are currently marketed or in
development, the Agency proposes to
certify that the proposed rule if finalized
would not have a significant economic
impact on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that Agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $141
million, using the most current (2012)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed rule to result in any 1year expenditure that would meet or
exceed this amount.
VI. Federalism
FDA has analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. FDA
has determined that the proposed rule,
if finalized, would not contain policies
that have substantial direct effects on
the States, on the relationship between
the National Government and the States,
or on the distribution of power and
responsibilities among the various
levels of government. Accordingly, the
Agency tentatively concludes that the
proposed rule does not contain policies
that have federalism implications as
defined in the Executive Order and,
consequently, a federalism summary
impact statement is not required.
tkelley on DSK3SPTVN1PROD with PROPOSALS
VII. Paperwork Reduction Act of 1995
This proposed rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520) is not required.
VIII. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
VerDate Mar<15>2010
17:43 Mar 14, 2014
Jkt 232001
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
List of Subjects in 21 CFR Part 514
[FR Doc. 2014–05432 Filed 3–14–14; 8:45 am]
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
Therefore under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 514 be amended as follows:
PART 514—NEW ANIMAL DRUG
APPLICATIONS
1. The authority citation for 21 CFR
part 514 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
356a, 360b, 371, 379e, 381.
2. In § 514.11, revise paragraphs (b),
(d), (e) introductory text, and (e)(2)(ii)
introductory text to read as follows:
■
§ 514.11 Confidentiality of data and
information in a new animal drug
application file.
*
*
*
*
*
(b) The existence of an NADA file will
not be disclosed by the Food and Drug
Administration before the application
has been approved, unless it has been
previously disclosed or acknowledged.
*
*
*
*
*
(d) If the existence of an NADA file
has been publicly disclosed or
acknowledged before the application
has been approved, no data or
information contained in the file is
available for public disclosure, but the
Commissioner may, in his discretion,
disclose a summary of such selected
portions of the safety and effectiveness
data as are appropriate for public
consideration of a specific pending
issue, i.e., at an open session of a Food
and Drug Administration advisory
committee or pursuant to an exchange
of important regulatory information
with a foreign government.
(e) After an application has been
approved, the following data and
information in the NADA file are
immediately available for public
disclosure unless extraordinary
circumstances are shown:
*
*
*
*
*
(2) * * *
(ii) For an NADA approved after July
1, 1975, a summary of such data and
information prepared in one of the
following two alternative ways shall be
publicly released when the application
is approved.
*
*
*
*
*
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BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 52, 62, and 70
[EPA–R07–OAR–2013–0724; FRL 9907–78Region 7]
Approval and Promulgation of
Implementation Plans, State Plans for
Designated Facilities and Pollutants,
and Operating Permits Program; State
of Missouri
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve
revisions to the Missouri State
Implementation Plan (SIP), the 40 CFR
part 62 state plans for designated
facilities and pollutants (111(d)), and
the 40 CFR part 70 operating permits
program, which were received on
August 25, 2011, May 8, 2012, and
February 11, 2013, respectively. The
revisions submitted by the state move
definitions currently in individual rules
into one rule and eliminates the risk of
the same term being defined differently
for different rules. This action provides
more clarity for the regulated public.
These revisions do not have an adverse
affect on air quality. EPA’s proposed
approval of these rule revisions is being
done in accordance with the
requirements of the Clean Air Act
(CAA).
DATES: Comments on this proposed
action must be received in writing by
April 16, 2014.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R07–
OAR–2013–0724, by mail to Paula
Higbee, Environmental Protection
Agency, Air Planning and Development
Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Comments may
also be submitted electronically or
through hand delivery/courier by
following the detailed instructions in
the ADDRESSES section of the direct final
rule located in the rules section of this
Federal Register.
FOR FURTHER INFORMATION CONTACT:
Paula Higbee, Environmental Protection
Agency, Air Planning and Development
Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at 913–551–7028,
or by email at higbee.paula@epa.gov.
SUMMARY:
E:\FR\FM\17MRP1.SGM
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Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules
In the
final rules section of the Federal
Register, EPA is approving the state’s
SIP revision as a direct final rule
without prior proposal because the
Agency views this as a noncontroversial
revision amendment and anticipates no
relevant adverse comments to this
action. A detailed rationale for the
approval is set forth in the direct final
rule. If no relevant adverse comments
are received in response to this action,
no further activity is contemplated in
relation to this action. If EPA receives
relevant adverse comments, the direct
final rule will be withdrawn and all
public comments received will be
addressed in a subsequent final rule
based on this proposed action. EPA will
not institute a second comment period
on this action. Any parties interested in
commenting on this action should do so
at this time. Please note that if EPA
receives adverse comment on part of
this rule and if that part can be severed
from the remainder of the rule, EPA may
adopt as final those parts of the rule that
are not the subject of an adverse
comment. For additional information,
see the direct final rule which is located
in the rules section of this Federal
Register.
SUPPLEMENTARY INFORMATION:
Dated: February 28, 2014.
Karl Brooks,
Regional Administrator, Region 7.
Authority: 42 U.S.C. 4104; 44 CFR 67.4.
Dated: January 31, 2014.
Roy E. Wright,
Deputy Associate Administrator for
Mitigation, Department of Homeland
Security, Federal Emergency Management
Agency.
