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 1- 

year 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. 

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 http://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. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

List of Subjects in 21 CFR Part 514 

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. 

* * * * * 

Dated: March 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–05432 Filed 3–14–14; 8:45 am] 

BILLING CODE 4160–01–P 

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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2014–0002; Internal 

Agency Docket No. FEMA–B–1152] 

Proposed Flood Elevation 

Determinations for Washington 

County, Pennsylvania (All 

Jurisdictions) 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: 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– 

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. 

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. 2014–05736 Filed 3–14–14; 8:45 am] 

BILLING CODE 9110–12–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2014–0002; Internal 

Agency Docket No. FEMA–B–1179] 

Proposed Flood Elevation 

Determinations for Bennington 

County, Vermont (All Jurisdictions) 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) is 

withdrawing its proposed rule 

concerning proposed flood elevation 

determinations for Bennington County, 

Vermont (All Jurisdictions). 

DATES: 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. 

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 

44 CFR Part 67 

[Docket ID FEMA–2014–0002; Internal 

Agency Docket No. FEMA–B–1311] 

Proposed Flood Hazard 

Determinations for Brown County, 

Texas, and Incorporated Areas 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Proposed notice; withdrawal. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) is 


tkelley on DSK3SPTVN1PROD with PROPOSALS