[FR Doc. 2014–05684 Filed 3–14–14; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2014–05736 Filed 3–14–14; 8:45 am]
BILLING CODE 9110–12–P
Federal Emergency Management
Agency
DEPARTMENT OF HOMELAND
SECURITY
44 CFR Part 67
[Docket ID FEMA–2014–0002; Internal
Agency Docket No. FEMA–B–1152]
Federal Emergency Management
Agency
Proposed Flood Elevation
Determinations for Washington
County, Pennsylvania (All
Jurisdictions)
44 CFR Part 67
The Federal Emergency
Management Agency (FEMA) is
withdrawing its proposed rule
concerning proposed flood elevation
determinations for Washington County,
Pennsylvania (All Jurisdictions).
DATES: The withdrawal is effective on
March 17, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. FEMA–B–
tkelley on DSK3SPTVN1PROD with PROPOSALS
16:33 Mar 14, 2014
Jkt 232001
Authority: 42 U.S.C. 4104; 44 CFR 67.4.
Dated: January 31, 2014.
Roy E. Wright,
Deputy Associate Administrator for
Mitigation, Department of Homeland
Security, Federal Emergency Management
Agency.
[FR Doc. 2014–05738 Filed 3–14–14; 8:45 am]
BILLING CODE 9110–12–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Proposed Flood Elevation
Determinations for Bennington
County, Vermont (All Jurisdictions)
Federal Emergency
Management Agency, DHS.
ACTION: Proposed rule; withdrawal.
SUMMARY:
This withdrawal is effective on
March 17, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. FEMA–B–
1179, to Luis Rodriguez, Chief,
Engineering Management Branch,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–4064,
or (email) Luis.Rodriguez3@
fema.dhs.gov.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov.
SUPPLEMENTARY INFORMATION: On April
6, 2011, FEMA published a proposed
rulemaking at 76 FR 19020–19021,
proposing flood elevation
determinations along one or more
flooding sources in Bennington County,
Vermont. Because FEMA has or will be
issuing a Revised Preliminary Flood
Insurance Rate Map, and if necessary a
Flood Insurance Study report, featuring
updated flood hazard information, the
proposed rulemaking is being
withdrawn. A Notice of Proposed Flood
Hazard Determinations will be
published in the Federal Register and in
the affected community’s local
newspaper.
DATES:
[Docket ID FEMA–2014–0002; Internal
Agency Docket No. FEMA–B–1179]
AGENCY:
VerDate Mar<15>2010
1152, to Luis Rodriguez, Chief,
Engineering Management Branch,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–4064,
or (email) Luis.Rodriguez3@
fema.dhs.gov.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov.
SUPPLEMENTARY INFORMATION: On
November 2, 2010, FEMA published a
proposed rulemaking at 75 FR 67308–
67310, proposing flood elevation
determinations along one or more
flooding sources in Washington County,
Pennsylvania. Because FEMA has or
will be issuing a Revised Preliminary
Flood Insurance Rate Map, and if
necessary a Flood Insurance Study
report, featuring updated flood hazard
information, the proposed rulemaking is
being withdrawn. A Notice of Proposed
Flood Hazard Determinations will be
published in the Federal Register and in
the affected community’s local
newspaper.
14633
44 CFR Part 67
Federal Emergency
Management Agency, DHS.
ACTION: Proposed rule; withdrawal.
AGENCY:
The Federal Emergency
Management Agency (FEMA) is
withdrawing its proposed rule
concerning proposed flood elevation
determinations for Bennington County,
Vermont (All Jurisdictions).
SUMMARY:
PO 00000
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Fmt 4702
Sfmt 4702
[Docket ID FEMA–2014–0002; Internal
Agency Docket No. FEMA–B–1311]
Proposed Flood Hazard
Determinations for Brown County,
Texas, and Incorporated Areas
Federal Emergency
Management Agency, DHS.
ACTION: Proposed notice; withdrawal.
AGENCY:
The Federal Emergency
Management Agency (FEMA) is
SUMMARY:
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Agencies
[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Proposed Rules]
[Pages 14632-14633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05684]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52, 62, and 70
[EPA-R07-OAR-2013-0724; FRL 9907-78-Region 7]
Approval and Promulgation of Implementation Plans, State Plans
for Designated Facilities and Pollutants, and Operating Permits
Program; State of Missouri
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Missouri State Implementation Plan (SIP), the
40 CFR part 62 state plans for designated facilities and pollutants
(111(d)), and the 40 CFR part 70 operating permits program, which were
received on August 25, 2011, May 8, 2012, and February 11, 2013,
respectively. The revisions submitted by the state move definitions
currently in individual rules into one rule and eliminates the risk of
the same term being defined differently for different rules. This
action provides more clarity for the regulated public. These revisions
do not have an adverse affect on air quality. EPA's proposed approval
of these rule revisions is being done in accordance with the
requirements of the Clean Air Act (CAA).
DATES: Comments on this proposed action must be received in writing by
April 16, 2014.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2013-0724, by mail to Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Comments may also be submitted electronically or
through hand delivery/courier by following the detailed instructions in
the ADDRESSES section of the direct final rule located in the rules
section of this Federal Register.
FOR FURTHER INFORMATION CONTACT: Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at 913-551-7028, or by email at
higbee.paula@epa.gov.
[[Page 14633]]
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.
Dated: February 28, 2014.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2014-05684 Filed 3-14-14; 8:45 am]
BILLING CODE 6560-50-P